A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls
Phase: PHASE3
Conditions: SARS-CoV-2
Sponsor: ModernaTX, Inc.

Confidential 
Page 1 
CLINICAL STUDY PROTOCOL 
Protocol Title: 
A Phase 3b, Open-Label, Safety and Immunogenicity Study of 
SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ 
Transplant Recipients and Healthy Controls 
Protocol Number: 
mRNA-1273-P304 
Sponsor Name: 
ModernaTX, Inc.  
Legal Registered Address: 
200 Technology Square 
Cambridge, MA 02139 
Sponsor 
Contact 
and 
Medical Monitor: 
 
ModernaTX, Inc. 
200 Technology Square 
Cambridge, MA 02139 
Telephone: 
 
e-mail: 
Regulatory 
Agency 
Identifier Number(s): 
IND: 019745 
Amendment Number: 
4 
Date of Amendment 4: 
20 Dec 2021 
Date of Amendment 3: 
23 Aug 2021 
Date of Amendment 2: 
28 Jul 2021 
Date of Amendment 1: 
18 June 2021 
Date of Original Protocol: 
31 Mar 2021 
CONFIDENTIAL 
All financial and nonfinancial support for this study will be provided by ModernaTX, Inc. The 
concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed 
written consent of ModernaTX, Inc. The study will be conducted according to the 
International Council for Harmonisation (ICH) of Technical Requirements for Registration of 
Pharmaceuticals for Human Use, E6(R2) Good Clinical Practice (GCP) Guidance. 
NCT #:  NCT04860297
CCI
CCI
CCI

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 2 
 
PROTOCOL APPROVAL – SPONSOR SIGNATORY 
Study Title: 
A Phase 3b, Open-Label, Safety and Immunogenicity Study of 
SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant 
Recipients and Healthy Controls 
Protocol Number: 
mRNA-1273-P304 
Amendment Number: 
4 
Date of Amendment: 
20 Dec 2021 
 
Protocol accepted and approved by: 
See eSignature and Date in the last page 
Of the document 
 
 
 
ModernaTX, Inc 
200 Technology Square 
Cambridge, MA 02139 
Telephone: 
 
 
Date 
 
 
CCI
CCI

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 3 
DECLARATION OF INVESTIGATOR 
I have read and understood all sections of the protocol entitled “A Phase 3b, Open-Label, Safety 
and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ 
Transplant Recipients and Healthy Controls” and the most recent version of the Investigator’s 
Brochure. 
I agree to supervise all aspects of the protocol and to conduct the clinical investigation in 
accordance with the current protocol, the International Council for Harmonisation (ICH) of 
Technical Requirements for Registration of Pharmaceuticals for Human Use, E6(R2) Good 
Clinical Practice (GCP) Guidance, and all applicable government regulations. I will not make 
changes to the protocol before consulting with ModernaTX, Inc. or implement protocol changes 
without Institutional Review Board (IRB) approval except to eliminate an immediate risk to 
participants. 
I agree to administer study treatment only to participants under my personal supervision or the 
supervision of a sub-investigator. I will not supply study treatment to any person not authorized to 
receive it. I also agree that persons debarred from conducting or working on clinical studies by any 
court or regulatory agency will not be allowed to conduct or work on studies for the Sponsor or a 
partnership in which the Sponsor is involved. I will immediately disclose it in writing to the 
Sponsor if any person who is involved in the study is debarred, or if any proceeding for debarment 
is pending, or, to the best of my knowledge, threatened. 
I will not disclose confidential information contained in this document including participant 
information, to anyone other than the recipient study staffs and members of the IRB. I agree to 
ensure that this information will not be used for any purpose other than the evaluation or conduct 
of the clinical investigation without the prior written consent from ModernaTX, Inc. I will not 
disclose information regarding this clinical investigation or publish results of the investigation 
without authorization from ModernaTX, Inc. 
The signature below provides the necessary assurance that this study will be conducted according 
to all stipulations of the protocol, including statements regarding confidentiality, and according to 
local legal and regulatory requirements, US federal regulations, and ICH E6(R2) GCP guidelines. 
 
Signature of Principal Investigator 
 
 
Date 
 
 
 
 
 
Printed Name of Principal Investigator  
 
 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 4 
PROTOCOL AMENDMENT SUMMARY OF CHANGES 
DOCUMENT HISTORY 
Document 
Date 
Amendment 4 
20 Dec 2021 
Amendment 3 
23 Aug 2021 
Amendment 2 
28 Jul 2021 
Amendment 1 
18 Jun 2021 
Original Protocol 
31 Mar 2021 
Amendment 4, 20 Dec 2021: Current Amendment 
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Main Rationale for the Amendment 
The main rationale for this amendment is to offer currently enrolled participants and eligible 
participants who received the primary coronavirus disease 2019 (COVID-19) vaccination series 
(ie, Pfizer, Moderna, Janssen) outside the study to receive a booster dose. This change is being 
made in accordance with the recent US CDC guidance recommending a COVID-19 booster dose 
in people aged ≥ 18 years who are moderately and severely immunocompromised which 
includes solid organ transplant (SOT) recipients. 
In addition, this amendment will modify the time interval requirement between informed consent 
and date of transplant from 6 months to 90 days to provide an opportunity for sites to enroll 
transplant recipients who are clinically eligible to receive the COVID-19 vaccine outside of the 
study. 
The Summary of Changes table provided below describes the major changes made in 
Amendment 4 relative to Protocol Amendment 3, including the sections modified and the 
corresponding rationales. The synopsis of Amendment 4 has been modified to correspond to 
changes in the body of the protocol. 
Summary of Changes in Protocol Amendment 4: 
Section # and Name 
Description of Change 
Brief Rationale 
Protocol Synopsis 
Changed North America to US 
and non-US sites 
To allow for flexibility 
in the location of the 
sites in the protocol  
Throughout the protocol 
Assigned each study arm with 
a group number 
To increase clarity in 
the protocol 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 5 
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1. Study Rationale, 
Section 1.2.2. Clinical Studies, 
Section 3.2. Scientific Rational for 
Study Design, Section 3.3 
Justification for Dose and Choice 
of Study Population 
Added in data from the 
mRNA-1273-P201 study. 
To provide support of 
the booster dose. 
Section 1.2.2. Clinical Studies 
• Added information about the 
BLA submission completion. 
 
• Added Study mRNA-1273-
P205. 
• To update the protocol 
on the status of the 
submission. 
• To provide support of 
the booster dose. 
Section 1.3.2. Risks to Study 
Participants and Risk Mitigation 
Clarified the timeframe of 
myocarditis and pericarditis 
events (from “shortly” to 
“within 7 days”). 
To provide more 
specific information in 
the protocol. 
Section 2. Objectives and 
Endpoints 
Added objectives for the 
addition of Part B. 
To add a new study part 
(Part B) to continue to 
evaluate the benefit-risk 
profile of a booster dose 
of mRNA-1273. 
Section 1.3.3. Overall Benefit/Risk 
Conclusion, Section 3.1. General 
Design, Section 3.1.1. Study 
Periods, Section 3.1.1.2. Treatment 
Period and Follow-up Period, 
Section 3.2. Scientific Rationale for 
Study Design, Section 3.3. 
Justification for Dose and Choice 
of Study Population, Section 4.2. 
Study Eligibility Criteria (Part B), 
Section 5.2. Randomization and 
Stratification, Section 5.3.2. 
Administration of Study Vaccine, 
Section 7.1. Safety Assessments 
and Procedures, Section 7.1.2. 
Safety Telephone Calls, 
Section 7.1.3. Safety Laboratory 
Assessments. Section 7.4. 
Exploratory Assessments, 
Section 7.6.1. Safety Review 
Committee, Section 8.1. Sample 
Size, Section 8.3.3. 
Part B is being added to Study 
mRNA-1273-P304 
To add a new study part 
(Part B) to continue to 
evaluate the benefit-risk 
profile of a booster dose 
of mRNA-1273. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 6 
Section # and Name 
Description of Change 
Brief Rationale 
Immunogenicity Analyses, 
Section 8.4.1. Interim Analyses, 
APPENDIX 1: Schedule of Events, 
Table 10  
Section 3.1. General Design 
Added a statement that the 
Part B Booster Phase may test 
or replace the prototype100 µg 
booster dose with a variant-
specific mRNA-1273 vaccine. 
To allow for flexibility 
in the protocol in case 
data show a decreased 
immune response. 
Section 3.1.1. Study Periods 
Added dose delay information 
for Part A. 
To provide guidance to 
the investigators if the 
last dose is delayed. 
Section 3.2. Scientific Rational for 
Study Design 
Added Study mRNA-1273-
P205. 
To provide support of 
the booster dose. 
Section 3.3. Justification for Dose 
and Choice of Study Population 
Added Study mRNA-1273-
P205. 
To provide support of 
the booster dose. 
Section 4.1.1.1. Inclusion Criteria 
for Transplant Recipients: Inclusion 
Criterion 1 
Modified the time interval 
requirement between informed 
consent and date of transplant 
from 6 months to 90 days. 
To provide opportunity 
for sites to enroll 
transplant recipients 
who are clinically 
eligible to receive the 
COVID-19 vaccine 
outside of the study. 
Section 4.1.1.1. Inclusion Criteria 
for Transplant Recipients: Inclusion 
Criterion 1 
Modified the time interval to 
be eligible at the time of 
consent after the second dose 
of Moderna COVID-19 
vaccine from 2 months to 1 
month. 
For consistency with 
CDC guidance which 
states, “the additional 
dose of an mRNA 
COVID-19 vaccine 
should be administered 
at least 28 days after 
completion of the initial 
2-dose mRNA COVID-
19 primary vaccine 
series”. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 7 
Section # and Name 
Description of Change 
Brief Rationale 
Section 4.1.1.1. Inclusion Criteria 
for Transplant Recipients: Inclusion 
Criterion 1 
Added a statement that 
participants who received 
2 doses of Moderna COVID-
19 vaccine before transplant 
are not eligible. 
To incorporate 
Clarification Memo 4 
into the protocol. 
Section 4.1.1.1. Inclusion Criteria 
for Transplant Recipients: Inclusion 
Criterion 2 
Modified to specify that 
receipt of chronic 
immunosuppressive therapy 
for the prevention of allograft 
rejection be from 6 months to 
90 days before signing 
consent. 
For consistency with 
Inclusion Criterion 1. 
Section 4.1.1.2. Exclusion Criteria 
for Transplant Recipients: 
Exclusion Criterion 4 
Clarified that the exclusion 
criterion of prior or planned 
administration of a vaccine for 
SARS-CoV-2 is applicable to 
unvaccinated participants. 
To incorporate 
Clarification Memo 3 
into the protocol. 
Section 4.1.1.2. Exclusion Criteria 
for Transplant Recipients: 
Exclusion Criterion 5 
Clarified that the exclusion 
criterion of current 
administration of an 
investigational agent for 
COVID-19 is applicable to 
unvaccinated participants. 
To incorporate 
Clarification Memo 3 
into the protocol. 
Section 4.1.1.2. Exclusion Criteria 
for Transplant Recipients: 
Exclusion Criterion 7 
Modified the time interval 
between informed consent and 
history of biopsy-proven T-cell 
or Ab-mediated rejection from 
6 months to 3 months. 
For consistency with 
Inclusion Criterion 1. 
Section 5.3.5. Study Vaccine 
Storage 
Removed information that 
vials can be refrigerated for 30 
days prior to use. 
To align with the 
pharmacy manual. 
Section 6.1.1. Individual Participant 
Criteria for Delay of Study 
Vaccination 
Added “if possible or at a time 
the participant is clinically 
stable according to the 
judgement of the investigator” 
to the text describing 
rescheduling a visit. 
To incorporate 
Clarification Memo 4 
into the protocol. 
Section 7.1.1 Use of Electronic 
Diaries 
Updated the days for the safety 
telephone calls for previously 
vaccinated SOT recipients who 
receive dose 3. 
To correct an error in 
the protocol. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 8 
Section # and Name 
Description of Change 
Brief Rationale 
Section 7.1.1. Use of Electronic 
Diaries (as well as other sections 
such as SoE that cross-reference 
this change) 
The language was clarified 
concerning the timing of 
eDiary prompts and safety 
calls when the last vaccine 
dose is delayed. If the last dose 
is delayed beyond the standard 
window, clinic visits will be 
adjusted based on if 2 dose or 
3 dose regimens. 
To incorporate 
Clarification Memo 5 
into the protocol. 
Section 7.1.2. Safety Telephone 
Calls 
Added language regarding 
additional safety calls every 
4 weeks should be scheduled 
when there is a gap beyond 
28 days between the last safety 
call and the last study visit for 
Part A. 
To incorporate 
Clarification Memo 5 
into the protocol. 
Section 7.3.1. Surveillance for 
COVID-19 Symptoms 
Added safety phone call 
information for Part B 
participants. 
To accommodate the 
new study part (Part B). 
Section 7.10. Biomarkers 
Added blood collection for 
biomarker analysis. 
To accommodate the 
new study part (Part B). 
Section 10.1. Appendix 1: Schedule 
of Events (Table 7 and Table 8) 
Added a footnote for dose 
delay information. 
To provide guidance to 
the investigators if the 
last dose is delayed. 
Section 10.1. Appendix 1: Schedule 
of Events (Table 7, Table 8, and 
Table 9) 
Removed the specific number 
of days since the most recent 
injection from below the 
eDiary and SC columns. 
To align with other 
Sponsor protocols. 
Abbreviations: AE = adverse event; COVID-19 = coronavirus disease 2019; mRNA = messenger 
RNA; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SC = safety call; SOT = 
solid organ transplant. 
IRB/IEC/Regulatory Authority/Approval 
A copy of this amended protocol will be sent to the Institutional Review Board (IRB)/Independent 
Ethics Committee (IEC)/Regulatory Authority, as relevant. 
The changes described in this amended protocol require IRB/IEC approval prior to 
implementation. In addition, if the changes herein affect the informed consent, sites are required 
to update and submit a revised informed consent for approval that incorporates the changes 
described in this amended protocol. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 9 
PROTOCOL SYNOPSIS 
Name of Sponsor/Company: ModernaTX, Inc. 
Name of Investigational Product: mRNA-1273 for injection 
Name of Active Ingredient: mRNA-1273 
Protocol Title: A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 
mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls 
Protocol Number: mRNA-1273-P304 
Study Period (years): Approximately 1 year (~12 months for participants not receiving a 
booster dose, ~10 months for the single-dose plus booster dose regimen, ~10 months for 2-dose 
regimen plus booster dose regimen, ~13 months for 3-dose regimen plus booster dose, and ~6-
months for booster dose regimen) 
Phase of Development: Phase 3b 
Estimated date first participant enrolled: Apr 2021 
Estimated date last participant completed: May 2023 
Total Number of Sites: ~20 US and non-US sites 
Objectives and Endpoints 
Objectives 
Endpoints 
Part A 
Primary Objectives 
Primary Endpoints 
• 
To evaluate the safety of 100 µg 
mRNA-1273 administered in 
2-dose or 3-dose regimens 
 
• 
Unsolicited adverse events (AEs) through 
28 days after each injection 
• 
Medically attended adverse events (MAAEs) 
from Day 1 and throughout the study period 
• 
Serious adverse events (SAEs) from Day 1 
and throughout the study period 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 10 
• 
Adverse events of special interest (AESIs), 
including myocarditis/pericarditis, from Day 1 
and throughout the study period 
• 
AEs leading to discontinuation from dosing 
and/or study participation (withdrawal) from 
Day 1 and throughout the study period 
• 
Biopsy-proven organ rejection from Day 1 
and throughout the study period 
• 
To evaluate the reactogenicity 
of 100 µg mRNA-1273 
administered in 2-dose or 3-
dose regimen 
• 
Solicited local and systemic adverse reactions 
(ARs) through 7 days after each injection (for 
unvaccinated participants who received 
2 doses of mRNA-1273) 
• 
Solicited local and systemic ARs through 
7 days after each injection (for unvaccinated 
SOT recipients who received 3 doses and SOT 
recipients previously vaccinated outside the 
study who received a third dose) 
• 
To evaluate serum neutralizing 
antibody (nAb) responses to 
doses of 100 µg mRNA-1273 
obtained 28 days after the 
second dose or third dose 
• 
The geometric mean titer (GMT) value of 
serum Severe Acute Respiratory Syndrome 
coronavirus 2 (SARS-CoV-2)-specific nAb 
level after the second dose (Day 57 for 
unvaccinated participants) 
• 
The GMT value of SARS-CoV-2-specific nAb 
level 28 days after dose 3 (Day 113 for 
unvaccinated SOT recipients and Day 29 for 
previously vaccinated SOT recipients) 
Secondary Objectives 
Secondary Endpoints 
• To evaluate the persistence of 
the immune response to 2 or 
3 doses of 100 µg mRNA-1273, 
as assessed by the level of 
anti-SARS-CoV-2 Spike (S) 
specific binding antibody (bAb) 
through 1 year after dose 2 or 
dose 3 
• 
For all unvaccinated participants, the 
geometric mean (GM) value of anti-SARS-
CoV-2 S-specific bAb on Day 1, Day 29 
(28 days after dose 1), and Day 57 (28 days 
after dose 2) 
o For participants receiving the 2-dose 
regimen, GM will be evaluated on Day 
209 (6 months after dose 2), and Day 394 
(1 year after dose 2) 
o For participants receiving the 3-dose 
regimen, GM will be evaluated on Day 85 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 11 
(dose 3), Day 113 (28 days after dose 3), 
Day 265 (6 months after dose 3), and Day 
450 (1 year after dose 3) 
• 
For all previously vaccinated SOT recipients, 
GM will be evaluated on Day 1 (dose 3), 
Day 29 (28 days after dose 3), Day 180 
(6 months after dose 3), and Day 365 (1 year 
after dose 3) 
• 
For all unvaccinated participants, the 
geometric mean fold rise (GMFR) of bAb 
relative to Day 1 on Day 29 (28 days after 
dose 1), and Day 57 (28 days after dose 2) 
o For participants receiving the 2-dose 
regimen, GMFR will evaluated on Day 
209 (6 months after dose 2), and Day 394 
(1 year after dose 2) 
o For participants in the 3-dose regimen, 
GMFR will be evaluated on Day 85 (dose 
3), Day 113 (28 days after dose 3), Day 
265 (6 months after dose 3), and Day 450 
(1 year after dose 3) 
• 
For all previously vaccinated SOT recipients, 
GMFR of bAb relative to Day 1 (dose 3) will 
be evaluated on Day 29 (28 days after dose 3), 
Day 180 (6 months after dose 3), and Day 365 
(1 year after dose 3) 
• To evaluate the persistence of 
the immune response to 2 or 
3 doses of 100 µg mRNA-1273, 
as assessed by the level of nAb 
through 1 year after dose 2 or 
dose 3 
• 
For all unvaccinated participants, the GMT 
values of SARS-CoV-2-specific nAb on 
Day 1 and Day 29 (28 days after dose 1) 
o For participants in the 2-dose regimen, 
GMT will be evaluated on Day 209 (6 
months after dose 2) and Day 394 (1 year 
after dose 2) 
o For participants in the 3-dose regimen, 
GMT will be evaluated on Day 85 
(dose 3), Day 113 (28 days after dose 3), 
Day 265 (6 months after dose 3), and 
Day 450 (1 year after dose 3) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 12 
• 
For all previously vaccinated SOT recipients, 
GMT values of SARS-CoV-2-specific nAb 
will be evaluated on Day 1 (dose 3), Day 29 
(28 days after dose 3), Day 180 (6 months 
after dose 3), and Day 365 (1 year after 
dose 3) 
• 
For all unvaccinated participants, GMFR of 
nAb relative to Day 1 will be evaluated on 
Day 29 (28 days after dose 1) and Day 57 
(28 days after dose 2) 
o For participants receiving the 2-dose 
regimen, GMFR will be evaluated on Day 
209 (6 months after dose 2) and Day 394 
(1 year after dose 2) 
o For participants in the 3-dose regimen, 
GMFR will be evaluated on Day 85 (dose 
3), Day 113 (28 days after dose 3), Day 
265 (6 months after dose 3), and Day 450 
(1 year after dose 3) 
• 
For all previously vaccinated SOT recipients, 
GMFR of nAb relative to Day 1 (dose 3) will 
be evaluated on Day 29 (28 days after dose 3), 
Day 180 (6 months after dose 3), and Day 365 
(1 year after dose 3) 
• To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult solid organ 
transplant (SOT) recipients and 
healthy adult participants with 
negative SARS-CoV-2 at 
baseline 
• 
The incidence of asymptomatic SARS-CoV-2 
infection among recipients of mRNA-1273 
SARS-CoV-2 vaccine will be defined in 
participants with negative SARS-CoV-2 at 
baseline as bAb levels against SARS-CoV-2 
nucleocapsid protein negative (as measured by 
Roche Elecsys) at Day 1, that becomes 
positive (as measured by Roche Elecsys) 
counted starting 28 days after the second dose 
and 28 days after the third dose of vaccine, 
OR 
• 
Positive reverse transcriptase polymerase 
chain reaction (RT-PCR) counted starting 
14 days after the second and after the third 
dose of vaccine 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 13 
• To describe the incidence of 
coronavirus disease 2019 
(COVID-19) after vaccination 
with mRNA-1273 in SOT 
recipients and healthy 
participants 
• 
First occurrence of COVID-19 starting 
14 days after the second dose and after the 
third dose of vaccine, where COVID-19 is 
defined as symptomatic disease based on the 
following criteria 
• 
The participant must have experienced at least 
TWO of the following symptoms: fever 
(≥ 38°C/≥ 100.4°F), chills, myalgia, headache, 
sore throat, or new olfactory and taste 
disorder(s), OR 
• 
The participant must have experienced at least 
ONE of the following respiratory 
signs/symptoms: cough, shortness of breath or 
difficulty breathing, OR clinical or 
radiographical evidence of pneumonia, AND 
• 
The participant must have at least 
1 nasopharyngeal (NP) swab, nasal swab, or 
saliva sample (or respiratory sample, if 
hospitalized) positive for SARS-CoV-2 by 
RT-PCR 
• 
First occurrence of severe COVID-19 starting 
14 days after the second dose and after the 
third dose of vaccine, where severe 
COVID-19 is defined as symptomatic 
COVID-19 AND any of the following: 
o Clinical signs indicative of severe systemic 
illness, respiratory rate ≥ 30 per minute, 
heart rate ≥ 125 beats per minute, oxygen 
saturation (SpO2) ≤ 93% on room air at 
sea level, or partial pressure of oxygen 
(PaO2)/fraction of inspired oxygen (FIO2) 
< 300 mm Hg, OR 
o Respiratory failure or acute respiratory 
distress syndrome (ARDS, defined as 
needing high-flow oxygen, noninvasive or 
mechanical ventilation, or extracorporeal 
membrane oxygenation) or evidence of 
shock (systolic blood pressure [BP] 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 14 
< 90 mm Hg, diastolic BP < 60 mm Hg, or 
requiring vasopressors), OR 
o Significant acute renal, hepatic, or 
neurologic dysfunction, OR 
o Admission to an intensive care unit or 
death 
o The secondary case definition of 
COVID-19 is defined as the following 
symptoms: fever (temperature ≥ 38ºC) or 
chills, cough, shortness of breath or 
difficulty breathing, fatigue, muscle aches 
or body aches, headache, new loss of taste 
or smell, sore throat, nasal congestion or 
rhinorrhea, nausea or vomiting or diarrhea 
AND a positive NP swab, nasal swab, or 
saliva sample (or respiratory sample, if 
hospitalized) for SARS-CoV-2 by 
RT-PCR 
• 
To describe changes in liver and 
renal function through 
laboratory tests over time in 
SOT recipients after vaccination 
with mRNA-1273 vaccine 
• 
Safety laboratory assessments of kidney 
(serum creatinine, urine protein, and urine 
protein to creatinine ratio [UPCR]) and liver 
(alanine aminotransferase [ALT], aspartate 
aminotransferase [AST], alkaline phosphatase 
[ALP], and bilirubin) function: 
o For unvaccinated SOT recipients, from 
Day 1 through Day 57 for SOT recipients 
who receive 2 doses and through Day 113 
for SOT recipients who receive 3 doses of 
mRNA-1273 
o For previously vaccinated SOT recipients, 
from Day 1 (dose 3) through Day 29 
(28 days after dose 3) 
• To describe changes in 
immunosuppressant medications 
in SOT recipients after 
vaccination with mRNA-1273 
vaccine 
• 
Change in immunosuppressant medications to 
treat organ transplant rejection or to improve 
immune tolerance from Day 1 and throughout 
the study period. Change in 
immunosuppressant medication is defined as 
any of the following: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 15 
o any adjustments (temporarily or 
permanently) in immunosuppressants, 
o addition of new immunosuppressants, 
o or switching from 1 maintenance rejection 
prophylaxis regimen to another. 
Exploratory Objectives 
Exploratory Endpoints 
• 
To evaluate the genetic and/or 
phenotypic relationships of 
isolated SARS-CoV-2 strains to 
the vaccine sequence 
• 
Comparison of genetic sequence of viral 
isolates with that of the vaccine sequence 
• 
To characterize the clinical 
profile and immune responses 
of participants with COVID-19 
or with SARS-CoV-2 infection 
• 
Description of clinical severity and immune 
responses of participants who are identified as 
infected by SARS-CoV-2 or having 
COVID-19 
• 
To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult SOT 
recipients and healthy adult 
participants with serologic 
evidence of infection at baseline 
• 
GM and GMFR of bAb levels against 
SARS-CoV-2 nucleocapsid protein 
(quantitative immunoglobulin G [IgG]) and 
percent of study participants with 2×, 3×, and 
4× rise of bAb relative to baseline 
• 
To assess, in a subset of SOT 
recipients who received 3-dose 
regimen and healthy 
participants who received 
2-dose regimen, SARS-CoV-2 
S protein-specific T-cell 
responses 
• 
Magnitude, phenotype, and percentage of 
cytokine producing S protein-specific T-cells 
as measured by flow cytometry at Day 1, 
Day 36, and Day 92 for unvaccinated 
participants, at Day 1 and Day 8 for 
previously vaccinated SOT recipients, and at 
Day 1 and Day 36 in healthy participants 
• 
To define, in a subset of SOT 
recipients who received 3-dose 
regimen and healthy 
participants, the epitopes 
recognized by B-cells and 
antibodies generated in 
response to mRNA-1273 
• 
Magnitude and phenotype of S protein-specific 
B-cells as measured by flow cytometry at 
Day 1, Day 36, and Day 92 for unvaccinated 
SOT recipients, at Day 1 and Day 8 for 
previously vaccinated SOT recipients, and at 
Day 1 and Day 36 in healthy participants 
• 
Determination of targeted major antigenic sites 
and amino acid residues on SARS-CoV-2 
S protein 
Part B – Booster Phase 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 16 
Primary Objectives 
Primary Endpoints 
• 
To evaluate the safety of the 
100 µg BD of mRNA-1273 
• 
Solicited local and systemic ARs through 
7 days after BD injection 
• 
Unsolicited AEs through 28 days after BD 
injection 
• 
MAAEs throughout the study period 
• 
SAEs throughout the study period 
• 
AESIs, 
including 
myocarditis/pericarditis 
throughout the study period 
• 
AEs leading to discontinuation from dosing 
and/or 
study 
participation 
(withdrawal) 
throughout the study period 
• 
Biopsy-proven organ rejection throughout the 
study period 
• 
To evaluate serum nAb 
responses elicited by the 100 µg 
mRNA-1273 obtained 28 days 
after the BD 
• 
The GMT value of serum SARS-CoV-2-
specific nAb level 28 days after the BD in 
SOT participants who received the Moderna 
primary series 
• 
The GMT value of SARS-CoV-2-specific nAb 
level 28 days after BD in SOT participants 
who received non-Moderna primary series  
Exploratory Objectives 
Exploratory Endpoints 
• 
To evaluate the persistence of 
the immune response of the BD 
of mRNA 1273 vaccine 
(100 µg) as assessed by the 
level of SARS-CoV-2 S2P 
specific bAb through 6 months 
after BD 
• 
The GM value of SARS-CoV-2 S2P specific 
bAb on BD-Day 1, BD-Day 29 (28 days after 
BD), BD-Day 181 (6 months after BD) 
• 
To evaluate the persistence of 
the immune response of the BD 
of mRNA-1273 vaccine 
(100 µg) as assessed by the 
level of nAb through 6 months 
after BD 
• 
The GM values of SARS-CoV-2-specific nAb 
on BD-Day 1, BD-Day 29 (28 days after BD), 
BD-Day 181 (6 months after BD) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 17 
• 
To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult solid SOT 
recipients and healthy adult 
participants with negative 
SARS-CoV-2 at baseline 
• 
The incidence of asymptomatic SARS-CoV-2 
infection among recipients of mRNA-1273 
SARS-CoV-2 vaccine will be defined in 
participants with negative SARS-CoV-2 at 
baseline as: 
o bAb levels against SARS-CoV-2 
nucleocapsid protein negative (as 
measured by Roche Elecsys) at Day 1, that 
becomes positive (as measured by Roche 
Elecsys) counted starting 28 days after the 
BD, OR 
o Positive RT-PCR counted starting 14 days 
after the BD 
• 
To describe the incidence of 
COVID-19 after vaccination 
with mRNA-1273 in SOT 
recipients and healthy 
participants 
• 
First occurrence of COVID-19 starting 
14 days after BD of vaccine, where COVID-
19 is defined as symptomatic disease based on 
the following criteria 
• 
The participant must have experienced at least 
TWO of the following symptoms: fever 
(≥ 38°C/≥ 100.4°F), chills, myalgia, headache, 
sore throat, or new olfactory and taste 
disorder(s), OR 
• 
The participant must have experienced at least 
ONE of the following respiratory 
signs/symptoms: cough, shortness of breath or 
difficulty breathing, OR clinical or 
radiographical evidence of pneumonia, AND 
• 
The participant must have at least 
1 nasopharyngeal (NP) swab, nasal swab, or 
saliva sample (or respiratory sample, if 
hospitalized) positive for SARS-CoV-2 by 
RT-PCR 
• 
First occurrence of severe COVID-19 starting 
14 days after the BD of vaccine, where severe 
COVID-19 is defined as symptomatic 
COVID-19 AND any of the following: 
o Clinical signs indicative of severe systemic 
illness, respiratory rate ≥ 30 per minute, 
heart rate ≥ 125 beats per minute, oxygen 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 18 
saturation (SpO2) ≤ 93% on room air at 
sea level, or partial pressure of oxygen 
(PaO2)/fraction of inspired oxygen (FIO2) 
< 300 mm Hg, OR 
o Respiratory failure or acute respiratory 
distress syndrome (ARDS, defined as 
needing high-flow oxygen, noninvasive or 
mechanical ventilation, or extracorporeal 
membrane oxygenation) or evidence of 
shock (systolic blood pressure [BP] 
< 90 mm Hg, diastolic BP < 60 mm Hg, or 
requiring vasopressors), OR 
o Significant acute renal, hepatic, or 
neurologic dysfunction, OR 
o Admission to an intensive care unit or 
death. 
• 
The secondary case definition of COVID-19 is 
defined as the following symptoms: fever 
(temperature ≥ 38ºC) or chills, cough, 
shortness of breath or difficulty breathing, 
fatigue, muscle aches or body aches, 
headache, new loss of taste or smell, sore 
throat, nasal congestion or rhinorrhea, nausea 
or vomiting or diarrhea AND a positive NP 
swab, nasal swab, or saliva sample (or 
respiratory sample, if hospitalized) for 
SARS-CoV-2 by RT-PCR 
• 
To describe changes in liver and 
renal function through 
laboratory tests over time in 
SOT recipients after vaccination 
with mRNA-1273 vaccine 
• 
Safety laboratory assessments of kidney 
(serum creatinine, urine protein, and UPCR) 
and liver (ALT, AST, ALP, and bilirubin) 
function from BD-D1 through BD-D29 
(28 days after BD) 
• 
To describe changes in 
immunosuppressant 
medications in SOT recipients 
after vaccination with 
mRNA-1273 vaccine 
• 
Change in immunosuppressant medications to 
treat organ transplant rejection or to improve 
immune tolerance from BD-D1 and 
throughout the study period. Change in 
immunosuppressant medication is defined as 
any of the following: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 19 
o any adjustments (temporarily or 
permanently) in immunosuppressants, 
o addition of new immunosuppressants, 
o or switching from 1 maintenance rejection 
prophylaxis regimen to another 
• 
To evaluate the genetic and/or 
phenotypic relationships of 
isolated SARS-CoV-2 strains to 
the vaccine sequence 
• 
Comparison of genetic sequence of viral 
isolates with that of the vaccine sequence 
• 
To characterize the clinical 
profile and immune responses 
of participants with COVID-19 
or with SARS-CoV-2 infection 
• 
Description of clinical severity and immune 
responses of participants who are identified as 
infected by SARS-CoV-2 or having 
COVID-19 
• 
To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult SOT 
recipients and healthy adult 
participants with serologic 
evidence of infection at baseline 
• 
GM and GMFR of bAb levels against SARS-
CoV-2 nucleocapsid protein (quantitative IgG) 
and percent of study participants with 2×, 3×, 
and 4× rise of bAb relative to baseline 
• 
To assess, in a subset of SOT 
recipients and healthy 
participants who received BD, 
SARS-CoV-2 S protein-specific 
T-cell responses 
• 
Magnitude, phenotype, and percentage of 
cytokine producing S protein-specific T-cells 
BD-D1 and BD-D8  
• 
To define, in a subset of SOT 
recipients and healthy 
participants, the epitopes 
recognized by B-cells and 
antibodies generated in 
response to mRNA-1273 
• 
Magnitude and phenotype of S protein-specific 
B-cells as measured by flow cytometry at BD-
D1 and BD-D8 
• 
Determination of targeted major antigenic sites 
and amino acid residues on SARS-CoV-2 
S protein 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 20 
Abbreviations: AE = adverse event; AESI = Adverse Event of Special Interest; 
ALP = alkaline phosphatase; ALT = alanine aminotransferase; AR = adverse reaction; 
ARDS = acute respiratory distress syndrome; AST = aspartate aminotransferase; 
bAb = binding antibody; BD = booster dose; BP = blood pressure; COVID-19 
= coronavirus disease 2019; D = day; FIO2 = fraction of inspired oxygen; GM = 
geometric mean; GMFR = geometric mean fold rise; GMT = geometric mean titer; 
IgG = immunoglobulin G; MAAE = medically attended adverse event; nAb = neutralizing 
antibody; NP = Nasopharyngeal; PaO2 = partial pressure of oxygen; RT-PCR = reverse 
transcriptase polymerase chain reaction; S = spike; S2P = SARS-CoV-2 spike protein 
modified with 2 proline substitutions to stabilize the spike protein in a prefusion 
conformation; SAE = severe adverse event; SARS-CoV-2 = Severe Acute Respiratory 
Syndrome coronavirus 2; SOT = solid organ transplant; SpO2 = oxygen saturation; 
UPCR = urine protein to creatinine ratio. 
Overall Study Design: 
This is a Phase 3b, open-label study to evaluate the safety, reactogenicity, and immunogenicity 
of mRNA-1273 SARS-CoV-2 vaccine in SOT recipients and healthy controls. Adult kidney and 
liver transplant recipients and healthy control participants who are at least 18 years of age will 
be enrolled. 
Approximately 240 adult participants (220 previously vaccinated or unvaccinated who have had 
a kidney or liver transplant and 20 unvaccinated healthy adults) will be enrolled. At least 50 
SOT recipients who completed primary vaccination series with a non-Moderna COVID-19 
vaccine under Emergency Use Authorization (EUA) (outside of the mRNA-1273-P304 study) 
will be enrolled in Part B. 
In Part A, all SOT recipients who were unvaccinated prior to enrollment will receive 2 doses of 
100 µg of mRNA-1273 28 days apart (window of -3/+7 days for the second dose) (Group A1). 
The SOT recipients will be offered the opportunity to receive a third primary dose of mRNA-
1273 at Day 85 (window of -3/+7 days for the third dose) as per the EUA Fact Sheet available 
at the time of protocol finalization (Group A2). All healthy participants will receive 2 doses of 
100 µg of mRNA-1273 28 days apart (window of -3/+7 days for the second dose) (Group A5). 
The SOT recipients who were previously vaccinated with 2 doses of Moderna COVID-19 
vaccine under the EUA prior to enrollment will receive dose 3 on Day 1 (Group A3). These 
participants will be referred to as “previously vaccinated” throughout this document. Under 
Amendment #4, unvaccinated SOT participants who will be enrolled will be given 3 100 µg 
doses in Part A then proceed to Part B to receive a 100 µg booster dose. Under Amendment #4, 
SOT participants previously vaccinated with 2 doses of Moderna COVID-19 vaccine outside of 
the study who will be enrolled will receive a third 100 µg dose in Part A then proceed to Part B 
to receive a 100 µg BD. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 21 
In Part B, all participants in Part A will be offered a 100 µg BD of mRNA-1273 at least 4 months 
from the last dose. SOT recipients who completed primary COVID-19 vaccination series under 
EUA will receive a 100 µg BD on BD-D1 (Group B4).  
 
Study Arm 
Part A 
Doses 
in 
P304 
Part 
A 
Part 
A 
Dose 
Move 
on to 
Part 
B? 
Part B 
Doses 
in 
P304 
Part B 
Part B 
B-Dose 
Total 
Doses in 
P304 
SOT Recipient Cohorts  
Unvaccinated 
participants who 
consent to receive 
only 2 doses in Part A  
(Days 1 and 29) 
Group 
A1 
2 
100 
µg 
 
NA 
N/A 
N/A 
2 
Unvaccinated 
participants who 
consent to receive 
3 doses in Part A  
(Days 1, 29, and 85) 
Group 
A2 
3 
100 
µg 
 
Group 
B2 
1 
100 µg 
4 
Participants 
previously vaccinated 
with 2 doses of the 
Moderna COVID-19 
vaccine under the 
EUA who consent to 
receive a third dose in 
Part A (Day 1) 
Group 
A3 
1 
100 
µg 
 
Group 
B3 
1 
100 µg 
2 
SOT recipients who 
completed primary 
vaccination with an 
mRNA or non-mRNA 
COVID-19 vaccine 
outside mRNA-1273-
P304 who consent to 
receive 1 booster dose 
(in Part B) 
N/A 
N/A 
N/A 
 
Group 
B4 
1 
100 µg 
1 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 22 
Healthy Adult Cohort 
Healthy adults who 
consent to receive 
2 doses in Part A 
(Days 1 and 29) 
Group 
A5 
2 
100 
µg 
 
Group 
B5 
1 
100 µg 
3 
Abbreviations: B-Dose = booster dose; EUA = Emergency Use Authorization; SOT = solid organ transplant 
 
For Part A, the primary immunogenicity goal of the study is to evaluate serum antibody (Ab) 
responses obtained 28 days after the third dose (Day 113 for unvaccinated SOT participants who 
receive the 3-dose regimen and Day 29 for previously vaccinated SOT participants ) of mRNA-
1273 in SOT recipients. Using the Ab threshold established from Study P301 (if available at the 
time of database lock), an additional exploratory analysis will be performed by measuring the 
proportion of participants with a serum Ab level at Day 57 for unvaccinated participants of 2-
dose regimen), Day 113 (unvaccinated SOT recipients of the 3-dose regimen), and Day 29 
(previously vaccinated SOT recipients who receive dose 3) greater than or equal to the Ab 
threshold of protection against COVID-19, with a 2 sided 95% CI using the Clopper Pearson 
method by cohort arm. 
This study will monitor participants for a total of up to 12 months (12 months after the last dose 
of the vaccine for participants not receiving a BD or 6 months after their BD). The SOT 
participants who do not consent to receive a third dose of mRNA-1273 and healthy adult 
participants will be monitored for a total of 12 months after their second dose. Safety 
assessments will include solicited local and systemic adverse reactions (ARs) for 7 days after 
each dose; unsolicited AEs for 28 days after each dose; MAAEs; SAEs; AESIs; AEs leading to 
discontinuation from dosing and/or study participation (withdrawal) from dose 1 through the 
end of study; concomitant medications associated with AEs, MAAEs, or COVID-19 or 
SARS-CoV-2 infection; participant experience of COVID-19 symptoms; biopsy-proven organ 
rejection; safety laboratory assessments; vital sign measurements; and physical examination 
findings as presented in the applicable schedule of events (SoE). 
From all unvaccinated SOT participants who receive 3 doses of mRNA-1273 (Group A2), blood 
samples will be collected at baseline (Day 1), Day 29 (28 days after dose 1), Day 57 (28 days 
after dose 2), Day 85 (dose 3), Day 113 (28 days after dose 3), Day 265 (6 months after dose 3), 
and Day 450 (12 months after dose 3). 
From unvaccinated participants who receive 2 doses of mRNA-1273 (healthy adults [Group A5] 
and SOT recipients who decline to receive a third dose [Group A1]), blood samples will be 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 23 
collected at baseline (Day 1), Day 29 (28 days after dose 1), Day 57 (28 days after dose 2), Day 
209 (6 months after dose 2), and Day 394 (12 months after dose 2). 
From previously vaccinated SOT participants who receive dose 3 of mRNA-1273 (Group A3), 
blood samples will be collected at pre-dose 3 (Day 1), Day 29 (28 days after dose 3), Day 180 
(6 months after dose 3), and Day 365 (12 months after dose 3) for assessment of the following 
endpoints and analytes: 
• Measurement of SARS-CoV-2-specific bAb and nAb responses 
• Development of Ab directed against nonvaccine antigen (nucleocapsid protein), 
which will signify infection with SARS-CoV-2. Participants who tested positive for 
Ab against SARS-CoV-2 nucleocapsid protein at baseline can continue in the 
study. 
From unvaccinated participants, blood samples for cell-mediated immunity (CMI) studies will 
also be collected at Day 1, Day 36, and Day 92 (SOT recipients receiving 3 doses [Group A2]) 
from a subset of up to 50 SOT participants, as well as, from 20 healthy controls (Group A5) 
(Day 1 and Day 36), and from a subset of at least 50 previously vaccinated SOT recipients 
(Group  A3) at Day 1 and Day 8 for exploratory assessments to characterize T- and B-cell 
responses to vaccine. 
The NP swab samples obtained at illness visits will be used as sources of SARS-CoV-2 for 
genetic sequencing. 
SARS-CoV-2 bAb against the nonvaccine antigen (nucleocapsid protein) will also be collected 
at Illness and Convalescent visits. 
The number of cases of COVID-19 will be assessed throughout the study. Once a participant is 
identified as a case of COVID-19, a convalescent visit will be scheduled approximately 28 days 
after the confirmed diagnosis for a clinical evaluation and immunologic assessment of 
SARS-CoV-2 infection. 
For unvaccinated SOT recipients (Group A1 and Group A2), laboratory assessments for safety 
related to kidney function for kidney SOT recipients (serum creatinine, urine protein, and 
UPCR) and liver function for liver SOT recipients (ALT, AST, ALP, and bilirubin) will be 
monitored on Day 1, Day 8, Day 29, Day 36, and Day 57 for SOT recipients who receive 2 doses 
only (Group A1) and on additional Day 85, Day 92, and Day 113 for SOT recipients who receive 
3 doses (Group A2). 
For previously vaccinated SOT recipients (Group A3), laboratory assessments for safety will be 
monitored on Day 1 (dose 3), Day 8, and Day 29. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 24 
After Day 57 (for unvaccinated SOT participants who receive 2 doses [Group A1]) or after 
Day 113 (for unvaccinated SOT participants who receive 3 doses [Group A2]) or after Day 29 
(for previously vaccinated SOT recipients who receive a 1 dose (dose 3) of mRNA-1273 
[Group A3]), the investigator will review standard-of-care laboratory assessments related to 
kidney and liver function, and report any laboratory-related AEs and suspected or confirmed 
events of organ transplant rejection until the end of study. 
Part B – Booster Phase 
Part B is designed to offer participants in Part A, who are at least 4 months from the last dose, 
the option to receive a BD (100 µg) of the prototype mRNA-1273 vaccine (Group B2, 
Group B3, and Group B5). Part B is also designed to enroll SOT participants who completed 
primary vaccination series with mRNA or non-mRNA COVID-19 vaccine under the EUA who 
are at least 4 months from last dose. At least 50 SOT recipients who completed primary 
vaccination series with a non-Moderna COVID-19 vaccine under the EUA (outside of the 
mRNA-1273-P304 study) will be enrolled in Part B. In case a variant of concern emerges and 
available data show a decreased immune response after vaccination with the prototype 100 µg 
BD, the Part B Booster Phase may test or replace the prototype 100 µg BD with a variant-
specific mRNA-1273 vaccine (ie, Omicron-specific or mRNA-1273.529). 
Primary Series Vaccine 
Primary Series Number of Doses  
mRNA COVID-19 vaccine (ie. Moderna, 
Pfizer) 
3 doses 
non-mRNA COVID-19 vaccine (ie. Janssen)  
2 doses or at least 1 dose combined with 
an mRNA COVID-19 vaccine 
 
If eligible, each study participant in Part A will receive a notification letter and will be asked to 
schedule a BD-1 visit at their study site. Principal Investigators should consider current local 
public health guidance for administration of COVID-19 vaccines under EUA and marketing 
authorization (if any) when determining the scheduling priority of participants. 
At the BD-1 visit, each participant will: 
• Each study participant in Part A will be encouraged to remain in the ongoing study, 
• Sign a revised informed consent form (ICF) that includes both updated safety 
information relevant to the ongoing study and a BD. 
o Active participants from Part A will be offered the option to receive a 100 µg BD 
(Group A5, Group B2 and Group B3), 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 25 
o Eligible SOT participants who completed the primary vaccination series under 
EUA will be given a 100 µg BD of mRNA-1273 (Group B4), 
o Under Amendment #4, unvaccinated SOT participants who will be enrolled will 
be given 3 100 µg doses in Part A then proceed to Part B to receive a 100 µg 
booster dose. 
o Under Amendment #4, SOT participants previously vaccinated with 2 doses of 
Moderna COVID-19 vaccine outside of the study who will be enrolled will 
receive a third 100 µg dose in Part A then proceed to Part B to receive a 100 µg 
BD. 
• Be counselled about the importance of continuing other public health measures to limit 
the spread of disease including social distancing, wearing a mask, and hand-washing. 
At the BD-1 visit, participants will have the following study site visits and complete scheduled 
activities according to the Part B SoE: 
• BD-1 visit: Participants will receive a single 100 µg dose of mRNA-1273 
• BD-1a visit: Day 4, 3 days after BD on Day 1 
• BD-2 visit: Day 8, 7 days after BD on Day 1 
• BD-3 visit: Day 29, 28 days after the BD on Day 1 
• BD-4 visit: Day 181, 180 days after the BD on Day 1 
 
Study Periods 
There will be 3 study periods: a Screening Period, a Treatment Period, and a Follow-up Period. 
For unvaccinated participants (SOT and healthy) who receive the 2-dose vaccine regimen 
in Part A (Group A1 and Group A5): 
The study comprises 8 scheduled visits, including a screening visit and 7 scheduled clinic visits. 
Electronic diary (eDiary) recording of solicited local and systemic reactogenicity will occur on 
the day of each injection and for 6 days following injection. Safety follow-up via an eDiary 
questionnaire will be performed every 4 weeks from Day 71 to Day 183 and again from Day 223 
to Day 363. Additional safety follow-up via a safety telephone call will be performed every 
4 weeks from Day 85 to Day 197 and again from Day 237 to Day 377. If the last dose is delayed, 
additional safety calls every 4 weeks should be scheduled when the gap between the safety call 
scheduled on D377 and the last study visit is beyond 28 days. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 26 
Per participant, the study duration will be approximately 13 months, which includes 1 week for 
screening (Day ˗7 to Day 1), 28 days for dosing (on Day 1 and Day 29), and 12 months of 
follow-up after the second dose to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. Day 0 and Day 1 may be combined on the same day. 
For unvaccinated SOT participants who receive the 3-dose vaccine regimen in Part A 
(Group A2): 
The study comprises 11 scheduled visits, including a screening visit and 10 scheduled clinic 
visits. The eDiary recording of solicited local and systemic reactogenicity will occur on the day 
of each injection and for 6 days following injection. Safety follow-up via an eDiary 
questionnaire will be performed every 4 weeks from Day 127 to Day 239 and again from 
Day 279 to Day 419. Additional safety follow-up via a safety telephone call will be performed 
every 4 weeks from Day 141 to Day 253 and again from Day 293 to Day 433. If the last dose is 
delayed, additional safety calls every 4 weeks should be scheduled when the gap between the 
safety call scheduled on D433 and the last study visit is beyond 28 days. 
Per participant, the study duration will be approximately 15 months, which includes 1 week for 
screening (Day ˗7 to Day 1), 3 months for dosing (on Day 1, Day 29, and Day 85), and 12 months 
of follow-up after the third dose to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. Day 0 and Day 1 may be combined on the same day. 
For previously vaccinated SOT participants who receive the single-dose vaccination 
regimen (dose 3) in Part A (Group A3): 
The study comprises 6 scheduled visits, including a screening visit and 5 scheduled clinic visits. 
eDiary recording of solicited local and systemic reactogenicity (Section 7.5.3) will occur on the 
day of injection and for 6 days following injection. Safety follow-up via an eDiary questionnaire 
will be performed every 4 weeks from Day 43 to Day 155 and again from Day 194 to Day 306. 
Additional safety follow-up via a safety telephone call will be performed every 4 weeks from 
Day 57 to Day 169 and again from Day 208 to Day 320. 
Per participant, the study duration will be approximately 12 months, which includes 1 week for 
screening (Day ˗7 to Day 1), and 12 months of follow-up after dose 3 to monitor for safety, 
immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. The screening visit 
and Day 1 may be combined on the same day (Table 9). 
For participants who receive the BD in Part B (Group B2, Group B3, Group B4, and 
Group B5): 
The study comprises 5 scheduled clinic visits and 6 safety calls (BD-D15, BD-D22, BD-D59, 
BD-D89, BD-D119, and BD-D149). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 27 
Per healthy participant receiving 2 mRNA-1273 doses in Part A who consent to receive a BD 
(Group B5), the study duration will be approximately 10 months, which includes 1 week for 
screening (Day ˗7 to Day 1), 4 months for dosing (on Day 1, Day 29, and Day 129 for BD), and 
6 months of follow-up after the BD to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. 
Per SOT study participant who received the 3 mRNA-1273 doses in Part A (Group B2) who 
consent to receive a BD, the study duration will be approximately 13 months which includes 1 
week for screening (Day ˗7 to Day 1), approximately 7 months of dosing (on Day 1, Day 29, 
Day 85, and Day 205 for BD) and 6 months of follow-up after BD to monitor for safety, 
immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. 
Per SOT study participant who previously received 2 doses under EUA, enrolled in Part A to 
receive a third dose (Group B3) and who consent to receive a BD, the study duration will be 
approximately 10 months which includes 1 week for screening (Day ˗7 to Day 1), 4 months of 
dosing (Day 1 [dose 3] and Day 120 [BD]) and 6 months of follow-up after BD to monitor for 
safety, immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. 
Per SOT study participant who previously completed primary vaccination series (3 doses) under 
EUA (Group B4) who consent to receive a BD, the study duration will be approximately 6 
months which includes 1 week for screening (Day ˗7 to Day 1), 1 day for dosing and 6 months 
of follow-up after BD to monitor for safety, immunogenicity, and breakthrough SARS-CoV-2 
infection or COVID-19. 
This study will be conducted in compliance with the protocol, Good Clinical Practice, and all 
applicable regulatory requirements. 
Screening Period 
The Screening Period for each participant starts with the first screening visit (Day 0) and ends 
with the Day 1 visit. The Screening Period can last up to 7 days. After signing the ICF, 
participants will undergo screening assessments to determine study eligibility. The investigator 
will review study entry criteria to determine the participant eligibility during the Screening 
Period. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 28 
Participants deemed eligible will enter the Treatment Period. 
Treatment Period and Follow-up Period 
The Treatment Period for each participant starts with Day 1 and is scheduled to end 28 days 
after each dose of vaccine. In Part A, for unvaccinated SOT and healthy participants who receive 
the 2-dose regimen (Group A1 and A5), the Follow-up Period starts with Day 58 and is 
scheduled to end on Day 394 (12 months after the second dose). The Follow-up Period for 
unvaccinated SOT participants who receive the 3-dose regimen (Group A2) starts with Day 114 
and is scheduled to end on Day 450 (12 months after the third dose). The Follow-up Period for 
previously vaccinated participants (Group A3) starts with Day 29 and is scheduled to end on 
Day 365 (12 months after dose 3). In Part B (Group B2, Group B3, Group B4, and Group B5), 
Follow-up Period starts with Day 29 and is scheduled to end on BD-D181 (6 months after BD). 
For Part A: On Day 1, after the completion of the scheduled assessments, all participants will 
be administered a single intramuscular (IM) dose of 100 µg of mRNA-1273. Participants will 
be closely monitored for safety and will remain at the study site for observation for at least 
30 minutes after dosing. For unvaccinated SOT and healthy participants (Group A1, Group A2, 
and Group A5), the second dose of vaccine will be administered on Day 29. Unvaccinated SOT 
recipients who consent to receive a third dose of vaccine (Group A2) will receive it on Day 85. 
Previously vaccinated SOT recipients (Group A3) will receive dose 3 on Day 1. Participants 
will be monitored for 12 months after the second and third dose (as applicable) of vaccine for 
safety, immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. 
For Part B (Group B2, Group B3, Group B4, and Group B5): On BD-D1, after the completion 
of the scheduled assessments, at least 4 months after the last dose, all participants will be 
administered a single IM dose of 100 µg BD of mRNA-1273. Participants will be closely 
monitored for safety and will remain at the study site for observation for at least 30 minutes after 
dosing. Participants will be monitored for 6 months after the BD for safety, immunogenicity, 
and breakthrough SARS-CoV-2 infection or COVID-19. 
Scheduled testing for the presence of SARS-CoV-2 by RT-PCR will occur after collecting NP 
swab samples on each day of injection: in Part A, on Day 1, Day 29, and Day 85 before dosing 
as well as on Day 57 (28 days after the second dose for unvaccinated SOT and healthy 
participants [Group A1 Group A2, and Group A5]) and Day 113 (28 days after the third dose 
for unvaccinated SOT recipients [Group A2]); and Day 29 (for previously vaccinated SOT 
recipients [Group A3]), and in Part B (Group B2, Group B3, Group B4, and Group B5), on BD-
D1 before dosing. During the Treatment Period and Follow-up Period, participants who meet 
prespecified disease criteria that suggest possible SARS-CoV-2 infection, will be asked to 
contact the study site to arrange for a prompt and thorough assessment, including an NP swab 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 29 
sample to be tested for the presence of SARS-CoV-2 by RT-PCR. Confirmed, symptomatic 
cases of SARS-CoV-2 infection will be captured as MAAEs. 
Blood samples for immunogenicity assessment: 
All participants will be monitored for safety and reactogenicity and provide pre- and post-dose 
blood specimens for immunogenicity through 12 months after additional primary dose (dose 3 
[Group A3]) and second (Group A1) and third (Group A2) (as applicable) doses of mRNA-1273 
(Part A) and through 6 months after BD (Group B2, Group B3, Group B4, and Group B5). 
Blood sampling for immunogenicity testing is scheduled throughout the study: 
• For unvaccinated SOT and healthy participants who receive the 2-dose regimen, on Days 
1 and 29, as well as 28 days and 6 and 12 months after the second dose (Part A, Group A1 
and Group A5), 
• For unvaccinated SOT participants who receive the 3-dose regimen, on Days 1, 29, 57, 
and 85, as well as 28 days and 6 and 12 months after the third dose (Part A, Group A2), 
• For previously vaccinated SOT participants who receive dose 3, on Days 1 and 29 
(28 days after dose 3), as well as 6 and 12 months after dose 3 (Part A, Group A3). 
• For participants in Part B (participants in Part A who consented to receive a BD 
[Group B2, Group B3, and Group B5] and SOT participants who completed the primary 
vaccination series with any COVID-19 vaccine under EUA who receive a BD 
[Group B4]), on BD-D1, BD-D29, and BD-D181 
Blood samples for CMI Analysis: 
Part A 
For unvaccinated SOT participants (Group A1 and Group A2), blood samples will also be 
collected for CMI analysis at Day 1, Day 36, and Day 92 (SOT recipients who receive a third 
dose [Group A2]) from a subset of up to 50 SOT recipients, as well as, from 20 healthy controls 
(Group A5) at Day 1 and Day 36. 
Blood samples will also be collected from a subset of at least 50 previously vaccinated SOT 
recipients (Group A3) for CMI analysis at Day 1 (dose 3) and Day 8 (7 days after dose 3). 
Part B 
For participants in Part B (participants in Part A who consented to receive a BD [Group B2, 
Group B3, and Group B5] and SOT participants who completed the primary vaccination series 
under EUA who receive a BD [Group B4]), blood samples will be collected for CMI analysis at 
BD-D1 and BD-D8 (7 days after BD) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 30 
 
Blood and urine samples for kidney and liver function: 
Blood and urine samples related to kidney (for kidney SOT) and liver function (for liver SOT) 
will be monitored: 
Part A 
• On Day 1, Day 8, Day 29, Day 36, and Day 57 for unvaccinated SOT participants who 
receive 2 doses only (Group A1) and on additional Days 85, 92, and 113 for 
unvaccinated SOT recipients receiving 3 doses (Group A2). 
• On Day 1 (dose 3), Day 8, and Day 29 for previously vaccinated SOT recipients 
(Group A3). 
• After Day 57 (for unvaccinated SOT recipients receiving 2 doses [Group A1]) or after 
Day 113 (for unvaccinated SOT recipients receiving 3 doses [Group A2]), or after 
Day 29 (for previously vaccinated SOT recipients receiving 1 dose of mRNA-1273 
[Group A3]), the investigator will review standard-of-care laboratory assessments 
related to kidney and liver function, and report any laboratory-related AEs and suspected 
or confirmed events of organ transplant rejection until the end of study. 
Part B 
• On BD-D1, BD-D8, and BD-D29 for SOT participants (Group B2, Group B3, and 
Group B4): After Day 29, the investigator will review standard-of-care laboratory 
assessments related to kidney and liver function, and report any laboratory-related AEs 
and suspected or confirmed events of organ transplant rejection until the end of study. 
Blood samples for biomarker analysis:  
During BD-D4 (Part B of the study [Group B2, Group B3, Group B4], and Group B5), 
participants who chose to receive a BD will have blood draws (biomarker plasma and biomarker 
serum samples) which will be stored for potential future biomarker assessment. 
Participants will be instructed on the day of the first dose and reminded on the days of the 
second, third, and fourth doses (as applicable) how to document and report solicited local or 
systemic ARs in a provided eDiary. Solicited ARs, unsolicited AEs, MAAEs, SAEs, AESIs, 
AEs leading to discontinuation from dosing and/or study participation (withdrawal), or biopsy-
proven organ rejection will be assessed according to the time points in the applicable SoE. 
Participants may experience or report an AE that necessitates an unscheduled visit. Additional 
examinations may be conducted at these visits as necessary to ensure the safety and well-being 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 31 
of the participant during the study at the investigator’s discretion. Electronic case report forms 
(eCRFs) should be completed for each unscheduled visit. 
Safety Oversight: 
The contract research organization’s medical monitor, the Sponsor’s medical monitor, and the 
individual study site investigator(s) will monitor safety throughout the study. 
An independent safety review committee (SRC) consisting of transplant nephrologist(s) and 
hepatologist(s) not involved in the conduct of the study will monitor and adjudicate for events 
of organ transplant rejection starting after the first dose on Day 1 and throughout the study 
period. The SRC will operate under the rules of an approved charter that will be written and 
reviewed at the organizational meeting of the SRC. Details regarding the SRC composition, 
responsibilities, procedures, and frequency of data review will be defined in its charter. 
An independent cardiac event adjudication committee (CEAC) that includes pediatric and adult 
cardiologists will review suspected cases of myocarditis and pericarditis to determine if they 
meet Centers for Disease Control and Prevention (CDC) criteria of “probable” or “confirmed” 
events, and to assess severity (Gargano et al 2021). Any cases that the CEAC assesses as 
representing probable or confirmed cases of myocarditis or pericarditis will be referred to the 
Sponsor, which will then make a final decision on whether to suspend further enrollment and/or 
study dosing based on an assessment of the overall potential risk to study participants or 
potential study participants. 
The CEAC will operate under the rules of an approved charter that will be written and reviewed 
at the organizational meeting of the CEAC. Details regarding the CEAC composition, 
responsibilities, procedures, and frequency of data review will be defined in its charter. 
In addition, an Internal Safety Team (IST) will be created specifically to review safety and 
reactogenicity data after: 
• At least 10 SOT recipients have received their third dose of study vaccine 
(Group A2 and Group A3) and have at least 7 days of reactogenicity data 
• At least 55 SOT recipients have received their third dose of study vaccine 
(Group A2 and Group A3), unless a safety event requires earlier review 
• Any other ad hoc safety concerns based on ongoing safety surveillance 
The IST will operate under the rules of an approved charter that will be written and reviewed at 
the organizational meeting of the IST. Details regarding the IST composition, responsibilities, 
procedures, and frequency of data review will be defined in its charter. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 32 
Study Duration: 
Part A: 
Per participant receiving 2 vaccine doses (Group A1), the study duration will be approximately 
13 months, which includes 1 week for screening, 1 month for dosing, and 12 months of follow-
up after the second dose to monitor for safety, immunogenicity, and breakthrough SARS-CoV-2 
infection or COVID-19. 
Per participant receiving 3 vaccine doses (Group A2), the study duration will be approximately 
15 months, which includes 1 week for screening, 3 months for dosing, and 12 months of follow-
up after the third dose to monitor for safety, immunogenicity, and breakthrough SARS-CoV-2 
infection or COVID-19. 
Per participant receiving 1 vaccine dose only (dose 3) (Group A3), the study duration will be 
approximately 12 months, which includes 1 week for screening, 1 day for dosing, and 12 months 
of follow-up after dose 3 to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. 
Part B – Booster Phase 
Per healthy participant receiving 2 doses of mRNA-1273 in Part A (Group B5), the study 
duration will be approximately 10 months, which includes 1 week for screening (Day ˗7 to 
Day 1), 6 months for dosing (on Day 1, Day 29, and Day 129 for BD), and 6 months of follow-
up after the BD to monitor for safety, immunogenicity, and breakthrough SARSCoV2 infection 
or COVID-19. 
Per SOT study participant receiving 3 doses of mRNA-1273 in Part A (Group B2), the study 
duration will be approximately 13 months which includes 1 week for screening (Day ˗7 to 
Day 1), approximately 9 months of dosing (on Day 1, Day 29, Day 85, and Day 205 for BD) 
and 6 months of follow-up after BD to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. 
Per SOT study participant who previously completed primary vaccination series (3 doses) under 
EUA (Group B4), the study duration will be approximately 6 months which includes 1 week for 
screening (Day ˗7 to Day 1), 1 day for dosing and 6 months of follow-up after BD to monitor 
for safety, immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. 
Number of Participants: 
Approximately 240 participants (220 unvaccinated and previously vaccinated SOT recipients 
and 20 unvaccinated healthy controls) will be enrolled in the study. At least 50 SOT recipients 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 33 
who completed primary vaccination series with a non-Moderna COVID-19 vaccine under EUA 
(outside of the mRNA-1273-P304 study) will be enrolled in Part B. 
Study Eligibility Criteria (Part A): 
Eligibility Criteria for Transplant Recipients (Group A1, Group A2, and Group A3): 
Inclusion Criteria for Transplant Recipients: 
Each participant must meet all of the following criteria at the screening visit (Day 0) or at Day 1, 
unless noted otherwise, to be enrolled in this study: 
1. Is an adult male or female individual, at least 18 years of age at the time of signing 
informed consent (Day 0), is EITHER a kidney or a liver (single organ) transplant 
recipient who is at least 90 days after transplantation at the time of consent, and is 
EITHER: 
a. Unvaccinated, or 
b. Previously vaccinated with 2 doses of Moderna COVID-19 vaccine who is at least 
1 month after the second dose at the time of consent. Participants who received the 
2 doses of Moderna COVID-19 vaccine before transplant are not eligible 
2. Received chronic immunosuppressive therapy for the prevention of allograft rejection 
for a minimum of 90 days before signing consent, including but not limited to: 
glucocorticoids (eg, prednisolone), immunophilin binding agents (eg, calcineurin 
inhibitors, mTOR inhibitors), or inhibitors of de novo nucleotide synthesis (eg, 
mycophenolic acid, mizoribine, leflunomide, azathioprine). 
3. Understands, agrees, and is able to comply with the study procedures and provides 
written informed consent. 
4. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all the following criteria: 
• Has a negative pregnancy test at Screening and on the day of the first dose (Day 1). 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to the first dose (Day 1). 
• Has agreed to continue adequate contraception through 3 months following the 
second dose (Day 29) for those receiving 2-dose regimen, through 3 months 
following the third dose (Day 85) for those receiving 3-dose regimen, and through 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 34 
3 months following the third dose (Day 1) for those previously vaccinated SOT 
recipients. 
• Is not currently breastfeeding. 
See Section 10.3, Appendix 3 for Contraceptive Guidance. 
5. Is medically stable, according to investigator’s judgement, during the 3 months before 
signing consent. Medically stable is defined as having no significant worsening of a 
medical condition requiring medical intervention (eg, hospitalization, change in 
medical therapy). 
Exclusion Criteria for Transplant Recipients 
Participants who meet any of the following criteria at the screening visit (Day 0) or at Day 1, 
unless noted otherwise, will be excluded from the study: 
1. Known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection 
or COVID-19 within 2 weeks prior to vaccine administration or any known history of 
SARS-CoV-2 infection or positive SARS-CoV-2 test. 
2. Is pregnant or breastfeeding. 
3. Is acutely ill or febrile 24 hours prior to or at the screening visit (Day 0). Fever is 
defined as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion 
may have visits rescheduled within the relevant study visit windows. Afebrile 
participants with minor illnesses can be enrolled at the discretion of the investigator. 
4. Has prior or planned administration of a coronavirus vaccine (eg, SARS-CoV-2 [for 
unvaccinated participants only], SARS-CoV, or MERS [Middle East Respiratory 
Syndrome] -CoV vaccine). 
5. Has current treatment with investigational agents for either prophylaxis against 
COVID-19 (for unvaccinated participants only) or treatment of COVID-19 (eg, anti-
SARS-CoV-2 monoclonal antibodies). 
6. Has a medical, psychiatric, or occupational condition that may pose additional risk as a 
result of participation or that could interfere with safety assessments or interpretation 
of results according to the investigator’s judgment. 
7. Has a history of a diagnosis or condition that, in the judgment of the investigator, may 
affect study endpoint assessment or compromise participant safety, specifically: 
• A history of more than 1 solid organ transplanted (eg, kidney and pancreas). A 
history of previous kidney or liver transplant is acceptable. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 35 
• A history of clinically relevant donor-specific Ab. 
• A history of complications of immunosuppression; for example, the following: 
o Hypogammaglobulinemia and post-transplant lymphoproliferative disorders 
o Cytomegalovirus viremia or BK viremia within 1 month of informed consent 
• Active infection at the time of consent 
• A history of biopsy-proven T-cell or Ab-mediated rejection within 3 months of 
informed consent, or suspected active or chronic rejection according to the 
investigator’s judgment 
• Suspected clinically relevant active hepatitis, including viral hepatitis, according to 
the investigator’s judgment 
• Bleeding disorder that is considered a contraindication to IM injection or 
phlebotomy 
• Dermatologic conditions that could affect local solicited AR assessments 
• Known or suspected allergy or history of anaphylaxis, urticaria, or other significant 
AR to the vaccine or its excipients 
• Known human immunodeficiency virus infection 
8. Has received: 
• Any nonstudy vaccine within 28 days before or after any dose of vaccine (except 
for seasonal influenza vaccine, which is not permitted within 14 days before or after 
any dose of vaccine) 
• Intravenous blood products (red blood cells, platelets, immunoglobulins) within 
3 months prior to Day 1 
• Therapies that have depleting properties on T-cells, B-cells, and plasma cells 
(examples of depletional therapies include, but are not limited to, antithymocyte 
globulin, monoclonal antibodies, and proteosome inhibitors) within the last 3 
months prior to enrollment 
9. Participated in an interventional clinical study within 28 days prior to Day 0 or plans to 
donate blood products while participating in this study. 
10. Is an immediate family member or has a household contact who is an employee of the 
research center or otherwise involved with the conduct of the study. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 36 
Eligibility Criteria for Healthy Adults (Group A5): 
Inclusion Criteria for Healthy Adults: 
Each participant must meet all of the following criteria at the screening visit (Day 0) or at Day 1, 
unless noted otherwise, to be enrolled in this study: 
1. Is an adult male or female individual, at least 18 years of age at the time of signing 
informed consent (Day 0), and is in good general health without current or previous 
diagnosis of immunocompromising condition, immune-mediated disease, or other 
immunosuppressive condition, according to investigator assessment, at the time of 
consent, and has not been vaccinated with any COVID-19 vaccine at the time of 
consent. 
2. Understands, agrees, and is able to comply with the study procedures and provides 
written informed consent. 
3. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all the following criteria: 
• Has a negative pregnancy test at Screening and on the day of the first dose (Day 1) 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to the first dose (Day 1) 
• Has agreed to continue adequate contraception through 3 months following the 
second dose (Day 29) 
• Is not currently breastfeeding 
See Section 10.3, Appendix 3 for Contraceptive Guidance. 
4. Is medically stable, according to investigator’s judgment, during the 3 months before 
signing consent. Medically stable is defined as having no significant worsening of a 
medical condition requiring medical intervention (eg, hospitalization, change in 
medical therapy). 
Exclusion Criteria for Healthy Adults: 
Participants who meet any of the following criteria at the screening visit (Day 0) or at Day 1, 
unless noted otherwise, will be excluded from the study: 
1. Known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection 
or COVID-19 within 2 weeks prior to vaccine administration or any known history of 
SARS-CoV-2 infection or SARS-CoV-2 test. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 37 
2. Is pregnant or breastfeeding. 
3. Is acutely ill or febrile 24 hours prior to or at the screening visit (Day 0). Fever is 
defined as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion 
may have visits rescheduled within the relevant study visit windows. Afebrile 
participants with minor illnesses can be enrolled at the discretion of the investigator. 
4. Has prior or planned administration of a coronavirus vaccine (eg, SARS-CoV-2, 
SARS-CoV, or MERS-CoV vaccine). 
5. Has current treatment with investigational agents for either prophylaxis against 
COVID-19 or treatment of COVID-19 (eg, anti-SARS-CoV-2 monoclonal antibodies). 
6. Has a medical, psychiatric, or occupational condition that may pose additional risk as a 
result of participation or that could interfere with safety assessments or interpretation 
of results according to the investigator’s judgment. 
7. Has a history of a diagnosis or condition that, in the judgment of the investigator, may 
affect study endpoint assessment or compromise participant safety, specifically: 
• Active infection at the time of consent 
• Bleeding disorder that is considered a contraindication to IM injection or 
phlebotomy 
• Dermatologic conditions that could affect local solicited AR assessments 
• Known or suspected allergy or history of anaphylaxis, urticaria, or other significant 
AR to the vaccine or its excipients 
• Current or previous diagnosis of immunocompromising condition, immune-
mediated disease, or other immunosuppressive condition 
8. Has received: 
• Any nonstudy vaccine within 28 days before or after any dose of vaccine (except 
for seasonal influenza vaccine, which is not permitted within 14 days before or after 
any dose of vaccine) 
• Intravenous blood products (red blood cells, platelets, immunoglobulins) within 
3 months prior to Day 1 
• Systemic immunosuppressants or immune-modifying drugs for > 14 days in total 
within 6 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone 
equivalent) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 38 
9. Participated in an interventional clinical study within 28 days prior to Day 0 or plans to 
donate blood products while participating in this study. 
10. Is an immediate family member or has a household contact who is an employee of the 
research center or otherwise involved with the conduct of the study. 
Study Eligibility Criteria (Part B): 
Inclusion Criteria (Group B2, Group B3, Group B4, and Group B5) 
1. a. Participants must have been previously enrolled in the mRNA-1273-P304 study, are 
actively participating in Part A and are at least 4 months from the last dose, or 
b. Is an adult male or female individual, at least 18 years of age at the time of signing 
informed consent, is EITHER a kidney or a liver (single organ) transplant recipient who 
is at least 90 days after transplantation at the time of consent AND who completed 
primary vaccination series (3 doses for mRNA COVID-19 vaccine; 2 doses for non-
mRNA COVID-19 vaccine or at least 1 dose of non-mRNA combined with 1 dose of 
mRNA COVID-19 vaccine) under the EUA who are at least 4 months from the last dose. 
All primary COVID-19 vaccination series must be completed after transplant. 
2. Female participants of childbearing potential may be enrolled in the study if the 
participant has a negative pregnancy test on the day of the booster dose injection (BD-
Day 1). 
Exclusion Criteria (for participants who completed primary vaccination series under 
EUA) (Group B4) 
Exclusion Criteria in Part A will apply except prior or planned administration of a coronavirus 
vaccine and current treatment with investigational agents for either prophylaxis against 
COVID-19. 
Study Treatments: 
Investigational Product: 
The investigational product (mRNA-1273 vaccine) is a lipid nanoparticle (LNP) dispersion of a 
messenger RNA (mRNA) encoding the prefusion stabilized spike (S) protein of SARS-CoV-2 
formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available): the 
proprietary 
ionizable 
lipid 
SM-102 
(heptadecane-9-yl 
8-((2-hydroxyethyl)(6-oxo-6-
(undecyloxy)hexyl)amino)octanoate); 
cholesterol; 
1,2-distearoyl-sn-glycero-3-
phosphocholine; and 1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol polyethylene 
glycol 2000. mRNA-1273 injection is provided as a sterile liquid for injection, white to off-white 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 39 
dispersion in appearance, at a concentration of 0.2 mg/mL in 20 mM Tris buffer containing 
87 mg/mL sucrose and 10.7 mM sodium acetate at pH 7.5. 
Mode of Administration: 
Doses will be administered by IM injection into the deltoid muscle according to the procedures 
specified in the mRNA-1273-P304 Pharmacy Manual. Preferably, all doses should be 
administered into the same nondominant arm for each dose. Neither dose should be administered 
into an arm that contains an arteriovenous fistula. 
Procedures and Assessments: 
Safety Assessments: 
Safety assessments will include monitoring and recording of the following for each participant, 
according to the applicable SoE: 
• Solicited local and systemic ARs that occur during the 7 days following each 
injection (ie, the day of injection and 6 subsequent days). Solicited ARs will be 
recorded daily using the eDiary 
• Unsolicited AEs observed or reported during the 28 days following each injection 
(ie, the day of injection and 27 subsequent days) 
• MAAEs throughout the study period 
• SAEs throughout the study period 
• AESIs throughout the study period 
• AEs leading to discontinuation from dosing and/or study participation (withdrawal) 
throughout the study period 
• Biopsy-proven organ rejection throughout the study period. A biopsy report will be 
needed for documentation 
• Safety laboratory assessments: 
Part A 
− For unvaccinated SOT recipients who receive the 2-dose regimen (Group A1), 
safety laboratory assessments related to kidney (for kidney transplant 
recipients) and liver function (for liver transplant recipients) will be monitored 
on Day 1, Day 8, Day 29, Day 36, and Day 57. After Day 57, the investigator 
will review standard-of-care laboratory assessments related to kidney and liver 
function (as related to the SOT) and report any laboratory-related AEs and 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 40 
suspected or confirmed events of organ transplant rejection until the end of 
study. 
− For unvaccinated SOT recipients who receive the 3-dose regimen (Group A2), 
safety laboratory assessments related to kidney (for kidney transplant 
recipients) and liver function (for liver transplant recipients) will be monitored 
on Day 1, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, and Day 113. After 
Day 113, the investigator will review standard-of-care laboratory assessments 
related to kidney and liver function (as related to the SOT) and report any 
laboratory-related AEs and suspected or confirmed events of organ transplant 
rejection until the end of study. 
− For previously vaccinated SOT recipients who receive dose 3 (Group A3), 
safety laboratory assessments related to kidney (for kidney transplant 
recipients) and liver function (for liver transplant recipients) will be monitored 
on Day 1, Day 8, and Day 29. After Day 29, the investigator will review 
standard-of-care laboratory assessments related to kidney and liver function (as 
related to the SOT) and report any laboratory-related AEs and suspected or 
confirmed events of organ transplant rejection until the end of study. 
Part B 
- 
For SOT participants who completed primary vaccination series (Group B2, 
Group B3, and Group B4), safety laboratory assessments related to kidney (for 
kidney transplant recipients) and liver function (for liver transplant recipients) 
will be monitored on BD-D1, BD-D8, and BD-D29. After BD-D29, the 
investigator will review standard-of-care laboratory assessments related to 
kidney and liver function, and report any laboratory-related AEs and suspected 
or confirmed events of organ transplant rejection until the end of study. 
• Vital sign measurements 
• Physical examination findings 
• Assessments for SARS-CoV-2 infection from Day 1 through study completion 
• Details of all pregnancies in female participants will be collected after the start of 
study treatment and until the end of their participation in the study 
• Changes in immunosuppressant medications in SOT recipients 
Safety Procedures: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 41 
The eDiary will be used throughout the study as specified in the applicable SoE. The eDiary 
will be the only source documents allowed for solicited local or systemic ARs. In Part A, the 
eDiary will also be used every 4 weeks to capture the occurrence of AEs, MAAEs, SAEs, AESIs, 
or AEs leading to discontinuation from dosing and/or study participation (withdrawal) as 
follows: 
• Starting at Day 71 through Day 183 and again starting at Day 223 through Day 363 for 
unvaccinated SOT and healthy participants of 2 vaccine doses (Group A1 and Group 
A5), 
• Starting at Day 127 through Day 239 and again starting at Day 279 through Day 419 for 
unvaccinated SOT recipients of 3 vaccine doses (Group A2), and 
• Starting at Day 43 through Day 155 and again starting at Day 194 through Day 306 for 
previously vaccinated SOT recipients who receive dose 3 (Group A3). 
In Part A, safety telephone calls will be used every 4 weeks to collect information as 
specified in the applicable SoE about occurrence of AEs, MAAEs (including biopsy-proven 
organ rejection), SAEs, AESIs, AEs leading to discontinuation from dosing and/or study 
participation (withdrawal), concomitant medications associated with those events, and any 
nonstudy vaccinations (Section 7.5.8). In addition, study personnel will collect information 
on known participant close contact exposure to someone with known COVID-19 or SARS-
CoV-2 infection and on participant experience of COVID-19 symptoms: 
• From Day 85 through Day 197 and again from Day 237 through Day 377 for 
unvaccinated SOT and healthy participants of 2 vaccine doses (Group A1 and Group 
A5); 
• From Day 141 through Day 253 and again starting at Day 293 through Day 433 for 
unvaccinated SOT recipients of 3 vaccine doses (Group A2); 
• Starting at Day 57 through Day 169 and again starting at Day 208 through Day 320 for 
previously vaccinated SOT recipients who receive dose 3 (Group A3). 
The timing of eDiary prompts for safety follow-ups and safety calls will not be adjusted if the 
last dose is delayed. Additional safety calls every 4 weeks should be scheduled if there is a gap 
beyond 28 days between the safety call scheduled on D377 (for 2 doses [Group A1 and Group 
A5]) or D433 (for 3 doses [Group A2]) and the last study visit. 
In Part B, safety telephone calls will be performed on BD-D15, BD-D22, and every 4 weeks 
from BD-D59 to BD-D149 (BD-D59, BD-D89, BD-D119, and BD-D149) to collect information 
about occurrence of AEs, MAAEs (including biopsy-proven organ rejection), SAEs, AESIs, 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 42 
AEs leading to discontinuation from dosing and/or study participation (withdrawal), 
concomitant medications associated with those events, and any nonstudy vaccinations (Section 
7.5.8). 
All safety laboratory assessments will be conducted at laboratories local to the study sites. To 
help monitor for potential event of organ transplant rejection in the SOT recipients, safety 
laboratory assessments will be performed, including assessments related to kidney and liver 
function (eg, serum creatinine, urine protein, and UPCR for kidney SOT recipients; and ALT, 
AST, ALP, and bilirubin for liver SOT recipients) at prespecified study visits. After Day 57 
(unvaccinated SOT recipients who receive 2 vaccine doses [Group A1]) or after Day 113 
(unvaccinated SOT recipients who receive 3 vaccine doses [Group A2]) or after Day 29 
(previously vaccinated SOT recipients who receive dose 3 [Group A3] or SOT recipients who 
completed the primary vaccination series who receive BD [Group B4]), the investigator will 
review standard-of-care laboratory assessments related to kidney and liver function (as 
applicable), and report any laboratory-related AEs and suspected or confirmed events of organ 
transplant rejection until the end of study. 
A confirmed diagnosis of organ transplant rejection will be based on histologic assessment or 
tissue biopsy. The investigator must review results of safety laboratory assessments as soon as 
they are available. The schedule of sampling for safety laboratory assessments is presented in 
the applicable SoE. 
Vital sign measurements will include systolic and diastolic blood pressure, heart rate, respiratory 
rate, and body temperature (preferred route is oral). The participant will be seated for at least 
5 minutes before all measurements are taken. Vital signs will be measured at the time points 
indicated in the applicable SoE. At dosing visits, vital sign measurements will be collected once 
before injection and at least 30 minutes after injection (before participants are discharged from 
the study site). 
Physical examinations will be conducted according to the applicable SoE. A full physical 
examination will be performed at Day 1 and symptom-directed physical examinations will be 
performed at other time points. 
Immunogenicity Assessments: 
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the applicable SoE. The following analytes will be measured: 
• Serum nAb level against SARS-CoV-2 as measured by pseudovirus and/or live 
virus neutralization assays 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 43 
• Serum binding antibody (bAb) against SARS-CoV-2 S protein measured by ligand 
binding assay specific to the SARS-CoV-2 S protein 
Assessments for SARS-CoV-2 Infection 
Study participants will have NP samples collected for SARS-CoV-2 testing by RT-PCR at time 
points specified in the applicable SoE. A study illness visit or a consultation will be arranged 
within 72 hours or as soon as possible to collect an NP or nasal swab sample (NP is preferred) 
to ascertain the presence of SARS-CoV-2 via RT-PCR if a participant experiences any of the 
following: 
• Signs or symptoms of SARS-CoV-2 infection as defined by the US Centers for 
Disease Control and Prevention 
• Close contact exposure to an individual confirmed to be infected with SARS-CoV-
2 
• MAAE suggesting a SARS-CoV-2 infection 
If the participant had known close contact exposure to COVID-19 (eg, close contact exposure 
to someone with confirmed COVID-19), it will be captured in the COVID-19 exposure form. 
If scheduled, the study illness visit may collect additional clinical information at the 
investigator’s discretion, including but not limited to medical history, physical examination, 
blood sampling for clinical laboratory testing, and nasal, saliva, and/or NP swab sampling for 
viral PCR (including multiplex PCR for respiratory viruses, including SARS-CoV-2) to evaluate 
the severity of the clinical case. Radiologic imaging studies may be conducted. During this visit, 
a blood sample will also be collected for immunologic assessment of SARS-CoV-2. All findings 
will be recorded in the eCRF. 
If participants are confirmed to have SARS-CoV-2 infection, the investigator will notify the 
participant and the participant’s primary care physician of the diagnosis. If the study participant 
does not have a primary care physician, the investigator will assist them in obtaining one. The 
participant will also be instructed on infection prevention measures consistent with local public 
health guidance. 
Any confirmed symptomatic SARS-CoV-2 infection occurring in participants will be captured 
as an MAAE along with relevant concomitant medications and details about severity, 
seriousness, and outcome. Additionally, a convalescent visit will be scheduled approximately 
28 days (+7 days) after diagnosis. At this visit, an NP swab sampling for viral PCR and a blood 
sample will be collected for potential immunologic assessment of SARS-CoV-2 infection. 
Exploratory Assessments: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 44 
Qualitative and quantitative measures of viral load of SARS-CoV-2 will be assessed by RT-PCR 
material from NP swab samples obtained at illness visits. Any SARS-CoV-2 genetic sequencing 
will be performed on the same samples. 
In Part A, cellular immune response (eg, markers of CMI, T-cells, and B-cells) will be assessed 
on Day 1 before vaccination and at Days 36 and Day 92 in a subset of up to 50 unvaccinated 
participants who receive 3 doses of vaccine in the SOT group (kidney or liver) (Group A2); 
from 20 unvaccinated healthy study participants (Group A5) (Day 1 before vaccination and 
Day 36); and from a subset of at least 50 previously vaccinated SOT recipients who receive 
dose 3 (Group A3) (Day 1 before vaccination and Day 8). In Part B Booster Phase, CMI will 
also be assessed on BD-D1 before vaccination and BD-D8 from all participants in Part B. In 
Part B Booster Phase, blood sample will be collected for future biomarker analysis. 
Statistical Methods: 
Sample Size: 
The planned sample size of approximately 240 participants (220 unvaccinated or previously 
vaccinated participants who have had a kidney or liver transplant and 20 unvaccinated healthy 
participants) who receive 2-dose regimen or 3-dose regimen of 100 µg of mRNA-1273, or 
100 µg BD regimen are expected to provide useful estimates of Ab response at Day 29 for 
previously vaccinated SOT recipients who receive dose 3 in Part A, Day 113 for unvaccinated 
SOT recipients who receive the 3-dose regimen, at Day 57 for unvaccinated participants who 
receive the 2-dose regimen, and at BD-D29 (participants who receive a BD) (primary 
endpoints), respectively, for comparison to results from Study P301 (if available at the time of 
database lock). The healthy adult participants will be used primarily as a biological control for 
the CMI analysis. This study is designed for estimation purposes, and no between-group 
comparisons are planned. 
Analysis Sets: 
The analysis sets are defined in the following table: 
Analysis Set 
Description 
Full Analysis Set (FAS) 
All participants who received at least 1 dose of 
vaccine. 
Modified Intent-to-Treat Set (mITT) 
All participants who have negative SARS-CoV-2 
status at baseline, defined as who have a negative 
RT-PCR test for SARS-CoV-2 and a negative 
serology test based on bAb specific to SARS-CoV-
2 nucleocapsid protein (as measured by Roche 
Elecsys Anti‑SARS‑CoV-2 assay) at baseline. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 45 
Per-Protocol (PP) Subset 
All participants in the mITT set who receive all 
planned doses of study vaccination per schedule 
and have no major protocol deviations that impact 
key or critical data. 
PP Immunogenicity Subset 
All participants who received planned doses of 
study vaccination per schedule, complied with 
immunogenicity testing schedule, and have no 
major protocol deviations that impact key or 
critical data. Participants who are seropositive at 
baseline will be excluded from the PP 
Immunogenicity Subset. The PP Immunogenicity 
Subset will be used for analyses of immunogenicity 
unless specified otherwise. The 
PP Immunogenicity Set will serve as the primary 
population for the analysis of SARS-CoV-2-
specific bAb and nAb immunogenicity data. 
Solicited Safety Set 
All participant in the FAS who contributed any 
solicited AR data. The Solicited Safety Set will be 
used for the analyses of solicited ARs. 
Safety Set 
All participants who received at least 1 dose of 
vaccine. The Safety Set will be used for all 
analyses of safety except for the solicited ARs. 
Abbreviations: AR = adverse reaction; bAb = binding antibody; nAb = neutralizing 
antibody; RT-PCR = reverse transcriptase polymerase chain reaction; 
SARS-CoV-2 = Severe Acute Respiratory Syndrome coronavirus 2; 
vaccine = investigational product. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 46 
Safety Analyses: 
Given that the study does not have a concurrent unvaccinated SOT control group, descriptive 
statistics will be used to present safety data, and no comparisons with the healthy adult 
participants will be made. 
All safety analyses will be based on the Safety Set, except summaries of solicited ARs, which 
will be based on the Solicited Safety Set. All safety analyses will be summarized by cohort and 
subcohort arm. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters, 
including solicited ARs (local and systemic events), unsolicited AEs, MAAEs, SAEs, AESIs, 
AEs leading to discontinuation from dosing and/or study participation (withdrawal), biopsy-
proven organ rejection, safety laboratory assessments, vital sign measurements, and physical 
examination findings. 
The number and percentage of participants with any solicited local AR, with any solicited 
systemic AR, and with any solicited AR during the 7-day Follow-up Period after each dose will 
be summarized. 
The number and percentage of participants with unsolicited AEs, SAEs, AESIs, MAAEs, 
Grade 3 or higher ARs and AEs, AEs leading to discontinuation from dosing and/or study 
participation (withdrawal), and biopsy-proven organ rejection will be summarized. Unsolicited 
AEs will be presented by Medical Dictionary for Regulatory Activities preferred term and 
system organ class. 
The number of events of solicited ARs, unsolicited AEs/SAEs, AESIs, MAAEs, and adjudicated 
biopsy-proven organ rejection will be reported in summary tables. 
Clinical laboratory data will be summarized by severity for each visit and as the maximum over 
all postvaccination visits. Graphical presentations may include box plots and shift plots. 
Evaluation of clinically significant changes in safety laboratory measurements will be 
considered independent of the toxicity grading scale. 
For all other safety parameters, descriptive summary statistics will be provided. Further details 
will be described in the statistical analysis plan (SAP). 
Immunogenicity Analyses: 
The SAP will describe the complete set of immunogenicity analyses. The PP Immunogenicity 
Subset is the primary analysis set for immunogenicity unless otherwise specified. In Part A, the 
primary immunogenicity objective of this study is to evaluate serum Ab responses obtained 
28 days after the second or third injection of 100 µg mRNA-1273 (Day 57 in unvaccinated 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 47 
participants who receive 2 doses, Day 113 for unvaccinated SOT recipients who receive 3 doses, 
and Day 29 for previously vaccinated SOT recipients who receive dose 3). In Part B, the primary 
immunogenicity objective of this study is to evaluate serum Ab responses obtained 28 days after 
the BD. The results of the study will be described and evaluated against the Ab responses of 
adult healthy participants in this study and Study P301 (if available at the time of database lock). 
Using the Ab threshold established from Study P301 (if available at the time of database lock), 
an additional exploratory analysis will be performed by measuring the proportion of participants 
with a serum Ab level at Day 57 (unvaccinated participants who receive 2 doses), Day 113 
(unvaccinated SOT recipients who the receive 3 doses), and Day 29 (previously vaccinated SOT 
recipients who receive dose 3) in Part A, and at BD-D29 (participants who receive a BD) greater 
than or equal to the Ab threshold of protection against COVID-19, with a 2 sided 95% CI using 
the Clopper Pearson method by cohort arm. 
The GM level of serum Ab with corresponding 95% CI will be provided at each time point by 
cohort arm. The 95% CIs will be calculated based on the t-distribution of the log transformed 
values then back transformed to the original scale for presentation. Additionally, the proportion 
of participants with a 2×, 3×, and 4× rise in GM level from Day 1 will be measured. 
All nAb and bAb endpoints will be summarized at each time point with Day 29 (previously 
vaccinated SOT recipients who receive dose 3) and Day 57 and Day 113(unvaccinated 
participants), and at BD-D29 (participants who receive a BD) as the time points of interest. The 
GM levels and GM fold rise of both nAb and bAb will be provided with corresponding 95% 
CIs. Reverse cumulative distribution curves for antibody titers for all time points will be 
presented. 
Incident Cases of COVID-19 After Vaccination: 
The number and percentage of participants with COVID-19 after vaccination in the SOT 
recipient and healthy cohorts will be provided. The number and percentage of participants with 
severe COVID-19 will be provided similarly. 
For serologically confirmed SARS-CoV-2 infection or COVID-19, regardless of 
symptomatology or severity, infection rate will be provided by the healthy cohort arm. 
As an additional analysis, the number and percentage of participants with symptomatic and 
asymptomatic COVID-19 or SARS-CoV-2 infection throughout the study will be summarized. 
Study Analyses: 
Interim Analyses: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273-P304 
 
Confidential 
 
Page 48 
An interim analysis of safety and immunogenicity data is planned after Day 57 (28 days after 
the second dose for unvaccinated participants), after Day 29 (28 days after dose 3 in previously 
vaccinated SOT recipients) in Part A, and at BD-D29 (28 days after BD in participants who 
receive a BD) in Part B; a clinical study report (CSR) will be prepared. An analysis of safety 
and/or immunogenicity may be performed at the Sponsor’s discretion based on the availability 
of data. 
Final Analysis: 
The final analysis of all endpoints will be performed after all participants have completed all 
planned study procedures. Results of this analysis will be presented in a final CSR, including 
individual listings. 
Additional information about all study analyses may be provided the SAP. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 49 
TABLE OF CONTENTS 
 
CLINICAL STUDY PROTOCOL ..................................................................................................1 
PROTOCOL APPROVAL – SPONSOR SIGNATORY ................................................................2 
DECLARATION OF INVESTIGATOR .........................................................................................3 
PROTOCOL AMENDMENT SUMMARY OF CHANGES ..........................................................4 
PROTOCOL SYNOPSIS ................................................................................................................9 
TABLE OF CONTENTS ...............................................................................................................49 
LIST OF TABLES .........................................................................................................................54 
LIST OF FIGURES .......................................................................................................................54 
LIST OF ABBREVIATIONS AND TERMS ................................................................................55 
1. 
INTRODUCTION ......................................................................................................58 
1.1. 
Study Rationale ...........................................................................................................58 
1.2. 
Background and Overview .........................................................................................60 
1.2.1. 
Nonclinical Studies .....................................................................................................60 
1.2.2. 
Clinical Studies ...........................................................................................................61 
1.3. 
Benefit/Risk Assessment ............................................................................................66 
1.3.1. 
Potential Benefits from Participation ..........................................................................66 
1.3.2. 
Risks to Study Participants and Risk Mitigation ........................................................66 
1.3.3. 
Overall Benefit/Risk Conclusion ................................................................................68 
2. 
OBJECTIVES AND ENDPOINTS ............................................................................69 
3. 
STUDY DESIGN .......................................................................................................81 
3.1. 
General Design ...........................................................................................................81 
3.1.1. 
Study Periods ..............................................................................................................92 
3.2. 
Scientific Rationale for Study Design ........................................................................97 
3.3. 
Justification for Dose and Choice of Study Population ..............................................99 
3.4. 
End of Study Definition ............................................................................................100 
4. 
STUDY POPULATION ...........................................................................................101 
4.1. 
Eligibility Criteria (Part A) .......................................................................................101 
4.1.1. 
Eligibility Criteria for Transplant Recipients (Group A1, Group A2, and 
Group A3) .................................................................................................................101 
4.1.2. 
Eligibility Criteria for Healthy Adults (Group A5) ..................................................103 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 50 
4.2. 
Study Eligibility Criteria (Part B) .............................................................................105 
4.2.1. 
Inclusion Criteria (Group B2, Group B3, Group B4, and Group B5) ......................105 
4.2.2. 
Exclusion Criteria (for Participants who Completed Primary Vaccine Series 
under EUA) (Group B4) ...........................................................................................106 
4.3. 
Lifestyle Restrictions ................................................................................................106 
4.4. 
Screen Failures ..........................................................................................................106 
5. 
STUDY TREATMENT ............................................................................................107 
5.1. 
Investigational Product Administered ......................................................................107 
5.2. 
Randomization and Stratification .............................................................................107 
5.3. 
Dosing and Management of mRNA-1273 Vaccine ..................................................107 
5.3.1. 
Preparation of Study Vaccine for Injection ..............................................................107 
5.3.2. 
Administration of Study Vaccine .............................................................................107 
5.3.3. 
Study Vaccine Delivery and Receipt ........................................................................108 
5.3.4. 
Study Vaccine Packaging and Labeling ...................................................................109 
5.3.5. 
Study Vaccine Storage ..............................................................................................109 
5.3.6. 
Study Vaccine Accountability and Disposal ............................................................109 
5.4. 
Study Treatment Compliance ...................................................................................110 
5.5. 
Prior and Concomitant Medications .........................................................................110 
5.5.1. 
Prior Medications and Therapies ..............................................................................110 
5.5.2. 
Concomitant Medications and Therapies ..................................................................111 
5.5.3. 
Concomitant Medications and Vaccines that May Lead to the Elimination of 
a Participant from Per-Protocol Analysis .................................................................112 
5.6. 
Intervention After the End of the Study ...................................................................112 
6. 
DELAYING OR DISCONTINUING STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL FROM THE STUDY ........................................113 
6.1. 
Criteria for Delay of Vaccine Administration ..........................................................113 
6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination ...............................113 
6.2. 
Discontinuing Study Vaccination .............................................................................113 
6.3. 
Participant Discontinuation/Withdrawal from the Study .........................................114 
6.4. 
Lost to Follow-up .....................................................................................................115 
7. 
STUDY ASSESSMENTS AND PROCEDURES ....................................................117 
7.1. 
Safety Assessments and Procedures .........................................................................117 
7.1.1. 
Use of Electronic Diaries ..........................................................................................119 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 51 
7.1.2. 
Safety Telephone Calls .............................................................................................122 
7.1.3. 
Safety Laboratory Assessments ................................................................................123 
7.1.4. 
Vital Sign Measurements ..........................................................................................123 
7.1.5. 
Physical Examinations ..............................................................................................124 
7.1.6. 
Assessments for SARS-CoV-2 Infection ..................................................................124 
7.2. 
Immunogenicity Assessments ..................................................................................125 
7.3. 
COVID-19 and SARS-CoV-2 Infection ...................................................................126 
7.3.1. 
Surveillance for COVID-19 Symptoms ....................................................................127 
7.3.2. 
Follow-up/Convalescent Period After Diagnosis with COVID-19 ..........................130 
7.4. 
Exploratory Assessments ..........................................................................................131 
7.5. 
Safety Definitions and Related Procedures ..............................................................131 
7.5.1. 
Adverse Event ...........................................................................................................131 
7.5.2. 
Serious Adverse Events ............................................................................................132 
7.5.3. 
Solicited Adverse Reactions .....................................................................................133 
7.5.4. 
Medically Attended Adverse Events ........................................................................137 
7.5.5. 
Adverse Events of Special Interest ...........................................................................137 
Anaphylaxis .................................................................................................................................138 
Acute Myocarditis and/or Pericarditis .........................................................................................138 
Acute Myocarditis Case Definition...........................................................................................139 
Acute Pericarditis Case Definition...............................................................................................140 
Myopericarditis Case Definition ..................................................................................................140 
7.5.6. 
Suspected or Confirmed Organ Transplant Rejection ..............................................140 
7.5.7. 
Recording and Follow-up of Pregnancy ...................................................................141 
7.5.8. 
Eliciting and Documenting Adverse Events .............................................................141 
7.5.9. 
Assessment of Severity .............................................................................................142 
7.5.10. 
Assessment of Causality ...........................................................................................143 
7.5.11. 
Reporting Adverse Events ........................................................................................143 
7.5.12. 
Reporting SAEs ........................................................................................................144 
7.5.13. 
Time Period and Frequency for Collecting AE and SAE Information .....................144 
7.5.14. 
Method of Detecting AEs and SAEs ........................................................................145 
7.5.15. 
Follow-up of AEs and SAEs .....................................................................................145 
7.5.16. 
Regulatory Reporting Requirements for SAEs .........................................................146 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 52 
7.6. 
Safety Monitoring .....................................................................................................146 
7.6.1. 
Safety Review Committee ........................................................................................146 
7.6.2. 
Internal Safety Committee and Study Pause Rules ..................................................147 
7.6.3. 
Independent Cardiac Event Adjudication Committee ..............................................148 
7.7. 
Treatment of Overdose .............................................................................................148 
7.8. 
Pharmacokinetics ......................................................................................................149 
7.9. 
Pharmacodynamics ...................................................................................................149 
7.10. 
Biomarkers ................................................................................................................149 
7.11. 
Health Economics .....................................................................................................149 
8. 
STATISTICAL ANALYSIS PLAN .........................................................................150 
8.1. 
Sample Size ..............................................................................................................150 
8.2. 
Analyses Sets ............................................................................................................151 
8.3. 
Statistical Methods ....................................................................................................152 
8.3.1. 
Baseline Characteristics and Demographics .............................................................152 
8.3.2. 
Safety Analyses ........................................................................................................153 
8.3.3. 
Immunogenicity Analyses ........................................................................................154 
8.3.4. 
Incident Cases of COVID-19 After Vaccination ......................................................155 
8.3.5. 
Exploratory Analyses ................................................................................................155 
8.3.6. 
Subgroup Analysis ....................................................................................................156 
8.4. 
Study Analyses .........................................................................................................156 
8.4.1. 
Interim Analyses .......................................................................................................156 
8.4.2. 
Final Analyses ..........................................................................................................156 
9. 
REFERENCES .........................................................................................................157 
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................164 
10.1. 
APPENDIX 1: Schedule of Events ...........................................................................165 
10.2. 
APPENDIX 2: Study Governance Considerations ...................................................184 
10.2.1. 
Regulatory and Ethical Considerations ....................................................................184 
10.2.2. 
Study Monitoring ......................................................................................................184 
10.2.3. 
Audits and Inspections ..............................................................................................185 
10.2.4. 
Financial Disclosure .................................................................................................186 
10.2.5. 
Recruitment Procedures ............................................................................................186 
10.2.6. 
Informed Consent Process ........................................................................................186 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 53 
10.2.7. 
Protocol Amendments ..............................................................................................187 
10.2.8. 
Protocol Deviations ..................................................................................................188 
10.2.9. 
Data Protection .........................................................................................................188 
10.2.10. 
Sample Retention and Future Biomedical Research ................................................189 
10.2.11. 
Dissemination of Clinical Study Data ......................................................................189 
10.2.12. 
Data Quality Assurance and Quality Control ...........................................................190 
10.2.13. 
Data Collection and Management ............................................................................191 
10.2.14. 
Source Documents ....................................................................................................191 
10.2.15. 
Retention of Records ................................................................................................192 
10.2.16. 
Study and Site Closure..............................................................................................192 
10.2.17. 
Publication Policy .....................................................................................................193 
10.3. 
APPENDIX 3: Contraceptive Guidance ...................................................................194 
10.4. 
APPENDIX 4: Toxicity Grading Scale Tables ........................................................195 
10.5. 
APPENDIX 5: Adverse Event of Special Interest Terms ........................................197 
10.6. 
APPENDIX 6: Protocol Amendment History ..........................................................200 
10.6.1. 
Amendment 3: 23 Aug 2021 .....................................................................................200 
10.6.2. 
Amendment 2: 28 Jul 2021 .......................................................................................204 
10.6.3. 
Amendment 1: 18 Jun 2021 ......................................................................................209 
 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 54 
LIST OF TABLES 
Table 1: 
Study Objectives and Endpoints .................................................................................69 
Table 2: 
Study Arms .................................................................................................................82 
Table 3: 
Primary Series Vaccination for Booster Dose Eligibility ...........................................91 
Table 4: 
Solicited Adverse Reactions and Grades ..................................................................134 
Table 5: 
Analysis Sets .............................................................................................................152 
Table 6: 
Analysis Strategy for Safety Parameters ..................................................................154 
Table 7: 
Primary Schedule of Events for Unvaccinated SOT and Healthy Participants 
Who Receive the 2-Dose Vaccination Regimen (Part A: Group A1 and 
Group A5) .................................................................................................................166 
Table 8: 
Primary Schedule of Events for Unvaccinated Participants Who Receive the 
3-Dose Vaccination Regimen (Part A: Group A2) ...................................................170 
Table 9: 
Primary Schedule of Events for Previously Vaccinated Participants Who 
Receive a Single-dose Vaccination Regimen (dose 3) (Part A: Group A3) .............175 
Table 10: Booster Dose Phase (Part B: Group B2, Group B3, Group B4, and 
Group B5) .................................................................................................................179 
Table 11: Severity Grading of Laboratory Abnormalities ........................................................195 
Table 12: Severity Grading of Vital Sign Abnormalities .........................................................196 
Table 13: Adverse Events of Special Interest ...........................................................................197 
LIST OF FIGURES 
Figure 1: 
Study Schema for Unvaccinated Participants Who Receive the 2-Dose 
Vaccination Regimen (Part A) ....................................................................................84 
Figure 2: 
Study Schema for Unvaccinated Participants Who Receive the 3-Dose 
Vaccination Regimen (Part A) ....................................................................................85 
Figure 3: 
Study Schema for Previously Vaccinated Participants Who Receive a 
Single-dose Vaccination Regimen (dose 3) (Part A) ..................................................86 
Figure 4: 
Booster Phase Study Pathway ....................................................................................87 
Figure 5: 
Study Schema for Booster Dose Phase (Part B) .........................................................88 
Figure 6: 
Surveillance for COVID-19 Symptoms and the Corresponding Clinical Data 
Pathways ...................................................................................................................129 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 55 
 
LIST OF ABBREVIATIONS AND TERMS 
The following abbreviations and terms are used in this study protocol. 
Abbreviation or Specialist Term Definition 
Ab 
antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AR 
adverse reaction 
AST 
aspartate aminotransferase 
bAb 
binding antibody 
BD 
booster dose 
CDC 
US Centers for Disease Control and Prevention 
CEAC 
Cardiac Event Adjudication Committee 
CFR 
Code of Federal Regulations 
CMI 
cell-mediated immunity 
cMRI 
cardiac magnetic resonance imaging 
CoV 
coronavirus 
COVID-19 
coronavirus disease 2019 
CRO 
contract research organization 
CSR 
clinical study report 
DMID 
Division of Microbiology and Infectious Diseases 
ECG (or EKG) 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eDiary 
electronic diary 
EOS 
end of study 
ERD 
enhanced respiratory disease 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 56 
EUA 
Emergency Use Authorization 
FAS 
Full Analysis Set 
FDA 
US Food and Drug Administration 
FIO2 
fraction of inspired oxygen 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
GM  
geometric mean 
GMT 
geometric mean titer 
GMFR 
geometric mean fold rise 
HCP 
healthcare practitioner 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IM 
intramuscular(ly) 
IRB 
institutional review board 
IST 
internal safety team 
LNP 
lipid nanoparticle 
LTFU 
lost to follow-up 
MAAE 
medically attended adverse event 
MedDRA 
Medical Dictionary for Regulatory Activities 
MERS 
Middle East Respiratory Syndrome 
mITT 
modified intent-to-treat 
MN 
microneutralization 
mRNA 
messenger RNA 
nAb 
neutralizing antibody 
NHP 
nonhuman primate 
NP 
nasopharyngeal 
PaO2 
partial pressure of oxygen 
PCR 
polymerase chain reaction 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 57 
PP 
per protocol 
Previously vaccinated 
SOT recipients who were previously vaccinated with 2 doses 
of the Moderna COVID-19 vaccine under the EUA prior to 
enrollment 
PsVNT 
Pseudovirus neutralization titer (ID50) 
RT-PCR 
reverse transcriptase polymerase chain reaction 
S 
spike 
S2P 
SARS-CoV-2 spike protein modified with 2 proline 
substitutions to stabilize the spike protein in a prefusion 
conformation 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS 
Severe Acute Respiratory Syndrome 
SARS-CoV-2 
Severe Acute Respiratory Syndrome coronavirus 2 
SM-102 
heptadecane-9-yl8-((2hydroxyethyl)(6oxo6-
(undecyloxy)hexyl)amino)octanoate 
SoE 
schedule of events 
SOT 
solid organ transplant 
SpO2 
oxygen saturation 
SRC 
safety review committee 
Study P301 
Phase 3 clinical endpoint efficacy study mRNA-1273-P301; 
NCT04470427 
Th1 
T helper cell 1 
UPCR 
urine protein to creatinine ratio 
US 
United States 
WHO 
World Health Organization 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 58 
1. 
INTRODUCTION 
1.1. 
Study Rationale 
Coronaviruses (CoVs) are a large family of viruses that cause illness ranging from the common 
cold to more severe diseases, such as Middle East Respiratory Syndrome (MERS) and Severe 
Acute Respiratory Syndrome (SARS). Coronaviruses are zoonotic, meaning they are transmitted 
between animals and people. An outbreak of the CoV disease 2019 (COVID-19) caused by SARS 
coronavirus 2 (SARS-CoV-2) began in Wuhan, Hubei Province, China in December 2019 and has 
spread throughout China and to over 215 other countries, territories, and areas including the United 
States (WHO 2020a). On 11 Mar 2020, the World Health Organization (WHO) officially declared 
COVID-19 a pandemic. As of 26 Mar 2021, the WHO dashboard (WHO 2020b) reported there 
have been 2,744,543 COVID-19 deaths worldwide and more than 500,000 deaths in the United 
States. The US Centers for Disease Control and Prevention (CDC) have reported that the highest 
risk of disease burden is in older adults (≥ 65 years old) and in people of any age who have serious 
underlying medical conditions, such as chronic lung disease or moderate to severe asthma, serious 
heart conditions, severe obesity, diabetes, chronic kidney disease requiring dialysis, and liver 
disease, and in those who are immunocompromised (CDC 2020a). 
Immunocompromised populations, such as individuals who are solid organ transplant (SOT) 
recipients, are at especially high risk for increased complications of COVID-19 because of their 
associated co-morbidities and chronic immunosuppression. A recent meta-analysis of 215 studies 
assessing clinical outcomes of COVID-19 in SOT recipients (kidney, liver, heart, and lung) 
internationally showed an overall mortality rate of 18.6% (Raja et al 2020). Initial results on the 
clinical outcomes of COVID-19 estimated a high mortality rate ranging between 13% and 39% in 
kidney transplant recipients (Azzi et al 2020 [patients in the US]; Cravedi et al 2020 [patients in 
the US, Italy, and Spain]; Lubetzky et al 2020 [patients in the US]; Mehta et al 2020 [patients in 
the US]; Nair et al 2020 [patients in the US]; Pereira et al 2020 [patients in the US]) and 12% in 
European liver transplant recipients (Bechetti et al 2020). In a recent prospective cohort study, 
(Walsh et al 2020) a low proportion (17%) of SOT recipients mounted a positive antibody response 
to the first dose of SARS-CoV-2 messenger RNA (mRNA) vaccines, with those who receive 
anti-metabolite maintenance immunosuppression less likely to respond (Boyarsky et al 2021a). In 
the published follow-up study (Boyarsky et al 2021b), antibody response was assessed after the 
second dose. Overall, of the 658 participants, 98 (15%) had measurable antibody response after 
dose 1 and dose 2; 301 (46%) had no antibody response after dose 1 or dose 2; and 259 (39%) had 
no antibody response after dose 1 but had subsequent antibody response after dose 2. In addition, 
recent data based on post-Emergency Use Authorization (EUA) experience show that SOT 
recipients’ immune response to mRNA-based vaccination has been shown to be substantially 
lower than what has been reported in the general population with antibody responses detectable in 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 59 
only 30-60% after 2 doses (Benotmane et al 2021; Boyarsky et al 2021b, Grupper et al 2021; 
Marinaki et al 2021). 
A more recent small case series evaluated the antibody responses and vaccine reactions in 30 SOT 
recipients who had suboptimal response to standard vaccination (Moderna or Pfizer COVID-19 
vaccine) and subsequently received a third dose of the vaccine (either Janssen, Moderna, or Pfizer 
COVID-19 vaccine), the investigators observed that of the 6 patients with low-positive antibody 
titers before the third dose, all had high-positive antibody titers after the third dose. In contrast, of 
the 24 patients with negative antibody titers before the third dose, only 6 (25%) had high-positive 
antibody titers after the third dose. Two (8%) had low-positive antibody titers, and 16 (67%) 
remained negative (Werbel et al 2021). 
In addition, a recently published article described a double-blind, randomized, controlled trial of a 
third dose of mRNA-1273 vaccine (Moderna) as compared with placebo (NCT04885907; Hall et 
al 2021). The results demonstrated that a third dose of mRNA-1273 vaccine in transplant recipients 
elicited a substantially higher immune response than placebo, as determined in the analysis of both 
primary and secondary trial endpoints. The third dose was considered safe when risk versus benefit 
was considered. 
Interim data are available from an ongoing Moderna Phase 2 study, mRNA-1273-P201 (Study 
P201) where healthy adult participants in Study mRNA-1273-P201 received 2 doses of either 
50 µg or 100 µg of mRNA-1273 and were administered a 50 µg booster of mRNA-1273 6 to 
8 months after the second dose. Participants in mRNA-1273-P201 who received the booster dose 
(BD), demonstrated enhanced immune responses to SARS-CoV-2 compared to pre-boost levels 
and met the noninferiority criteria stipulated in the US Food and Drug Administration Guidance 
on EUA for Vaccines to Prevent COVID-19. Available data also show that heterologous or mixed 
series of COVID-19 vaccine induced high immune response in the adult population (Atmar et al 
2021). Additionally, no new safety signals emerged upon administration of the BD in Study P201. 
Based on cumulative evidence, the benefit-risk profile of a BD of mRNA-1273 is favorable, 
particularly in light of increasing breakthrough disease with the emergence of the Delta variant. 
Providing the option for a BD to all eligible participants currently enrolled in the study as well as 
enrolling eligible SOT recipients who completed primary vaccination series under EUA is 
expected to generate valuable homologous and heterologous booster data in the 
immunocompromised population. 
The study vaccine, mRNA-1273, is currently being evaluated in a pivotal Phase 3 efficacy, safety, 
and immunogenicity study in an adult population at high risk of COVID-19 disease (Study P301). 
Success criteria for early efficacy were met at first interim analysis based on 95 adjudicated cases 
with a vaccine efficacy of 94.5% (95% CI: 86.5%, 97.8%; one-sided p-value < 0.0001). However, 
immunocompromised individuals were excluded from this study. The current study aims to 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 60 
evaluate the antibody (Ab) responses following the second or third dose of mRNA-1273 vaccine 
among adult recipients of kidney or liver transplants. The data are expected to provide clinical 
information whether this population of immunocompromised participants are able to mount an 
antibody response following vaccination compared with adult participants with normal immune 
function. 
1.2. 
Background and Overview 
The Sponsor has developed a rapid-response, proprietary vaccine platform based on a messenger 
RNA (mRNA) delivery system. The platform is based on the principle and observations that cells 
in vivo can take up mRNA, translate it, and then display protein viral antigen(s) on the cell surface. 
The delivered mRNA does not enter the cellular nucleus or interact with the genome, is 
nonreplicating, and is expressed transiently. Messenger RNA vaccines have been used to induce 
immune responses against infectious pathogens such as SARS-CoV-2 (NCT04283461, 
NCT04405076), cytomegalovirus (NCT03382405), metapneumovirus and parainfluenza virus 
type 3 (NCT03392389), Zika virus (NCT04917861), and influenza virus (NCT03076385 and 
NCT03345043). 
The Sponsor is using its mRNA-based platform to develop a novel lipid nanoparticle (LNP) 
encapsulated mRNA-based vaccine against SARS-CoV-2 (mRNA-1273). mRNA-1273 encodes 
the full-length spike (S) protein of SARS-CoV-2, modified with 2 proline substitutions to stabilize 
the S protein in a prefusion conformation (S2P). The CoV S protein mediates attachment and entry 
of the virus into host cells (by fusion), making it a primary target for neutralizing antibodies (nAbs) 
that prevent infection (Johnson et al 2016; Wang et al 2015; Wang et al 2018; Chen et al 2017; 
Corti et al 2015; Yu et al 2015; Kim et al 2019; Widjaja et al 2019; Corbett et al 2020a; Ju et al 
2020; Robbiani et al 2020). It has been confirmed that the stabilized SARS-CoV-2 S2P expresses 
well and is in the prefusion conformation (Wrapp et al 2020). More details on mRNA-1273 and 
its variants are provided in the Investigator’s Brochure (IB). 
The development of the mRNA-1273 vaccine is being accelerated to address the current 
SARS-CoV-2 outbreak as a result of the uniquely rapid and scalable manufacturing process for 
the mRNA-1273 vaccine. 
1.2.1. 
Nonclinical Studies 
Nonclinical pharmacology, biodistribution, and toxicology studies have been completed using 
mRNA-1273 or other mRNA vaccines that encode various antigens developed with the Sponsor’s 
mRNA‑based platform using SM‑102-containing LNPs. Data from the nonclinical testing program 
support the clinical efficacy and safety of mRNA-1273 at doses up to 100 µg administered twice, 
intramuscularly (IM), 28 days apart. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 61 
• mRNA-1273 induced high levels of binding and neutralizing antibodies in young and 
aged mice, rats, hamsters, and nonhuman primates (NHPs); protected against viral 
replication in the upper (nasal turbinates) and lower (lung) airways; and did not 
promote vaccine-associated enhanced respiratory disease (ERD) in these nonclinical 
models. 
• The biodistribution of mRNA-based vaccines formulated in LNPs is consistent with 
administration of IM drug products and distribution via the lymphatic system. mRNA 
does not persist past 1 to 3 days in tissues other than muscle (injection site), proximal 
popliteal and distal axillary lymph nodes, and spleen, in which the average half-life 
values ranged from 14.9 to 63.0 hours. 
• The rat aggregate Good Laboratory Practice (GLP) repeat-dose toxicity data of 
mRNA vaccines developed with the Sponsor’s mRNA-based platform, together with 
results from the mRNA-1273 non-GLP study, demonstrate a similar, consistent, and 
acceptable toxicity profile supportive of the clinical development of mRNA-1273. 
• Results from the GLP developmental and reproductive toxicity study showed that 
administration of a 100 µg dose of mRNA-1273 to Sprague Dawley rats did not result 
in any adverse effects on dams, fetuses, or pups and demonstrated a strong transfer of 
SARS-CoV-2 S2P antibodies from dam to fetus and from dam to pup. Results from 
this study support the safety of mRNA-1273 for trials in pregnant women. 
In support of the development of mRNA-1273 for prophylaxis against SARS-CoV-2 infection, 
nonclinical immunogenicity, biodistribution, and safety studies have been completed with similar 
mRNA-based 
vaccines 
formulated 
in 
LNPs 
containing 
SM-102 
(heptadecane-9-yl 
8-((2-hydroxyethyl)(6-oxo-6-(undecyloxy)hexyl)amino)octanoate), the novel proprietary lipid 
used in the mRNA-1273 LNP formulation. 
A detailed review of nonclinical experience with mRNA-1273 vaccine is provided in the IB along 
with nonclinical experience with modified mRNA-1273 vaccines. 
1.2.2. 
Clinical Studies 
The clinical development of mRNA-1273 vaccines to support its use in the adult population 
consists of 5 ongoing clinical trials being conducted in the US: 
• Phase 1, open-label, dose ranging studies (Study 20-0003; NCT04283461; Study 21-0002, 
NCT04785144) sponsored by the National Institute of Allergy and Infectious Diseases 
• Phase 2a, randomized, observer-blind, placebo-controlled, dose-confirmation study (Study 
mRNA-1273-P201; NCT04405076) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 62 
• Phase 3 randomized, stratified, observer-blind, placebo-controlled study (Study mRNA-1273-
P301; NCT04470427) to evaluate the efficacy, safety, and immunogenicity of the vaccine 
• Phase 3b, open-label study (Study mRNA-1273-P304, NCT04860297) to evaluate the safety 
and immunogenicity of the vaccine in adult SOT recipients and healthy controls. 
In addition, 2 ongoing trials are being conducted in the pediatric population: 
• Phase 2/3 randomized, placebo-controlled safety and immunogenicity study of mRNA-
1273 in children 12 to less than 18 years of age (Study mRNA-1273-P203; NCT04649151) 
• Phase 2/3, study to evaluate the safety and immunogenicity of mRNA-1273 in children less 
than 12 years of age (mRNA-1273-P204; NCT04796896). 
In addition, Study mRNA-1273-P205 (NCT04927065) is an open-label, Phase 2/3 study with 
multiple parts to evaluate the safety and immunogenicity of boosters for SARS-CoV-2 variants. 
The safety and immunogenicity of mRNA-1273 was evaluated in Phase 1 (Division of 
Microbiology and Infectious Diseases [DMID] 20-0003) and Phase 2 (mRNA-1273-P201) studies, 
which were important in selecting and confirming the dose of the vaccine used in the pivotal 
Phase 3 study. 
In Study 20-0003 (Phase 1), 2 doses of 100 µg or higher generated the highest titers of nAb or 
binding antibody (bAb) with an acceptable safety profile, and this observation was the basis for 
selecting the 100-μg dose for use in the pivotal Phase 3 study. Importantly, the Ab levels after 
2 doses of mRNA-1273 exceeded those from a pool of convalescent sera. Neutralizing activity 
was observed for the 100 µg mRNA-1273 dose as of Day 36 and was higher than that of the 
convalescent sera control group, and the median titers remained in the same range as the median 
titer in the convalescent sera control group at Day 119 across the age strata. In this study, the 
majority of the solicited adverse reactions (ARs) were mild or moderate. A higher incidence of 
severe solicited ARs was observed with the 250 µ dose (in the 18 to 55-year age cohort) compared 
with the lower doses (25 µg, 50 µg, and 100 µg); thus, the 250-μg mRNA-1273 dose was not 
evaluated in participants ≥ 56 years of age. One severe unsolicited adverse event (AE) related to 
mRNA-1273 and 1 severe clinically meaningful elevation in serum lipase related to mRNA-1273 
were also observed with the 250 µg dose (in the 18 to 55-year age cohort). Additionally, in Study 
20-0003, T helper cell 1 (Th1) directed CD4+ T-cells were observed to be induced across age 
groups, with limited indication of a Th2-directed response, and similar responses were observed 
among all age groups for the 100-μg dose. The predominance of a Th1 directed T-cell profile helps 
to mitigate concern of the risk of enhanced disease associated with Th2 driven pathophysiology. 
mRNA-1273-P201 (Study P201) is an ongoing Phase 2a, safety, reactogenicity, and 
immunogenicity study in healthy adults that provided confirmation of the immunogenicity of both 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 63 
the 100 µg and 50 µg doses. The study was designed as a randomized, observer-blind, placebo-
controlled dose-confirmation study (Part A). Two mRNA-1273 dose levels, 50 µg and 100 µg, and 
placebo were evaluated in 2 age cohorts: Cohort 1 enrolled participants ≥ 18 to < 55 years old 
(300 participants), and Cohort 2 enrolled participants ≥ 55 years old (300 participants). A total of 
600 participants received either mRNA-1273 or placebo according to a 1:1:1 randomization ratio, 
ie, within each age cohort, 100 participants each received mRNA-1273 50 µg, mRNA-1273 
100 µg, or placebo. 
An amendment to the Study 201 protocol adapted the study design to include open-label 
interventional phases (Part B and Part C). Part B allowed unblinding of participants and offered 
2 injections of mRNA-1273 in an open-label manner, 28 days apart, to all participants who 
received placebo in Part A. Part B also offered a single BD of mRNA-1273 (50 µg) to participants 
who received 1 or 2 doses of mRNA-1273 (50 µg or 100 µg) in Part A. Part C was prompted by 
the need to proactively prepare for vaccination strategies that might induce broader protection, 
including against emerging variants of SARS-CoV-2 such as B.1.351. Part C enrolled participants 
from Study 301 who received 2 doses of mRNA-1273 100 µg at least 6 months prior. Part C 
participants received a single injection of mRNA-1273.351 (20 µg or 50 µg) or mRNA-1273.351 
mixture (50 µg total – 25 µg of mRNA-1273 and 25 µg of mRNA-1273.351). mRNA-1273 
demonstrated an acceptable safety profile in the participant population enrolled in this study at 
both dose levels and both age cohorts, as observed through 6 months after the second injection. 
Vaccination with mRNA-1273 in Study 201 resulted in robust immune responses to SARS-CoV-2 
in participants 18 years and older at both dose levels, and persistence of immune response was 
observed up to 6 months after the second injection in Part A of the study. In Part A of Study 201, 
the time course and magnitude of antibody (both bAb and nAb) responses to mRNA-1273 was 
similar between 100 µg and 50 µg dose levels at each postbaseline time point (Days 29, 43, 57, 
and 209), although the 100 µg dose group had numerically greater responses (and was the dose 
selected for the pivotal Phase 3 efficacy study). In Part B of Study 201, administration of a 50 µg 
BD of mRNA-1273 6 months or more after the primary series improved the immune responses to 
1.7-fold the peak achieved after the primary vaccination series in the current mRNA-1273-P301 
study, where efficacy of mRNA-1273 against COVID-19 was demonstrated. Safety data based on 
preliminary results for 50 µg BDs of mRNA-1273 (selected participants in Part B) or mRNA-
1273.351 (Part C Cohort 1) are available. Percentages of participants with solicited local and 
systemic AEs were similar in the group who received mRNA-1273.351 as a BD compared to those 
who received mRNA-1273 vaccine as a BD. The majority of solicited local and systemic AEs 
were mild (Grade 1) or moderate (Grade 2). The frequency of any Grade 3 solicited local or 
systemic AE was 15% (3 of 20 participants) after the BD of mRNA-1273 and 10.5% (2 of 19 
participants) after the BD of mRNA-1273.351. There were no Grade 4 solicited local or systemic 
AEs. The most common solicited local AE was injection site pain after injection in both groups 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 64 
(68.4% for the mRNA-1273.351 vaccine and 90.0% for the mRNA-1273 vaccine). The most 
common solicited systemic AEs after the BD of the mRNA-1273.351 vaccine were fatigue 
(36.8%), headache (36.8%), myalgia (31.6%), and arthralgia (21.1%). The most common solicited 
systemic AEs after the BD of the mRNA-1273 vaccine were fatigue (70.0%), headache (55.0%), 
arthralgia (50.0%), and myalgia (45.0%). Fever was reported after the BD of mRNA-1273 in 3 of 
20 participants (15%) but not after the booster dose of mRNA-1273.351 (0 of 19 participants). 
There were no SAEs reported in this study. 
Interim results from the mRNA-1273-P205 study are available. Neutralizing antibodies against 
Omicron were assessed in a pseudovirus neutralization titer (ID50) (PsVNT) assay conducted at 
laboratories established by the National Institute of Allergy and Infectious Diseases’ Vaccine 
Research Center and Duke University Medical Center - Data includes sera from 20 booster 
recipients each of mRNA-1273 at the 50 µg and 100 µg dose levels, multivalent candidate mRNA-
1273.211 at the 50 µg and 100 µg dose levels, and multivalent candidate mRNA-1273.213 at the 
100 µg dose level. 
All groups had low neutralizing antibody levels in the Omicron PsVNT assay prior to boosting. 
At Day 29 post boost, the authorized 50 µg booster of mRNA-1273 increased neutralizing 
geometric mean titers (GMT) against Omicron to 850, which is approximately 37-fold higher than 
pre-boost levels. At Day 29 post boost, the 100 µg dose booster of mRNA-1273 increased 
neutralizing GMT to 2228, which is approximately 83-fold higher than pre-boost levels. The 
multivalent candidates boosted Omicron specific neutralizing antibody levels to similarly high 
levels at both the 50 µg and 100 µg levels. 
Safety and tolerability data from the Phase 2/3 study of the 100 µg booster dose of mRNA-1273 
(N = 305) show that a 100 µg booster dose of mRNA-1273 was generally safe and well tolerated. 
The frequency and nature of solicited systemic and local AEs 7 days after receiving a booster were 
generally comparable to those seen after the 2-dose primary series. There was a trend toward more 
frequent local and systemic solicited ARs following the 100 µg booster dose relative to the 
authorized 50 µg booster dose of mRNA-1273. 
Currently, a Phase 3 pivotal, randomized, placebo-controlled, observer-blind clinical study 
(mRNA-1273-P301; NCT04470427; Study P301) is being conducted in participants 18 years of 
age and older who were at increased risk of COVID-19 disease. In addition, prespecified cohorts 
of participants who were either ≥ 65 years of age or 18 to < 65 years of age with comorbid medical 
conditions were included. At the time of the 25 Nov 2020 data snapshot (which was the basis for 
the EUA), a total of 30,351 participants were followed for a median of 92 days (range: 1-122 days) 
for the development of COVID-19 disease (Moderna mRNA-1273 IB). Success criteria for early 
efficacy were met at the first interim analysis based on 95 adjudicated cases with a vaccine efficacy 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 65 
of 94.5% (95% CI: 86.5%, 97.8%; one-sided p value < 0.0001). Study P301 is expected to provide 
immunogenicity data where an Ab threshold of protection against COVID-19 will be estimated. 
In Study P301, solicited ARs were reported more frequently among vaccine participants than 
placebo participants. The most frequently reported ARs after any dose in the vaccine group were 
pain at the injection site (92.0% any grade; 6.1% grade ≥ 3), fatigue (70% any grade; 10.1% 
grade ≥ 3), headache (64.7% any grade; 5.7% grade ≥ 3), myalgia (61.5% any grade; 9.1% 
grade ≥ 3), and chills (45.4% any grade; 1.4% grade ≥ 3). The majority of local and systemic ARs 
had a median duration of 1 to 3 days. Overall, there was a higher reported rate of some ARs in 
younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, 
arthralgia, chills, nausea/vomiting, and fever was higher in adults aged 18 to < 65 years than in 
those aged 65 years and above. Grade 3 solicited local ARs were more frequently reported after 
dose 2 than after dose 1. In the participants who received the vaccine, solicited systemic ARs were 
reported numerically more frequently by vaccine participants after dose 2 than after dose 1. 
Grade 3 systemic ARs (fatigue, myalgia, arthralgia, and headache) were reported more frequently 
after dose 2 than after dose 1. 
Unsolicited AEs and serious adverse events (SAEs) were reported at generally similar rates in 
participants who received mRNA-1273 and placebo from the first dose until the last observation. 
Unsolicited AEs that occurred in ≥ 1% of study participants who received mRNA-1273 and at a 
rate at least 1.5-fold higher rate than placebo were lymphadenopathy related events (1.1% of versus 
0.6%). All of the lymphadenopathy events are similar to the axillary swelling/tenderness in the 
injected arm reported as solicited ARs. Hypersensitivity AEs were reported in 1.5% of vaccine 
recipients and 1.1% of placebo recipients. Hypersensitivity events in the vaccine group included 
injection site rash and injection site urticaria, which are likely related to vaccination. There have 
been no cases of severe hypersensitivity or anaphylactic reactions reported immediately after 
vaccination in the trial to date. Delayed injection site reactions that began >7 days after vaccination 
were reported in 1.2% of vaccine recipients and 0.4% of placebo recipients. Delayed injection site 
reactions included pain, erythema, and swelling and are likely related to vaccination. 
There were 3 reports of Bell’s palsy in the mRNA-1273 vaccine group (one of which was an SAE), 
which occurred 22, 28, and 32 days after vaccination, and one in the placebo group, which occurred 
17 days after vaccination. The currently available information on Bell’s palsy is insufficient to 
determine a causal relationship with the vaccine. There were 2 SAEs of facial swelling in vaccine 
recipients with a history of injection of dermatological fillers. The onset of swelling was reported 
1 and 2 days, respectively, after vaccination and was likely related to vaccination. There was 
1 SAE of intractable nausea and vomiting in a participant with prior history of severe headache 
and nausea requiring hospitalization. This event occurred 1 day after vaccination and was likely 
related to vaccination. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 66 
There were no other notable patterns or numerical imbalances between treatment groups for 
specific categories of AEs (including other neurologic, neuro-inflammatory, and thrombotic 
events) that would suggest a causal relationship to mRNA-1273. 
Efficacy and safety results based on the final analysis of Part A with a database lock of 
04 May 2021 are provided in the IB. The results are generally comparable to the interim analysis. 
On 25 Aug 2021, Moderna announced that it had completed the rolling submission process for its 
Biologics License Application to the Food and Drug Administration (FDA) for the full licensure 
of the Moderna COVID-19 vaccine (mRNA-1273) for active immunization to prevent COVID-19 
in individuals 18 years of age and older. mRNA-1273 has been showing durable efficacy of 93% 
through 6 months after the second dose. 
In the post-EUA period, anaphylaxis has been reported following mRNA-1273 administration. 
There have been very rare reports of myocarditis and pericarditis occurring after vaccination with 
COVID-19 mRNA vaccines; however, no cases of myocarditis were observed in the clinical 
program. 
A detailed review of the clinical experience with LNPs containing SM-102 (mRNA vaccines and 
placebo) is provided in the IB. 
1.3. 
Benefit/Risk Assessment 
1.3.1. 
Potential Benefits from Participation 
The following benefits may accrue to participants: 
• The mRNA-1273 vaccine may be effective to prevent COVID-19. 
• Participants will have a baseline (Day 1) evaluation for SARS-CoV-2 infection and 
ongoing surveillance for COVID-19 throughout the study. 
• The study will contribute to the development of a vaccine against COVID-19 for 
immunocompromised individuals. 
1.3.2. 
Risks to Study Participants and Risk Mitigation 
Immediate systemic allergic reactions (eg, anaphylaxis) can occur following any vaccination. The 
risk of anaphylaxis after all vaccines is estimated to be 1.31 (95% CI, 0.90-1.84) per million 
vaccine doses (McNeil and DeStefano 2018). Anaphylaxis has been reported in the post-EUA 
period for mRNA-1273 (more than 7.7 million doses administered; CDC 2021a), although not in 
the ongoing Study P301, at the time of the 25 Nov 2020 data snapshot (Section 1.2.2). In the post-
EUA period, the rate of anaphylaxis following first dose of Moderna COVID-19 vaccine from 21 
Dec 2020 to 10 Jan 2021 was estimated to be 2.5 cases per million doses administered, and most 
cases occurred in individuals with a history of allergic reactions or anaphylaxis unrelated to 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 67 
vaccines (CDC 2021b). As a precaution, all participants will remain under observation at the study 
site for at least 30 minutes after injection. 
Vasovagal syncope (fainting) can occur before or after any vaccination, is usually triggered by the 
pain or anxiety caused by the injection and is not related to the substance injected. Therefore, it is 
important that standard precautions and procedures are followed to avoid injury from fainting. 
Intramuscular injection with other mRNA vaccines manufactured by the Sponsor containing the 
SM-102 lipid formulation commonly results in a transient and self-limiting local inflammatory 
reaction. This typically includes pain, erythema (redness), or swelling (hardness) at the injection 
site, which are mostly mild to moderate in severity and usually occur within 24 hours of injection. 
A summary of the safety profile of the mRNA-1273 vaccine observed during the ongoing 
Stud P301 is presented in Section 1.2.2. 
There is a theoretical risk that active vaccination to prevent SARS-CoV-2 infection may cause a 
paradoxical increase in the risk of COVID-19. This possibility is based on the rare phenomenon 
of vaccine-associated disease enhancement, which was first seen in the 1960s with 2 vaccines 
made in the same way (formalin-inactivated whole virus) and designed to protect children against 
infection with respiratory syncytial virus (Chin et al 1969) or measles virus (Fulginiti et al 1967). 
Disease enhancement has also been proposed as a possible explanation for cases of more serious 
disease associated with dengue vaccination (Thomas and Yoon 2019; WHO 2019). 
In order to address this theoretical risk, animal studies were performed in young and aged wild 
type mice and rhesus macaques (NHPs). These studies were designed to capture immunogenicity 
endpoints that would be predictive of ERD and also to evaluate if, at protective or subprotective 
dose levels of mRNA-1273, evidence of disease enhancement would be observed after challenge 
of the animals with SARS-CoV-2. These nonclinical studies demonstrated that mRNA-1273 is 
safe and well tolerated in different animal species; is immunogenic; drives a robust SARS-CoV-2 
specific Ab, neutralization, and Th1 directed CD4+ T-cell response; fully protects animals from 
challenge at dose levels as low as 1 µg/dose in mice and 30 µg/dose in NHPs; and does not lead 
to ERD at protective or subprotective dose levels (Corbett et al 2020a; Corbett et al 2020b). 
Clinical immunogenicity data from the DMID Phase 1 study of mRNA-1273 demonstrated high 
levels of nAbs and Th1 polarized CD4+ T-cell responses (Jackson et al 2020), consistent with the 
immunogenicity observed in these nonclinical studies. Lastly, in Study P301, after a median 
follow-up of 2 months after the second dose of vaccine, the overwhelming majority of COVID-19 
cases occurred in participants who received placebo rather than mRNA-1273 (Baden et al 2020), 
consistent with a low risk of ERD following vaccination with mRNA-1273. These data suggest 
that a paradoxical increase in the risk of disease, while not eliminated, is likely to be low. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 68 
In the context of the EUA for individuals 18 years and older for mRNA-1273, there have been 
very rare reports of myocarditis and pericarditis occurring after vaccination with Moderna 
COVID-19 vaccine. Although causality has not been established, the majority of the cases have 
been reported in young males within 7 days after the second dose of the vaccine. These are 
typically mild cases and individuals tend to recover within a short time following standard 
treatment and rest (Gargano et al 2021). 
The AEs after receiving a third dose of mRNA-1273 are described in Section 1.2.2. In general, 
solicited local and systemic adverse reactions after the BD (Study P201) were comparable to what 
had been observed with the primary series (Study P301). The AEs after receiving a 100 µg booster 
dose of mRNA-1273 are described in Section 1.2.2. The frequency and nature of solicited systemic 
and local AEs 7 days after receiving a 100 µg booster dose of mRNA-1273 were generally 
comparable to those seen after the 2-dose primary series. There was a trend toward more frequent 
local and systemic solicited ARs following the 100 µg booster dose relative to the authorized 50 µg 
booster dose of mRNA-1273. The AEs after receiving a fourth dose are currently being evaluated. 
It is unknown if the AEs after getting a fourth dose of mRNA-1273 are different from getting 2 or 
3 doses of mRNA-1273. 
1.3.3. 
Overall Benefit/Risk Conclusion 
In Part A, all healthy participants (Group A5) will benefit from the 2-dose regimen of 100 µg 
mRNA-1273 vaccine administered in 2 doses 28 days apart, the same regimen and dose that 
received EUA. All SOT unvaccinated recipients will receive the same 2-dose regimen (Group A1) 
and also be offered the option of receiving a third dose on Day 85 (Group A2) (Section 3.1). All 
previously vaccinated SOT recipients who received 2 doses of the Moderna COVID-19 vaccine 
outside of the study will receive a third dose on Day 1 (Group A3). In the booster phase Part B, all 
participants in Part A will be offered to receive a 100 µg BD of mRNA-1273 (Group B2, 
Group B3, and Group B5); Eligible SOT recipients who completed primary vaccination series 
under EUA will be enrolled and given a 100 µg BD of mRNA-1273 (Group B4). 
Safety will be monitored throughout the study (Section 7.6). 
Considering the limited number of approved vaccines for COVID-19, the participants’ risk of 
COVID-19 outside the study during a pandemic, and the nonclinical and clinical data to date, the 
Sponsor considers the potential benefits of participation to exceed the risks. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 69 
2. 
OBJECTIVES AND ENDPOINTS 
The objectives which will be evaluated in this study and endpoints associated with each objective 
are provided in Table 1. 
Table 1: Study Objectives and Endpoints
Objectives 
Endpoints 
Part A 
Primary Objectives 
Primary Endpoints 
• 
To evaluate the safety of 100 µg 
mRNA-1273 administered in 
2-dose or 3-dose regimens 
 
• 
Unsolicited adverse events (AEs) through 
28 days after each injection 
• 
Medically attended adverse events 
(MAAEs) from Day 1 and throughout the 
study period 
• 
Serious adverse events (SAEs) from Day 1 
and throughout the study period 
• 
Adverse events of special interest (AESIs) 
from Day 1 and throughout the study period 
• 
AEs leading to discontinuation from dosing 
and/or study participation (withdrawal) on 
Day 1 and throughout the study period 
• 
Biopsy-proven organ rejection from Day 1 
and throughout the study period 
• 
To evaluate the reactogenicity of 
100 µg mRNA-1273 administered 
in 2-dose or 3-dose regimen 
• 
Solicited local and systemic adverse 
reactions (ARs) through 7 days after each 
injection (for unvaccinated participants 
who received 2 doses of mRNA-1273 ) 
• 
Solicited local and systemic ARs through 
7 days after each injection (for 
unvaccinated SOT recipients who received 
3 doses and SOT recipients previously 
vaccinated outside the study who received a 
third dose) 
• 
To evaluate serum neutralizing 
antibody (nAb) responses to doses 
of 100 µg mRNA-1273 obtained 
• 
The geometric mean titer (GMT) value of 
serum Severe Acute Respiratory Syndrome 
coronavirus 2 (SARS-CoV-2)-specific nAb 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 70 
Objectives 
Endpoints 
28 days after the second dose or 
third dose 
level after the second dose (Day 57 for 
unvaccinated participants []) 
• 
The GMT value of SARS-CoV-2-specific 
nAb level 28 days after dose 3 (Day 113 for 
unvaccinated SOT recipients and Day 29 
for previously vaccinated SOT recipients) 
Secondary Objectives 
Secondary Endpoints 
• To evaluate the persistence of the 
immune response to 2 or 3 doses of 
100 µg mRNA-1273, as assessed 
by the level of anti-SARS-CoV-2 
Spike (S) specific binding antibody 
(bAb) through 1 year after dose 2 
or dose 3 
• 
For all unvaccinated participants, the 
geometric mean (GM) value of anti-SARS-
CoV-2 S-specific bAb on Day 1, Day 29 
(28 days after dose 1), and Day 57 (28 days 
after dose 2) 
o For participants receiving the 2-dose 
regimen, GM will be evaluated on Day 
209 (6 months after dose 2), and Day 
394 (1 year after dose 2) 
o For participants receiving the 3-dose 
regimen, GM will be evaluated on Day 
85 (dose 3), Day 113 (28 days after dose 
3), Day 265 (6 months after dose 3), and 
Day 450 (1 year after dose 3) 
• 
For all previously vaccinated SOT 
recipients, GM will be evaluated on Day 1 
(dose 3), Day 29 (28 days after dose 3), 
Day 180 (6 months after dose 3), and 
Day 365 (1 year after dose 3) 
• 
For all unvaccinated participants, the 
geometric mean fold rise (GMFR) of bAb 
relative to Day 1 on Day 29 (28 days after 
dose 1), and Day 57 (28 days after dose 2) 
o For participants receiving the 2-dose 
regimen, GMFR will evaluated on Day 
209 (6 months after dose 2), and Day 
394 (1 year after dose 2) 
o For participants in the 3-dose regimen, 
GMFR will be evaluated on Day 85 
(dose 3), Day 113 (28 days after 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 71 
Objectives 
Endpoints 
dose 3), Day 265 (6 months after dose 
3), and Day 450 (1 year after dose 3) 
• 
For all previously vaccinated SOT 
recipients, GMFR of bAb relative to Day 1 
(dose 3) will be evaluated on Day 29 
(28 days after dose 3), Day 180 (6 months 
after dose 3), and Day 365 (1 year after 
dose 3) 
• To evaluate the persistence of the 
immune response to 2 or 3 doses of 
100 µg mRNA-1273, as assessed 
by the level of nAb through 1 year 
after dose 2 or dose 3 
• 
For all unvaccinated participants, the GMT 
values of SARS-CoV-2-specific nAb on 
Day 1 and Day 29 (28 days after dose 1) 
o For participants in the 2-dose regimen, 
GMT will be evaluated on Day 209 (6 
months after dose 2) and Day 394 (1 
year after dose 2) 
o For participants in the 3-dose regimen, 
GMT will be evaluated on Day 85 (dose 
3), Day 113 (28 days after dose 3), Day 
265 (6 months after dose 3), and Day 
450 (1 year after dose 3) 
• 
For all previously vaccinated SOT 
recipients, GMT values of SARS-CoV-2-
specific nAb will be evaluated on Day 1 
(dose 3), Day 29 (28 days after dose 3), 
Day 180 (6 months after dose 3), and 
Day 365 (1 year after dose 3) 
• 
For all unvaccinated participants, GMFR of 
nAb relative to Day 1 will be evaluated on 
Day 29 (28 days after dose 1) and Day 57 
(28 days after dose 2) 
o For participants receiving the 2-dose 
regimen, GMFR will be evaluated on 
Day 209 (6 months after dose 2), and 
Day 394 (1 year after dose 2) 
o For participants in the 3-dose regimen, 
GMFR will be evaluated on Day 85 
(dose 3), Day 113 (28 days after dose 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 72 
Objectives 
Endpoints 
3), Day 265 (6 months after dose 3), and 
Day 450 (1 year after dose 3) 
• 
For all previously vaccinated SOT 
recipients, GMFR of nAb relative to Day 1 
(dose 3) will be evaluated on Day 29 
(28 days after dose 3), Day 180 (6 months 
after dose 3), and Day 365 (1 year after 
dose 3) 
• To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult solid organ 
transplant (SOT) recipients and 
healthy adult participants with 
negative SARS-CoV-2 at baseline 
• 
The incidence of asymptomatic 
SARS-CoV-2 infection among recipients of 
mRNA-1273 SARS-CoV-2 vaccine will be 
defined in participants with negative 
SARS-CoV-2 at baseline as bAb levels 
against SARS-CoV-2 nucleocapsid protein 
negative (as measured by Roche Elecsys) at 
Day 1 that become positive (as measured 
by Roche Elecsys) counted starting 28 days 
after the second dose and 28 days after the 
third dose of vaccine, OR 
• 
Positive reverse transcriptase polymerase 
chain reaction (RT-PCR) counted starting 
14 days after the second and after the third 
dose of vaccine 
• To describe the incidence of 
coronavirus disease 2019 
(COVID-19) after vaccination with 
mRNA-1273 in SOT recipients and 
healthy participants 
• 
First occurrence of COVID-19 starting 
14 days after the second dose and after the 
third dose of vaccine, where COVID-19 is 
defined as symptomatic disease based on 
the following criteria 
• 
The participant must have experienced at 
least TWO of the following symptoms: 
fever (≥ 38°C/≥ 100.4°F), chills, myalgia, 
headache, sore throat, or new olfactory and 
taste disorder(s), OR 
• 
The participant must have experienced at 
least ONE of the following respiratory 
signs/symptoms: cough, shortness of breath 
or difficulty breathing, OR clinical or 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 73 
Objectives 
Endpoints 
radiographical evidence of pneumonia, 
AND 
• 
The participant must have at least 
1 nasopharyngeal (NP) swab, nasal swab, 
or saliva sample (or respiratory sample, if 
hospitalized) positive for SARS-CoV-2 by 
RT-PCR 
• 
First occurrence of severe COVID-19 
starting 14 days after the second dose and 
after the third dose of vaccine, where 
severe COVID-19 is defined as 
symptomatic COVID-19 AND any of the 
following: 
o Clinical signs indicative of severe 
systemic illness, respiratory rate ≥ 30 
per minute, heart rate ≥ 125 beats per 
minute, oxygen saturation (SpO2) ≤ 
93% on room air at sea level, or partial 
pressure of oxygen (PaO2)/fraction of 
inspired oxygen (FIO2) < 300 mm Hg, 
OR 
o Respiratory failure or acute respiratory 
distress syndrome (ARDS, defined as 
needing high-flow oxygen, noninvasive 
or mechanical ventilation, or 
extracorporeal membrane oxygenation) 
or evidence of shock (systolic blood 
pressure [BP] < 90 mm Hg, diastolic BP 
< 60 mm Hg, or requiring 
vasopressors), OR 
o Significant acute renal, hepatic, or 
neurologic dysfunction, OR 
o Admission to an intensive care unit or 
death 
o The secondary case definition of 
COVID-19 is defined as the following 
symptoms: fever (temperature ≥ 38ºC) 
or chills, cough, shortness of breath or 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 74 
Objectives 
Endpoints 
difficulty breathing, fatigue, muscle 
aches or body aches, headache, new loss 
of taste or smell, sore throat, nasal 
congestion or rhinorrhea, nausea or 
vomiting or diarrhea AND a positive 
NP swab, nasal swab, or saliva sample 
(or respiratory sample, if hospitalized) 
for SARS-CoV-2 by RT-PCR. 
• To describe changes in liver and 
renal function through laboratory 
tests over time in SOT recipients 
after vaccination with mRNA-1273 
vaccine 
• Safety laboratory assessments of kidney 
(serum creatinine, urine protein, and urine 
protein to creatinine ratio [UPCR]) and liver 
(alanine aminotransferase [ALT], aspartate 
aminotransferase [AST], alkaline 
phosphatase [ALP], and bilirubin) function: 
o For unvaccinated SOT recipients, from 
Day 1 through Day 57 for SOT 
recipients who receive 2 doses and 
through Day 113 for SOT recipients 
who receive 3 doses of mRNA-1273 
o For previously vaccinated SOT 
recipients, from Day 1 (dose 3) through 
Day 29 (28 days after dose 3) 
• To describe changes in 
immunosuppressant medications in 
SOT recipients after vaccination 
with mRNA-1273 vaccine 
• 
Change in immunosuppressant medications 
to treat organ transplant rejection or to 
improve immune tolerance from Day 1 and 
throughout the study period. Change in 
immunosuppressant medication is defined 
as any of the following: 
o any adjustments (temporarily or 
permanently) in immunosuppressants, 
o addition of new immunosuppressants, 
o or switching from 1 maintenance 
rejection prophylaxis regimen to 
another. 
Exploratory Objectives 
Exploratory Endpoints 
• 
To evaluate the genetic and/or 
phenotypic relationships of 
• 
Comparison of genetic sequence of viral 
isolates with that of the vaccine sequence 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 75 
Objectives 
Endpoints 
isolated SARS-CoV-2 strains to 
the vaccine sequence 
• 
To characterize the clinical profile 
and immune responses of 
participants with COVID-19 or 
with SARS-CoV-2 infection 
• 
Description of clinical severity and immune 
responses of participants who are identified 
as infected by SARS-CoV-2 or having 
COVID-19 
• 
To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult SOT 
recipients and healthy adult 
participants with serologic 
evidence of infection at baseline 
• 
GM and GMFR of bAb levels against 
SARS-CoV-2 nucleocapsid protein 
(quantitative immunoglobulin G [IgG]) and 
percent of study participants with 2×, 3×, 
and 4× rise of bAb relative to baseline 
• 
To assess, in a subset of SOT 
recipients who received 3-dose 
regimen and healthy participants 
who received 2-dose regimen, 
SARS-CoV-2 S protein-specific 
T-cell responses 
• 
Magnitude, phenotype, and percentage of 
cytokine producing S protein-specific T-
cells as measured by flow cytometry at Day 
1, Day 36, and Day 92 for unvaccinated 
SOT recipients, at Day 1 and Day 8 for 
previously vaccinated SOT recipients, and 
at Day 1 and Day 36 in healthy participants 
• 
To define, in a subset of SOT 
recipients who received 3-dose 
regimen and healthy participants, 
the epitopes recognized by B-cells 
and antibodies generated in 
response to mRNA-1273 
• 
Magnitude 
and 
phenotype 
of 
S 
protein-specific B-cells as measured by flow 
cytometry at Day 1, Day 36, and Day 92 for 
unvaccinated SOT recipients, at Day 1 and 
Day 8 for previously vaccinated SOT 
recipients, and at Day 1 and Day 36 in 
healthy participants 
• 
Determination of targeted major antigenic 
sites 
and 
amino 
acid 
residues 
on 
SARS-CoV-2 S protein 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 76 
Objectives 
Endpoints 
Part B – Booster Phase 
Primary Objectives 
Primary Endpoints  
• 
To evaluate the safety of the 
100 µg BD of mRNA-1273 
• 
Solicited local and systemic ARs through 7 
days after BD injection 
• 
Unsolicited AEs through 28 days after BD 
injection 
• 
MAAEs throughout the study period 
• 
SAEs throughout the study period 
• 
AESIs, including myocarditis/pericarditis 
throughout the study period 
• 
AEs leading to discontinuation from dosing 
and/or study participation (withdrawal) 
throughout the study period 
• 
• Biopsy-proven 
organ 
rejection 
throughout the study period 
• 
To evaluate serum nAb responses 
elicited by the 100 µg mRNA-
1273 obtained 28 days after the 
BD 
• 
The GMT value of serum SARS-CoV-2-
specific nAb level 28 days after the BD in 
SOT participants who received the Moderna 
primary series 
• 
The GMT value of SARS-CoV_2-specific 
nAb level 28 days after BD in SOT 
participants who received non-Moderna 
primary series  
Exploratory Objectives 
Exploratory Endpoints 
• 
To evaluate the persistence of the 
immune response of the BD of 
mRNA 1273 vaccine (100 µg) as 
assessed by the level of 
SARS-CoV-2 S2P specific bAb 
through 6 months after BD 
• 
The GM value of SARS-CoV-2 S2P specific 
bAb on BD-Day 1, BD-Day 29 (28 days 
after BD), BD-Day 181 (6 months after BD) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 77 
Objectives 
Endpoints 
• 
To evaluate the persistence of the 
immune response of the BD of 
mRNA 1273 vaccine (100 µg) as 
assessed by the level of nAb 
through 6 months after BD 
• 
The GM values of SARS-CoV-2-specific 
nAb on BD-Day 1, BD-Day 29 (28 days 
after BD), BD-Day 181 (6 months after BD) 
• 
To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult SOT 
recipients and healthy adult 
participants with negative 
SARS-CoV-2 at baseline 
• 
The 
incidence 
of 
asymptomatic 
SARS-CoV- 2 infection among recipients of 
mRNA-1273 SARS-CoV-2 vaccine will be 
defined in participants with negative 
SARS-CoV-2 at baseline as: 
o bAb 
levels 
against 
SARS-CoV-2 
nucleocapsid 
protein 
negative 
(as 
measured by Roche Elecsys) at Day 1, 
that becomes positive (as measured by 
Roche Elecsys) counted starting 28 days 
after the BD, OR 
o Positive 
RT-PCR 
counted 
starting 
14 days after the BD 
• 
To describe the incidence of 
COVID-19 after vaccination with 
mRNA-1273 in SOT recipients 
and healthy participants 
• 
First occurrence of COVID-19 starting 
14 days after BD of vaccine, where COVID-
19 is defined as symptomatic disease based 
on the following criteria 
• 
The participant must have experienced at 
least TWO of the following symptoms: fever 
(≥ 38°C/≥ 100.4°F), chills, 
myalgia, 
headache, sore throat, or new olfactory and 
taste disorder(s), OR 
• 
The participant must have experienced at 
least ONE of the following respiratory 
signs/symptoms: cough, shortness of breath 
or difficulty breathing, OR clinical or 
radiographical evidence of pneumonia, 
AND 
• 
The 
participant 
must 
have 
at 
least 
1 nasopharyngeal (NP) swab, nasal swab, or 
saliva sample (or respiratory sample, if 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 78 
Objectives 
Endpoints 
hospitalized) positive for SARS-CoV-2 by 
RT-PCR 
• 
First occurrence of severe COVID-19 
starting 14 days after the BD of vaccine, 
where severe COVID-19 is defined as 
symptomatic COVID-19 AND any of the 
following: 
o Clinical signs indicative of severe 
systemic illness, respiratory rate ≥ 30 per 
minute, heart rate ≥ 125 beats per 
minute, oxygen saturation (SpO2) ≤ 
93% on room air at sea level, or partial 
pressure of oxygen (PaO2)/fraction of 
inspired oxygen (FIO2) < 300 mm Hg, 
OR 
o Respiratory failure or acute respiratory 
distress syndrome (ARDS, defined as 
needing high-flow oxygen, noninvasive 
or 
mechanical 
ventilation, 
or 
extracorporeal membrane oxygenation) 
or evidence of shock (systolic blood 
pressure [BP] < 90 mm Hg, diastolic BP 
< 60 mm Hg, or requiring vasopressors), 
OR 
o Significant acute renal, hepatic, or 
neurologic dysfunction, OR 
o Admission to an intensive care unit or 
death. 
• 
The secondary case definition of COVID-19 
is defined as the following symptoms: fever 
(temperature ≥ 38ºC) or chills, cough, 
shortness of breath or difficulty breathing, 
fatigue, muscle aches or body aches, 
headache, new loss of taste or smell, sore 
throat, nasal congestion or rhinorrhea, 
nausea or vomiting or diarrhea AND a 
positive NP swab, nasal swab, or saliva 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 79 
Objectives 
Endpoints 
sample 
(or 
respiratory 
sample, 
if 
hospitalized) for SARS-CoV-2 by RT-PCR. 
• 
To describe changes in liver and 
renal function through laboratory 
tests over time in SOT recipients 
after vaccination with mRNA-
1273 vaccine 
• 
Safety laboratory assessments of kidney 
(serum creatinine, urine protein, and UPCR) 
and liver (ALT, aspartate AST, ALP, and 
bilirubin) function from BD-D1 through 
BD-D29 (28 days after BD) 
• 
To describe changes in 
immunosuppressant medications in 
SOT recipients after vaccination 
with mRNA-1273 vaccine 
• 
Change in immunosuppressant medications 
to treat organ transplant rejection or to 
improve immune tolerance from BD-D1 and 
throughout the study period. Change in 
immunosuppressant medication is defined 
as any of the following: 
o any adjustments (temporarily or 
permanently) in immunosuppressants, 
o addition of new immunosuppressants, 
o or switching from 1 maintenance 
rejection 
prophylaxis 
regimen 
to 
another. 
• 
To evaluate the genetic and/or 
phenotypic relationships of 
isolated SARS-CoV-2 strains to 
the vaccine sequence 
• 
Comparison of genetic sequence of viral 
isolates with that of the vaccine sequence 
• 
To characterize the clinical profile 
and immune responses of 
participants with COVID-19 or 
with SARS-CoV-2 infection 
• 
Description of clinical severity and immune 
responses of participants who are identified 
as infected by SARS-CoV-2 or having 
COVID-19 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 80 
Objectives 
Endpoints 
• 
To describe the incidence of 
asymptomatic SARS-CoV-2 
infection after mRNA-1273 
vaccination in adult SOT 
recipients and healthy adult 
participants with serologic 
evidence of infection at baseline 
• 
GM and GMFR of bAb levels against 
SARS-CoV-2 
nucleocapsid 
protein 
(quantitative IgG) and percent of study 
participants with 2×, 3×, and 4× rise of bAb 
relative to baseline 
• 
To assess, in a subset of SOT 
recipients and healthy participants 
who received BD, SARS-CoV-2 S 
protein-specific T-cell responses 
• 
Magnitude, phenotype, and percentage of 
cytokine 
producing 
S 
protein-specific 
T-cells BD-D1 and BD-D8 
• 
To define, in a subset of SOT 
recipients and healthy participants, 
the epitopes recognized by B-cells 
and antibodies generated in 
response to mRNA-1273 
• 
Magnitude and phenotype of S protein-
specific B-cells as measured by flow 
cytometry at BD-D1 and BD-D8 
• 
Determination of targeted major antigenic 
sites and amino acid residues on SARS-
CoV-2 S protein 
Abbreviations: AE = adverse event; AESI = Adverse Event of Special Interest; ALP = alkaline 
phosphatase; ALT = alanine aminotransferase; AR = adverse reaction; ARDS = acute respiratory 
distress syndrome; AST = aspartate aminotransferase; bAb = binding antibody; BD = booster 
dose; BP = blood pressure; COVID-19 = coronavirus disease 2019; D = day; FIO2 = fraction of 
inspired oxygen; GM = geometric mean; GMFR = geometric mean fold rise; GMT = geometric 
mean titer; IgG = immunoglobulin G; MAAE = medically attended adverse event; nAb = 
neutralizing antibody; NP = Nasopharyngeal; PaO2 = partial pressure of oxygen; RT-PCR = 
reverse transcriptase polymerase chain reaction; S = spike; S2P = SARS-CoV-2 spike protein 
modified with 2 proline substitutions to stabilize the spike protein in a prefusion conformation; 
SAE = severe adverse event; SARS-CoV-2 = Severe Acute Respiratory Syndrome coronavirus 
2; SOT = solid organ transplant; SpO2 = oxygen saturation; UPCR = urine protein to creatinine 
ratio. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 81 
3. 
STUDY DESIGN 
3.1. 
General Design 
This is a Phase 3b, open-label study to evaluate the safety, reactogenicity, and immunogenicity of 
mRNA-1273 SARS-CoV-2 vaccine in SOT recipients and healthy controls. Adult kidney and liver 
transplant recipients and healthy control participants who are at least 18 years of age will be 
enrolled. 
Approximately 240 adult participants (220 previously vaccinated or unvaccinated participants who 
have had a kidney or liver transplant and 20 unvaccinated healthy adults) will be enrolled. At least 
50 SOT recipients who completed primary vaccination series with a non-Moderna COVID-19 
vaccine under EUA (outside of the mRNA-1273-P304 study) will be enrolled in Part B 
(Group B4). 
In Part A, all SOT recipients who were unvaccinated prior to enrollment will receive 2 doses of 
100 µg of mRNA-1273 (vaccine) 28 days apart (window of -3/+7 days for the second dose) 
(Group A1). The SOT recipients will be offered the opportunity to receive a third primary dose of 
vaccine at Day 85 (window of -3/+7 days for the third dose) as per the EUA Fact Sheet available 
at the time of protocol finalization (Group A2). All healthy participants will receive 2 doses of 
vaccine 28 days apart (window of -3/+7 days for the second dose) (Group A5). SOT recipients 
who were previously vaccinated with 2 doses of Moderna COVID-19 vaccine under the EUA prior 
to enrollment will receive dose 3 on Day 1 (Group A3). These participants will be referred to as 
previously vaccinated throughout this document. Under Amendment #4, unvaccinated SOT 
participants who will be enrolled will be given 3 100 µg doses in Part A then proceed to Part B to 
receive a 100 µg booster dose. Under Amendment #4, SOT participants previously vaccinated with 
2 doses of Moderna COVID-19 vaccine outside of the study who will be enrolled will receive a 
third 100 µg dose in Part A then proceed to Part B to receive a 100 µg BD. 
In Part B, all eligible active participants in Part A will be offered to receive a 100 µg BD of mRNA-
1273 who are at least 4 months from the last dose. SOT recipients who completed primary COVID-
19 vaccination series under EUA will receive a 100 µg BD on BD-D1. 
The schematic of study arms and major study events is illustrated in Figure 1, Figure 2, Figure 3, 
and Figure 4. The schedules of events (SoEs) for the study are presented in Section 10.1. Study 
arms and doses are presented in Table 2. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 82 
Table 2: Study Arms 
Study Arm 
Part A 
Doses in 
P304 
Part A 
Part A 
Dose 
Move on 
to Part B? 
Part B 
Doses in 
P304 
Part B 
Part B 
B-Dose 
Total Doses in 
P304 
SOT Recipient Cohorts  
Unvaccinated participants who 
consent to receive only 2 doses in 
Part A  
(Days 1 and 29) 
Group A1 
2 
100 µg 
 
NA 
N/A 
N/A 
2 
Unvaccinated participants who 
consent to receive 3 doses in 
Part A  
(Days 1, 29, and 85) 
Group A2 
3 
100 µg 
 
Group B2 
1 
100 µg 
4 
Participants previously 
vaccinated with 2 doses of the 
Moderna COVID-19 vaccine 
under the EUA who consent to 
receive a third dose in Part A 
(Day 1) 
Group A3 
1 
100 µg 
 
Group B3 
1 
100 µg 
2 
SOT recipients who completed 
primary vaccination with an 
mRNA or non-mRNA COVID-19 
vaccine outside mRNA-1273-
P304 who consent to receive 
1 booster dose (in Part B) 
N/A 
N/A 
N/A 
 
Group B4 
1 
100 µg 
1 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 83 
Study Arm 
Part A 
Doses in 
P304 
Part A 
Part A 
Dose 
Move on 
to Part B? 
Part B 
Doses in 
P304 
Part B 
Part B 
B-Dose 
Total Doses in 
P304 
Healthy Adult Cohort 
Healthy adults who consent to 
receive 2 doses in Part A (Days 1 
and 29) 
Group A5 
2 
100 µg 
 
Group B5 
1 
100 µg 
3 
Abbreviations: B-Dose = booster dose; EUA = Emergency Use Authorization; SOT = solid organ transplant, 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 84 
Figure 1: Study Schema for Unvaccinated Participants Who Receive the 2-Dose Vaccination Regimen (Part A) 
Abbreviations: CMI = cell-mediated immunity; IA = interim analysis; immuno = immunogenicity; NP = nasopharyngeal; SOT = solid 
organ transplant (recipients). 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 85 
Figure 2: Study Schema for Unvaccinated Participants Who Receive the 3-Dose Vaccination Regimen (Part A) 
Abbreviations: CMI = cell-mediated immunity; NP = nasopharyngeal; SOT = solid organ transplant (recipients). 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 86 
Figure 3: Study Schema for Previously Vaccinated Participants Who Receive a Single-dose Vaccination Regimen (dose 3) 
(Part A) 
 
Abbreviations: CMI = cell-mediated immunity; NP = nasopharyngeal; SOT = solid organ transplant. 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 87 
 
 
 
 
 
 
Figure 4: Booster Phase Study Pathway 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
 
 
 
 
 
 
 
Page 88 
Figure 5: Study Schema for Booster Dose Phase (Part B) 
 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 89 
For Part A, the primary immunogenicity goal of the study is to evaluate serum Ab responses 
obtained 28 days after the second or third dose of vaccine (Day 57 for unvaccinated participants 
of the 2-dose regimen, Day 113 for unvaccinated SOT participants of the 3-dose regimen, and Day 
29 for previously vaccinated SOT participants of dose 3 ). Using the Ab threshold established from 
Study P301 (if available at the time of database lock), an additional exploratory analysis will be 
performed by measuring the proportion of participants with a serum Ab level at Day 57 (for 
unvaccinated participants of 2-dose regimen ), Day 113 (unvaccinated SOT recipients of 3-dose 
regimen), and Day 29 (previously vaccinated SOT recipients of dose 3) greater than or equal to 
the Ab threshold of protection against COVID-19, with a 2 sided 95% CI using the Clopper 
Pearson method by cohort arm. 
This study will monitor participants for a total of up to 12 months (12 months after their last dose 
of vaccine for participants not receiving a BD or 6 months after their BD). The SOT participants 
who do not consent to receive a third dose of mRNA-1273 (Group  A1) and healthy adult 
participants (Group  A5) will be monitored for a total of 12 months after their second dose. Safety 
assessments will include solicited local and systemic ARs for 7 days after each dose; unsolicited 
AEs for 28 days after each dose; MAAEs; SAEs; AESIs, AEs leading to discontinuation from 
dosing and/or study participation (withdrawal) from dose 1 through the end of study (EOS); 
concomitant medications associated with AEs, MAAEs, or COVID-19 or SARS-CoV-2 infection; 
participant experience of COVID-19 symptoms; biopsy-proven organ rejection; safety laboratory 
assessments; vital sign measurements; and physical examination findings as presented in the 
applicable SoE (Section 10.1). 
From all unvaccinated SOT participants who receive 3 doses of mRNA-1273 (Group  A2), blood 
samples will be collected at baseline (Day 1), Day 29 (28 days after dose 1), Day 57 (28 days after 
dose 2), Day 85 (dose 3), Day 113 (28 days after dose 3), Day 265 (6 months after dose 3), and 
Day 450 (12 months after dose 3). 
From unvaccinated participants who receive 2 doses of vaccine (healthy adults [Group  A5] and 
SOT recipients who decline to receive a third dose [Group A1]), blood samples will be collected 
at baseline (Day 1), Day 29 (28 days after dose 1), Day 57 (28 days after dose 2), Day 209 (6 
months after dose 2), and Day 394 (12 months after dose 2). 
From previously vaccinated SOT participants who receive 1 dose of mRNA-1273 (Group A3), 
blood samples will be collected at pre-dose 3 (Day 1), Day 29 (28 days after dose 3), Day 180 (6 
months after dose 3), and Day 365 (12 months after dose 3). 
These blood samples will be for the assessment of the following endpoints and analytes: 
• Measurement of SARS-CoV-2-specific bAb and nAb responses 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 90 
• Development of Ab directed against nonvaccine antigen (nucleocapsid protein), 
which will signify infection with SARS-CoV-2. Participants who tested positive for 
Ab against SARS-CoV-2 nucleocapsid protein at baseline can continue in the study. 
From unvaccinated SOT participants (Group A1 and Group A2), blood samples for cell-mediated 
immunity (CMI) studies will also be collected at Day 1, Day 36, and Day 92 (SOT recipients 
receiving 3 doses [Group A2]) from a subset of at up to 50 SOT participants, as well as, from 20 
healthy controls (Group A5) (Day 1 and Day 36), and from a subset of at least 50 previously 
vaccinated SOT recipients (Group A3) at Day 1 and Day 8, for exploratory assessments to 
characterize T- and B-cell responses to vaccine. 
The NP swab samples obtained at illness visits (Section 7.3.1) will be used as sources of 
SARS-CoV-2 for genetic sequencing. 
SARS-CoV-2 bAb against the nonvaccine antigen (nucleocapsid protein) will also be collected at 
the Illness and Convalescent visits. 
The number of cases of COVID-19 will be assessed throughout the study (Section Error! 
Reference source not found.). Once a participant is identified as a case of COVID-19, a 
convalescent visit will be scheduled approximately 28 days after the confirmed diagnosis for a 
clinical evaluation and immunologic assessment of SARS-CoV-2 infection. 
For unvaccinated SOT recipients (Group A1 and Group A2), laboratory assessments for safety 
related to kidney function for kidney SOT recipients (serum creatinine, urine protein, and UPCR) 
and liver function for liver SOT recipients (alanine aminotransferase [ALT], aspartate 
aminotransferase [AST], alkaline phosphatase [ALP], and bilirubin) will be monitored on Day 1, 
Day 8, Day 29, Day 36, and Day 57 for SOT recipients who receive 2 doses only (Group A1) and 
on additional Days 85, 92, and Day 113 for SOT recipients who receive 3 doses (Group A2). 
For previously vaccinated SOT recipients (Group A3), laboratory assessments for safety will be 
monitored on Day 1 (dose 3), Day 8, and Day 29. 
After Day 57 (for unvaccinated SOT participants who receive 2 doses [Group A1]) or after Day 
113 (for unvaccinated SOT participants who receive 3 doses [Group A2]), or after Day 29 (for 
previously vaccinated SOT recipients who receive dose 3 [Group A3]), the investigator will 
review standard-of-care laboratory assessments related to kidney and liver function and report any 
laboratory-related AEs and suspected or confirmed events of organ transplant rejection until the 
EOS. 
Part B - Booster Phase 
Part B is designed to offer participants in Part A, who are at least 4 months from the last dose, the 
option to request a BD (100 µg) of the prototype mRNA-1273 (Group B2, Group B3, and 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 91 
Group B5). Part B is also designed to enroll SOT participants who completed primary vaccination 
series with mRNA or non-mRNA COVID-19 vaccine under the EUA who are at least 4 months 
from last dose (Table 3). At least 50 SOT recipients who completed primary vaccination series 
with a non-Moderna COVID-19 vaccine under the EUA (outside of the mRNA-1273-P304 study) 
will be enrolled in Part B. In case a variant of concern emerges and available data show a decreased 
immune response after vaccination with the prototype 100 µg BD, the Part B Booster Phase may 
test or replace the prototype 100 µg BD with a variant-specific mRNA-1273 vaccine (ie, Omicron-
specific or mRNA-1273.529). 
Table 3: Primary Series Vaccination for Booster Dose Eligibility 
Primary Series Vaccine 
Primary Series Number of Doses 
mRNA COVID-19 vaccine (ie, Moderna, 
Pfizer) 
3 doses 
Non-mRNA COVID-19 vaccine (ie, Janssen) 
2 doses or at least 1 dose combined with an 
mRNA COVID-19 vaccine 
If eligible, each study participant in Part A will receive a notification letter and will be asked to 
schedule a BD-1 visit at their study site. Principal Investigators should consider current local public 
health guidance for administration of COVID-19 vaccines under EUA and marketing authorization 
(if any) when determining the scheduling priority of participants. 
At the BD-1 visit, each participant will: 
• Each study participant in Part A will be encouraged to remain in the ongoing study, 
• Sign a revised informed consent form (ICF) that includes both updated safety 
information relevant to the ongoing study and a BD. 
− Participants from Part A will be offered the option to receive a 100 µg BD 
(Group B2 and Group B3), 
− Eligible SOT participants who completed the primary vaccination series under 
EUA will be given a 100 µg BD of mRNA-1273 (Group B4), 
− Under Amendment #4, unvaccinated SOT participants who will be enrolled will 
be given 3 100 µg doses in Part A then proceed to Part B to receive a 100 µg 
booster dose. 
− Under Amendment #4, SOT participants previously vaccinated with 2 doses of 
Moderna COVID-19 vaccine outside of the study who will be enrolled will 
receive a third 100 µg dose in Part A then proceed to Part B to receive a 100 µg 
BD. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 92 
• Be counselled about the importance of continuing other public health measures to 
limit the spread of disease including social distancing, wearing a mask, and hand-
washing. 
At the BD-1 visit, participants will have the following study site visits and complete scheduled 
activities according to the Part B SoE: 
• BD-1 visit: Participants will receive a single 100 µg dose of mRNA-1273 
• BD-1a visit: Day 4, 3 days after BD on Day 1 
• BD-2 visit: Day 8, 7 days after BD on Day 1 
• BD-3 visit: Day 29, 28 days after the BD on Day 1 
• BD-4 visit: Day 181, 180 days after the BD on Day 1 
3.1.1. 
Study Periods 
There will be 3 study periods: a Screening Period, a Treatment Period, and a Follow-up Period. 
For unvaccinated SOT and Healthy participants who receive the 2-dose vaccine regimen in 
Part A (Group A1 and Group A5): 
The study comprises 8 scheduled visits, including a screening visit and 7 scheduled clinic visits. 
Electronic diary (eDiary) recording of solicited local and systemic reactogenicity (Section 7.5.3) 
will occur on the day of each injection and for 6 days following injection. Safety follow-up via an 
eDiary questionnaire will be performed every 4 weeks from Day 71 to Day 183 and again from 
Day 223 to Day 363. Additional safety follow-up via a safety telephone call will be performed 
every 4 weeks from Day 85 to Day 197 and again from Day 237 to Day 377. If the last dose is 
delayed, additional safety calls every 4 weeks should be scheduled when the gap between the 
safety call scheduled on D377 and the last study visit is beyond 28 days. 
Per participant, the study duration will be approximately 13 months, which includes 1 week for 
screening (Day ˗7 to Day 1), 28 days for dosing (on Day 1 and Day 29), and 12 months of follow-
up after the second dose to monitor for safety, immunogenicity, and breakthrough SARS-CoV-2 
infection or COVID-19. Day 0 and Day 1 may be combined on the same day (Table 7). 
For unvaccinated participants who receive the 3-dose vaccine regimen in Part A (Group A2): 
The study comprises 11 scheduled visits, including a screening visit and 10 scheduled clinic visits. 
eDiary recording of solicited local and systemic reactogenicity (Section 7.5.3) will occur on the 
day of each injection and for 6 days following injection. Safety follow-up via an eDiary 
questionnaire will be performed every 4 weeks from Day 127 to Day 239 and again from Day 279 
to Day 419. Additional safety follow-up via a safety telephone call will be performed every 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 93 
4 weeks from Day 141 to Day 253 and again from Day 293 to Day 433. If the last dose is delayed, 
additional safety calls every 4 weeks should be scheduled when the gap between the safety call 
scheduled on D433 and the last study visit is beyond 28 days. 
Per participant, the study duration will be approximately 15 months, which includes 1 week for 
screening (Day ˗7 to Day 1), 3 months for dosing (on Day 1, Day 29, and Day 85), and 12 months 
of follow-up after the third dose to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. Day 0 and Day 1 may be combined on the same day (Table 
8). 
For previously vaccinated participants who receive the single-dose vaccination regimen 
(dose 3) in Part A (Group A3): 
The study comprises 6 scheduled visits, including a screening visit and 5 scheduled clinic visits. 
eDiary recording of solicited local and systemic reactogenicity (Section 7.5.3) will occur on the 
day of injection and for 6 days following injection. Safety follow-up via an eDiary questionnaire 
will be performed every 4 weeks from Day 43 to Day 155 and again from Day 194 to Day 306. 
Additional safety follow-up via a safety telephone call will be performed every 4 weeks from 
Day 57 to Day 169 and again from Day 208 to Day 320. 
Per participant, the study duration will be approximately 12 months, which includes 1 week for 
screening (Day ˗7 to Day 1), and 12 months of follow-up after dose 3 to monitor for safety, 
immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. The screening visit and 
Day 1 may be combined on the same day (Table 9). 
For participants who receive the BD in Part B (Group B2, Group B3, Group B4, and 
Group B5): 
The study comprises 5 scheduled clinic visits and 6 safety calls (BD-D15, BD-D22, BD-D59, BD-
D89, BD-D119, and BD-D149). 
Per healthy participant receiving 2 doses of mRNA-1273 in Part A (Group B5) who consent to 
receive BD, the study duration will be approximately 10 months, which includes 1 week for 
screening (Day ˗7 to Day 1), 4 months for dosing (on Day 1, Day 29, and Day 129 for BD), and 6 
months of follow-up after the BD to monitor for safety, immunogenicity, and breakthrough SARS-
CoV-2 infection or COVID-19. 
Per SOT study participant who received 3 doses of mRNA-1273 in Part A (Group B5) who consent 
to receive BD, the study duration will be approximately 13 months which includes 1 week for 
screening (Day ˗7 to Day 1), 7 months of dosing (on Day 1, Day 29, Day 85, and Day 205 for BD) 
and 6 months of follow-up after BD to monitor for safety, immunogenicity, and breakthrough 
SARS-CoV-2 infection or COVID-19. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 94 
Per SOT study participant who previously received 2 doses under EUA, enrolled in Part A to 
receive a third dose (Group B3) and who consent to receive a BD, the study duration will be 
approximately 10 months which includes 1 week for screening (Day ˗7 to Day 1), 4 months of 
dosing (Day 1 [dose 3] and Day 120 [BD]) and 6 months of follow-up after BD to monitor for 
safety, immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. 
Per SOT study participant who previously completed primary vaccination series (3 doses) under 
EUA (Group B4), the study duration will be approximately 6 months which includes 1 week for 
screening (Day ˗7 to Day 1), 1 day for dosing and 6 months of follow-up after BD to monitor for 
safety, immunogenicity, and breakthrough SARS-CoV-2 infection or COVID-19. 
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), and 
all applicable regulatory requirements (Section 10.2.1). 
3.1.1.1. 
Screening Period 
The Screening Period for each participant starts with the first screening visit (Day 0) and ends with 
the Day 1 visit; the Screening Period can last up to 7 days. After signing the informed consent 
form, participants will undergo screening assessments to determine study eligibility. Screening 
assessments must be completed after signing the informed consent form (ICF). The investigator 
will review study entry criteria to determine the participant eligibility during the Screening Period. 
Participants deemed eligible will enter the Treatment Period. 
3.1.1.2. 
Treatment Period and Follow-up Period 
The Treatment Period for each participant starts with Day 1 and is scheduled to end 28 days after 
each dose of vaccine. In Part A, for unvaccinated SOT and healthy participants who receive the 2-
dose regimen (Group A1 and Group A5), the Follow-up Period starts with Day 58 and is scheduled 
to end on Day 394 (12 months after the second dose). The Follow-up Period for unvaccinated SOT 
participants who receive the 3-dose regimen (Group A2) starts with Day 114 and is scheduled to 
end on Day 450 (12 months after the third dose). The Follow-up Period for previously vaccinated 
participants (Group A3) starts with Day 29 and is scheduled to end on Day 365 (12 months after 
dose 3). In Part B (Group B2, Group B3, Group B4, and Group B5), Follow-up Period starts with 
Day 29 and is scheduled to end on BD-D181 (6 months after BD). 
For Part A (Group A1, Group A2, Group A3, and Group A5): On Day 1, after the completion of 
the scheduled assessments (Section 10.1), all participants will be administered a single IM dose of 
100 µg of mRNA-1273 (Section 5.3.2). Participants will be closely monitored for safety and will 
remain at the study site for observation for at least 30 minutes after dosing. For unvaccinated SOT 
and healthy participants (Group A1, Group A2, and Group A5), the second dose of vaccine will 
be administered on Day 29. Unvaccinated SOT recipients who consent to receive a third dose of 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 95 
vaccine (Group A2) will receive it on Day 85. Previously vaccinated SOT recipients (Group A3) 
will receive dose 3 on Day 1. Participants will be monitored for 12 months after the second and 
third dose (as applicable) of vaccine for safety, immunogenicity, and breakthrough SARS-CoV-2 
infection or COVID-19. 
For Part B (Group B2, Group B3, Group B4, and Group B5): On BD-D1, after the completion of 
the scheduled assessments, at least 4 months after the last dose, all participants will be 
administered a single intramuscular (IM) dose of 100 µg BD of mRNA-1273. Participants will be 
closely monitored for safety and will remain at the study site for observation for at least 30 minutes 
after dosing. Participants will be monitored for 6 months after the BD for safety, immunogenicity, 
and breakthrough SARS-CoV-2 infection or COVID-19. 
Testing and assessments for SARS-CoV-2 infection and COVID-19 are detailed in Section 7.1.6. 
Scheduled testing for the presence of SARS-CoV-2 by reverse transcriptase polymerase chain 
reaction (RT-PCR) will occur after collecting nasopharyngeal (NP) swab samples on each day of 
injection. In Part A, on Day 1, Day 29, and Day 85 before dosing as well as on Day 57 (28 days 
after the second dose for unvaccinated SOT and healthy participants [Group A1 Group A2, and 
Group A5]), Day 113 (28 days after the third dose for unvaccinated SOT participants [Group A2]), 
and on Day 29 (28 days after dose 3) for previously vaccinated SOT recipients [Group A3], and 
in Part B (Group B2, Group B3, Group B4, and Group B5), on BD-D1 before dosing. During the 
Treatment Period and Follow-up Period, participants who meet prespecified disease criteria that 
suggest possible SARS-CoV-2 infection will be asked to contact the study site to arrange for a 
prompt, thorough, and careful assessment, including an NP swab sample to be tested for the 
presence of SARS-CoV-2 by RT-PCR (Section 7.1.6). Confirmed, symptomatic cases of SARS-
CoV-2 infection will be captured as MAAEs (Section 7.3.2). 
Blood Samples for Immunogenicity Assessment: 
All participants will be monitored for safety and reactogenicity and provide pre- and post-dose 
blood specimens for immunogenicity through 12 months after additional primary dose (dose 3 
[Group A3]) and second (Group A1) and third (Group A2) (as applicable) doses of mRNA-1273 
(Part A) and through 6 months after BD Group B2, Group B3, Group B4, and Group 5). Blood 
sampling for immunogenicity testing is scheduled throughout the study as follows: 
• For unvaccinated SOT and healthy participants who receive the 2-dose regimen on Day 1 
and Day 29, as well as well as 28 days and 6 and 12 months after the second dose (Part A, 
Group A1 and Group A5), 
• For unvaccinated SOT participants who receive the 3-dose regimen on Day 1, Day 29, 
Day 57, and Day 85, as well as 28 days and 6 and 12 months after the third dose (Part A, 
Group A2), and 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 96 
• For previously vaccinated SOT participants who receive dose 3 on Day 1 and Day 29 (28 
days after dose 3), as well as 6 and 12 months after dose 3 (Part A, Group A3). 
• For participants in Part B (participants in Part A who consented to receive a BD 
[Group B2, Group B3, and Group B5] and SOT participants who completed the primary 
vaccination series under EUA who receive a BD [Group B4]), on BD-D1, BD-D-29, and 
BD-D181. 
Blood Samples for CMI Analysis: 
Part A 
For unvaccinated SOT participants (Group A1 and Group A2), blood samples will also be 
collected for CMI analysis at Day 1, Day 36, and Day 92 (SOT recipients who receive a third dose 
[Group A2]) from a subset of up to 50 SOT participants, as well as, from 20 healthy controls (Day 
1 and Day 36) (Group A5). 
Blood samples will also be collected from a subset of at least 50 previously vaccinated SOT 
recipients (Group A3) for CMI analysis at Day 1 (dose 3) and Day 8 (7 days after dose 3). 
Part B 
For participants in Part B (participants in Part A who consented to receive a BD [Group B2, 
Group B3, and Group B5] and SOT participants who completed the primary vaccination series 
under EUA who receive a BD [Group B4]), blood samples will be collected for CMI analysis at 
BD-D1 and BD-D8 (7 days after BD) from all Part B participants. 
 
Blood and urine samples for kidney and liver function 
Blood and urine samples related to kidney (kidney SOT) and liver function (liver SOT) will be 
monitored on: 
Part A 
• Day 1, Day 8, Day 29, Day 36, and Day 57 for unvaccinated SOT recipients who receive 
2 doses only (Group A1) and on additional Days 85, 92, and 113 for unvaccinated SOT 
recipients receiving 3 doses (Group A2). 
• On Day 1, Day 8, and Day 29 for previously vaccinated SOT recipients who receive dose 3 
(Group A3). 
• After Day 57 (for unvaccinated SOT recipients receiving 2 doses) [Group A1], after Day 
113 (for unvaccinated SOT recipients receiving 3 doses [Group A2]), or after Day 29 (for 
previously vaccinated SOT recipients who receive dose 3 [Group A3]), the investigator 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 97 
will review standard-of-care laboratory assessments related to kidney and liver function, 
and report any laboratory-related AEs and suspected or confirmed events of organ 
transplant rejection until the EOS. 
Part B 
• 
On BD-D1, BD-D8, and BD-D29 for SOT participants who completed primary vaccination 
series (Group B2, Group B3, and Group B4): After Day 29, the investigator will review 
standard-of-care laboratory assessments related to kidney and liver function, and report any 
laboratory-related AEs and suspected or confirmed events of organ transplant rejection until 
the EOS. 
Blood samples for biomarker analysis:  
During BD-D4 (Part B of the study [Group B2, Group B3, Group B4, and Group B5]), participants 
who chose to receive a BD will have blood draws (biomarker plasma and biomarker serum 
samples) which will be stored for potential future biomarker assessment. 
Participants will be instructed on the day of the first dose and reminded on the days of the second, 
third, and fourth doses (as applicable) how to document and report solicited local or systemic ARs 
in a provided eDiary. Solicited ARs, unsolicited AEs, MAAEs, SAEs, AESIs, AEs leading to 
discontinuation from dosing and/or study participation (withdrawal), and biopsy-proven organ 
rejection will be assessed as described in Section 7.1, according to the time points in the applicable 
SoE (Section 10.1). 
Participants may experience and report AEs that necessitate an unscheduled visit. At the discretion 
of the investigator, additional examinations may be conducted at these visits as necessary to ensure 
the safety and well-being of participants during the study. Electronic case report forms (eCRFs) 
should be completed for each unscheduled visit. 
3.2. 
Scientific Rationale for Study Design 
The study vaccine, mRNA-1273, is currently being evaluated in a pivotal Phase 3 efficacy, safety, 
and immunogenicity study in an adult population at high risk of COVID-19 disease (Study P301). 
Success criteria for early efficacy were met at first interim analysis based on 95 adjudicated cases 
with a vaccine efficacy of 94.5% (95% CI: 86.5%, 97.8%; one-sided p value < 0.0001). 
Immunocompromised individuals were excluded from this study. 
The current study aims to describe the safety and Ab responses elicited following the last dose of 
vaccine among adult kidney and liver transplant recipients evaluated against the Ab responses of 
healthy adult participants in this study and in Study P301 (if available at the time of database lock). 
This study is expected to provide initial clinical information whether vaccination with mRNA-
1273 can induce vaccine response in this population of immunocompromised participants, and 
whether 3 doses of vaccine induces a greater response than a 2-dose regimen. Recent data based 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 98 
on post-EUA experience show that solid organ transplant recipients’ response to mRNA-based 
COVID-19 vaccines were substantially lower compared to what has been reported in the general 
population with antibody responses detectable in only 30-60% after 2 doses (Benotmane et al 
2021; Boyarsky et al 2021b, Grupper et al 2021; Marinaki et al 2021). 
A small case series which evaluated the antibody responses and vaccine reactions in 30 solid organ 
transplant recipients who had suboptimal response to standard vaccination show that SOT 
recipients who had low-positive antibody response before the third dose had high-positive 
antibody titers after dose 3 and some of those who had negative antibody response had either low- 
to high-positive antibody response after dose 3 (Werbel et al 2021). 
In addition, a recently published article described a double-blind, randomized, controlled trial of a 
third dose of mRNA-1273 vaccine (Moderna) as compared with placebo (NCT04885907; Hall et 
al 2021). The results demonstrated that a third dose of mRNA-1273 vaccine in transplant recipients 
elicited a substantially higher immune response than placebo, as determined in the analysis of both 
primary and secondary trial endpoints. The third dose was considered safe when risk versus benefit 
was considered. 
Administration of additional vaccination is a strategy shown to improve immune response to viral 
antigens based on clinical experiences with hepatitis B and influenza vaccines (Nevens et al 2006; 
Natori et al 2018). 
Interim data are available from an ongoing Moderna Phase 2 study, mRNA-1273-P201 (Study 
P201) where healthy adult participants in Study mRNA-1273-P201 received 2 doses of either 
50 µg or 100 µg of mRNA-1273 and were administered a 50 µg booster of mRNA-1273 6 to 8 
months after the second dose. Participants in mRNA-1273-P201 who received the BD, 
demonstrated enhanced immune responses to SARS-CoV-2 compared to pre-boost levels and met 
the noninferiority criteria stipulated in the US Food and Drug Administration Guidance on EUA 
for Vaccines to Prevent COVID-19. Available data also show that heterologous or mixed series of 
COVID-19 vaccine induced high immune response in the adult population (Atmar et al 2021). 
Additionally, no new safety signals emerged upon administration of the BD in Study P201. In 
addition, interim results from the mRNA-1273-P205 study show that the currently authorized 
50 µg booster of mRNA-1273 increased neutralizing antibody levels against Omicron 
approximately 37-fold compared to pre-boost levels and a 100 µg dose of mRNA-1273 increased 
neutralizing antibody levels approximately 83-fold compared to pre-boost levels. Based on 
cumulative evidence, the benefit-risk profile of a BD of mRNA-1273 is favorable, particularly in 
light of increasing breakthrough disease with the emergence of the Delta variant. Providing the 
option for a BD to all eligible participants currently enrolled in the study as well as enrolling 
eligible SOT recipients who completed primary vaccination series under EUA is expected to 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 99 
generate valuable homologous and heterologous booster data in the immunocompromised 
population. 
With SARS-CoV-2 expected to be circulating in the general population during the study, all 
participants will provide pre- and post-dose blood samples for Ab analysis through 12 months after 
the last dose of vaccine in Part A or through 6 months after the BD in Part B. In addition, in Part 
A, unvaccinated participants will have NP swab samples collected, before the injections on Day 1 
and Day 29, and on Day 57 for those receiving the 2-dose regimen, before injections on Day 1, 
Day 29, and Day 85,and on Day 57, and Day 113 for those receiving the 3-dose regimen, and 
before injection on Day 1 and on Day 29 for previously vaccinated SOT recipients who receive 
dose 3. In Part B, NP swabs will be collected before BD injection on BD-D1. Furthermore, with 
any signs or symptoms or MAAE suggesting SARS-CoV-2 infection in a participant, an additional 
nasal or NP swab sample and a blood sample will be taken to confirm the diagnosis of 
SARS-CoV-2 via serology and RT-PCR. Additionally, clinical information will be carefully 
collected to evaluate the severity of the clinical case. 
As it is possible that participants are naturally exposed to SARS-CoV-2 through community 
exposure, the NP and/or nasal swab samples collected before study injection and the serologic 
assays for Ab responses to nonvaccine antigen(s) may help discriminate between natural infection 
and vaccine-induced Ab responses, should such discrimination be needed. 
3.3. 
Justification for Dose and Choice of Study Population 
The 100 µg dose level is currently being investigated in a large Phase 3 efficacy study in adults 
18 years of age and older (Study P301). The 50 µg BD level is currently being investigated in a 
Phase 2 study in adults 18 years of age and older (P201). Interim results from the mRNA-1273-
P205 study show that the 100 µg BD had robust GM titers against the Omicron variant, which 
were higher numerically than what were observed for the 50 µg BD. Therefore, based on this study 
and the results of the studies described in Section 1.2.2, the Sponsor intends to study a single-dose 
level of 100 µg mRNA-1273 primary series and single 100 µg BD in this Phase 3b study in an 
adult immunocompromised population. 
There is no placebo treatment arm for this study. On 18 Dec 2020, the US FDA issued an EUA for 
the Moderna mRNA-1273 COVID-19 vaccine to be distributed in the US for use in individuals 18 
years of age and older (FDA 2020) in response to the ongoing pandemic. On 12 Aug 2021, the US 
FDA issued an extension of the EUA for a third dose of Moderna mRNA-1273 COVID-19 vaccine 
in certain immunocompromised individuals, specifically, SOT recipients or those who are 
diagnosed with conditions that are considered to have an equivalent level of immunocompromise 
(FDA 2021). Recent US CDC guidance recommends a COVID-19 BD in people aged ≥ 18 years 
who are moderately and severely immunocompromised which includes SOT recipients (CDC 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 100 
2021c). Accordingly, the inclusion of a placebo treatment group would be inappropriate. Instead, 
an open-label study was designed which intends to enroll adult SOT recipients (kidney and liver 
transplants) and healthy adults. Participants in the transplant cohort are therapeutically 
immunosuppressed to avoid transplant rejection. The healthy cohort serves as a concurrent 
nonimmunosuppressed comparison group for the analysis of cellular immune response. 
3.4. 
End of Study Definition 
The EOS for the full study is defined as completion of the last visit of the last participant in the 
study or the last scheduled procedure as shown in the applicable SoE (Section 10.1) for the last 
participant in this study. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 101 
4. 
STUDY POPULATION 
Participants will be enrolled at ~20 US and non-US sites 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, are not permitted. 
Inclusion and exclusion criteria are listed separately for the SOT recipients (Section 4.1) and for 
healthy adults (Section 4.1.2). 
4.1. 
Eligibility Criteria (Part A) 
4.1.1. 
Eligibility Criteria for Transplant Recipients (Group A1, Group A2, and 
Group A3) 
4.1.1.1. 
Inclusion Criteria for Transplant Recipients 
Each participant must meet all of the following criteria at the screening visit (Day 0) or at Day 1, 
unless noted otherwise, to be enrolled in this study: 
1. Is an adult male or female individual, at least 18 years of age at the time of signing 
informed consent (Day 0), is EITHER a kidney or liver (single organ) transplant recipient 
who is at least 90 days after transplantation at the time of consent, and is EITHER: 
a. Unvaccinated, or 
b. Previously vaccinated with 2 doses of Moderna COVID-19 vaccine who is at least 
1 month after the second dose at the time of consent. Participants who received the 
2 doses of Moderna COVID-19 vaccine before transplant are not eligible. 
2. Received chronic immunosuppressive therapy for the prevention of allograft rejection for 
a minimum of 90 days before signing consent, including but not limited to: 
glucocorticoids (eg, prednisolone), immunophilin binding agents (eg, calcineurin 
inhibitors, mTOR inhibitors), or inhibitors of de novo nucleotide synthesis (eg, 
mycophenolic acid, mizoribine, leflunomide, azathioprine). 
3. Understands, agrees, and is able to comply with the study procedures and provides 
written informed consent. 
4. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all the following criteria: 
• Has a negative pregnancy test at Screening and on the day of the first dose (Day 1) 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to the first dose (Day 1) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 102 
• Has agreed to continue adequate contraception through 3 months following the 
second dose (Day 29) for those receiving 2-dose regimen, through 3 months 
following the third dose (Day 85) for those receiving 3-dose regimen, and through 
3 months following the third dose (Day 1) for those previously vaccinated SOT 
recipients 
• Is not currently breastfeeding 
See Section 10.3, Appendix 3 for Contraceptive Guidance. 
5. Is medically stable, according to investigator’s judgment, during the 3 months before 
signing consent. Medically stable is defined as having no significant worsening of a 
medical condition requiring medical intervention (eg, hospitalization, change in medical 
therapy). 
4.1.1.2. 
Exclusion Criteria for Transplant Recipients 
Participants who meet any of the following criteria at the screening visit (Day 0) or at Day 1, unless 
noted otherwise, will be excluded from the study: 
1. Known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or 
COVID-19 within 2 weeks prior to vaccine administration or any known history of 
SARS-CoV-2 infection or positive SARS-CoV-2 test. 
2. Is pregnant or breastfeeding. 
3. Is acutely ill or febrile 24 hours prior to or at the screening visit (Day 0). Fever is defined 
as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion may have 
visits rescheduled within the relevant study visit windows. Afebrile participants with 
minor illnesses can be enrolled at the discretion of the investigator. 
4. Has prior or planned administration of a coronavirus vaccine (eg, SARS-CoV-2 [for 
unvaccinated participants only], SARS-CoV, or MERS-CoV vaccine). 
5. Has current treatment with investigational agents for either prophylaxis against 
COVID-19 (for unvaccinated participants only) or treatment of COVID-19 (eg, anti-
SARS-CoV-2 monoclonal antibodies). 
6. Has a medical, psychiatric, or occupational condition that may pose additional risk as a 
result of participation or that could interfere with safety assessments or interpretation of 
results according to the investigator’s judgment. 
7. Has a history of a diagnosis or condition that, in the judgment of the investigator, may 
affect study endpoint assessment or compromise participant safety, specifically: 
• A history of more than 1 solid organ transplanted (eg, kidney and pancreas). A history 
of previous kidney or liver transplant is acceptable. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 103 
• A history of clinically relevant donor-specific Ab. 
• A history of complications of immunosuppression; for example, the following: 
o Hypogammaglobulinemia and post-transplant lymphoproliferative disorders 
o Cytomegalovirus viremia or BK viremia within 1 month of informed consent 
• Active infection at the time of consent 
• A history of biopsy-proven T-cell or Ab-mediated rejection within 3 months of 
informed consent, or suspected active or chronic rejection according to the 
investigator’s judgment 
• Suspected clinically relevant active hepatitis, including viral hepatitis, according to 
the investigator’s judgment 
• Bleeding disorder that is considered a contraindication to IM injection or phlebotomy 
• Dermatologic conditions that could affect local solicited AR assessments 
• Known or suspected allergy or history of anaphylaxis, urticaria, or other significant 
AR to the vaccine or its excipients 
• Known human immunodeficiency virus infection 
8. Has received: 
a. Any nonstudy vaccine within 28 days before or after any dose of vaccine (except for 
seasonal influenza vaccine, which is not permitted within 14 days before or after any 
dose of vaccine) 
b. Intravenous blood products (red blood cells, platelets, immunoglobulins) within 
3 months prior to Day 1 
c. Therapies that have depleting properties on T-cells, B-cells, and plasma cells 
(examples of depletional therapies include, but are not limited to, antithymocyte 
globulin, monoclonal antibodies, and proteosome inhibitors) within the last 3 months 
prior to enrollment 
9. Participated in an interventional clinical study within 28 days prior to Day 0 or plans to 
donate blood products while participating in this study. 
10. Is an immediate family member or has a household contact who is an employee of the 
research center or otherwise involved with the conduct of the study. 
4.1.2. 
Eligibility Criteria for Healthy Adults (Group A5) 
4.1.2.1. 
Inclusion Criteria for Healthy Adults 
Each participant must meet all of the following criteria at the screening visit (Day 0) or at Day 1, 
unless noted otherwise, to be enrolled in this study: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 104 
1. Is an adult male or female individual, at least 18 years of age at the time of signing 
informed consent (Day 0), and is in good general health without current or previous 
diagnosis of immunocompromising condition, immune-mediated disease, or other 
immunosuppressive condition, according to investigator assessment, at the time of 
consent, and has not been vaccinated with any COVID-19 vaccine at the time of consent. 
2. Understands, agrees, and is able to comply with the study procedures and provides 
written informed consent. 
3. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all the following criteria: 
• Has a negative pregnancy test at Screening and on the day of the first dose (Day 1) 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to the first dose (Day 1) 
• Has agreed to continue adequate contraception through 3 months following the 
second dose (Day 29) 
• Is not currently breastfeeding 
See Section 10.3, Appendix 3 for Contraceptive Guidance 
4. Is medically stable, according to investigator’s judgment, during the 3 months before 
signing consent. Medically stable is defined as having no significant worsening of a 
medical condition requiring medical intervention (eg, hospitalization, change in medical 
therapy). 
4.1.2.2. 
Exclusion Criteria for Healthy Adults 
Participants who meet any of the following criteria at the screening visit (Day 0) or at Day 1, unless 
noted otherwise, will be excluded from the study: 
1. Known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or 
COVID-19 within 2 weeks prior to vaccine administration or any known history of 
SARS-CoV-2 infection or positive SARS-CoV-2 test. 
2. Is pregnant or breastfeeding. 
3. Is acutely ill or febrile 24 hours prior to or at the screening visit (Day 0). Fever is defined 
as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion may have 
visits rescheduled within the relevant study visit windows. Afebrile participants with 
minor illnesses can be enrolled at the discretion of the investigator. 
4. Has prior or planned administration of a coronavirus vaccine (eg, SARS-CoV-2, 
SARS-CoV, or MERS-CoV vaccine). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 105 
5. Has current treatment with investigational agents for either prophylaxis against 
COVID-19 or treatment of COVID-19 (eg, anti-SARS-CoV-2 monoclonal antibodies). 
6. Has a medical, psychiatric, or occupational condition that may pose additional risk as a 
result of participation or that could interfere with safety assessments or interpretation of 
results according to the investigator’s judgment. 
7. Has a history of a diagnosis or condition that, in the judgment of the investigator, may 
affect study endpoint assessment or compromise participant safety, specifically: 
• Active infection at the time of consent 
• Bleeding disorder that is considered a contraindication to IM injection or phlebotomy 
• Dermatologic conditions that could affect local solicited AR assessments 
• Known or suspected allergy or history of anaphylaxis, urticaria, or other significant 
AR to the vaccine or its excipients 
• Current or previous diagnosis of immunocompromising condition, immune-mediated 
disease, or other immunosuppressive condition. 
8. Has received: 
• Any nonstudy vaccine within 28 days before or after any dose of vaccine (except for 
seasonal influenza vaccine, which is not permitted within 14 days before or after any 
dose of vaccine) 
• Intravenous blood products (red blood cells, platelets, immunoglobulins) within 
3 months prior to Day 1 
• Systemic immunosuppressants or immune-modifying drugs for >14 days in total 
within 6 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone 
equivalent) 
9. Participated in an interventional clinical study within 28 days prior to Day 0 or plans to 
donate blood products while participating in this study. 
10. Is an immediate family member or has a household contact who is an employee of the 
research center or otherwise involved with the conduct of the study. 
4.2. 
Study Eligibility Criteria (Part B) 
4.2.1. 
Inclusion Criteria (Group B2, Group B3, Group B4, and Group B5) 
1.  a. Participants must have been previously enrolled in the mRNA-1273-P304 study, are 
actively participating in Part A and are at least 4 months from the last dose, or 
b. Is an adult male or female individual, at least 18 years of age at the time of signing 
informed consent, is EITHER a kidney or a liver (single organ) transplant recipient who 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 106 
is at least 90 days after transplantation at the time of consent AND who completed 
primary vaccination series (3 doses for mRNA COVID-19 vaccine; 2 doses for non-
mRNA COVID-19 vaccine or at least 1 dose of non-mRNA combined with 1 dose of 
mRNA COVID-19 vaccine) under the EUA who are at least 4 months from the last dose. 
All primary COVID-19 vaccination series must be completed after transplant. 
2. Female participants of childbearing potential may be enrolled in the study if the 
participant has a negative pregnancy test on the day of the booster dose injection (BD-
Day 1). 
4.2.2. 
Exclusion Criteria (for Participants who Completed Primary Vaccine Series 
under EUA) (Group B4) 
Exclusion Criteria in Part A will apply except prior or planned administration of a coronavirus 
vaccine and current treatment with investigational agents for either prophylaxis against COVID 
19. 
4.3. 
Lifestyle Restrictions 
Participants must not eat or drink anything hot or cold within 10 minutes before oral temperature 
is taken. 
4.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently given dose 1 of study vaccine and are not allowed to continue to participate in 
the study. A minimum set of screen failure information is required to ensure transparent reporting 
of screen failures to meet the Consolidated Standards of Reporting Trials publishing requirements 
and to respond to queries from regulatory authorities. Minimum information includes date of 
informed consent, demography, reason(s) for screen failure, eligibility criteria, and information on 
any SAE that may have occurred from Day 1 to the time of withdrawal. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 107 
5. 
STUDY TREATMENT 
5.1. 
Investigational Product Administered 
The term vaccine refers to 100 µg mRNA-1273 primary series vaccine and 100 µg mRNA-1273 
BD vaccine in this study. Each dose, regardless of the regimen (single-dose, 2-dose, or 3-dose 
100 µg mRNA-1273), administered in the study will be 100 µg mRNA-1273. No placebo will be 
administered during this study. 
The mRNA-1273 vaccine is an LNP dispersion of an mRNA encoding the prefusion stabilized 
S protein of SARS-CoV-2, formulated in LNPs composed of 4 lipids (1 proprietary and 
3 commercially available): the proprietary ionizable lipid SM 102; cholesterol; 1,2 distearoyl sn 
glycero-3 
phosphocholine; 
and 
1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol 
polyethylene glycol 2000. Vaccine is provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL in 20 mM Tris buffer containing 
87 mg/mL sucrose and 10.7 mM sodium acetate at pH 7.5. 
5.2. 
Randomization and Stratification 
This is an open-label, single treatment study: there is no randomization. An interactive response 
technology system will be used to sequentially assign a unique participant identification number 
within each cohort of the study (transplant recipient cohort or healthy comparison cohort). 
Approximately 240 adult participants (220 unvaccinated or previously vaccinated participants who 
received two 100 µg doses of the Moderna COVID-19 vaccine who have had a kidney or liver 
transplant and 20 healthy adults) will be enrolled and vaccinated; there will be no stratification or 
enrollment in blocks. At least 50 SOT recipients who completed primary vaccination series with a 
non-Moderna COVID-19 under EUA (outside of the mRNA-1273-P304 study) will be enrolled in 
Part B. 
5.3. 
Dosing and Management of mRNA-1273 Vaccine 
5.3.1. 
Preparation of Study Vaccine for Injection 
Each dose of vaccine will be prepared for each participant as detailed in the mRNA1273P304 
Pharmacy Manual. For Part A, the volume of vaccine injected will be 0.5 mL, containing a 100 µg 
dose of mRNA-1273 as detailed in the mRNA-1273-P304 Pharmacy Manual. For Part B, the 
booster phase, each injection will have a volume of 0.5 mL and contain mRNA-1273 100 µg as in 
Part A. 
5.3.2. 
Administration of Study Vaccine 
Each unvaccinated SOT and Healthy participant (Group A1Group A2, and Group A5) will receive 
two 100-µg doses of vaccine by IM injection, 28 days apart (ie, Day 1 and Day 29) into the deltoid 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 108 
muscle, according to the procedures specified in the mRNA-1273-P304 Pharmacy Manual. 
Preferably, both doses should be administered into the same nondominant arm. Neither dose 
should be administered into an arm that contains an arteriovenous fistula. Unvaccinated SOT 
recipients will be offered to receive a third dose of vaccine (Group A2) on Day 85 (56 days after 
dose 2). Previously vaccinated SOT recipients (Group A3) will receive a single 100-µg dose (dose 
3) on Day 1. In Part B (Group B2, Group B3, Group B4, and Group B5), participants will receive 
a single 100-µg dose on BD-D1. Under Amendment #4, unvaccinated SOT participants who will 
be enrolled will be given 3 100 µg doses in Part A then proceed to Part B to receive a 100 µg 
booster dose. Under Amendment #4, SOT participants previously vaccinated with 2 doses of 
Moderna COVID-19 vaccine outside of the study who will be enrolled will receive a third 100 µg 
dose in Part A then proceed to Part B to receive a 100 µg BD. 
At each visit when vaccine is administered, participants will be monitored for a minimum of 
30 minutes after administration. Assessments will include vital sign measurements and monitoring 
for local or systemic ARs. 
Eligibility for a subsequent dose of vaccine will be determined by following the criteria outlined 
in Section 6. 
The study sites will be appropriately staffed with individuals with basic cardiopulmonary 
resuscitation training/certification. Either onsite resuscitation equipment and personnel or 
appropriate protocols for the rapid transport of participant to a resuscitation area or facility are 
required. 
5.3.3. 
Study Vaccine Delivery and Receipt 
The Sponsor or designee is responsible for the following: 
• Supplying the vaccine 
• Confirming the appropriate labeling of the vaccine, so that it complies with the legal 
requirements of the United States 
The investigator is responsible for acknowledging the receipt of the vaccine by a designated staff 
member at the study site, including the following: 
• Confirming that the vaccine was received in good condition 
• Confirming that the temperature during shipment from the Sponsor to the 
investigator’s designated storage location was appropriate 
• Confirming that the Sponsor has authorized the vaccine for use 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 109 
• Ensuring the appropriate dose level of vaccine is properly prepared using aseptic 
technique 
Further description of the vaccine and instructions for the receipt, storage, preparation, 
administration, accountability, and destruction of the vaccine are described in the 
mRNA-1273-P304 Pharmacy Manual. 
5.3.4. 
Study Vaccine Packaging and Labeling 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of vaccine. The sterile vaccine is packaged in 10R glass vials with a 6.3-mL or 8.0-mL fill volume. 
The vaccine will have all required labeling per regulations and will be supplied to the pharmacy 
in an unblinded manner. 
The vaccine will be packaged and labeled in accordance with the standard operating procedures of 
the Sponsor or of its designee, Code of Federal Regulations (CFR) Title 21, Good Manufacturing 
Practice guidelines, International Council for Harmonisation (ICH) GCP guidelines, guidelines for 
Quality System Regulations, and applicable regulations. 
5.3.5. 
Study Vaccine Storage 
The Moderna COVID-19 vaccine vials are to be stored in a secure area with limited access and 
protected from moisture and light until it is prepared for administration (Section 5.3.1). Vials are 
to be stored frozen between -25°C and -15°C (13°F and 5°F). Unpunctured vials may be stored 
between 8°C and 25°C (46°F and 77°F) for up to 12 hours. The refrigerator should have automated 
temperature recording and a 24-hour alert system in place that allows for rapid response in case of 
refrigerator malfunction. There must be an available backup refrigerator. The refrigerators must 
be connected to a backup generator. In addition, vaccine accountability study staff are required to 
keep a temperature log to establish a record of compliance with these storage conditions. 
The study site is responsible for reporting any vaccine that was not temperature controlled during 
shipment or during storage. Such vaccine will be retained for inspection by the monitor and 
disposed of according to approved methods. 
5.3.6. 
Study Vaccine Accountability and Disposal 
It is the investigator’s responsibility that the vaccine accountability study staff maintain accurate 
records in a vaccine accountability log of receipt of all vaccine, study site vaccine inventory, 
vaccine dispensing, vaccine injections, and return to the Sponsor or alternative disposition of used 
and unused vaccine vials. 
A study site monitor will review vaccine accountability during study site visits and at the 
completion of the study during onsite and/or remote monitoring visits. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 110 
Vaccine may be destroyed at the study site only if permitted by local regulations and authorized 
by the Sponsor. A certificate of destruction must be completed and sent to the Sponsor or designee. 
Additional details are found in the mRNA-1273-P304 Pharmacy Manual. 
5.4. 
Study Treatment Compliance 
All doses of vaccine will be administered at the study site under direct observation of medically 
qualified study staff and appropriately recorded (date and time) in the eCRF. Qualified study site 
staff will confirm that the participant has received the entire dose of vaccine. If a participant does 
not receive vaccine or does not receive all of the planned doses, the reason for the missed dose will 
be recorded. Data will be reconciled with study site accountability records to assess compliance. 
Participants who miss the second or third dose due to noncompliance with the visit schedule and 
not due to a safety pause will still be required to follow the original visit and testing schedule as 
described in the protocol and their regimen schedule. Unless consent is withdrawn, a participant 
who withdraws or is withheld from receiving the second or third dose will remain in the study and 
complete all safety and immunogenicity assessments required through the participant’s last 
scheduled study visit. 
The study site staff are responsible for ensuring that participants comply with the allowed study 
visit windows. If a participant misses a visit, every effort should be made to contact the participant 
and complete a visit within the defined visit window (Section 10.1). If a participant does not 
complete a visit within the time window, that visit will be classified as a protocol deviation. The 
participant will continue with subsequent scheduled study visits. All safety requirements of the 
missed visit will be captured and included in the subsequent visit. 
5.5. 
Prior and Concomitant Medications 
5.5.1. 
Prior Medications and Therapies 
Information about prior medications (including any prescription or over-the-counter medications, 
vaccines, or blood products) taken by the participant within the 28 days before providing informed 
consent (or as designated in the inclusion/exclusion requirements) will be recorded in the 
participant’s eCRF. In addition, for previously vaccinated participants, the 2 previous doses of the 
Moderna COVID-19 vaccine received prior to signing the informed consent will be recorded in 
the participant’s eCRF regardless of the timing. 
For SOT recipients, all immunosuppressant medications will be recorded in the eCRF page, 3 
months prior to Screening and throughout the study. Any change in the maintenance therapy 
should be recorded and the reason for the change documented. Changes include any adjustments 
(temporarily or permanently), addition of new immunosuppressants, or switching from 1 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 111 
maintenance rejection prophylaxis regimen to another. Reasons for change may include, but are 
not limited to, per center protocol, drug interaction, toxicity, or treatment or prevention of graft 
rejection. 
5.5.2. 
Concomitant Medications and Therapies 
At each study visit and each safety telephone call, study site staff must question the participant 
regarding any medications taken and vaccinations received by the participant and record the 
following information in the eCRF: 
• All immunosuppressant medications, including but not limited to, glucocorticoids (eg, 
prednisolone), immunophilin binding agents (eg, calcineurin inhibitors, mTOR 
inhibitors), and inhibitors of de novo nucleotide synthesis (eg, mycophenolic acid, 
mizoribine, leflunomide, azathioprine) for 3 months prior to Screening and 
throughout the study. Any immunosuppressants listed in the exclusion criteria if taken 
during the study should also be recorded. 
• All nonstudy vaccinations administered within the period starting 28 days before the 
first dose of study vaccine, including seasonal influenza vaccine administered for the 
current influenza season (typically October through April in the Northern 
Hemisphere). 
• All concomitant medications and nonstudy vaccinations taken through 28 days after 
each dose of study vaccine. Antipyretics and analgesics taken prophylactically (ie, 
taken in the absence of any symptoms in anticipation of an injection reaction) will be 
recorded as such. 
• Any concomitant medications relevant to or for the treatment of an SAE or MAAE. 
• Any concomitant medications used to prevent or treat COVID-19 or its symptoms. 
• Participants will be asked in the eDiary if they have taken any antipyretic or analgesic 
to treat or prevent fever or pain within 7 days after each dose of vaccine, including 
the day of injection. Reported antipyretic or analgesic medications should be recorded 
in the source document by the study site staff during the post-injection study visits or 
via other participant interactions (eg, telephone calls). 
Concomitant medications (including vaccinations) will be coded using the WHO Drug Dictionary. 
If a participant takes a prohibited drug therapy, the investigator and the contract research 
organization’s (CRO’s) medical monitor will make a joint decision about continuing or 
withholding further injection of the participant based on the time the medication was administered, 
the drug’s pharmacology and pharmacokinetics, and whether use of the medication will 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 112 
compromise the participant’s safety or interpretation of the data. It is the investigator’s 
responsibility to ensure that details regarding the concomitant medications are adequately recorded 
in the eCRF. 
5.5.3. 
Concomitant Medications and Vaccines that May Lead to the Elimination of a 
Participant from Per-Protocol Analysis 
The use of the following concomitant medications and/or vaccines will not require withdrawal of 
the participant from the study, but may determine a participant’s eligibility to receive a second or 
third dose or evaluability in the PP analysis (analysis sets are described in Section 8.2): 
• Any investigational or nonregistered product (drug or vaccine) other than the 
mRNA-1273 vaccine used during the study period 
• Any medications listed in the study exclusion criteria (Section 4.1.1.2 and Section 
4.1.2.2) 
• Immunoglobulins and/or any blood products administered during the study period 
5.6. 
Intervention After the End of the Study 
Any SAE occurring after a participant’s scheduled EOS and considered to be caused by the vaccine 
must be reported to the Sponsor. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 113 
6. 
DELAYING OR DISCONTINUING STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL FROM THE STUDY 
6.1. 
Criteria for Delay of Vaccine Administration 
6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination 
Body temperature (oral) must be measured on dosing visits before vaccine administration. The 
following events constitute criteria for delay of injection, and if either of these events occur at the 
time scheduled for dosing, the participant may receive the study injection at a later date within the 
time window specified in the applicable SoE (Section 10.1), or the participant may be discontinued 
from dosing at the discretion of the investigator (Section 6.2): 
• Acute moderate or severe infection with or without fever at the time of dosing 
• Fever, defined as body temperature ≥ 38.0°C/≥ 100.4°F at the time of dosing (oral 
temperature preferred) 
Participants with a minor illness without fever, as assessed by the investigator, can be vaccinated. 
Participants with a fever of ≥ 38.0°C/≥ 100.4°F will be contacted within the time window 
acceptable for participation and re-evaluated for eligibility. If the investigator determines that the 
participant’s health on the day of dosing temporarily precludes injection, the visit should be 
rescheduled within the allowed interval for that visit if possible or at a time the participant is 
clinically stable according to the judgement of the investigator. 
If a participant takes a prohibited drug therapy, an injection could be delayed within the visit 
window based on the joint decision of the investigator and the CRO’s medical monitor 
(Section 5.5.3). 
6.2. 
Discontinuing Study Vaccination 
Participants can discontinue study injection (ie, refuse the second or third dose) for any reason, 
without prejudice to further treatment the participant may need to receive. 
The investigator, in consultation with the Sponsor’s medical monitor, may withhold a participant 
from further injection if the participant does any of the following: 
• Withdraws consent to participate in the study (Section 6.3) 
• Becomes pregnant (Section 7.5.5) 
• Develops, during the course of the study, symptoms or conditions listed in the 
exclusion criteria (Section 4.1.1.2 or Section 4.1.2.2) 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 114 
• Experiences an unsolicited AE (other than reactogenicity) after injection that is 
considered by the investigator to be related to vaccine (Section 7.5.10) and is assessed 
as severe (Section 7.5.9) 
• Experiences an AE or SAE that, in the judgment of the investigator, requires vaccine 
withdrawal due to its nature, severity, or required treatment, regardless of the causal 
relationship to vaccine 
• Experiences a clinically significant change in vital sign measurements or general 
condition that, in the judgment of the investigator, requires vaccine withdrawal 
• Experiences anaphylaxis (Section 7.5.5) clearly related to vaccine 
• Experiences an event that meets the criteria for study pause rules (Section 7.6.2) 
The reason(s) for withdrawal from further injection will be recorded in the eCRF. 
If a participant takes a prohibited drug therapy, the investigator could withhold the second or third 
dose based on a joint decision of the investigator and the CRO’s medical monitor (Section 5.5.2). 
Every reasonable attempt will be made to follow-up with participants for safety throughout the 
entire scheduled study period according to their regimen, even if the participant does not receive 
the second or third dose or misses 1 or more visits. Unless participants withdraw consent, they are 
expected to remain in the study and complete all scheduled visits and assessments. 
6.3. 
Participant Discontinuation/Withdrawal from the Study 
Participants who withdraw or are withdrawn from the study will not be replaced. A “withdrawal” 
from the study refers to a situation wherein a participant does not return for the final visit planned 
in the protocol. The statistical management of participant withdrawals is discussed in Section 8. 
Participants can withdraw consent and withdraw from the study at any time, for any reason, 
without prejudice to further treatment the participant may need to receive. The investigator will 
request that the participant complete all study procedures pending at the time of withdrawal. 
If the participant desires to withdraw from the study because of an AE, the investigator will try to 
obtain agreement to follow-up with the participant until the event is considered resolved or stable 
and will then complete the EOS eCRF. 
Information related to the withdrawal will be documented in the eCRF. The investigator will 
document whether the decision to withdraw a participant from the study was made by the 
participant or by the investigator, as well as which of the following possible reasons was 
responsible for withdrawal: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 115 
• AE (specify) 
• SAE (specify) 
• Death 
• Lost to follow-up (LTFU) 
• Physician decision (specify) 
• Pregnancy 
• Protocol deviation 
• Study terminated by Sponsor 
• Withdrawal of consent by participant (specify) 
• Other (specify) 
Participants who are withdrawn from the study because of AEs (including SAEs) must be clearly 
distinguished from participants who are withdrawn for other reasons. Investigators will follow-up 
with participants who are withdrawn from the study as result of an SAE or AE until resolution of 
the event. 
A participant who withdraws from the study may request destruction of any samples taken and not 
tested, and the investigator must document this in the study site study records. 
If the participant withdraws consent for disclosure of future information, the Sponsor may retain 
and continue to use any data collected before such a withdrawal of consent (Section 10.2.10). 
The Sponsor will continue to retain and use all research data that have already been collected for 
the study evaluation, unless the participant has requested destruction of these samples. All 
biological samples that have already been collected may be retained and analyzed at a later date 
(or as permitted by local regulations) 
6.4. 
Lost to Follow-up 
A participant will be considered LTFU if he or she repeatedly fails to return for scheduled visits 
without stating an intention to withdraw consent and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• The study site staff must attempt to contact the participant and reschedule the missed 
visit as soon as possible, counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether the participant wishes to and/or should 
continue in the study. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 116 
• Before a participant is deemed LTFU, the investigator or designee must make every 
effort to regain contact with the participant (where possible, 3 telephone calls, emails, 
and, if necessary, a certified letter to the participant’s last known mailing address or 
local equivalent methods). These contact attempts (eg, dates of telephone calls, 
emails, and certified letters) should be documented in the participant’s medical 
record. 
• A participant who continues to be unreachable or continues to be noncompliant with 
study visits or procedures will be considered to have withdrawn from the study. 
• A participant should not be considered LTFU until due diligence has been completed. 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 117 
7. 
STUDY ASSESSMENTS AND PROCEDURES 
Before performing any study procedures, all potential participants will sign an ICF (as detailed in 
Section 10.2.6). Participants will undergo study procedures at the time points specified in the 
applicable SoE (Section 10.1). A participant can also be seen for an unscheduled visit at any time 
during the study. An unscheduled visit may be prompted by reactogenicity issues, illness visit 
criteria for COVID-19, or new or ongoing AEs. The study site also has the discretion to make 
reminder telephone calls or send text messages to inform the participant about visits, review eDiary 
requirements, or follow-up on ongoing or outstanding issues. 
In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during 
COVID-19 Public Health Emergency” (DHHS 2020), investigators may convert study site visits 
to telemedicine visits with the approval of the Sponsor. Such action should be taken to protect the 
safety and well-being of study participants and study site staff or to comply with state or municipal 
mandates. 
General considerations for study assessments and procedures include the following: 
• Protocol waivers or exemptions are not allowed. The study procedures and their 
timing must be followed as presented in Section 10.1. Adherence to the study design 
requirements is essential and required for study conduct. 
• Immediate safety concerns should be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue study 
treatment or participation in the study. 
• All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log 
to record details of all participants screened and to confirm eligibility or record 
reasons for screening failure, as applicable. 
• Procedures conducted as part of the participant’s routine clinical management (eg, 
blood count) and obtained before signing of the ICF may be utilized for screening or 
baseline assessments provided the procedures met the protocol-specified criteria and 
were performed within the time frame defined in the applicable SoE. 
7.1. 
Safety Assessments and Procedures 
Safety assessments will include monitoring and recording of the following for each participant, 
according to the applicable SoE: 
• Solicited local and systemic ARs (Section 7.5.3) that occur during the 7 days 
following each injection (ie, the day of injection and 6 subsequent days). Solicited 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 118 
ARs will be recorded daily using the eDiary (Section 7.1.1). The definition of AR is 
presented in Section 7.5.1. 
• Unsolicited AEs observed or reported during the 28 days following each injection (ie, 
the day of injection and 27 subsequent days). Unsolicited AEs are defined in Section 
7.5.1. 
• MAAEs throughout the study period. 
• SAEs throughout the study period. 
• AESIs throughout the study period. 
• AEs leading to discontinuation from dosing and/or study participation (withdrawal) 
throughout the study period. 
• Biopsy-proven organ rejection throughout the study period. A biopsy report will be 
needed for documentation. 
• Safety laboratory assessments: 
Part A 
− For unvaccinated SOT recipients who receive the 2-dose regimen (Group A1), 
safety laboratory assessments related to kidney (for kidney transplant recipients) 
and liver function (for liver transplant recipients) will be monitored on Day 1, 
Day 8, Day 29, Day 36, and Day 57. After Day 57, the investigator will review 
standard-of-care laboratory assessments related to kidney and liver function (as 
related to the SOT) and report any laboratory-related AEs and suspected or 
confirmed events of organ transplant rejection until the EOS. 
− For unvaccinated SOT recipients who receive the 3-dose regimen (Group A2), 
safety laboratory assessments related to kidney (for kidney transplant recipients) 
and liver function (for liver transplant recipients) will be monitored on Day 1, 
Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, and Day 113. After Day 113, 
the investigator will review standard-of-care laboratory assessments related to 
kidney and liver function (as related to the SOT) and report any laboratory-related 
AEs and suspected or confirmed events of organ transplant rejection until the 
EOS. 
− For previously vaccinated SOT recipients who receive dose 3 (Group A3), safety 
laboratory assessments related to kidney (for kidney transplant recipients) and 
liver function (for liver transplant recipients) will be monitored on Day 1, Day 8, 
and Day 29. After Day 29, the investigator will review standard-of-care 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 119 
laboratory assessments related to kidney and liver function (as related to the SOT) 
and report any laboratory-related AEs and suspected or confirmed events of organ 
transplant rejection until the EOS. 
Part B 
− For SOT participants who completed primary vaccination series (Group B2, 
Group B3, and Group B4), safety laboratory assessments related to kidney (for 
kidney transplant recipients) and liver function (for liver transplant recipients) 
will be monitored on BD-D1, BD-D8, and BD-D29. After BD-D29, the 
investigator will review standard-of-care laboratory assessments related to kidney 
and liver function, and report any laboratory-related AEs and suspected or 
confirmed events of organ transplant rejection until the EOS. 
• Vital sign measurements (Section 7.1.4). 
• Physical examination findings (Section 7.1.5). 
• Assessments for SARS-CoV-2 infection from Day 1 through study completion 
(Section 7.1.6). 
• Details of all pregnancies in female participants will be collected after the start of 
study treatment and until the end of their participation in the study (Section 7.5.5). 
• Changes in immunosuppressant medications in SOT recipients 
7.1.1. 
Use of Electronic Diaries 
At the time of consent, participants must confirm that they will be willing to complete an eDiary 
using either an application downloaded to their smartphone or using a device that is provided at 
the time of enrollment. Before enrollment on Day 1, participants will be instructed to download 
the eDiary application or will be provided an eDiary device to record solicited ARs (Section 7.5.3) 
on Day 1. 
At each injection visit, participants will be instructed on thermometer usage to measure body 
temperature, ruler usage to measure injection site erythema and swelling/induration (hardness), 
and self-assessment for localized axillary swelling or tenderness on the same side as the injection 
arm. 
At each injection visit, participants will record data into the eDiary starting approximately 
30 minutes after injection under supervision of the study site staff to ensure successful entry of 
assessments. The study site staff will perform any retraining as necessary. Participants will 
continue to record data in the eDiary after they leave the study site, preferably in the evening and 
at the same time each day, on the day of injection and for 6 days following injection. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 120 
Participants will record the following data in the eDiary: 
• Solicited local and systemic reactogenicity ARs, as defined in Section 7.5.3, that 
occur on the day of each vaccine administration and during the 7 days after vaccine 
administration (ie, the day of injection and 6 subsequent days). If a solicited local or 
systemic AR continues beyond Day 7 after vaccination, the participant will be 
prompted to capture details of the solicited local or systemic AR in the eDiary until it 
is resolved or the next vaccine injection occurs, whichever occurs first; capture of 
details of ARs in the eDiary should not exceed 28 days after each vaccination. 
Adverse reactions recorded in the eDiary beyond Day 7 should be reviewed by the 
study site staff either during the next scheduled telephone call or at the next study site 
visit. 
• Daily oral body temperature measurement should be performed at approximately the 
same time each day using the thermometer provided by the study site. If body 
temperature is taken more than once in a given day, only the highest temperature 
reading should be recorded. 
• Measurement, as applicable, for solicited local ARs (injection site erythema and 
swelling/induration); the size measurements will be performed using the ruler 
provided by the study site. 
• Any medications taken to treat or prevent pain or fever on the day of injection or for 
the next 6 days. 
The eDiary will be the only source documents allowed for solicited local or systemic ARs 
(including body temperature measurements). Participants will be instructed to complete eDiary 
entries daily. The participant will have a limited window on the following day to complete 
assessments for the previous day; quantitative temperature recordings and measurement of any 
injection site erythema or swelling/induration reported on the following day may be excluded from 
the analyses of solicited ARs. 
Any new safety information reported during safety telephone calls or at study site visits (including 
a solicited reaction) that is not already captured in the eDiary will be described in the source 
documents as a verbally reported event. An event reported in this manner must be described as a 
solicited event and entered on the solicited AR eCRF. 
Study site staff will review eDiary data with participants at visits 7 days after each injection. 
In Part A, the eDiary will also be used every 4 weeks to capture the occurrence of AEs, MAAEs, 
SAEs, AESIs, or AEs leading to discontinuation from dosing and/or study participation 
(withdrawal) as follows: 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 121 
• Starting at Day 71 through Day 183 and again starting at Day 223 through Day 363 for 
unvaccinated SOT and healthy recipients of 2 vaccine doses (Group A1 and Group A5), 
• Starting at Day 127 through Day 239 and again Day 279 through Day 419 for unvaccinated 
SOT recipients of 3 vaccine doses (Group A2), and 
• Starting at Day 43 through Day 155 and again starting at Day 194 through Day 306 
(previously vaccinated SOT recipients who receive dose 3) (Group A3). 
The timing of eDiary prompts and safety calls will not be adjusted when the last dose is delayed. 
If the last dose is delayed beyond the standard window, the following clinic visits should be 
adjusted: 
For the 2-dose regimen (Group A1 and Group A5), the actual date of the last delayed dose should 
be used to adjust D36 (7 days after last dose), D57 (28 days after last dose), 6 months visit (180 
days after last dose) and 12 months visit (365 days after last dose). 
For the 3-dose regimen (Group A2), the actual date of the last delayed dose should be used to 
adjust dates for D97 (7 days after last dose), D113 (28 days after last dose), 6 months visit (180 
days after last dose) and 12 months visit (365 days after last dose). 
Additional safety calls every 4 weeks should be scheduled when there is a gap beyond 28 days 
between the safety call scheduled on D377 (for 2 doses [Group A1 and Group A5]) or D433 (for 
3 doses [Group A2]) and the last study visit. 
As specified in the applicable SoE, the eDiary will prompt the participant to complete an eDiary 
questionnaire that collects the following data: 
• Changes in health since last completing the questionnaire or since in contact with the 
study site 
• Known close contact exposure to someone with known COVID-19 or SARS-CoV-2 
infection 
• Any experience of symptoms of COVID-19 
• Any MAAEs or SAEs 
If an eDiary record results in identification of relevant safety events according to the study period, 
or of symptoms of COVID-19, a follow-up safety telephone call will be triggered. 
Completion of eDiary questionnaires will alternate with safety telephone calls (Section 7.1.2) as 
the procedure for safety follow-up approximately every 4 weeks: 
• Starting at Day 85 through Day 197 and again starting at Day 237 through Day 377 for 
unvaccinated SOT and healthy recipients of 2 vaccine doses (Group A1 and Group A5), 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 122 
• Starting every 4 weeks from Day 141 through Day 253 and again from Day 293 through 
Day 433 for unvaccinated SOT recipients of 3 vaccine doses (Group A2), and 
• Starting at Day 57 through Day 169 and again starting at Day 208 through Day 320 
(previously vaccinated SOT recipients who receive dose 3) (Group A3). 
The follow-up eDiary questionnaires and the safety calls conducted by the study staff will occur 
~2 weeks apart on a 4 week cycle. 
7.1.1.1. 
Ancillary Supplies for Participant Use 
Study sites will distribute Sponsor-provided oral thermometers and rulers for use by participants 
in assessing body temperature and injection site reactions, respectively, for recording solicited ARs 
in the eDiary. Based on availability, smartphone devices may be provided to those participants 
who do not have their own device to use for eDiary activities. 
7.1.2. 
Safety Telephone Calls 
A safety telephone call is a telephone call made to the participant by trained study site personnel. 
This call will follow a script, which will facilitate the collection of relevant safety information. In 
Part A, safety telephone calls follow a schedule for each participant as indicated in the applicable 
SoE: 
• Every 4 weeks from Day 85 to Day 197 and again from Day 237 to Day 377 for 
unvaccinated SOT and Healthy recipients of 2 vaccine doses (Group A1 and Group A5), 
• Every 4 weeks from Day 141 to Day 253 and again from Day 293 to Day 433 for 
unvaccinated SOT recipients of 3 vaccine doses (Group A2), and 
• Every 4 weeks from Day 57 through Day 169 and again starting at Day 208 through Day 
320 for previously vaccinated SOT recipients who receive dose 3 (Group A3). 
The schedule of safety telephone calls will not be adjusted for each participant based on the actual 
day of the last dose, if delayed. Additional safety calls every 4 weeks should be scheduled when 
there is a gap beyond 28 days between the safety call scheduled on D377 (for 2 doses [Group A1 
and Group A5]) or D433 (for 3 doses [Group A2]) and the last study visit. 
In Part B, safety telephone calls will be performed on BD-D15, BD-D22, BD-D59, BD-D89, BD-
119, and BD-D149 to collect information about occurrence of AEs, MAAEs (including biopsy-
proven organ rejection), SAEs, AESIs, AEs leading to discontinuation from dosing and/or study 
participation (withdrawal), concomitant medications associated with those events, and any 
nonstudy vaccinations (Section 7.5.8). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 123 
The participant will be interviewed according to the script about occurrence of AEs, MAAEs 
(including biopsy-proven organ rejection), SAEs, AESIs, AEs leading to discontinuation from 
dosing and/or study participation (withdrawal), concomitant medications associated with those 
events, and any nonstudy vaccinations (Section 7.5.8). In addition, study personnel will collect 
information on known participant close contact exposure to someone with known COVID-19 or 
SARS-CoV-2 infection and on participant experience of COVID-19 symptoms. All safety 
information collected from the telephone contact must be documented in source documents as 
described by the participant and not documented on the script used for the safety telephone contact. 
As noted in Section 7.1.1, an unscheduled follow-up safety telephone call may be triggered if an 
eDiary record results in identification of a relevant safety event. 
7.1.3. 
Safety Laboratory Assessments 
All safety laboratory assessments will be conducted at laboratories local to the study sites. To help 
monitor for potential event of organ transplant rejection in the SOT recipients, safety laboratory 
assessments will be performed, including assessments related to kidney and liver function (eg, 
serum creatinine, urine protein, and UPCR for kidney SOT recipients; and ALT, AST, ALP, and 
bilirubin for liver SOT recipients) at prespecified study visits. After Day 57 (unvaccinated SOT 
recipients who receive 2 vaccine doses [Group A1]) or after Day 113 (unvaccinated SOT recipients 
who receive 3 vaccine doses [Group A2]) or after Day 29 (previously vaccinated SOT recipients 
who receive dose 3 [Group A3] in Part A or SOT recipients who completed the primary 
vaccination series who receive BD [Group B4]) in Part B, the investigator will review 
standard-of-care laboratory assessments related to kidney and liver function (as applicable), and 
report any laboratory-related AEs and suspected or confirmed events of organ transplant rejection 
until the EOS. The investigator must review results of safety laboratory assessments as soon as 
they are available. Schedules of sampling for safety laboratory assessments are presented in the 
SoEs- (Section 10.1). 
A point-of-care urine pregnancy test will be performed at the screening visit (Day 0) and before 
each dose of vaccine. One pregnancy test is sufficient if Day 0 and Day 1 are combined in the 
same. At any time, a pregnancy test either via blood or point-of-care urine can be performed, at 
the discretion of the investigator. Pregnancy is one of the exclusion criteria (Section 4.1.1.2 and 
Section 4.1.2.2) in this study and is a reason for dosing discontinuation (Section 6.2). 
Appendix 3 (Section 10.3) details the study guidance on contraception. 
7.1.4. 
Vital Sign Measurements 
Vital sign measurements will include systolic and diastolic blood pressure, heart rate, respiratory 
rate, and body temperature (preferred route is oral). The participant will be seated for at least 
5 minutes before all measurements are taken. Vital signs will be measured at the time points 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 124 
indicated in the applicable SoE. At dosing visits, vital sign measurements will be collected once 
before injection and at least 30 minutes after injection (before participants are discharged from the 
study site). 
Febrile participants at dosing visits (fever is defined as a body temperature ≥ 38.0°C/≥ 100.4°F) 
may have visits rescheduled within the relevant study visit windows. Afebrile participants with 
minor illnesses may be injected at the discretion of the investigator. 
When procedures overlap and are scheduled to occur at the same time point, the order of 
procedures should be vital sign measurements and then the blood collection. 
7.1.5. 
Physical Examinations 
A full physical examination, including height and weight, will be performed at Day 1 as indicated 
in the applicable SoE (Section 10.1). The full examination will include assessment of skin, head, 
ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular system, abdomen, lymph nodes, 
and musculoskeletal system/extremities. Any clinically significant finding identified during a 
study visit should be reported as an MAAE. Symptom-directed physical examinations will be 
performed at other time points. 
On each injection day before injection and again 7 days after injection, the arm that received the 
injection should be examined and the associated lymph nodes must be evaluated. Any clinically 
significant finding identified during a study visit should be reported as an MAAE. 
Body mass index will be calculated at the screening visit (Day 0) only. 
7.1.6. 
Assessments for SARS-CoV-2 Infection 
Study participants will have NP samples collected for SARS-CoV-2 testing by RT-PCR at time 
points specified in the applicable SoE (Section 10.1). A study illness visit or a consultation will be 
arranged within 72 hours or as soon as possible to collect an NP or nasal swab sample (NP is 
preferred) to ascertain the presence of SARS-CoV-2 via RT-PCR if a participant experiences any 
of the following: 
• Signs or symptoms of SARS-CoV-2 infection as defined by the CDC (CDC 2020a) 
• Close contact exposure to an individual confirmed to be infected with SARS-CoV-2 
• MAAE suggesting a SARS-CoV-2 infection 
If the participant had known close contact exposure to COVID-19 (eg, close contact exposure to 
someone with confirmed COVID-19), it will be captured in the COVID-19 exposure form. 
If scheduled, the study illness visit may collect additional clinical information at the investigator’s 
discretion, including but not limited to medical history, physical examination, blood sampling for 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 125 
clinical laboratory testing, and nasal, saliva, and/or NP swab sampling for viral PCR (including 
multiplex PCR for respiratory viruses, including SARS-CoV-2) to evaluate the severity of the 
clinical case. Radiologic imaging studies may be conducted. During this visit, a blood sample will 
also be collected for immunologic assessment of SARS-CoV-2. All findings will be recorded in 
the eCRF. 
If participants are confirmed to have SARS-CoV-2 infection, the investigator will notify the 
participant and the participant’s primary care physician of the diagnosis. If the study participant 
does not have a primary care physician, the investigator will assist them in obtaining one. The 
participant will also be instructed on infection prevention measures consistent with local public 
health guidance. 
Any confirmed symptomatic SARS-CoV-2 infection occurring in participants will be captured as 
an MAAE along with relevant concomitant medications and details about severity, seriousness, 
and outcome. Additionally, a convalescent visit will be scheduled approximately 28 days (+7 days) 
after diagnosis (Section 7.3.2). At this visit, an NP swab sampling for viral PCR and a blood sample 
will be collected for potential immunologic assessment of SARS-CoV-2 infection 
7.2. 
Immunogenicity Assessments 
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the applicable SoE (Section 10.1): The following analytes will be measured: 
• Serum nAb level against SARS-CoV-2 as measured by pseudovirus and/or live virus 
neutralization assays 
• Serum bAb against SARS-CoV-2 spike protein measured by ligand binding assay 
specific to the SARS-CoV-2 S protein 
Sample aliquots will be designed to ensure that backup samples are available and that vial volumes 
are likely to be adequate for future testing needs. The actual time and date of each sample collected 
will be recorded in the eCRF, and unique sample identification will be utilized to maintain the 
blind at the laboratory at all times and to allow for automated sample tracking and housing. 
Handling and preparation of the samples for analysis, as well as shipping and storage requirements, 
will be provided in a separate study manual. 
Measurement of bAb and nAb levels will be performed in a laboratory designated by the Sponsor. 
According to the ICF (Section 10.2.6), serum from immunogenicity testing may be used for future 
research, which may be performed at the discretion of the Sponsor to further characterize the 
immune response to SARS-CoV-2, additional assay development, and the immune response across 
CoVs. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 126 
7.3. 
COVID-19 and SARS-CoV-2 Infection 
To be considered as a case of symptomatic COVID-19 for the evaluation of the secondary 
endpoint, the following case definition must be met: 
• The participant must have experienced at least TWO of the following symptoms: 
Fever (≥ 38°C/≥ 100.4°F), chills, myalgia, headache, sore throat, or new olfactory and 
taste disorder(s), OR 
• The participant must have experienced at least ONE of the following respiratory 
signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or 
radiographical evidence of pneumonia; AND 
• The participant must have at least 1 NP swab, nasal swab, or saliva sample (or 
respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR. 
Severe COVID-19: 
To be considered severe COVID-19, the following criteria must be met: 
• Confirmed symptomatic COVID-19 as per the secondary endpoint case definition, 
plus any of the following: 
• Clinical signs indicative of severe systemic illness, respiratory rates ≥ 30 breaths per 
minute, heart rate ≥ 125 beats per minute, oxygen saturation ≤ 93% on room air at sea 
level, or partial pressure of oxygen/fraction of inspired oxygen < 300 mm Hg, OR 
o Respiratory failure or ARDS (defined as needing high-flow oxygen, noninvasive 
or mechanical ventilation, or extracorporeal membrane oxygenation), evidence of 
shock (systolic blood pressure < 90 mm Hg, diastolic BP < 60 mm Hg, or 
requiring vasopressors), OR 
o Significant acute renal, hepatic, or neurologic dysfunction, OR 
o Admission to an intensive care unit or death. 
The alternative case definition of COVID-19, used for surveillance of COVID-19 symptoms 
(Section 7.3.1), is defined as the following symptoms: fever (temperature ≥ 38°C/≥ 100.4°F), 
chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches, body aches, 
headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, or 
diarrhea AND a positive NP swab or saliva sample for SARS-CoV-2 by RT-PCR. 
Death attributed to COVID-19 is defined as any participant who dies during the study with a cause 
directly attributed to a complication of COVID-19. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 127 
Serologic Evidence of SARS-CoV-2 Infection: 
Serologic evidence of SARS-CoV-2 infection is defined in participants with negative 
SARS-CoV-2 at baseline as (Table 1): 
• bAb levels against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche 
Elecsys) at Day 1 that become positive (as measured by Roche Elecsys) counted starting 
at Day 29 (previously vaccinated SOT recipients who receive dose 3 [Group A3]), 
Day 57 (unvaccinated participants who receive 2 doses [Group A1]), or at Day 113 
(unvaccinated SOT recipients who receive 3 doses [Group A2]), or at BD-D29 (for 
participants who receive BD), or later. 
7.3.1. 
Surveillance for COVID-19 Symptoms 
According to the CDC as of 10 Jun 2020 (CDC 2020b), patients with COVID-19 have reported a 
wide range of symptoms ranging from mild symptoms to severe illness. Throughout the study, to 
survey for COVID-19, the participant will be instructed to notify the site if the following 
prespecified symptoms that meet the criteria for suspicion of COVID-19 occur. If any one of these 
symptoms lasts for at least 48 hours (except for fever and/or respiratory symptoms), the study staff 
will arrange an illness visit to collect an NP swab within 72 hours: 
• Fever (temperature ≥ 38°C/≥ 100.4°F) or chills (of any duration, including ≤ 48 
hours) 
• Shortness of breath or difficulty breathing (of any duration, including ≤ 48 hours) 
• Cough (of any duration, including ≤ 48 hours) 
• Fatigue 
• Muscle or body aches 
• Headache 
• New loss of taste or smell 
• Sore throat 
• Congestion or runny nose 
• Nausea or vomiting 
• Diarrhea 
Surveillance for COVID-19 symptoms will also be conducted via eDiary prompts or telephone 
calls (alternating every 2 weeks) as specified in Section 7.1.1 and Section 7.1.2, respectively. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 128 
• For unvaccinated SOT and Healthy participants who receive 2 vaccine doses (Group A1 and 
Group A5), the eDiary will also be used every 4 weeks, starting at Day 71 through Day 183 
and again starting at Day 223 through Day 363. Safety telephone calls will be made every 4 
weeks from Day 85 to Day 197 and again from Day 237 to Day 377. 
• For unvaccinated SOT participants who receive 3 vaccine doses (Group A2), the eDiaries will 
be collected every 4 weeks starting on Day 127 through Day 239 and again from Day 279 
through Day 419. Safety calls will be made every 4 weeks starting on Day 141 through Day 
253 and again on Day 293 through Day 433. 
• For previously vaccinated SOT participants who receive dose 3 (Group A3), the eDiaries will 
be collected every 4 weeks starting on Day 43 through Day 155 and again from Day 194 
through Day 306. Safety calls will be made every 4 weeks starting on Day 57 through Day 169 
and again on Day 208 through Day 320. 
• For participants who receive a BD in Part B, safety telephone calls will be performed on BD-
15, BD-22, BD-D59, BD-D89, BD-D119, and BD-D149. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 129 
Figure 6: Surveillance for COVID-19 Symptoms and the Corresponding Clinical Data 
Pathways 
 
Abbreviations: BP = blood pressure; COVID-19 = coronavirus disease 2019; ECMO = 
extracorporeal membrane oxygenation; FIO2 = fraction of inspired oxygen; HCP = healthcare 
practitioner; NP = nasopharyngeal; PaO2 = partial pressure of oxygen; RT-PCR = reverse 
transcriptase polymerase chain reaction; SARS-CoV-2 = Severe Acute Respiratory Syndrome 
coronavirus 2; SpO2 = oxygen saturation. 
 
It is important to note that some of the symptoms of COVID-19 overlap with solicited systemic 
ARs that are expected after vaccination with mRNA-1273 (eg, myalgia, headache, fever, and 
chills). During the first 7 days after vaccination, when these solicited ARs are common, 
investigators should use their clinical judgment to decide if an NP swab should be collected. The 
collection of an NP swab prior to the Day 1 and Day 29 vaccinations (for unvaccinated SOT and 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 130 
healthy participants receiving 2 doses [Group A1 and Group A5]); prior to Day 1, Day 29, and 
Day 85 vaccinations (for unvaccinated SOT recipients of 3 doses [Group A2]);prior to Day 1 
vaccination (for previously vaccinated SOT recipients [Group A3]), and prior to BD-D1 (for 
participants who receive a BD in Part B) can help ensure that cases of COVID-19 are not 
overlooked. Any study participant who reports respiratory symptoms during the 7-day period after 
vaccination should be evaluated for COVID-19. 
During the course of the study, participants with symptoms of COVID-19 will be asked to return 
within 72 hours or as soon as possible to the study site to collect an NP swab sample (for RT-PCR) 
for evaluation of COVID-19 and collect a blood sample for immunologic assessment of 
SARS-CoV-2 infection. Both study site visits and telemedicine visits are referred to as illness visits 
(Section 7.1.6). The NP swab sample will also be tested for the presence of other respiratory 
infections. Additionally, a convalescent visit will be scheduled approximately 28 days (+7 days) 
after diagnosis (Section 7.3.2). At this visit, an NP swab sampling for viral PCR and a blood sample 
will be collected for potential immunologic assessment of SARS-CoV-2 infection. In addition, the 
study site may collect an additional respiratory sample for SARS-CoV-2 testing to be able to render 
appropriate medical care for the study participant as determined by local standards of care. 
Cases are defined as participants meeting clinical criteria based both on symptoms for COVID-19 
and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study 
participant reporting symptoms meeting the definition of COVID-19. Participants who are 
hospitalized for COVID-19 without the opportunity for a clinic visit will also be considered cases, 
assuming that the symptomology criteria for COVID-19 are met and a respiratory sample is 
positive for SARS-CoV-2 by PCR at a clinical laboratory improvement amendments certified 
laboratory. Investigators are encouraged to try to obtain a respiratory sample during the course of 
hospitalization for submission to the study central laboratory, if feasible. The investigator should 
determine if the criteria for severe COVID-19 have been met. 
Severe COVID-19 is defined in Section 7.3. 
All clinical findings will be recorded in the eCRF. All confirmed cases of COVID-19 will be 
captured as MAAEs, along with relevant concomitant medications and details about severity, 
seriousness, and outcome, and will be reported immediately to the Sponsor or designee 
(Section 7.5.4). 
7.3.2. 
Follow-up/Convalescent Period After Diagnosis with COVID-19 
Any confirmed COVID-19 occurring in a participant will be captured as an MAAE along with 
relevant concomitant medications and details about severity, seriousness, and outcome. A 
convalescent visit will be scheduled approximately 28 days (+7 days) after diagnosis. At this visit, 
an NP swab sampling for viral PCR and a blood sample will be collected for potential immunologic 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 131 
assessment of SARS-CoV-2 infection. The investigator should determine if the criteria for severe 
COVID-19 have been met. If the participant is hospitalized, medically qualified study site 
personnel will try to obtain medical records and SARS-CoV-2 diagnostic results. If the participant 
is later discharged from the hospital during the 28 day period following diagnosis of COVID-19, 
the study site personnel will arrange for a resumption of the protocol schedule. 
7.4. 
Exploratory Assessments 
Qualitative and quantitative measures of viral load of SARS-CoV-2 will be assessed by RT-PCR 
of material from NP swab samples obtained at illness visits (Section 7.3.1). Any SARS-CoV-2 
genetic sequencing will be performed on the same samples. 
In Part A, cellular immune response (eg, markers of CMI, T-cells, and B-cells) will be assessed 
on Day 1 (before vaccination) and on Day 36 and Day 92 in a subset of at least 50 unvaccinated 
SOT recipients (kidney or liver) who receive 3 doses (Group A2), from all 20 unvaccinated 
healthy study participants (Group A5) (Day 1 before vaccination and Day 36), and from a subset 
of at least 50 previously vaccinated SOT recipients who receive dose 3 (Group A3) (Day 1 
before vaccination and Day 8). In Part B Booster Phase, CMI will also be assessed on BD-D1 
before vaccination and BD-D8 from all participants in Part B. 
Analysis of markers of CMI will be performed in a laboratory designated by the Sponsor. 
Blood samples for biomarker analysis will be collected during BD-D4 (Part B of the study 
[Group B2, Group B3, Group B4, and Group B5]) which will be stored for potential future 
biomarker assessment. 
Handling and preparation of the samples for analysis, as well as shipping and storage 
requirements, will be provided in a separate study manual. 
7.5. 
Safety Definitions and Related Procedures 
7.5.1. 
Adverse Event 
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, 
whether or not it is considered drug-related. 
Events Meeting the Adverse Event Definition 
• Exacerbation of a chronic or intermittent pre-existing condition, including an increase 
in the frequency and/or severity of the condition. 
• New conditions detected or diagnosed after the first dose of vaccine even though they 
may have been present before the start of the study. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 132 
Events NOT Meeting the Adverse Event Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure should be the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
An AR is any AE for which there is a reasonable possibility that the vaccine caused the AE 
(Section 7.5.10). For the purposes of investigational new drug safety reporting, “reasonable 
possibility” means that there is evidence to suggest a causal relationship between the vaccine and 
the AE. 
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AR in 
the protocol or is specified as a solicited AR but starts outside the protocol-defined period for 
reporting solicited ARs (ie, for the 7 days after each dose of vaccine). 
7.5.2. 
Serious Adverse Events 
An AE (including an AR) is considered an SAE if, in the view of either the investigator or Sponsor, 
it results in any of the following outcomes: 
• Death 
A death that occurs during the study or that comes to the attention of the investigator during 
the protocol-defined Follow-up Period must be reported to the Sponsor, whether or not it 
is considered related to the vaccine. 
• Is life-threatening 
An AE is considered life-threatening if, in the view of either the investigator or the Sponsor, 
its occurrence places the participant at immediate risk of death. It does not include an AE 
that, had it occurred in a more severe form, might have caused death. 
• Inpatient hospitalization or prolongation of existing hospitalization 
In general, inpatient hospitalization indicates the participant was admitted to the hospital 
or emergency ward for at least 1 overnight stay for observation and/or treatment that would 
not have been appropriate in the physician’s office or outpatient setting. The hospital or 
emergency ward admission should be considered an SAE regardless of whether opinions 
differ as to the necessity of the admission. Complications that occur during inpatient 
hospitalization will be recorded as an AE; however, if a complication/AE prolongs 
hospitalization or otherwise fulfills SAE criteria, the complication/AE will be recorded as 
a separate SAE. 
• Persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea/vomiting, diarrhea, influenza, and 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 133 
accidental trauma (eg, sprained ankle), which may interfere with or prevent everyday life 
functions but do not constitute a substantial disruption. 
• Congenital anomaly or birth defect 
• Medically important event 
Medical judgment should be exercised in deciding whether SAE reporting is appropriate 
in other situations, such as important medical events that may not be immediately life-
threatening or result in death or hospitalization but may jeopardize the participant or require 
medical or surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious. Examples of such medical 
events include allergic bronchospasm requiring intensive treatment in an emergency room 
or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, 
or the development of drug dependency or drug abuse. 
7.5.3. 
Solicited Adverse Reactions 
The term “reactogenicity” refers to the occurrence and severity of selected signs and symptoms 
(ARs) occurring after vaccine injection. The eDiary will solicit daily participant reporting of ARs 
using a structured checklist (Section 7.1.1). Participants will record such occurrences in an eDiary 
on the day of each dose injection and for the 6 days after the day of dosing. 
Severity grading of reactogenicity will occur automatically based on participant entry into the 
eDiary according to the grading scales presented in Table 4 modified from the Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical 
Trials (DHHS 2007). 
If a solicited local or systemic AR continues beyond Day 7 after vaccination, the participant will 
be prompted to capture details of the solicited local or systemic AR in the eDiary until it resolves 
or the next vaccine injection occurs, whichever occurs first; capture of details of ARs in the eDiary 
should not exceed 28 days after each vaccination. Adverse reactions recorded in the eDiary beyond 
Day 7 should be reviewed by the study site staff either during the next scheduled telephone call or 
at the next study site visit. All solicited ARs (local and systemic) will be considered causally 
related to dosing.

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 134 
Table 4: Solicited Adverse Reactions and Grades 
Reaction 
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4a 
Injection site pain 
None 
Does not interfere 
with activity  
Repeated use of over-the-
counter pain reliever > 24 
hours or interferes with 
activity  
Any use of 
prescription 
pain reliever or 
prevents daily 
activity 
Requires 
emergency room 
visit or 
hospitalization 
Injection site erythema 
(redness) 
< 25 mm/ 
 < 2.5 cm 
25 - 50 mm/ 
2.5 - 5 cm 
51 - 100 mm/ 
5.1 - 10 cm 
> 100 mm/ 
> 10 cm 
Necrosis or 
exfoliative 
dermatitis 
Injection site 
swelling/induration 
(hardness) 
< 25 mm/ 
< 2.5 cm 
25 - 50 mm/ 
2.5 - 5 cm 
51 - 100 mm/ 
5.1 - 10 cm 
> 100 mm/ 
> 10 cm 
Necrosis  
Axillary (underarm) 
swelling or tenderness 
ipsilateral to the side of 
injection 
None 
No interference with 
activity 
Repeated use of over-the-
counter (non-narcotic) pain 
reliever > 24 hours or some 
interference with activity 
Any use of 
prescription 
(narcotic) pain 
reliever or 
prevents daily 
activity 
Emergency room 
visit or 
hospitalization 
Headache 
None 
No interference with 
activity 
Repeated use of 
over-the-counter pain 
reliever > 24 hours or some 
interference with activity 
Significant; any 
use of 
prescription 
pain reliever or 
prevents daily 
activity 
Requires 
emergency room 
visit or 
hospitalization 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 135 
Reaction 
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4a 
Fatigue 
None 
No interference with 
activity  
Some interference with 
activity 
Significant; 
prevents daily 
activity  
Requires 
emergency room 
visit or 
hospitalization 
Myalgia (muscle aches 
all over body) 
None 
No interference with 
activity  
Some interference with 
activity 
Significant; 
prevents daily 
activity  
Requires 
emergency room 
visit or 
hospitalization 
Arthralgia (joint aches in 
several joints) 
None 
No interference with 
activity  
Some interference with 
activity 
Significant; 
prevents daily 
activity  
Requires 
emergency room 
visit or 
hospitalization 
Nausea/vomiting 
None 
No interference with 
activity or 1-2 
episodes/ 24 hours 
Some interference with 
activity or 
> 2 episodes/24 hours 
Prevents daily 
activity, 
requires 
outpatient 
intravenous 
hydration 
Requires 
emergency room 
visit or 
hospitalization for 
hypotensive shock 
Chills 
None 
No interference with 
activity 
Some interference with 
activity not requiring 
medical intervention 
Prevents daily 
activity and 
requires 
medical 
intervention 
Requires 
emergency room 
visit or 
hospitalization 
Fever (oral) 
< 38.0°C 
< 100.4°F 
38.0°C-38.4°C 
100.4°F-101.1°F 
38.5°C-38.9°C 
101.2°F-102.0°F 
39.0°C-40.0°C 
102.1°F-
104.0°F 
> 40.0°C 
> 104.0°F 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 136 
a. Grading for Grade 4 events per investigator assessment (with exception of fever). 
Note: Events listed above but starting > 7 days post study injection will be recorded on the Adverse Event page of the electronic case 
report form. Causality for each event will be determined per assessment by the investigator. 
Source: Guidance for industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative 
Vaccine Clinical Trials (DHHS 2007).

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 137 
Any solicited AR that meets any of the following criteria must be entered into the participant’s 
source document and must also be recorded by the study site staff on the solicited AR page of the 
participant’s eCRF: 
• Solicited local or systemic AR that results in a visit to a healthcare practitioner (HCP; 
otherwise meets the definition of an MAAE) 
• Solicited local or systemic AR leading to the participant withdrawing from the study 
or the participant being withdrawn from the study by the investigator (AE leading to 
withdrawal) 
• Solicited local or systemic AR lasting beyond 7 days after injection 
• Solicited local or systemic AR that leads to participant withdrawal from vaccine 
• Solicited local or systemic AR that otherwise meets the definition of an SAE 
7.5.4. 
Medically Attended Adverse Events 
A MAAE is an AE that leads to an unscheduled visit to an HCP. This would include visits to a 
study site for unscheduled assessments (eg, abnormal laboratory test results follow-up, COVID-19 
[Section 7.3.1]) and visits to HCPs external to the study site (eg, urgent care, primary care 
physician). Investigators will review unsolicited AEs for the occurrence of any MAAE. 
Unsolicited AEs will be captured on the AE page of the eCRF. 
All confirmed COVID-19 cases (Section 7.3.1) will be recorded as MAAEs and reported to the 
Sponsor or designee immediately and in all circumstances within 24 hours, using the SAE 
Mailbox, the SAE Hotline, or the SAE Fax line (Section 7.5.12). The investigator will submit any 
updated COVID-19 case data to the Sponsor within 24 hours of it being available. 
7.5.5. 
Adverse Events of Special Interest 
An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the 
Sponsor’s product or program, for which ongoing monitoring and immediate notification by the 
investigator to the Sponsor is required and documentation is in the form of a case narrative. Such 
events may require further investigation to characterize and understand them. Refer to 
Section 10.5, Appendix 5 for a list of AESIs pertinent to this study. All AESIs will be collected 
through the entire study period and must be reported to the Sponsor or designee immediately and 
in all circumstances within 24 hours of becoming aware of the event via the electronic data capture 
(EDC) system. If a site receives a report of a new AESI from a study participant or receives updated 
data on a previously reported AESI, and the eCRF has been taken offline, then the site can report 
this information on a paper AESI form using the SAE Mailbox, the SAE Hotline, or the SAE Fax 
line (Section 7.5.12). 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 138 
Anaphylaxis 
All suspected cases of anaphylaxis should be recorded as an AESI, a MAAEs, and reported as 
SAEs, based on criteria for a medically important event (Section 7.5.2), unless the event meets 
other serious criteria. As an SAE, the event should be reported to the Sponsor or designee 
immediately and in all circumstances within 24 hours as per Section 7.5.12 (Reporting SAEs). The 
investigator will submit any updated anaphylaxis case data to the Sponsor within 24 hours of it 
being available. For reporting purposes, a participant who displays signs/symptoms consistent with 
anaphylaxis as shown below should be reported as a potential case of anaphylaxis. This is provided 
as general guidance for investigators and is based on the Brighton Collaboration case definition 
(Rüggeberg et al 2007). 
Anaphylaxis is an acute hypersensitivity reaction with multi-organ-system involvement that can 
present as, or rapidly progress to, a severe life-threatening reaction. It may occur following 
exposure to allergens from a variety of sources. Anaphylaxis is a clinical syndrome characterized 
by: 
• Sudden onset AND 
• Rapid progression of signs and symptoms AND 
• Involving 2 or more organ systems, as follows: 
o Skin/mucosal: urticaria (hives), generalized erythema, angioedema, generalized 
pruritus with skin rash, generalized prickle sensation, red and itchy eyes 
o Cardiovascular: measured hypotension, clinical diagnosis of uncompensated shock, 
loss of consciousness or decreased level of consciousness, evidence of reduced 
peripheral circulation 
o Respiratory: bilateral wheeze (bronchospasm), difficulty breathing, stridor, upper 
airway swelling (lip, tongue, throat, uvula, or larynx), respiratory distress, persistent 
dry cough, hoarse voice, sensation of throat closure, sneezing, rhinorrhea 
o Gastrointestinal: diarrhea, abdominal pain, nausea, vomiting 
Acute Myocarditis and/or Pericarditis 
All suspected cases of probable or confirmed myocarditis, pericarditis, or myopericarditis should 
be recorded as an AESI, and reported as an SAE, if the event meets seriousness criteria. As an 
SAE, the event should be reported to the Sponsor or designee immediately and in all circumstances 
within 24 hours as per Section 7.5.12. The investigator will submit any updated myocarditis, 
pericarditis, or myopericarditis case data to the Sponsor within 24 hours of it being available. For 
reporting purposes, a participant who displays signs/symptoms consistent with the CDC case 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 139 
definitions as described below (Gargano et al 2021), should be reported as a potential case of 
confirmed or probable myocarditis, pericarditis, or myopericarditis. 
The CDC case definitions are intended to serve as a guide to help in the diagnosis and reporting 
of suspected cases of myocarditis and/or pericarditis; however, the diagnosis of suspected cases is 
left to the investigator’s clinical judgement. 
Acute Myocarditis Case Definition 
Presence of ≥ 1 new or worsening of the following clinical symptoms (persons who lack the listed 
symptoms but who meet other criteria may be classified as subclinical myocarditis [probable or 
confirmed]): 
• Chest pain/pressure/discomfort 
• Dyspnea/shortness of breath/pain with breathing 
• Palpitations 
• Syncope 
AND 
For PROBABLE CASE: 
Presence of ≥ 1 new finding of the following: 
• Troponin level above upper limit of normal (any type of troponin) 
• Abnormal electrocardiogram (ECG or EKG) or rhythm monitoring findings consistent 
with myocarditis 
o To meet the ECG or rhythm monitoring criterion, a probable case must include at 
least one of the following: 
▪ ST segment or T-wave abnormalities 
▪ Paroxysmal or sustained atrial, supraventricular, or ventricular arrhythmias 
▪ AV nodal conduction delays or intraventricular conduction defects 
• Abnormal cardiac function or wall motion abnormalities on echocardiogram 
• Cardiac magnetic resonance imaging (cMRI) finding consistent with myocarditis 
(Ferreira et al 2018) 
AND 
• No other identifiable cause of the symptoms and findings 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 140 
For CONFIRMED CASE: 
• Histopathologic confirmation of myocarditis (using Dallas criteria [Aretz et al 1987]) 
OR 
• cMRI findings consistent with myocarditis in the presence of troponin level above 
upper limit of normal (any type of troponin) 
AND 
• No other identifiable cause of the symptoms and findings 
Acute Pericarditis Case Definition 
Presence of ≥ 2 new or worsening of the following clinical features (Adler et al 2015): 
• Acute chest pain (Typically described as pain made worse by lying down, deep 
inspiration, or cough; and relieved by sitting up or leaning forward, although other 
types of chest pain may occur) 
• Pericardial rub on examination 
• New ST-elevation or PR-depression on EKG 
• New or worsening pericardial effusion on echocardiogram or magnetic resonance 
imaging 
Myopericarditis Case Definition 
Participants who meet criteria for both myocarditis and pericarditis may be described under 
myopericarditis. 
7.5.6. 
Suspected or Confirmed Organ Transplant Rejection 
All cases of suspected or confirmed organ transplant rejection must be reported within EDC system 
as MAAEs. All cases of biopsy-proven organ transplant rejection should be reported as SAEs, 
based on criteria for a medically important event (Section 7.5.2). As an SAE, the event should be 
reported to the Sponsor or designee immediately and, in all circumstances, within 24 hours as per 
Section 7.5.12 (Reporting SAEs). Suspected cases of organ transplant rejection that meet the 
criteria for SAEs should also be reported as SAEs per the same processes. For confirmed AND 
suspected cases of organ transplant rejection, the investigator should provide all relevant data (eg, 
signs and symptoms, associated laboratory tests, diagnostic testing including imaging and 
procedures, and biopsy results) to the Sponsor within 24 hours of these data being available. 
After Day 57 (for unvaccinated SOT recipients of 2 doses [Group A1]), after Day 113 
(unvaccinated SOT recipients of 3 doses [Group A2]), or after Day 29 (previously vaccinated SOT 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 141 
recipients who receive dose 3 [Group A3]) or after BD-D29 for SOT participants who receive a 
BD [Group B2, Group B3, and Group B4]), the investigator will review the standard-of-care 
laboratory assessments and report any suspected or confirmed event of organ transplant rejection 
until the EOS. 
7.5.7. 
Recording and Follow-up of Pregnancy 
Female individuals who have a positive pregnancy test at Screening should not be enrolled; 
participants who have a positive pregnancy test any time during the study should receive no further 
dosing with vaccine but should be asked to remain in the study and be monitored for safety. 
Details of all pregnancies in female participants will be collected after the start of study treatment 
and until the end of their participation in the study. 
• If a pregnancy is reported, the investigator should inform the Sponsor within 24 hours 
of learning of the pregnancy and should follow the procedures outlined in this section. 
• Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) are considered SAEs. 
Pregnancies occurring in participants after enrollment must be reported to Sponsor or designee 
within 24 hours of the study site learning of its occurrence, using the SAE Mailbox, the SAE 
Hotline, or the SAE Fax line (Section 7.5.12). If the participant agrees to submit this information, 
the pregnancy must be followed to determine the outcome, including spontaneous or voluntary 
termination, details of the birth, and the presence or absence of any birth defects, congenital 
abnormalities, or maternal and/or newborn complications. This follow-up should occur even if 
intended duration of the safety follow-up for the study has ended. Pregnancy report forms will be 
distributed to the study site to be used for this purpose. The investigator must immediately (within 
24 hours of awareness) report to the Sponsor any pregnancy resulting in an abnormal outcome 
according to the procedures described for SAEs. 
7.5.8. 
Eliciting and Documenting Adverse Events 
The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF and 
reported to the Sponsor. 
Solicited ARs will be collected from Day 1 through 7 days after each dose. Other (unsolicited) 
AEs will be collected from Day 1 through 28 days after each dose. 
Both MAAEs and SAEs will be collected from participants as specified in the applicable SoE until 
the end of their participation in the study. Any AEs that occur before administration of vaccine 
will be analyzed separately from AEs. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 142 
At every study site visit or telephone contact, participants will be asked a standard question to 
elicit any medically related changes in their well-being (including COVID-19 symptoms) 
according to the scripts provided. Participants will also be asked if they have been hospitalized, 
had any accidents, used any new medications, changed concomitant medication regimens (both 
prescription and over-the-counter medications), or had any nonstudy vaccinations. 
In addition to participant observations, physical examination findings or data relevant to 
participant safety classified as an AE will be documented on the AE page of the eCRF. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All AEs and SAEs will be treated as medically appropriate and 
followed until resolution, stabilization, the event is otherwise explained, or the participant is LTFU 
(as defined in Section 6.4). 
7.5.9. 
Assessment of Severity 
An event is defined as “serious” when it meets at least one of the predefined outcomes as described 
in the definition of an SAE (Section 7.5.2), NOT when it is rated as severe. 
The severity of an AR or AE refers to the extent to which it affects the participant’s daily activities. 
The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative 
Vaccine Clinical Trials (DHHS 2007) will be used to categorize local and systemic reactogenicity 
events (solicited ARs), clinical laboratory test results and vital sign measurements observed during 
this study. Specific criteria for local and systemic reactogenicity events are presented in 
Section 7.5.3. Specific criteria for vital signs and laboratory abnormalities are presented in 
Section 10.4, Appendix 4, and will be graded if outside of the reference range for the laboratory 
utilized. For laboratory abnormalities not included in the protocol-defined grading system, the 
guidelines for all unsolicited AEs will be used to describe severity. 
The determination of severity for all unsolicited AEs should be made by the investigator based 
upon medical judgment and the definitions of severity as follows: 
• Mild: These events do not interfere with the participant’s daily activities. 
• Moderate: These events cause some interference with the participant’s daily activities 
and require limited or no medical intervention. 
• Severe: These events prevent the participant’s daily activity and require intensive 
therapeutic intervention. 
Determination of Severe COVID-19 is described in Section 7.3. 
Study staff should elicit from the participant the impact of AEs on the participant’s activities of 
daily living to assess severity and document appropriately in the participant’s source 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 143 
documentation. Changes in the severity of an AE should be documented in the participant’s source 
documentation to allow an assessment of the duration of the event at each level of severity to be 
performed. An AE characterized as intermittent requires documentation of onset and duration of 
each episode. An AE that fluctuates in severity during the course of the event is reported once in 
the eCRF at the highest severity observed. 
7.5.10. 
Assessment of Causality 
The investigator’s assessment of an AE’s relationship to vaccine is part of the documentation 
process but is not a factor in determining what is or is not reported in the study. 
The investigator will assess causality (ie, whether there is a reasonable possibility that the vaccine 
caused the event) for all AEs and SAEs. The relationship will be characterized using the following 
classification: 
Not related: There is not a reasonable possibility of a relationship to the vaccine. Participant did 
not receive the vaccine OR temporal sequence of the AE onset relative to administration of the 
vaccine is not reasonable OR the AE is more likely explained by another cause than the vaccine. 
Related: There is a reasonable possibility of a relationship to the vaccine. There is evidence of 
exposure to the vaccine. The temporal sequence of the AE onset relative to the administration of 
the vaccine is reasonable. The AE is more likely explained by the vaccine than by another cause. 
7.5.11. 
Reporting Adverse Events 
The investigator is responsible for reporting all AEs that are observed or reported during the study, 
regardless of their relationship to vaccine or their clinical significance. If there is any doubt as to 
whether a clinical observation is an AE, the event should be reported. 
All unsolicited AEs reported or observed during the study will be recorded on the AE page of the 
eCRF. Information to be collected includes the type of event, time of onset, investigator specified 
assessment of severity (impact on activities of daily living) and relationship to vaccine, time of 
resolution of the event, seriousness, as well as any required treatment or evaluations, and outcome. 
The unsolicited AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions 
to concurrent medications, or progression of disease states must also be reported. All AEs will be 
followed until they are resolved or stable or judged by the investigator to be not clinically 
significant. The Medical Dictionary for Regulatory Activities (MedDRA) will be used to code all 
unsolicited AEs. 
Any medical condition that is present at the time that the participant is screened but does not 
deteriorate should not be reported as an unsolicited AE. However, if it deteriorates at any time 
during the study, it should be recorded as an unsolicited AE. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 144 
7.5.12. 
Reporting SAEs 
Prompt notification by the investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a study 
intervention under clinical investigation are met. 
Any AE considered serious by the investigator or that meets SAE criteria (Section 7.5.2) must be 
reported to the Sponsor immediately (within 24 hours of becoming aware of the SAE); these 
include anaphylaxis and confirmed organ transplant rejection. The investigator will assess whether 
there is a reasonable possibility that the vaccine caused the SAE. The Sponsor will be responsible 
for notifying the relevant regulatory authorities of any SAE as outlined in the 21 US CFR Parts 
312 and 320. The investigator is responsible for notifying the institutional review board (IRB) 
directly. 
If the eCRF is unavailable at the time of the SAE, the following contact information is to be used 
for SAE reporting: 
• SAE Mailbox: Safety_Moderna@iqvia.com 
• SAE Hotline (USA): +1-866-599-1341 
• SAE Fax line (USA): +1-866-599-1342 
Regulatory reporting requirements for SAEs are described in Section 7.5.16. 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE, including SAEs, and remain responsible for 
following up AEs that are serious, considered related to vaccine or study procedures, or that caused 
the participant to discontinue the study. 
7.5.13. 
Time Period and Frequency for Collecting AE and SAE Information 
Medical occurrences that begin before the start of vaccine dosing but after obtaining informed 
consent will be recorded in the Medical History/Current Medical Conditions section of the eCRF 
and not in the AE section; however, if the condition worsens at any time during the study, it will 
be recorded and reported as an AE. 
Adverse events may be collected as follows: 
• Observing the participant 
• Receiving an unsolicited complaint from the participant 
• Questioning the participant in an unbiased and nonleading manner 
Solicited ARs will be collected from the day of injection through 6 days after each dose. Other 
(unsolicited) AEs will be collected from the day of injection through 28 days after each dose. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 145 
SAEs will be collected from the start of vaccine dosing until the last day of study participation. 
All SAEs will be recorded and reported to the Sponsor or designee immediately and in all 
circumstances within 24 hours. The investigator will submit any updated SAE data to the Sponsor 
within 24 hours of it being available. 
An abnormal value or result from a clinical or laboratory evaluation can also indicate an AE if it 
is determined by the investigator to be clinically significant (eg, leads to dose modification or study 
drug discontinuation, or meets any serious criteria). If this is the case, it must be recorded in the 
source document and as an AE on the appropriate AE form(s). The evaluation that produced the 
value or result should be repeated until that value or result returns to normal or is stabilized and 
the participant’s safety is not at risk. 
Investigators are not obligated to actively seek AEs or SAEs after EOS participation. However, if 
the investigator learns of any SAE (including a death) at any time after a participant has withdrawn 
from or completed the study, and the investigator considers the event to be reasonably related to 
the vaccine or study participation, the investigator must promptly notify the Sponsor. 
7.5.14. 
Method of Detecting AEs and SAEs 
Electronic diaries have specifically been designed for this study by the Sponsor. The diaries will 
include prelisted AEs (solicited ARs) and severity scales; they will also include blank space for 
the recording of information 
on other AEs 
(unsolicited AEs) 
and concomitant 
medications/vaccinations. 
The investigator is responsible for the documentation of AEs regardless of suspected causal 
relationship to vaccine. For all AEs, the investigator must pursue and obtain information adequate 
to determine the outcome of the AE and to assess whether the AE meets the criteria for 
classification as an SAE requiring immediate notification to the Sponsor or its designated 
representative. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about the 
occurrence of AEs. 
7.5.15. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits and contacts. 
All AEs and SAEs will be treated as medically appropriate and followed until resolution, 
stabilization, the event is otherwise explained, or the participant is LTFU, as defined in Section 6.4, 
including ongoing SAEs after study completion. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 146 
7.5.16. 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the Sponsor of a SAE is essential so that 
legal obligations and ethical responsibilities toward the safety of participants and the 
safety of a study intervention under clinical investigation are met. 
• The Sponsor has a legal responsibility to notify both the local regulatory authority 
and other regulatory agencies about the safety of a study intervention under clinical 
investigation. The Sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, IRBs, and investigators. 
• Investigator safety reports must be prepared for suspected unexpected serious ARs 
according to local regulatory requirements and Sponsor policy and forwarded to 
investigators as necessary. 
• An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will 
review and then file it along with the IB and will notify the IRB, if appropriate 
according to local requirements. 
7.6. 
Safety Monitoring 
The CRO’s medical monitor, the Sponsor’s medical monitor, and the individual study site 
investigator(s) will monitor safety throughout the study. 
7.6.1. 
Safety Review Committee 
An independent safety review committee (SRC) consisting of transplant nephrologist(s) and 
hepatologist(s) not involved in the conduct of the study will monitor and adjudicate for events of 
organ transplant rejection starting from Day 1 and throughout the study period. The SRC will 
operate under the rules of an approved charter that will be written and reviewed at the 
organizational meeting of the SRC. Details regarding the SRC composition, responsibilities, 
procedures, and frequency of data review will be defined in its charter. 
In Part A, the investigator will review laboratory safety assessments of kidney and liver function 
performed as part of the study at Day 1, Day 8, Day 29, Day 36, and Day 57 for unvaccinated SOT 
recipients who receive 2 doses (Group A1) and on additional Days 85, 92, and 113 for 
unvaccinated SOT recipients who receive 3 doses (Group A2), and at Day 1 (dose 3), Day 8, and 
Day 29 for previously vaccinated SOT recipients (Group A3), for close monitoring around the 
time of vaccination. In Part B, the investigator will review laboratory safety assessments of kidney 
and liver function performed as part of the study at BD-D1, BD-D8, and BD-D29. If any of the 
following criteria are met, the laboratory test(s) must be repeated within 3 days: an increase in 
serum creatinine ≥ 25% from baseline or increase in UPCR > 0.5 g/g from baseline in kidney SOT 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 147 
recipients, and an increase in ALT or AST > 3x the baseline in liver SOT recipients. Additional 
tests may be performed at the discretion of the investigator upon approval of the Sponsor. The 
investigator should perform a clinical assessment (eg, elicit a history/narrative of the event, 
perform a physical examination, request diagnostic tests such as imaging or biopsy) of any 
laboratory abnormality if there is suspicion of an organ transplant rejection. Clinical referral to a 
transplant specialist for further assessment may be performed by the investigator if needed. A 
confirmed diagnosis of organ transplant rejection will be based on histologic assessment or tissue 
biopsy. After Day 57 (unvaccinated SOT recipients who receive 2 doses [Group A1]), after Day 
113 (unvaccinated SOT recipients who receive 3 doses [Group A2]), or after Day 29 (previously 
vaccinated SOT recipients who receive dose 3 [Group A3]) in Part A, or after BD-D29 in Part B 
Booster Phase, the investigator will review standard-of-care laboratory assessments and report any 
suspected or confirmed event of organ transplant rejection until the EOS. The investigator or 
designee is responsible for reporting to the Sponsor, via the EDC system within 24 hours of 
observation and subsequently routed to SRC for independent review, if any of the following is 
met: 
1. Any of the thresholds for kidney or liver function test is met, confirmed by repeat test, 
and clinically assessed as suggestive of organ transplant rejection, 
2. Any suspected event of organ transplant rejection based on clinically significant kidney 
or liver function test(s) associated with signs and symptoms suggestive of transplant 
rejection, or 
3. Any report of biopsy-proven organ transplant rejection. 
The SRC will assess if the event is a true case of organ transplant rejection. The Sponsor will then 
make a final decision on whether to suspend further enrollment and/or study dosing based on 
assessment of the overall potential safety risk to study participants or potential participants who 
have undergone SOT. 
7.6.2. 
Internal Safety Committee and Study Pause Rules 
An internal safety team (IST) will be created specifically to review safety and reactogenicity data 
after: 
• At least 10 SOT recipients have received their third dose of study vaccine and have at 
least 7 days of reactogenicity data 
• At least 55 SOT recipients have received their third dose of study vaccine, unless a 
safety event requires earlier review 
• Any other ad hoc safety concerns based on ongoing safety surveillance 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 148 
The IST will operate under the rules of an approved charter that will be written and reviewed at 
the organizational meeting of the IST. Details regarding the IST composition, responsibilities, 
procedures, and frequency of data review will be defined in its charter. 
Study pause rules will be implemented and will only remain in effect until all study participants 
who consented to receive a third dose have received their third dose of vaccine. If the following 
occur, vaccination with third dose may be temporarily suspended until expedited Sponsor review 
of safety data take place to assess over all potential safety risk to SOT recipients: 
• Reactogenicity: Two Grade 4 solicited local or systemic reactogenicities that are 
related to the vaccine 
• Hypersensitivity: Five SOT recipients experiencing a severe systemic allergic 
reaction that is related to the vaccine 
• Adverse Event: Three SAEs or Grade 4 AEs (laboratory and vital sign abnormalities 
per Section 10.4, Appendix 4 reported as AEs by the investigator) that are related to 
the vaccine 
• Fatal Outcome: One death that is related to the vaccine 
The investigators, study medical monitor, and Sponsor will monitor for events that could trigger a 
study pause. The investigator or designee is responsible for reporting to the Sponsor, via the EDC 
system within 24 hours of observation, each event potentially meeting any pause rule criterion. 
7.6.3. 
Independent Cardiac Event Adjudication Committee 
An independent cardiac event adjudication committee (CEAC) that includes pediatric and adult 
cardiologists will review suspected cases of myocarditis and pericarditis to determine if they meet 
CDC criteria of “probable” or “confirmed” events, and to assess severity (Gargano et al 2021). 
Any cases that the CEAC assesses as representing probable or confirmed cases of myocarditis or 
pericarditis will be referred to the Sponsor, which will then make a final decision on whether to 
suspend further enrollment and/or study dosing based on assessment of the overall potential risk 
to study participants or potential study participants. 
The CEAC will operate under the rules of an approved charter that will be written and reviewed 
at the organizational meeting of the CEAC. Details regarding the CEAC composition, 
responsibilities, procedures, and frequency of data review will be defined in its charter. 
7.7. 
Treatment of Overdose 
As the study treatment is to be administered by a healthcare professional, it is unlikely that an 
overdose will occur. Dose deviations will be tracked as protocol deviations (Section 10.2.8). 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 149 
7.8. 
Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 
7.9. 
Pharmacodynamics 
Pharmacodynamic parameters are not evaluated in this study. 
7.10. 
Biomarkers 
Immunogenicity assessments are presented in Section 7.2. Blood collection will be performed for 
future biomarker analysis. 
7.11. 
Health Economics 
Health economics are not evaluated in this study. 
 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 150 
8. 
STATISTICAL ANALYSIS PLAN 
This section summarizes the planned statistical analysis strategy and procedures for the study. The 
details of statistical analysis will be provided in the statistical analysis plan (SAP), which will be 
finalized before the clinical database lock for the study. If changes are made to primary and/or 
secondary objectives or the statistical methods related to the study objectives after the study has 
begun but prior to any data unblinding, then the protocol will be amended (consistent with ICH 
Guideline E9). Changes to other secondary or exploratory analyses made after the protocol has 
been finalized, along with an explanation as to when and why they occurred, will be listed in the 
SAP or clinical study report (CSR) for the study. Ad hoc exploratory analyses, if any, will be 
clearly identified in the CSR. 
This is an open-label study aimed to describe the safety and Ab responses elicited following doses 
of mRNA-1273 vaccine among SOT recipients compared to the Ab responses of adult healthy 
participants in this study and Study P301. Using the Ab threshold established from Study P301 (if 
available at the time of database lock), an additional exploratory analysis will be performed by 
measuring the number and proportion of participants with a serum Ab level at Day 57 (for 
unvaccinated participants who receive 2 doses), at Day 113 (for unvaccinated SOT recipients who 
receive 3 doses), at Day 29 (for previously vaccinated SOT recipients who receive dose 3), and at 
BD-D29 (for participants who receive a BD in Part B), greater than or equal to the Ab threshold 
of protection against COVID-19. No formal hypothesis testing will be performed. 
Given that the study does not have a concurrent unvaccinated SOT control group, descriptive 
statistics will be used to present safety data, and no comparisons with the healthy adult participants 
will be made. 
8.1. 
Sample Size 
The study vaccine, mRNA-1273, is currently being evaluated in a pivotal Phase 3 efficacy, safety, 
and immunogenicity study in an adult population at high risk of COVID-19 disease (Study P301). 
Success criteria for early efficacy was met at the first interim analysis based on 95 adjudicated 
cases with a vaccine efficacy of 94.5% (95% CI: 86.5%, 97.8%; one-sided p value < 0.0001 of 
testing the null hypothesis of VE ≤ 30%). Study P301 is expected to provide immunogenicity data 
by which an Ab threshold of protection against COVID-19 will be estimated. 
This current study, which aims to evaluate Ab responses following a second, third, or fourth 
(booster) dose of mRNA-1273 vaccine among kidney and liver transplant recipients, is expected 
to provide clinical data to determine whether vaccination with mRNA-1273 will induce vaccine 
response in this cohort of immunocompromised participants that is comparable to those of the 
participants in Study P301 and comparable to those of the concurrently assessed cohort of 
participants in this study with normal immune function. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 151 
With 200 SOT participants, if the true AE rate of biopsy-proven organ rejection is 3%, there is 
approximately >95% probability to observe at least 1 subject reporting such an AE. 
The planned sample size of approximately 240 participants (220 unvaccinated or previously 
vaccinated participants who have had a kidney or liver transplant and 20 unvaccinated healthy 
participants) who receive 2-dose regimen and 3-dose regimens of 100 µg of mRNA-1273, or 
100 µg BD regimen are expected to provide useful estimates of Ab response at Day 29 for 
previously vaccinated SOT recipients who receive dose 3 in Part A, and Day 113 for unvaccinated 
SOT recipients who receive the 3-dose regimen, at Day 57 for unvaccinated participants who 
receive the 2-dose regimen, and at BD-D29 for Part B participants (participants who receive a BD) 
(primary endpoints), respectively, for comparison to results from Study P301 (if available at the 
time of database lock). The healthy adult participants will be used primarily as a biological control 
for the CMI analysis. This study is designed for estimation purposes, and no between-group 
comparisons are planned. 
8.2. 
Analyses Sets 
The analysis sets are defined in Table 5. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 152 
Table 5: Analysis Sets 
Analysis Set 
Description 
Full Analysis Set (FAS) 
All participants who received at least 1 dose of vaccine. 
Modified Intent-to-Treat Set 
(mITT) 
All participants who have negative SARS-CoV-2 status at 
baseline, defined as who have a negative RT-PCR test for 
SARS-CoV-2 and a negative serology test based on bAb specific 
to SARS-CoV-2 nucleocapsid protein (as measured by Roche 
Elecsys Anti‑SARS‑CoV-2 assay) at baseline. 
PP Subset 
All participants in the mITT set who receive all planned doses of 
study vaccination per schedule and have no major protocol 
deviations that impact key or critical data. 
PP Immunogenicity Subset 
All participants who received planned doses of study vaccination 
per schedule, complied with immunogenicity testing schedule, and 
have no major protocol deviations that impact key or critical data. 
Participants who are seropositive at baseline will be excluded from 
the PP Immunogenicity Subset. The PP Immunogenicity Subset 
will be used for analyses of immunogenicity unless specified 
otherwise. The PP Immunogenicity Set will serve as the primary 
population for the analysis of SARS-CoV-2-specific bAb and nAb 
immunogenicity data. 
Solicited Safety Set 
All participants in the FAS who contributed any solicited AR data. 
The Solicited Safety Set will be used for the analyses of solicited 
ARs. 
Safety Set 
All participants who receive at least 1 dose of vaccine. The Safety 
Set will be used for all analyses of safety except for the solicited 
ARs.  
Abbreviations: AR = adverse reaction; bAb = binding antibody; nAb = neutralizing antibody; 
RT-PCR = reverse transcriptase polymerase chain reaction; SARS-CoV-2 = Severe Acute 
Respiratory Syndrome coronavirus 2; vaccine = investigational product. 
8.3. 
Statistical Methods 
8.3.1. 
Baseline Characteristics and Demographics 
Demographic variables (eg, age, sex, race, and ethnicity) and baseline characteristics (eg, height, 
weight, body mass index, date of transplant, type of SOT, type of donor transplant, indication for 
transplant, ABO blood group status, and relevant medical history) will be summarized by cohort 
arm (eg, SOT, healthy adult) and by subcohort as applicable (eg, SOT kidney, SOT liver). 
Relevant medical history (including prior medications) for SOT recipients may include history of 
human leukocyte antigen mismatch, induction therapy, panel reactive antibodies, and prior 
transplant rejection. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 153 
Summary statistics (mean, SD for continuous variables, and number and percentage for categorical 
variables) will be provided. 
8.3.2. 
Safety Analyses 
Given that the study does not have a concurrent unvaccinated SOT control group, descriptive 
statistics will be used to present safety data, and no comparisons with the healthy adult participants 
will be made. 
All safety analyses will be based on the Safety Set, except summaries of solicited ARs, which will 
be based on the Solicited Safety Set. All safety analyses will be summarized by cohort and 
subcohort arm. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters including 
solicited ARs (local and systemic events), unsolicited AEs, MAAEs, SAEs, AESIs, AEs leading 
to discontinuation from dosing and/or study participation (withdrawal), biopsy-proven organ 
rejection, safety laboratory assessments, vital sign measurements, and physical examination 
findings. 
The number and percentage of participants with any solicited local AR, with any solicited systemic 
AR, and with any solicited AR during the 7-day Follow-up Period after each dose will be 
summarized. 
The number and percentage of participants with unsolicited AEs, SAEs, MAAEs, Grade 3 or 
higher ARs and AEs, AESIs, AEs leading to discontinuation from dosing and/or study 
participation (withdrawal), and adjudicated biopsy-proven organ rejection will be summarized. 
Unsolicited AEs will be presented by MedDRA preferred term and system organ class. 
The number of events of solicited ARs, unsolicited AEs/SAEs, MAAEs, and adjudicated 
biopsy-proven organ rejection will be reported in summary tables. 
Clinical laboratory data will be summarized by severity for each visit (per Toxicity Grading Scale 
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials, 
DHHS 2007) and as the maximum over all postvaccination visits. Graphical presentations may 
include box plots and shift plots. Evaluation of clinically significant changes in safety laboratory 
measurements will be considered independent of the toxicity grading scale. 
For all other safety parameters, descriptive summary statistics will be provided, and Table 6 
summarizes the analysis strategy for safety parameters. Further details will be described in the 
SAP. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 154 
Table 6: Analysis Strategy for Safety Parameters 
Safety Endpoint 
Number and Percentage of Participants, 
Number of Events 
Any solicited AR (overall and by local, 
systemic) 
X 
Any unsolicited AE 
X 
Any SAE 
X 
Any AESI 
X 
Any unsolicited MAAE 
X 
Any adjudicated biopsy-proven organ 
rejection 
X 
Any change in immunosuppressant 
medications 
X 
Any unsolicited treatment-related AE 
X 
Any treatment-related SAE 
X 
Discontinuation due to AE 
X 
Any severe AE 
X 
Any treatment-related severe AE 
X 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse 
reaction; MAAE = medically attended adverse event; MedDRA = Medical Dictionary for 
Regulatory Activities; PT = preferred term; SAE = serious adverse event; SOC = system organ 
class. 
Notes: X = results will be provided. Unsolicited AEs will be summarized by SOC and PT coded 
by MedDRA. 
8.3.3. 
Immunogenicity Analyses 
The SAP will describe the complete set of immunogenicity analyses. The PP Immunogenicity 
Subset is the primary analysis set for immunogenicity unless otherwise specified. In Part A, the 
primary immunogenicity objective of this study is to evaluate serum Ab responses obtained 28 
days after the second or third injection of 100 µg mRNA-1273 (Day 57 for unvaccinated 
participants who receive 2 doses, Day 113 for unvaccinated SOT recipients who receive 3 doses, 
and Day 29 for previously vaccinated SOT recipients who receive dose 3) in adult kidney and liver 
transplant recipients. In Part B, the primary immunogenicity objective of this study is to evaluate 
serum Ab responses obtained 28 days after the BD. 
The study will also evaluate Ab responses obtained at Day 29 (28 days after dose 1), Day 209 
(6 months after dose 2), and Day 394 (1 year after dose 2) for unvaccinated participants who 
receive the 2-dose regimen; at Days 1, 29, and 85, as well as 28 days and 6 and 12 months after 
the third dose for unvaccinated SOT recipients who receive the 3-dose regimen; at Day 1 (dose 3) 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 155 
and Day 29 (28 days after dose 3), as well as 6 and 12 months after dose 3 for previously 
vaccinated SOT recipients; and at BD-D29 for participants who receive a BD. The results of the 
study will be described and evaluated against the Ab responses of adult healthy participants in this 
study and Study P301 (if available at the time of database lock). 
Using the Ab threshold established from Study P301 (if available at the time of database lock), an 
additional exploratory analysis will be performed by measuring the proportion of participants with 
a serum Ab level at Day 29 (previously vaccinated SOT recipients who receive dose 3 ), Day 113 
(unvaccinated SOT recipients who receive 3-dose regimen), and Day 57 (unvaccinated participants 
who receive 2 doses) in Part A, and at BD-29 (participants who receive BD)greater than or equal 
to the Ab threshold of protection against COVID-19, with a 2 sided 95% CI using the Clopper 
Pearson method by cohort arm. 
The GM level of serum Ab with corresponding 95% CI will be provided at each time point by 
cohort arm. The 95% CIs will be calculated based on the t-distribution of the log transformed 
values then back transformed to the original scale for presentation. Additionally, the proportion of 
participants with a 2×, 3×, and 4× rise in GM level from Day 1 will be measured. 
All nAb and bAb endpoints (Table 1, Study Objectives and Endpoints) will be summarized at each 
time point with Day 29 (previously vaccinated SOT recipients who receive dose 3), Day 57 
(unvaccinated participants who receive 2 doses ), Day 113 (unvaccinated SOT participants who 
receive 3 doses) and BD-29 (participants who receive BD) as the time points of interest. The GM 
levels and GMFRs of both nAb and bAb will be provided with corresponding 95% CIs. 
Reverse cumulative distribution curves for antibody titers for all time points will be presented. 
8.3.4. 
Incident Cases of COVID-19 After Vaccination 
The number and percentage of participants with COVID-19 after vaccination in the SOT recipient 
and healthy comparison cohorts will be provided. The number and percentage of participants with 
severe COVID-19 will be provided similarly. 
For serologically confirmed SARS-CoV-2 infection or COVID-19, regardless of symptomatology 
or severity, infection rate will be provided by the healthy cohort arm. 
As an additional analysis, the number and percentage of participants with symptomatic and 
asymptomatic COVID-19 or SARS-CoV-2 infection throughout the study will be summarized. 
8.3.5. 
Exploratory Analyses 
The magnitude, phenotype, and percentage of cytokine producing S protein-specific T-cells will 
be summarized in Part A at Day 1, Day 36, and Day 92 for unvaccinated SOT recipients and at 
Day 1 and Day 8 for previously vaccinated SOT recipients, and at Day 1 and Day 36 for healthy 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 156 
participants; and at BD-D1 and BD-D8 in Part B. In addition, the magnitude and phenotype of 
S protein-specific B-cells will be summarized at each timepoint by cohort arm. B-cell receptor 
sequence analysis to identify representative B-cell clones and associated major antigenic sites and 
amino acid residues will be described. Details of these exploratory analyses will be described in 
the SAP before database lock, and additional exploratory analyses may be described in the SAP. 
8.3.6. 
Subgroup Analysis 
Subgroup analyses will be performed as described in the SAP. 
8.4. 
Study Analyses 
8.4.1. 
Interim Analyses 
An interim analysis of safety and immunogenicity data is planned following Day 57 (28 days after 
the second dose for unvaccinated participants) in Part A, after Day 29 (28 days after dose 3 for 
previously vaccinated SOT recipients) in Part A, and at BD-D29 (28 days after BD in participants 
who receive a BD) in Part B; a CSR will be prepared. An analysis of safety and/or immunogenicity 
may be performed at the Sponsor’s discretion based on the availability of data. 
8.4.2. 
Final Analyses 
The final analysis of all endpoints will be performed after all participants have completed all 
planned study procedures. Results of this analysis will be presented in a final CSR, including 
individual listings. 
Additional information about all study analyses may be provided in the SAP. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 157 
9. 
REFERENCES 
Adler Y, Charron P, Imazio M, Badano L, Barón-Esquivias G, Bogaert J, et al. 2015 ESC 
guidelines for the diagnosis and management of pericardial diseases: the task force for the 
diagnosis and management of pericardial diseases of the european society of cardiology (ESC) 
endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 
2015;36(42):2921-64. 
Aretz HT. Myocarditis: the Dallas criteria. Hum Pathol. 1987;18(6):619-24. 
Atmar RL, Lyke KE, Deming ME, Jackson LA, Branche AR, El Sahly HM, et al. Heterologous 
SARS‐CoV‐2 
Booster 
Vaccinations 
– 
Preliminary 
Report. 
medRxiv. 
2021. 
doi: 
https://doi.org/10.1101/2021.10.10.21264827. Online ahead of print. 
Azzi Y, Parides M, Alani O, Loarte-Campos P, Bartash R, Forest S, et al. COVID-19 infection in 
kidney transplant recipients at the epicenter of pandemics. Kidney Int. 2020; 98(6):1559-67. 
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the 
mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2020. doi: 10.1056/NEJMoa2035389. Online 
ahead of print. 
Becchetti C, Zambelli MF, Pasulo L, Donato MF, Invernizzi F, Detry O, et al. COVID-19 in an 
international European liver transplant recipient cohort. Gut. 2020;69(10):1832-40. 
Benotmane I, Gautier-Vargas G, Cognard N, Olagne J, Heibel F, Braun-Parvez L, et al. Low 
immunization rates among kidney transplant recipients who received two doses of the 
mRNA-1273 
SARS-CoV-2 
vaccine. 
Kidney 
Int. 
2021. 
Epub 
2021/04/23. 
doi:10.1016/j.kint.2021.04.005. 
Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, et al. Immunogenicity 
of a single dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant recipients. 
JAMA. 2021a;325(17):1784-6. 
Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, et al. Antibody 
response to 2-dose SARS-CoV-2 mRNA vaccine series in solid organ transplant recipients. 
JAMA. 2021b; 325(21):2204-6. 
Centers for Disease Control and Prevention (CDC). 2020a. Coronavirus Disease 2019 
(COVID-19). Retrieved from: https://covid.cdc.gov/covid-data-tracker/#demographics. (accessed 
2020 Sep 21). 
Centers for Disease Control and Prevention (CDC). 2020b. Coronavirus Disease 2019 
(COVID-19). 
Retrieved 
from: 
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
testing/symptoms.html (accessed 2020 Jun 11). 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 158 
Centers for Disease Control and Prevention (CDC). 2021a. Coronavirus Disease 2019 
(COVID-19). Retrieved from: https://covid.cdc.gov/covid-data-tracker/#cases. (accessed 2021 Jan 
22). 
Centers for Disease Control and Prevention (CDC). 2021b. Allergic reactions including 
anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine – United States, 
December 21, 2020 – January 10, 2021. MMWR, early release 22 Jan 2021. Retrieved from: 
https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm. (accessed 2021 Jan 27). 
Centers for Disease Control and Prevention (CDC). 2021c. Considerations for COVID-19 
vaccination in moderately or severely immunocompromised people. Retrieved from: 
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-
us.html?j=456768&sfmc_sub=87176912&l=4746_HTML&u=17358623&mid=100001876&jb=
5007#considerations-covid19-vax-immunocopromised. (accessed 2021 Dec 01). 
Chen Y, Lu S, Jia H, Deng Y, Zhou J, Huang B, et al. A novel neutralizing monoclonal antibody 
targeting the N-terminal domain of the MERS-CoV spike protein. Emerg Microbes Infect. 
2017;6(5):e37. 
Chin J, Magoffin RL, Shearer LA, Schieble JH, Lennette EH. Field evaluation of a respiratory 
syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population. Am J 
Epidemiol. 1969;89(4):449-63. 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT03076385, Safety, tolerability, and immunogenicity of VAL-506440 in healthy adult subjects. 
Retrieved from: https://clinicaltrials.gov/ct2/keydates/NCT03076385. (accessed 2020 Jun 01). 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT04917861, A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic 
and 
Non-Endemic 
Flavivirus. 
Retrieved 
from: 
https://clinicaltrials.gov/ct2/keydates/NCT04917861. (accessed 2021 Jul 22). 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT03345043, Safety, tolerability, and immunogenicity of VAL-339851 in healthy adult subjects. 
Retrieved from: https://clinicaltrials.gov/ct2/keydates/NCT03345043. (accessed 2020 Jun 01). 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT03382405, Safety, reactogenicity, and immunogenicity of cytomegalovirus vaccines mRNA 
1647 
and 
mRNA 
1443 
in 
healthy 
adults. 
Retrieved 
from: 
https://clinicaltrials.gov/ct2/keydates/NCT03382405. (accessed 2020 Jun 01). 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 159 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT03392389, Safety, reactogenicity, and immunogenicity of mRNA-1653 in healthy adults. 
Retrieved from: https://clinicaltrials.gov/ct2/keydates/NCT03392389. (accessed 2020 Jun 01). 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT04283461, Safety and immunologic protocol of SARS-CoV-2 vaccine (mRNA-1273) to treat 
novel 
coronavirus; 
2020 
Feb 
22. 
Retrieved 
from: 
https://clinicaltrials.gov/ct2/keydates/NCT04283461. (accessed 2020 Jun 01). 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT04405076, Dose-confirmation study to evaluate the safety, reactogenicity, and 
immunogenicity of mRNA-1273 COVID-19 vaccine in adults aged 18 years and older; 2020 May 
28. Retrieved from: https://clinicaltrials.gov/ct2/keydates/NCT04405076. (accessed 2020 Aug 
24). 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). - Identifier 
NCT04470427, A study to evaluate efficacy, safety, and immunogenicity of mRNA-1273 vaccine 
in adults aged 18 years and older to prevent COVID-19; 2028 Jul 14. Retrieved from: 
https://clinicaltrials.gov/ct2/keydates/NCT04470427. (accessed 2020 Aug 24). 
Corbett KS, Edwards DK, Leist SR, Abiona OM, Boyoglu-Barnum S, Gillespie RA, et al. 
SARS-CoV-2 mRNA vaccine development enabled by prototype pathogen preparedness. Nature. 
2020a;586:567-71. 
Corbett KS, Flynn B, Foulds KE, Francica JR, Boyoglu-Barnum S, Werner AP, et al. Evaluation 
of the mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates. N Engl J Med. 
2020b;383(16):1544-55. 
Corti D, Zhao J, Pedotti M, Simonelli L, Agnihothram S, Fett C, et al. Prophylactic and 
postexposure efficacy of a potent human monoclonal antibody against MERS coronavirus. Proc 
Natl Acad Sci U S A. 2015;112(33):10473-8. 
Cravedi P, Mothi SS, Azzi Y, et al. COVID-19 and kidney transplantation: results from the 
TANGO International Transplant Consortium. Am J Transplant. 2020;20(11):3140-8. 
Department of Health and Human Services (DHHS), Food and Drug Administration, Center for 
Biologics Evaluation and Research (US). Guidance for industry: Toxicity grading scale for healthy 
adult and adolescent volunteers enrolled in preventative vaccine clinical trials. September 2007 
[cited 
2019 
Apr 
10] 
[10 
screens].Available 
from: 
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInfor
mation/Guidances/Vaccines/ucm091977.pdf. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 160 
Department of Health and Human Services (DHHS), Food and Drug Administration, Center for 
Biologics Evaluation and Research (US). Guidance for Industry, Investigators, and Institutional 
Review Boards. FDA guidance on conduct of clinical trials of medical products during COVID-19 
public health emergency. March 2020. Updated on January 27, 2021. [cited 2021 Feb 01]. 
Available from: https://www.fda.gov/media/136238/download. 
Department of Health and Human Services (DHHS), Food and Drug Administration, FDA News 
Release, Coronavirus (COVID-19) update: FDA authorizes additional vaccine dose for certain 
immunocompromise individuals. August 2021. [cited 2021 Aug 23]. Available from: 
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-
authorizes-additional-vaccine-dose-certain-immunocompromised. 
Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, et al. 
Cardiovascular magnetic resonance in nonischemic myocardial inflammation: expert 
recommendations. J Am Coll Cardiol. 2018;72(24):3158-76. 
Fulginiti VA, Eller JJ, Downie AW, Kempe CH. Altered reactivity to measles virus. Atypical 
measles in children previously immunized with inactivated measles virus vaccines. JAMA. 
1967;202(12):1075-80. 
Gargano JW, Wallace M, Hadler SC, Langley G, Su JR, Oster ME, et al. Use of mRNA COVID-19 
vaccine after reports of myocarditis among vaccine recipients: update from the advisory committee 
on immunization practices - United States, June 2021. MMWR Morb Mortal Wkly Rep. 
2021;70(27):977-82. 
Grupper A, Rabinowich L, Schwartz D, Schwartz IF, Ben-Yehoyada M, Shashar M, et al. Reduced 
humoral response to mRNA SARS-Cov-2 BNT162b2 vaccine in kidney transplant recipients 
without prior exposure to the virus. Am J Transplant. 2021. Epub 2021/04/19. 
doi:10.1111/ajt.16615. 
Hall VG, Ferreira VH, Ku T, Ierullo M, Majchrzak-Kita B, Chaparro C, et al. Randomized trial of 
a third dose of mRNA-1273 vaccine in transplant recipients. N Engl J Med. August 2021. 
Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, et al. An mRNA 
vaccine against SARS-CoV-2 – preliminary report. N Engl J Med. 2020;383(20):1920-31. 
Johnson RF, Bagci U, Keith L, Tang X, Mollura DJ, Zeitlin L, et al. 3B11-N, a monoclonal 
antibody against MERS-CoV, reduces lung pathology in rhesus monkeys following intratracheal 
inoculation of MERS-CoV Jordan-n3/2012. Virology. 2016;490:49-58. 
Ju B, Zhang Q, Ge J, Wang R, Sun J, Ge X, et al. Human neutralizing antibodies elicited by 
SARS-CoV-2 infection. Nature. 2020;584(7819):115-9. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 161 
Kim Y, Lee H, Park K, Park S, Lim JH, So MK, et al. Selection and characterization of monoclonal 
antibodies targeting Middle East Respiratory Syndrome coronavirus through a human synthetic 
fab phage display library panning. Antibodies (Basel). 2019;8(3):42. 
Lubetzky M, Aull MJ, Craig-Schapiro R, Lee JR, Marku-Podvorica J, Salinas T, et al. Kidney 
allograft recipients, immunosuppression, and coronavirus disease-2019: a report of consecutive 
cases from a New York City transplant center. Nephrol Dial Transplant. 2020;35(7):1250-61. 
Marinaki S, Adamopoulos S, Degiannis D, Roussos S, Pavlopoulou ID, Hatzakis A, et al. 
Immunogenicity of SARS-CoV-2 BNT162b2 vaccine in solid organ transplant recipients. Am J 
Transplant. 2021. Epub 2021/04/18. doi:10.1111/ajt.16607. 
McNeil MM, DeStefano F. Vaccine-associated hypersensitivity. J Allergy Clin Immunol. 2018; 
141(2):463-72. 
Mehta SA, Leonard J, Labella P, Cartiera K, Soomro I, Neumann H, et al. Outpatient management 
of kidney transplant recipients with suspected COVID-19—single-center experience during the 
New York City surge. Transpl Infect Dis. 2020;22(6):e13383. 
Moderna mRNA-1273 Investigator’s Brochure. Version 5.0. 21 Dec 2020. 
Nair V, Jandovitz N, Hirsch JS, Nair G, Abate M, Bhaskaran M, et al. COVID-19 in kidney 
transplant recipients. Am J Transplant. 2020;20(7):1819-25. 
Natori Y, Shiotsuka M, Slomovic J, Hoschler K, Ferreira V, Ashton P, et al. A double-blind, 
randomized trial of high-dose vs standard-dose influenza vaccine in adult solid-organ transplant 
recipients. Clin Infect Dis. 2018;66(11):1698-704. 
Nevens F, Zuckerman JN, Burroughs AK, Jung MC, Bayas JM, Kallinowski B, et al. 
Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver 
transplant patients. Liver Transpl. 2006;12(10):1489-95. 
Pereira MR, Mohan S, Cohen DJ, Husain SA, Dube GK, Ratner LE, et al. COVID-19 in solid 
organ transplant recipients: initial report from the US epicenter. Am J Transplant. 
2020;20(7):1800-8. 
Raja MA, Mendoza MA, Villavicencio A, Anjan S, Reynolds JM, Kittipibul V, et al. COVID-19 
in solid organ transplant recipients: A systematic review and meta-analysis of current literature. 
Transplant Rev (Orlando). 2020;35(1):100588. 
Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, et al. Convergent antibody 
responses to SARS-CoV-2 in convalescent individuals. Nature. 2020;584(7821):437-42. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 162 
Rüggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: 
case definition and guidelines for data collection, analysis, and presentation of immunization 
safety data. Vaccine. 2007;25(31):5675-84. 
Thomas SJ, Yoon IK. A review of Dengvaxia®: development to deployment. Hum Vaccin 
Immunother. 2019;15(10):2295-314. 
US Food and Drug Administration (FDA). 2020. Moderna COVID-19 Vaccine. Retrieved from: 
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-
19/moderna-covid-19-vaccine. (accessed 14 Jan 2021) 
Walsh EE, Frenck RW Jr., Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. Safety and 
immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med. 
2020;383(25):2439-50. 
Wang L, Shi W, Joyce MG, Modjarrad K, Zhang Y, Leung K, et al. Evaluation of candidate 
vaccine approaches for MERS-CoV. Nat Commun. 2015;6:7712. 
Wang L, Shi W, Chappell JD, Joyce MG, Zhang Y, Kanekiyo M, et al. Importance of neutralizing 
monoclonal antibodies targeting multiple antigenic sites on the middle east respiratory syndrome 
coronavirus spike glycoprotein to avoid neutralization escape. J Virol. 2018;92(10):e02002-17. 
Werbel WA, Boyarsky BJ, Ou MT, Massie AB, Tobian AAR, Garonzik-Wang JM, et al. Safety 
and immunogenicity of a third dose of SARS-CoV-2 vaccine in solid organ transplant recipients: 
A case series. Ann Intern Med. 2021 Jun 15:L21-0282. 
Widjaja I, Wang C, van Haperen R, Gutiérrez-Álvarez J, van Dieren B, Okba NMA, et al. Towards 
a solution to MERS: protective human monoclonal antibodies targeting different domains and 
functions 
of 
the 
MERS-coronavirus 
spike 
glycoprotein. 
Emerg 
Microbes 
Infect. 
2019;8(1):516--30. 
World Health Organization (WHO). Dengue vaccine: WHO position paper, September 2018 – 
recommendations. Vaccine. 2019;37(35):4848-9. 
World Health Organization. (2020a, Jun 25). Coronavirus disease 2019 (COVID-19) Situation 
Report – 157. Retrieved from: https://www.who.int/docs/default-source/coronaviruse/situation-
reports/20200625-covid-19-sitrep-157.pdf?sfvrsn=423f4a82_2. (accessed 2020 Jun 26). 
World Health Organization. (2020b, Sep 28). WHO coronavirus disease (COVID-19) dashboard. 
Retrieved from: https://covid19.who.int/. (accessed 2021 Mar 26). 
Wrapp D, Wang N, Corbett KS, Goldsmith JA, Hseih CL, Abiona O, et al. Cryo-EM structure of 
the 2019-nCoV spike in the prefusion conformation. Science. 2020;367(6483):1260-3. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 163 
Yu X, Zhang S, Jiang L, Cui Y, Li D, Wang D, et al. Structural basis for the neutralization of 
MERS-CoV by a human monoclonal antibody MERS-27. Sci Rep. 2015;5:13133. 

ModernaTX, Inc. 
 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
 
mRNA-1273 
 
Confidential 
 
Page 164 
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 165 
10.1. 
APPENDIX 1: Schedule of Events 
The primary SoEs are presented in Table 8, Table 9, Table 9, and Table 10. 
If a participant cannot attend a study site visit (scheduled or unscheduled) with the exception of 
Screening (Day 0), BD-D1, Day 1, Day 29, or Day 85 (for unvaccinated 3-dose regimen 
recipients), a telemedicine visit is acceptable if performed by appropriately delegated study site 
staff (Section 7). If a participant visit to the study site is not possible (with the aforementioned 
exceptions), a safety telephone call should be performed that includes the assessments scheduled 
for the safety telephone calls. 
In Part A, if the visit for the second or third dose (Day 29 for healthy participants or Day 85 for 
unvaccinated SOT recipients) is disrupted and cannot be completed at Day 29 or Day 85 -3/+7 
days as a result of the COVID-19 pandemic (self-quarantine or disruption of study site activities 
following business continuity plans and/or local government mandates for “stay at home” or 
“shelter in place”), the visit window may be extended to Day 29 or Day 85 + 21 days. In Part A, 
when the extended visit window is used, the remaining study clinic visits should be rescheduled 
to follow the scheduled inter-visit interval from the actual date of the second (or third) dose. The 
timing of ediary follow-ups and safety calls will not be adjusted if the last dose is delayed. 
Additional safety calls every 4 weeks should be scheduled if there is a gap beyond 28 days between 
the safety call scheduled on D377 (for 2 doses) or D433 (for 3 doses) and the last study visit 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 166 
Table 7: Primary Schedule of Events for Unvaccinated SOT and Healthy Participants Who Receive the 2-Dose Vaccination 
Regimen (Part A: Group A1 and Group A5) 
Visit Number 
0 
1 
2 
3 
4 
5 
- 
6 
- 
7 
Type of Visit 
C 
C 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
 
M2 
eDiary 
SC 
M7 
eDiary 
SC 
M13 
Study Visit Day 
D01 
(Screening) 
D1 (Baseline) 
D82 
D293 
D362,3 
D572, 3 
Every 4 weeks  
D71 – D1833, 4 
Every 4 weeks  
D85 – D1973, 5 
D2092, 3 
Every 4 weeks 
D223– D3633, 4 
Every 4 weeks 
D237– D3773, 5 
D3942, 3 
Window Allowance (Days) 
-7 
 
+3 
-3/+7 +3 
+7 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28/0 
7 
28 
- 
- 
180 
- 
- 
365 
Informed consent form, demographics, concomitant 
medications, medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Review of inclusion and exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
Physical examination including height and weight6 
X 
X 
 
X 
 
X 
 
 
X 
 
 
X 
Lymph node assessment7 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
Vital signs8 
X 
X 
 
X 
 
X 
 
 
X 
 
 
X 
Pregnancy test9 
X 
X 
 
X 
 
 
 
 
 
 
 
 
Blood and urine sampling for safety assessments10 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Recording of standard-of-care kidney or liver 
laboratory -related AEs11 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
Study injection (including 30‑minute post-dose 
observation period) 
 
X 
 
X 
 
 
 
 
 
 
 
 
Blood for immunogenicity and assessment of Ab 
against nonvaccine antigen12 
 
X 
 
X 
 
X 
 
 
X 
 
 
X 
Blood for cell-mediated immunity analysis13 
 
X 
 
 
X 
 
 
 
 
 
 
 
Nasopharyngeal swab sample for SARS-CoV-214 
 
X 
 
X 
 
X 
 
 
 
 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 167 
Visit Number 
0 
1 
2 
3 
4 
5 
- 
6 
- 
7 
Type of Visit 
C 
C 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
 
M2 
eDiary 
SC 
M7 
eDiary 
SC 
M13 
Study Visit Day 
D01 
(Screening) 
D1 (Baseline) 
D82 
D293 
D362,3 
D572, 3 
Every 4 weeks  
D71 – D1833, 4 
Every 4 weeks  
D85 – D1973, 5 
D2092, 3 
Every 4 weeks 
D223– D3633, 4 
Every 4 weeks 
D237– D3773, 5 
D3942, 3 
Window Allowance (Days) 
-7 
 
+3 
-3/+7 +3 
+7 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28/0 
7 
28 
- 
- 
180 
- 
- 
365 
Surveillance for COVID‑19/ Illness visit15/ 
Unscheduled visit 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Convalescent visit16 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
eDiary activation for recording solicited ARs (7 days)17 
 
X 
 
X 
 
 
 
 
 
 
 
 
Review of eDiary data 
 
 
X 
 
X 
 
 
 
 
 
 
 
Follow-up eDiary questionnaires 
 
 
 
 
 
 
X 
 
 
X 
 
 
Follow-up safety telephone calls18 
 
 
 
 
 
 
 
X 
 
 
X 
 
Recording of unsolicited AEs 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Recording of MAAEs and concomitant medications 
relevant to or for the treatment of the MAAE19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of AESIs18 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of SAEs and concomitant medications 
relevant to or for the treatment of the SAE19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of suspected AND confirmed organ 
transplant rejection19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant medications and nonstudy 
vaccinations19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant immunosuppressant 
medications20 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study completion 
 
 
 
 
 
 
 
 
 
 
 
X 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 168 
Abbreviations: Ab = antibody; AE = adverse event; AESI = adverse event of special interest; ALP = alkaline phosphatase; ALT = alanine aminotransferase; AR = adverse 
reaction; AST = aspartate aminotransferase; bAb = binding antibody; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; eDiary = electronic diary; FDA = US 
Food and Drug Administration; IRB = institutional review board; M = month; MAAE = medically attended adverse event; NP = nasopharyngeal; RT-PCR = reverse transcriptase 
polymerase chain reaction; SAE = serious adverse event; SARS-CoV-2 = Severe Acute Respiratory Syndrome coronavirus 2; SC = safety (telephone) call; SFU = safety 
follow-up; SOT = solid organ transplant; UPCR = urine protein to creatinine ratio. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (DHHS 2020), investigators may 
convert study site visits to telemedicine visits with the approval of the Sponsor. 
1. 
Day 0 and Day 1 may be combined on the same day. Additionally, the Day 0 visit may be performed over multiple visits if performed within the 7-day screening window. 
Demographic variables (ie, age, sex, race, and ethnicity) and baseline characteristics (ie, height, weight, body mass index, date of transplant, type of SOT, type of transplant, 
indication for transplant, ABO blood group status, and relevant medical history) will be collected. 
2. 
All scheduled study visits should be completed within the respective visit windows. If the participant is not able to attend a study site visit as a result of the COVID-19 
pandemic (self-quarantine or disruption of study site activities following business continuity plans and/or local government mandates for “stay at home” or “shelter in 
place”), a safety telephone call to the participant should be made in place of the study site visit. The safety telephone call should encompass all scheduled visit assessments 
that can be completed remotely, such as assessment for AEs and concomitant medications (eg, as defined in scheduled safety telephone calls). Telemedicine will be 
permitted for all nondosing visits, with the exception of Screening, if a participant cannot visit the study site as a result of the COVID-19 pandemic. Telemedicine visits must 
be permitted by the study site IRB and the participant via informed consent and have prior approval from the Sponsor (or its designee). 
3. 
If the visit for the second dose (Day 29) is disrupted and cannot be completed at Day 29 -3/+7 days as a result of the COVID-19 pandemic (self-quarantine or disruption of 
study site activities following business continuity plans and/or local government mandates for “stay at home” or “shelter in place”), the visit window may be extended to 
Day 29 + 21 days. When the extended visit window is used, the remaining clinic study visits D36 (last dose + 7 days), D57 (last dose + 28 days), 6 month visit (last dose + 
180 days), and 12 month visit (last dose + 365 days) should be rescheduled to follow the scheduled inter-visit interval from the actual date of the second dose. The timing of 
ediary follow-ups and safety calls will not be adjusted. Additional safety calls every 4 weeks should be scheduled if there is a gap beyond 28 days between the last safety call 
and the last study visit. Participants who agree to receive a booster dose in Part B of the study will follow the schedule of events for Part B (see Table 10). 
4. 
Safety follow-up via an eDiary questionnaire will be performed every 4 weeks from Day 71 to Day 183 and again from Day 223 to Day 363. 
5. 
Safety follow-up via a safety telephone call will be performed every 4 weeks from Day 85 to Day 197 and again from Day 237 to Day 377. 
6. 
Physical examination: A full physical examination, including height and weight, will be performed to determine eligibility prior to administration of vaccine dose on Day 1. 
Body mass index will be calculated only at the screening visit (Day 0). Symptom-directed physical examinations will be performed at Day 29, Day 57, Day 209, and Day 
394. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
7. 
On each injection day before injection and again 7 days after injection, the arm that received the injection should be examined and the associated lymph nodes must be 
evaluated. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
8. 
Vital signs are to be measured pre- and post-dose on days of injection (Day 1 and Day 29). When applicable, vital signs should be measured before blood collection. 
Participants who are febrile (body temperature ≥ 38.0°C/≥ 100.4°F) before injection on Day 1, or Day 29 must have the visit rescheduled within the relevant visit window to 
receive the injection. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 
9. 
The pregnancy test at Screening and Day 1 and before the second study injection will be a point-of-care urine test. At the discretion of the investigator, a pregnancy test 
either via blood or point-of-care urine test can be performed at any time. 
10. 
Samples for safety laboratory assessments (serum creatinine, urine protein, and UPCR for kidney transplant recipients only; ALT, AST, ALP, and bilirubin for liver 
transplant recipients only) must be collected prior to dosing on Day 1 and Day 29. 
11. 
After Day 57, the investigator will review standard-of-care kidney and liver laboratory assessments and report any laboratory-related AEs and suspected or confirmed events 
of organ transplant rejection until the EOS. 
12. 
Samples for immunogenicity (bAb against SARS-CoV-2 spike protein and neutralizing antibody against SARS-CoV-2) and assessment of SARS-CoV-2 bAb against the 
nonvaccine antigen (nucleocapsid protein) must be collected prior to dosing on Day 1, and Day 29. 
13. 
For assessment of cellular immune response, blood samples will be collected on Day 1 (prior to dosing) and Day 36. Note that 20 healthy participants receiving 2-dose 
regimen will also have blood samples collected at Day 1 (prior to dosing) and Day 36. 
14. 
The NP swab sample will be collected prior to dosing and used to ascertain the presence of SARS-CoV-2 via RT-PCR. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 169 
15. 
An unscheduled visit may be prompted by reactogenicity issues, illness visit criteria for COVID-19, or new or ongoing AEs. If a participant meets the prespecified criteria of 
suspicion for COVID-19 (Section 7.1.6), the participants will be asked to return within 72 hours or as soon as possible to the study site for an unscheduled illness visit, to 
include an NP swab sample (for RT-PCR testing) and other clinical evaluations including blood sample collection for immunologic assessment of SARS-CoV-2 infection 
(bAb against the nonvaccine antigen [nucleocapsid protein]). If a study site visit is not possible, the participant will be asked to submit a saliva sample to the study site by a 
Sponsor-approved method. At this illness visit, the NP swab samples will be collected to evaluate for the presence of SARS-CoV-2 infection. NP swab samples will also be 
tested for the presence of other respiratory pathogens. In addition, the study site may collect an additional NP sample for SARS-CoV-2 testing to be able to render 
appropriate medical care for the study participant as determined by local standards of care. Additionally, clinical information will be carefully collected to evaluate the 
severity of the clinical case. 
16. 
A convalescent visit will be scheduled approximately 28 days (+7 days) after diagnosis. At this visit, an NP swab sampling for viral PCR and a blood sample will be 
collected for potential immunologic assessment of SARS-CoV-2 infection. 
17. 
Diary entries will be recorded by the participant at approximately 30 minutes after injection while at the study site with instruction provided by study staff. Study participants 
will continue to record entries in the eDiary each day after they leave the study site, preferably in the evening, on the day of injection and for 6 days following injection. If a 
solicited local or systemic AR continues beyond Day 7 after vaccination, the participant will be prompted to capture details of the solicited local or systemic AR in the 
eDiary until the AR is resolved or the next vaccine injection occurs, whichever occurs first; capture of details of ARs in the eDiary should not exceed 28 days after each 
vaccination. Adverse reactions recorded in the eDiary beyond Day 7 should be reviewed either via telephone call or at the following study visit. 
18. 
Trained study site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, AESIs, AEs leading to discontinuation from dosing and/or 
study participation (withdrawal), information on concomitant medications associated with those events, and any nonstudy vaccinations. In addition, study personnel will 
collect information on known participant close contact exposure to someone with known COVID-19 or SARS-CoV-2 infection and on participant experience of COVID-19 
symptoms. 
19. 
All concomitant medications and nonstudy vaccinations will be recorded through 28 days after each injection; all concomitant medications relevant to or for the treatment of 
an SAE, confirmed (biopsy-proven) or suspected events of organ transplant rejection, or MAAE will be recorded from Day 1 through the final visit (Day 394). 
20. 
All immunosuppressant medications, for 3 months prior to Screening and throughout the study. Any change in the maintenance therapy should be recorded and the reason 
for the change documented. 
21. 
Additional safety calls every 4 weeks should be scheduled if the last dose was delayed and there is a gap beyond 28 days between the safety call scheduled on D377 and the 
last study visit. 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 170 
Table 8: Primary Schedule of Events for Unvaccinated Participants Who Receive the 3-Dose Vaccination Regimen (Part A: 
Group A2) 
Visit Number 
0 
1 
2 
3 
4 
5 
6 
7 
8 
- 
9 
- 
10 
Type of Visit 
C 
C 
C 
C 
C 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
 
M2 
M3 
 
M4 
eDiary 
SC 
M9 
eDiary 
SC 
M15 
Study Visit Day 
D01 
(Screening) 
D1 (Baseline) 
D82 
D293 
D362,3 
D572, 3 
D852,3 
D92 
D1132,3 
Every 4 weeks  
D127 – D2393, 4 
Every 4 weeks  
D141 – D2533, 5 
D2652, 3 
Every 4 weeks 
D279– D4193, 4 
Every 4 weeks 
D293– D4333, 5 
D4502, 3 
Window Allowance (Days) 
-7 
 
+3 
-3/+7 +3 
-3 
-3/+7 
+3 
-3/+7 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28/0 
7 
28 
56/0 
7 
28 
-  
- 
180 
- 
- 
365 
Informed consent form, demographics, 
concomitant medications, medical history  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review of inclusion and exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination including height and 
weight6 
X 
X 
 
X 
  
X 
X 
 
X 
 
 
X 
 
 
X 
Lymph node assessment7 
 
X 
X 
X 
X 
 
X 
X 
 
 
 
 
 
 
 
Vital signs8 
X 
X 
 
X 
 
X 
X 
 
X 
 
 
X 
 
 
X 
Pregnancy test9 
X 
X 
 
X 
 
 
X 
 
 
 
 
 
 
 
  
Blood and urine sampling for safety 
assessments10 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Recording of standard-of-care kidney or liver 
laboratory -related AEs11 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
Study injection (including 30-minute post-dose 
observation period) 
 
X 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
Blood for immunogenicity and assessment of Ab 
against nonvaccine antigen12 
 
X 
 
X 
 
X 
X 
 
X 
 
 
X 
 
 
X 
Blood for cell-mediated immunity analysis13 
 
X 
 
 
X 
 
 
X 
 
 
 
 
 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 171 
Visit Number 
0 
1 
2 
3 
4 
5 
6 
7 
8 
- 
9 
- 
10 
Type of Visit 
C 
C 
C 
C 
C 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
 
M2 
M3 
 
M4 
eDiary 
SC 
M9 
eDiary 
SC 
M15 
Study Visit Day 
D01 
(Screening) 
D1 (Baseline) 
D82 
D293 
D362,3 
D572, 3 
D852,3 
D92 
D1132,3 
Every 4 weeks  
D127 – D2393, 4 
Every 4 weeks  
D141 – D2533, 5 
D2652, 3 
Every 4 weeks 
D279– D4193, 4 
Every 4 weeks 
D293– D4333, 5 
D4502, 3 
Window Allowance (Days) 
-7 
 
+3 
-3/+7 +3 
-3 
-3/+7 
+3 
-3/+7 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28/0 
7 
28 
56/0 
7 
28 
-  
- 
180 
- 
- 
365 
Nasopharyngeal swab sample for SARS-CoV-
214 
 
X 
 
X 
 
X 
X 
 
X 
 
 
 
 
 
 
Surveillance for COVID-19/ Illness visit15/ 
Unscheduled visit 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Convalescent visit16 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
eDiary activation for recording solicited ARs 
(7 days)17 
 
X 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
Review of eDiary data 
 
 
X 
 
X 
 
 
X 
 
 
 
 
 
 
 
Follow-up eDiary questionnaires 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
Follow-up safety telephone calls18 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Recording of unsolicited AEs 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Recording of MAAEs and concomitant 
medications relevant to or for the treatment of 
the MAAE19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of AESIs18 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of SAEs and concomitant 
medications relevant to or for the treatment of 
the SAE19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of suspected AND confirmed organ 
transplant rejection19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 172 
Visit Number 
0 
1 
2 
3 
4 
5 
6 
7 
8 
- 
9 
- 
10 
Type of Visit 
C 
C 
C 
C 
C 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
 
M2 
M3 
 
M4 
eDiary 
SC 
M9 
eDiary 
SC 
M15 
Study Visit Day 
D01 
(Screening) 
D1 (Baseline) 
D82 
D293 
D362,3 
D572, 3 
D852,3 
D92 
D1132,3 
Every 4 weeks  
D127 – D2393, 4 
Every 4 weeks  
D141 – D2533, 5 
D2652, 3 
Every 4 weeks 
D279– D4193, 4 
Every 4 weeks 
D293– D4333, 5 
D4502, 3 
Window Allowance (Days) 
-7 
 
+3 
-3/+7 +3 
-3 
-3/+7 
+3 
-3/+7 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28/0 
7 
28 
56/0 
7 
28 
-  
- 
180 
- 
- 
365 
Recording of concomitant medications and 
nonstudy vaccinations19 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant immunosuppressant 
medications20 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study completion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Abbreviations: Ab = antibody; AE = adverse event; AESI = adverse event of special interest; ALP = alkaline phosphatase; ALT = alanine aminotransferase; AR = adverse 
reaction; AST = aspartate aminotransferase; bAb = binding antibody; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; eDiary = electronic diary; FDA = US 
Food and Drug Administration; IRB = institutional review board; M = month; MAAE = medically attended adverse event; NP = nasopharyngeal; RT-PCR = reverse transcriptase 
polymerase chain reaction; SAE = serious adverse event; SARS-CoV-2 = Severe Acute Respiratory Syndrome coronavirus 2; SC = safety (telephone) call; SFU = safety 
follow-up; SOT = solid organ transplant; UPCR = urine protein to creatinine ratio. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (DHHS 2020), investigators may 
convert study site visits to telemedicine visits with the approval of the Sponsor. 
1. 
Day 0 and Day 1 may be combined on the same day. Additionally, the Day 0 visit may be performed over multiple visits if performed within the 7-day screening 
window. Demographic variables (ie, age, sex, race, and ethnicity) and baseline characteristics (ie, height, weight, body mass index, date of transplant, type of SOT, type 
of transplant, indication for transplant, ABO blood group status, and relevant medical history) will be collected. 
2. 
All scheduled study visits should be completed within the respective visit windows. If the participant is not able to attend a study site visit as a result of the COVID-19 
pandemic (self-quarantine or disruption of study site activities following business continuity plans and/or local government mandates for “stay at home” or “shelter in 
place”), a safety telephone call to the participant should be made in place of the study site visit. The safety telephone call should encompass all scheduled visit 
assessments that can be completed remotely, such as assessment for AEs and concomitant medications (eg, as defined in scheduled safety telephone calls). Telemedicine 
will be permitted for all nondosing visits, with the exception of Screening, if a participant cannot visit the study site as a result of the COVID-19 pandemic. Telemedicine 
visits must be permitted by the study site IRB and the participant via informed consent and have prior approval from the Sponsor (or its designee). 
3. 
If the visit for the third dose (Day 85) is disrupted and cannot be completed at Day 85 -3/+7 days as a result of the COVID-19 pandemic (self-quarantine or disruption of 
study site activities following business continuity plans and/or local government mandates for “stay at home” or “shelter in place”), the visit window may be extended to 
+ 21 Day 85. When the extended visit window is used, the remaining clinic study visits D92 (last dose + 7 days), D113 (last dose + 28 days), 6 month visit (last dose + 
180 days), and 12 month visit (last dose + 365 days) should be rescheduled to follow the scheduled inter-visit interval from the actual date of the third dose. The timing 
of ediary follow-ups and safety calls will not be adjusted. Additional safety calls every 4 weeks should be scheduled if there is a gap beyond 28 days between the last 
safety call and the last study visit. Participants who agree to receive a booster dose in Part B of the study will follow the schedule of events for Part B (see Table 10). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 173 
4. 
Safety follow-up via an eDiary questionnaire will be performed every 4 weeks from Day 127 to Day 239 and again from Day 279 to Day 419. 
5. 
Safety follow-up via a safety telephone call will be performed every 4 weeks from Day 141 to Day 253 and again from Day 293 to Day 433. 
6. 
Physical examination: A full physical examination, including height and weight, will be performed to determine eligibility prior to administration of vaccine dose on 
Day 1. Body mass index will be calculated only at the screening visit (Day 0). Symptom-directed physical examinations will be performed at Day 29, Day 57, Day 85, 
Day 113, Day 265, and Day 450. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
7. 
On each injection day before injection and again 7 days after injection, the arm that received the injection should be examined and the associated lymph nodes must be 
evaluated. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
8. 
Vital signs are to be measured pre- and post-dose on days of injection (Day 1, Day 29, and Day 85). When applicable, vital signs should be measured before blood 
collection. Participants who are febrile (body temperature ≥ 38.0°C/≥ 100.4°F) before injection on Day 1, Day 29, or Day 85 must have the visit rescheduled within the 
relevant visit window to receive the injection. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 
9. 
The pregnancy test at Screening, Day 1, and before the second and third study injections will be a point-of-care urine test. At the discretion of the investigator, a 
pregnancy test either via blood or point-of-care urine test can be performed at any time. 
10. 
Samples for safety laboratory assessments (serum creatinine, urine protein, and UPCR for kidney transplant recipients only; ALT, AST, ALP, and bilirubin for liver 
transplant recipients only) must be collected prior to dosing on Day 1, Day 29, and Day 85. 
11. 
After Day 113, the investigator will review standard-of-care kidney and liver laboratory assessments and report any laboratory-related AEs and suspected or confirmed 
events of organ transplant rejection until the EOS. 
12. 
Samples for immunogenicity (bAb against SARS-CoV-2 spike protein and neutralizing antibody against SARS-CoV-2) and assessment of SARS-CoV-2 bAb against the 
nonvaccine antigen (nucleocapsid protein) must be collected prior to dosing on Day 1, Day 29, and Day 85. 
13. 
For assessment of cellular immune response, blood samples will be collected on Day 1 (prior to dosing), Day 36, and Day 92 from a subset of at least 50 unvaccinated 
SOT recipients (kidney or liver). 
14. 
The NP swab sample will be collected prior to dosing and used to ascertain the presence of SARS-CoV-2 via RT-PCR. 
15. 
An unscheduled visit may be prompted by reactogenicity issues, illness visit criteria for COVID-19, or new or ongoing AEs. If a participant meets the prespecified 
criteria of suspicion for COVID-19 (Section 7.1.6), the participants will be asked to return within 72 hours or as soon as possible to the study site for an unscheduled 
illness visit, to include an NP swab sample (for RT-PCR testing) and other clinical evaluations including blood sample collection for immunologic assessment of 
SARS-CoV-2 infection (bAb against the nonvaccine antigen [nucleocapsid protein]). If a study site visit is not possible, the participant will be asked to submit a saliva 
sample to the study site by a Sponsor-approved method. At this illness visit, the NP swab samples will be collected to evaluate for the presence of SARS-CoV-2 
infection. NP swab samples will also be tested for the presence of other respiratory pathogens. In addition, the study site may collect an additional NP sample for 
SARS-CoV-2 testing to be able to render appropriate medical care for the study participant as determined by local standards of care. Additionally, clinical information 
will be carefully collected to evaluate the severity of the clinical case. 
16. 
A convalescent visit will be scheduled approximately 28 days (+7 days) after diagnosis. At this visit, an NP swab sampling for viral PCR and a blood sample will be 
collected for potential immunologic assessment of SARS-CoV-2 infection. 
17. 
Diary entries will be recorded by the participant at approximately 30 minutes after injection while at the study site with instruction provided by study staff. Study 
participants will continue to record entries in the eDiary each day after they leave the study site, preferably in the evening, on the day of injection and for 6 days 
following injection. If a solicited local or systemic AR continues beyond Day 7 after vaccination, the participant will be prompted to capture details of the solicited local 
or systemic AR in the eDiary until the AR is resolved or the next vaccine injection occurs, whichever occurs first; capture of details of ARs in the eDiary should not 
exceed 28 days after each vaccination. Adverse reactions recorded in the eDiary beyond Day 7 should be reviewed either via telephone call or at the following study 
visit. 
18. 
Trained study site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, AESIs, AEs leading to discontinuation from dosing 
and/or study participation (withdrawal), information on concomitant medications associated with those events, and any nonstudy vaccinations. In addition, study 
personnel will collect information on known participant close contact exposure to someone with known COVID-19 or SARS-CoV-2 infection and on participant 
experience of COVID-19 symptoms. 
19. 
All concomitant medications and nonstudy vaccinations will be recorded through 28 days after each injection; all concomitant medications relevant to or for the 
treatment of an SAE, confirmed (biopsy-proven) or suspected events of organ transplant rejection, or MAAE will be recorded from Day 1 through the final visit 
(Day 450). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 174 
20. 
All immunosuppressant medications, for 3 months prior to Screening and throughout the study. Any change in the maintenance therapy should be recorded and the reason 
for the change documented. 
21. 
Additional safety calls every 4 weeks should be scheduled if there is a gap beyond 28 days between the safety call scheduled on D377 (for 2 doses) or D433 (for 3 doses) 
and the last study visit. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 175 
Table 9: Primary Schedule of Events for Previously Vaccinated Participants Who Receive a Single-dose Vaccination 
Regimen (dose 3) (Part A: Group A3) 
Visit Number 
0 
1 
2 
3 
- 
4 
- 
5 
Type of Visit 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
eDiary 
SC 
M6 
eDiary 
SC 
M12 
Study Visit Day  
D01 
(Screening) 
D1 
(Baseline) 
D82 
D29 
Every 
4 
weeks  
D43 – 
D1553 
Every 
4 
weeks  
D57 – 
D169 
4 
D180 
Every 
4 
weeks 
D194– 
D3063  
Every 
4 
weeks 
D208– 
D320 4 
D3652, 
3 
Window Allowance (Days) 
-7 
 
+3 
+3 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28 
- 
- 
180 
- 
- 
365 
Informed consent form, demographics, 
concomitant medications, medical 
history  
X 
 
 
 
 
 
 
 
 
 
Review of inclusion and exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
Physical examination including height 
and weight5 
X 
X 
 
X 
 
 
X 
 
 
X 
Lymph node assessment6 
 
X 
X 
 
 
 
 
 
 
 
Vital signs7 
X 
X 
 
X 
 
 
X 
 
 
X 
Pregnancy test8 
X 
X 
 
 
 
 
 
 
 
  
Blood and urine sampling for safety 
assessments9 
 
X 
X 
X 
 
 
 
 
 
 
Recording of standard-of-care kidney 
or liver laboratory-related AEs10 
 
 
 
 
X 
X 
X 
X 
X 
X 
Study injection (including 30-minute 
post-dose observation period) 
 
X 
 
 
 
 
 
 
 
 
Blood for immunogenicity and 
assessment of Ab against nonvaccine 
antigen11 
 
X 
 
X 
 
 
X 
 
 
X 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 176 
Visit Number 
0 
1 
2 
3 
- 
4 
- 
5 
Type of Visit 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
eDiary 
SC 
M6 
eDiary 
SC 
M12 
Study Visit Day  
D01 
(Screening) 
D1 
(Baseline) 
D82 
D29 
Every 
4 
weeks  
D43 – 
D1553 
Every 
4 
weeks  
D57 – 
D169 
4 
D180 
Every 
4 
weeks 
D194– 
D3063  
Every 
4 
weeks 
D208– 
D320 4 
D3652, 
3 
Window Allowance (Days) 
-7 
 
+3 
+3 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28 
- 
- 
180 
- 
- 
365 
Blood for cell-mediated immunity 
analysis12 
 
X 
X 
 
 
 
 
 
 
 
Nasopharyngeal swab sample for 
SARS-CoV-213 
 
X 
 
X 
 
 
 
 
 
 
Surveillance for COVID-19/ Illness 
visit14/ Unscheduled visit 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Convalescent visit15 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
eDiary activation for recording 
solicited ARs (7 days)16 
 
X 
 
 
 
 
 
 
 
 
Review of eDiary data 
 
 
X 
 
 
 
 
 
 
 
Follow-up eDiary questionnaires 
 
 
 
 
X 
 
 
X 
 
 
Follow-up safety telephone calls17 
 
 
 
 
 
X 
 
 
X 
 
Recording of unsolicited AEs 
 
X 
X 
X 
 
 
 
 
 
 
Recording of MAAEs and concomitant 
medications relevant to or for the 
treatment of the MAAE18 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of AESIs17 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of SAEs and concomitant 
medications relevant to or for the 
treatment of the SAE18 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 177 
Visit Number 
0 
1 
2 
3 
- 
4 
- 
5 
Type of Visit 
C 
C 
C 
C 
SFU 
C 
SFU 
C 
Month Timepoint 
 
M0 
 
M1 
eDiary 
SC 
M6 
eDiary 
SC 
M12 
Study Visit Day  
D01 
(Screening) 
D1 
(Baseline) 
D82 
D29 
Every 
4 
weeks  
D43 – 
D1553 
Every 
4 
weeks  
D57 – 
D169 
4 
D180 
Every 
4 
weeks 
D194– 
D3063  
Every 
4 
weeks 
D208– 
D320 4 
D3652, 
3 
Window Allowance (Days) 
-7 
 
+3 
+3 
±2 
±3 
±14 
±2 
±3 
±14 
Days Since Most Recent Injection 
- 
0 
7 
28 
- 
- 
180 
- 
- 
365 
Recording of suspected AND 
confirmed organ transplant rejection18 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant medications 
and nonstudy vaccinations18 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant 
immunosuppressant medications19 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study completion 
 
 
 
 
 
 
 
 
 
X 
Abbreviations: Ab = antibody; AE = adverse event; AESI = adverse event of special interest; ALP = alkaline phosphatase; ALT = alanine aminotransferase; AR = adverse 
reaction; AST = aspartate aminotransferase; bAb = binding antibody; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; eDiary = electronic diary; FDA = US 
Food and Drug Administration; IRB = institutional review board; M = month; MAAE = medically attended adverse event; NP = nasopharyngeal; RT-PCR = reverse transcriptase 
polymerase chain reaction; SAE = serious adverse event; SARS-CoV-2 = Severe Acute Respiratory Syndrome coronavirus 2; SC = safety (telephone) call; SFU = safety 
follow-up; SOT = solid organ transplant; UPCR = urine protein to creatinine ratio. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (DHHS 2020), investigators may 
convert study site visits to telemedicine visits with the approval of the Sponsor. 
1. 
Day 0 and Day 1 may be combined on the same day. Additionally, the Day 0 visit may be performed over multiple visits if performed within the 7-day screening 
window. Demographic variables (ie, age, sex, race, and ethnicity) and baseline characteristics (ie, height, weight, body mass index, date of transplant, type of SOT, type 
of transplant, indication for transplant, ABO blood group status, and relevant medical history) will be collected. 
2. 
All scheduled study visits should be completed within the respective visit windows. If the participant is not able to attend a study site visit as a result of the COVID-19 
pandemic (self-quarantine or disruption of study site activities following business continuity plans and/or local government mandates for “stay at home” or “shelter in 
place”), a safety telephone call to the participant should be made in place of the study site visit. The safety telephone call should encompass all scheduled visit 
assessments that can be completed remotely, such as assessment for AEs and concomitant medications (eg, as defined in scheduled safety telephone calls). Telemedicine 
will be permitted for all nondosing visits, with the exception of Screening, if a participant cannot visit the study site as a result of the COVID-19 pandemic. Telemedicine 
visits must be permitted by the study site IRB and the participant via informed consent and have prior approval from the Sponsor (or its designee). Participants who agree 
to receive a booster dose in Part B will follow the schedule of events for Part B (see Table 10). 
3. 
Safety follow-up via an eDiary questionnaire will be performed every 4 weeks from Day 43 to Day 155 and again from Day 194 to Day 306. 
4. 
Safety follow-up via a safety telephone call will be performed every 4 weeks from Day 57 to Day 169 and again from Day 208 to Day 320. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 178 
5. 
Physical examination: A full physical examination, including height and weight, will be performed to determine eligibility prior to administration of vaccine dose on 
Day 1. Body mass index will be calculated only at the screening visit (Day 0). Symptom-directed physical examinations will be performed at Day 29, Day 180, and 
Day 365. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
6. 
On the injection day before injection and again 7 days after injection, the arm that received the injection should be examined and the associated lymph nodes must be 
evaluated. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
7. 
Vital signs are to be measured pre and post-dose on days of injection (Day 1). When applicable, vital signs should be measured before blood collection. Participants who 
are febrile (body temperature ≥ 38.0°C/≥ 100.4°F) before injection on Day 1 must have the visit rescheduled within the relevant visit window to receive the injection. 
Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 
8. 
The pregnancy test at Screening and Day 1 (if on separate days) will be a point-of-care urine test. At the discretion of the investigator, a pregnancy test either via blood or 
point-of-care urine test can be performed at any time. 
9. 
Samples for safety laboratory assessments (serum creatinine, urine protein, and UPCR for kidney transplant recipients only; ALT, AST, ALP, and bilirubin for liver 
transplant recipients only) must be collected prior to dosing on Day 1. 
10. 
After Day 29, the investigator will review standard-of-care kidney and liver laboratory assessments and report any laboratory-related AEs and suspected or confirmed 
events of organ transplant rejection until the EOS. 
11. 
Samples for immunogenicity (bAb against SARS-CoV-2 spike protein and neutralizing antibody against SARS-CoV-2) and assessment of SARS-CoV-2 bAb against the 
nonvaccine antigen (nucleocapsid protein) must be collected prior to dosing on Day 1. 
12. 
For assessment of cellular immune response, blood samples will be collected on Day 1 (prior to dosing), and Day 8 from a subset of at least 50 previously vaccinated 
SOT recipients (kidney or liver). 
13. 
The NP swab sample will be collected prior to dosing and used to ascertain the presence of SARS-CoV-2 via RT-PCR. 
14. 
An unscheduled visit may be prompted by reactogenicity issues, illness visit criteria for COVID-19, or new or ongoing AEs. If a participant meets the prespecified 
criteria of suspicion for COVID-19 (Section 7.1.6), the participants will be asked to return within 72 hours or as soon as possible to the study site for an unscheduled 
illness visit, to include an NP swab sample (for RT-PCR testing) and other clinical evaluations including blood sample collection for immunologic assessment of 
SARS-Co-V2 infection (bAb against the nonvaccine antigen [nucleocapsid protein]). If a study site visit is not possible, the participant will be asked to submit a saliva 
sample to the study site by a Sponsor-approved method. At this illness visit, the NP swab samples will be collected to evaluate for the presence of SARS-CoV-2 
infection. NP swab samples will also be tested for the presence of other respiratory pathogens. In addition, the study site may collect an additional NP sample for 
SARS-CoV-2 testing to be able to render appropriate medical care for the study participant as determined by local standards of care. Additionally, clinical information 
will be carefully collected to evaluate the severity of the clinical case. 
15. 
A convalescent visit will be scheduled approximately 28 days (+7 days) after diagnosis. At this visit, an NP swab sampling for viral PCR and a blood sample will be 
collected for potential immunologic assessment of SARS-CoV-2 infection. 
16. 
Diary entries will be recorded by the participant at approximately 30 minutes after injection while at the study site with instruction provided by study staff. Study 
participants will continue to record entries in the eDiary each day after they leave the study site, preferably in the evening, on the day of injection and for 6 days 
following injection. If a solicited local or systemic AR continues beyond Day 7 after vaccination, the participant will be prompted to capture details of the solicited local 
or systemic AR in the eDiary until the AR is resolved; capture of details of ARs in the eDiary should not exceed 28 days after vaccination. Adverse reactions recorded in 
the eDiary beyond Day 7 should be reviewed either via telephone call or at the following study visit. 
17. 
Trained study site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, AESIs, AEs leading to discontinuation from dosing 
and/or study participation withdrawal, information on concomitant medications associated with those events, and any nonstudy vaccinations. In addition, study personnel 
will collect information on known participant close contact exposure to someone with known COVID-19 or SARS-CoV-2 infection and on participant experience of 
COVID-19 symptoms. 
18. 
All concomitant medications and nonstudy vaccinations will be recorded through 28 days after injection; all concomitant medications relevant to or for the treatment of 
an SAE, confirmed (biopsy-proven) or suspected events of organ transplant rejection, or MAAE will be recorded from Day 1 through the final visit (Day 365). In 
addition, the 2 previous doses of the Moderna COVID-19 vaccine will be recorded in the participant’s eCRF regardless of the timing. 
19. 
All immunosuppressant medications, for 3 months prior to Screening and throughout the study. Any change in the maintenance therapy should be recorded and the reason 
for the change documented. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 179 
Table 10: Booster Dose Phase (Part B: Group B2, Group B3, Group B4, and Group B5) 
Visit Number 
BD-1 
BD-1a 
BD-2 
- 
BD-3 
- 
BD-4 
Type of Visit 
C 
C 
C 
SC 
C 
SC 
C 
Study Visit Day 
BD-D11 
(D205 for SOTr who received 3 
doses; D120 for SOTr who received 
1 dose; D149 for healthy cohort; at 
least 4 mos from last dose for SOTr 
who received primary series under 
EUA) 
BD-D4 
BD-D8 
14 and 21 
days after 
BD-D1 
(BD-D15, 
BD-D22) 
 
 
 
BD-D29 
BD-D59, 
BD-D89, 
BD-D119, 
BD-149 
 
 
BD-
D181 
 
Window Allowance (Days) 
- 14 days 
-2 
+3 
+3 
-3/+14 
+3 
-3/+14 
Days Since Most Recent 
Vaccination (in Part B) 
0 
3 
7 
- 
28 
- 
180 
Informed consent form, 
demographics, concomitant 
medications, medical history 
X 
 
 
 
 
 
 
Review of inclusion and exclusion 
criteria 
X 
 
 
 
 
 
 
Physical examination including 
height and weight2 
X 
 
 
 
X 
 
X 
Lymph node assessment3 
X 
 
X 
 
 
 
 
Vital signs4 
X 
 
X 
 
X 
 
X 
Pregnancy testing5 
X 
 
 
 
 
 
 
Immunogenicity Assessment 
 
 
 
 
 
 
 
Blood for immunologic analysis and 
assessment of Ab against 
nonvaccine antigen6 
X 
 
 
 
X 
 
X 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 180 
Visit Number 
BD-1 
BD-1a 
BD-2 
- 
BD-3 
- 
BD-4 
Type of Visit 
C 
C 
C 
SC 
C 
SC 
C 
Study Visit Day 
BD-D11 
(D205 for SOTr who received 3 
doses; D120 for SOTr who received 
1 dose; D149 for healthy cohort; at 
least 4 mos from last dose for SOTr 
who received primary series under 
EUA) 
BD-D4 
BD-D8 
14 and 21 
days after 
BD-D1 
(BD-D15, 
BD-D22) 
 
 
 
BD-D29 
BD-D59, 
BD-D89, 
BD-D119, 
BD-149 
 
 
BD-
D181 
 
Window Allowance (Days) 
- 14 days 
-2 
+3 
+3 
-3/+14 
+3 
-3/+14 
Days Since Most Recent 
Vaccination (in Part B) 
0 
3 
7 
- 
28 
- 
180 
CMI 
 
 
 
 
 
 
 
Blood for cell-mediated immunity 
analysis7 
X 
 
X 
 
 
 
 
Biomarker Assessment 
 
 
 
 
 
 
 
Blood sample for potential 
biomarker analysis8 
 
X 
 
 
 
 
 
Blood and Urine Sampling for 
Safety Assessments9 
X 
 
X 
 
X 
 
 
Recording of standard-of-care 
kidney or liver laboratory-related 
AEs10 
 
 
 
 
 
X 
X 
Dosing 
 
 
 
 
 
 
 
Study injection (including 30-
minute post-dosing observation 
period11) 
X 
 
 
 
 
 
 
Efficacy Assessment 
 
 
 
 
 
 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 181 
Visit Number 
BD-1 
BD-1a 
BD-2 
- 
BD-3 
- 
BD-4 
Type of Visit 
C 
C 
C 
SC 
C 
SC 
C 
Study Visit Day 
BD-D11 
(D205 for SOTr who received 3 
doses; D120 for SOTr who received 
1 dose; D149 for healthy cohort; at 
least 4 mos from last dose for SOTr 
who received primary series under 
EUA) 
BD-D4 
BD-D8 
14 and 21 
days after 
BD-D1 
(BD-D15, 
BD-D22) 
 
 
 
BD-D29 
BD-D59, 
BD-D89, 
BD-D119, 
BD-149 
 
 
BD-
D181 
 
Window Allowance (Days) 
- 14 days 
-2 
+3 
+3 
-3/+14 
+3 
-3/+14 
Days Since Most Recent 
Vaccination (in Part B) 
0 
3 
7 
- 
28 
- 
180 
Surveillance for COVID-
19/Unscheduled Visit12 
X 
X 
X 
X 
X 
 
X 
NP swab13 
X 
 
 
 
 
 
 
Safety Assessments 
 
 
 
 
 
 
 
Follow-up safety14 
 
 
 
X 
 
X 
 
eDiary activation for recording 
solicited ARs (7 days)15 
X 
 
 
 
 
 
 
Review of eDiary data16 
 
 
X 
 
 
 
 
Recording of unsolicited AEs 
X 
X 
X 
X 
X 
 
 
Recording of MAAEs and 
concomitant medications relevant to 
or for the treatment of the MAAE17 
X 
X 
X 
X 
X 
X 
X 
Recording of AE leading to 
withdrawal 17 
X 
X 
X 
X 
X 
X 
X 
Recording of AESIs17 
X 
X 
X 
X 
X 
X 
X 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 182 
Visit Number 
BD-1 
BD-1a 
BD-2 
- 
BD-3 
- 
BD-4 
Type of Visit 
C 
C 
C 
SC 
C 
SC 
C 
Study Visit Day 
BD-D11 
(D205 for SOTr who received 3 
doses; D120 for SOTr who received 
1 dose; D149 for healthy cohort; at 
least 4 mos from last dose for SOTr 
who received primary series under 
EUA) 
BD-D4 
BD-D8 
14 and 21 
days after 
BD-D1 
(BD-D15, 
BD-D22) 
 
 
 
BD-D29 
BD-D59, 
BD-D89, 
BD-D119, 
BD-149 
 
 
BD-
D181 
 
Window Allowance (Days) 
- 14 days 
-2 
+3 
+3 
-3/+14 
+3 
-3/+14 
Days Since Most Recent 
Vaccination (in Part B) 
0 
3 
7 
- 
28 
- 
180 
Recording of SAEs and concomitant 
medications relevant to or for the 
treatment of the SAE17 
X 
X 
X 
X 
X 
X 
X 
Recording of suspected AND 
confirmed organ transplant 
rejection17 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant 
medications and nonstudy 
vaccinations17 
X 
X 
X 
X 
X 
X 
X 
Recording of concomitant 
immunosuppressant medications18 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; BD = booster dose; C = clinic visit; D = day; eDiary = electronic diary; 
ICF = informed consent form; MAAE = medically attended AE; NP = nasopharyngeal; SAE = serious adverse event; SC = safety (phone) call; SOTr = solid organ transplant 
recipients. 
Note: In accordance with FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (DHHS 2020), investigators may convert 
study site visits to home visits or telemedicine visits with the approval of the Sponsor. 
1. 
A BD may be administered to all eligible participants who are currently enrolled in Part A or Part B provided there are no current contraindications for further dosing 
(Section Error! Reference source not found.). A participant who is currently in the Convalescent Period may come in for a BD-1 visit and receive a BD as long they 
are no longer symptomatic, and this includes the possibility for a Convalescent Visit Day 28 to overlap and be combined with a BD-1 visit. For eligible participants in 
Part A who are at least 4 months from completion of primary vaccination series who consent to receive BD, the study visit or follow-up 4 months after their last dose in 
Part A may overlap with BD-D1. In this case, a participant will need to come in for the BD-D1 visit at least 4 months after the last dose and then follow Part B. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 183 
2. 
Symptom-directed physical examination will be performed at the BD-Day 1. At visits BD-2 (BD-D29), and BD-3 (BD-D181), a symptom-directed physical examination 
may be performed at the discretion of the investigator. Any clinically significant finding identified during a study visit should be reported as a MAAE. 
3. 
On dosing day before injection, the arm receiving the injection should be examined and the associated lymph nodes should be evaluated. 
4. 
Vital signs are to be collected pre- and post-dosing (participant will be seated for at least 5 minutes before all measurements are taken per Section 7.1.4) on the day of 
injection (BD-D1). Participants who are febrile (body temperature ≥ 38.0°C/100.4°F) before dosing (BD-D1) must be rescheduled to receive the injection. Afebrile 
participants with minor illnesses can be vaccinated at the discretion of the investigator. 
5. 
The pregnancy test at the BD-1 visit will be a point-of-care urine test. At the discretion of the investigator, a pregnancy test either via blood or point-of-care urine test can 
be performed. 
6. 
Samples for immunogenicity (bAb against SARS-CoV-2 spike protein and neutralizing antibody against SARS-CoV-2) and assessment of SARS-CoV-2 bAb against the 
nonvaccine antigen (nucleocapsid protein) must be collected prior to dosing on BD-D1. 
7. 
For assessment of cellular immune response, blood samples will be collected on Day 1 (prior to dosing), and Day 8 from previously vaccinated SOT recipients (kidney or 
liver). 
8. 
All participants who chose to receive a BD. Serum sample from two ~4 mL blood draws. Biomarker plasma and biomarker serum samples will be stored for potential 
future biomarker assessment. 
9. 
Samples for safety laboratory assessments (serum creatinine, urine protein, and UPCR for kidney transplant recipients only; ALT, AST, ALP, and bilirubin for liver 
transplant recipients only) must be collected prior to dosing on BD-D1. 
10. 
After BD-D29, the investigator will review standard-of-care kidney and liver laboratory assessments and report any laboratory-related AEs and suspected or confirmed 
events of organ transplant rejection until the EOS. 
11. 
Post-dosing, participants will have a 30-minute observation period. 
12. 
An unscheduled visit may be prompted by reactogenicity issues, illness visit criteria for COVID-19, or new or ongoing AEs. If a participant meets the prespecified 
criteria of suspicion for COVID-19 (Section 7.1.6), the participants will be asked to return within 72 hours or as soon as possible to the study site for an unscheduled 
illness visit, to include an NP swab sample (for RT-PCR testing) and other clinical evaluations including blood sample collection for immunologic assessment of SARS-
Co-V2 infection (bAb against the nonvaccine antigen [nucleocapsid protein]). If a study site visit is not possible, the participant will be asked to submit a saliva sample to 
the study site by a Sponsor-approved method. At this illness visit, the NP swab samples will be collected to evaluate for the presence of SARS-CoV-2 infection. NP swab 
samples will also be tested for the presence of other respiratory pathogens. In addition, the study site may collect an additional NP sample for SARS-CoV-2 testing to be 
able to render appropriate medical care for the study participant as determined by local standards of care. Additionally, clinical information will be carefully collected to 
evaluate the severity of the clinical case. 
13. 
The NP swab sample will be collected prior to dosing on BD-D1 and used to ascertain the presence of SARS-CoV-2 via RT-PCR. 
14. 
Trained study personnel will call all participants to collect information relating to any unsolicited AEs, MAAEs (including any signs and symptoms of COVID-19), 
AESIs, AEs leading to withdrawal, SAEs, information on concomitant medications associated with those events, any nonstudy vaccinations, and any changes in 
immunosuppressant medications. 
15. 
Diary entries will be recorded by the participant at approximately 30 minutes after injection while at the study site with instruction provided by study staff. Study 
participants will continue to record entries in the eDiary each day after they leave the study site, preferably in the evening, on the day of injection and for 6 days 
following injection. If a solicited local or systemic AR continues beyond Day 7 after vaccination, the participant will be prompted to capture details of the solicited local 
or systemic AR in the eDiary until the AR resolves; capture of details of ARs in the eDiary should not exceed 28 days after vaccination. Adverse reactions recorded in 
eDiaries beyond Day 7 should be reviewed either via telephone call or at the following study visit. 
16. 
Review of eDiary will occur on BD-D8. 
17. 
All concomitant medications and nonstudy vaccinations will be recorded through 28 days after injection; all concomitant medications relevant to or for the treatment of 
an SAE, confirmed (biopsy-proven) or suspected events of organ transplant rejection, or MAAE will be recorded from BD-D1 through the final visit (BD-D181). In 
addition, for SOT participants who completed the primary vaccination series under EUA, the previous doses of the COVID-19 vaccine will be recorded in the 
participant’s eCRF regardless of the timing. 
18. All immunosuppressant medications, for 3 months prior to Screening and throughout the study. Any change in the maintenance therapy should be recorded and the 
reason for the change documented. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 184 
10.2. 
APPENDIX 2: Study Governance Considerations 
10.2.1. 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences International Ethical Guidelines. 
• Applicable ICH GCP Guidelines. 
• Applicable laws and regulatory requirements. 
• The protocol, protocol amendments, ICF, IB, and other relevant documents (eg, 
advertisements) must be submitted to an IRB by the investigator and reviewed and 
approved by the IRB before the study is initiated. 
• Any amendments to the protocol will require IRB approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an 
immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB 
− Notifying the IRB of SAEs or other significant safety findings as required by IRB 
procedures 
− Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB, European regulation 536/2014 
for clinical studies (if applicable), and all other applicable local regulations 
10.2.2. 
Study Monitoring 
Before an investigational site can enter a participant into the study, a representative of the Sponsor 
or its representatives will visit the investigational study site, onsite or remotely, to do the following: 
• Determine the adequacy of the facilities 
• Discuss with the investigator(s) and other personnel their responsibilities with regard 
to protocol adherence, and the responsibilities of the Sponsor or its representatives. 
This will be documented in a clinical study agreement between the Sponsor, the 
designated CRO, and the investigator. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 185 
According to ICH GCP guidelines, the Sponsor of the study is responsible for ensuring the proper 
conduct of the study with regard to protocol adherence and validity of data recorded on the eCRFs. 
The study monitor’s duties are to aid the investigator and the Sponsor in the maintenance of 
complete, accurate, legible, well-organized, and easily retrievable data. The study monitor will 
advise the investigator of the regulatory necessity for study-related monitoring, audits, IRB review, 
and inspection by providing direct access to the source data/documents. In addition, the study 
monitor will explain to and interpret for the investigator all regulations applicable to the clinical 
evaluation of a vaccine as documented in ICH guidelines. 
It is the study monitor’s responsibility to inspect the eCRFs and source documentation throughout 
the study to protect the rights of the participants; to verify adherence to the protocol; to verify 
completeness, accuracy, and consistency of the data; and to confirm adherence of study conduct 
to any local regulations. Details will be outlined in the Clinical Monitoring Plan. During the study, 
a monitor from the Sponsor or a representative will have regular contacts with the investigational 
site, for the following: 
• Provide information and support to the investigator(s). 
• Confirm that facilities remain acceptable. 
• Confirm that the investigational team is adhering to the protocol, that the data are 
being accurately recorded in the eCRFs, and that vaccine accountability checks are 
being performed. 
• Perform source data verification. This includes a comparison of the data in the eCRFs 
with the participant’s medical records at the hospital or practice, and other records 
relevant to the study. This will require direct access to all original records for each 
participant (eg, clinical charts or electronic medical record system). 
• Record and report any protocol deviations not previously sent. 
• Confirm that AEs and SAEs have been properly documented on eCRFs, that any 
SAEs have been forwarded to the SAE Hotline, and that those SAEs that met criteria 
for reporting have been forwarded to the IRB. 
The monitor will be available between visits if the investigator(s) or other staff need information 
or advice. Visits may occur onsite or remotely depending on the site or state’s visitation 
restrictions. 
10.2.3. 
Audits and Inspections 
The Sponsor, their designee(s), the IRB, or regulatory authorities will be allowed to conduct study 
site visits to the investigational facilities for the purpose of monitoring or inspecting any aspect of 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 186 
the study. The investigator agrees to allow the Sponsor, their designee(s), the IRB, or regulatory 
authorities to inspect the vaccine storage area, vaccine stocks, vaccine records, participant charts 
and study source documents, and other records relative to study conduct. 
Authorized representatives of the Sponsor, a regulatory authority, and any IRB may visit the study 
site to perform audits or inspections, including source data verification. The purpose of a Sponsor 
audit or inspection is to systematically and independently examine all study-related activities and 
documents to determine whether these activities were conducted and the data were recorded, 
analyzed, and accurately reported according to the protocol, ICH E6(R2) GCP, and any applicable 
regulatory requirements. The investigator should contact the Sponsor immediately if contacted by 
a regulatory agency about an inspection. 
The principal investigator must obtain IRB approval for the investigation. Initial IRB approval and 
all materials approved by the IRB for this study, including the participant consent form and 
recruitment materials, must be maintained by the investigator and made available for inspection. 
10.2.4. 
Financial Disclosure 
The investigator is required to provide financial disclosure information to allow the Sponsor to 
submit the complete and accurate certification or disclosure statements required under 
21 CFR 54. In addition, the investigator must provide the Sponsor with a commitment to promptly 
update this information if any relevant changes occur during the course of the investigation and 
for 1 year following the completion of the study. 
The Sponsor, the CRO, and the study site are not financially responsible for further testing or 
treatment of any medical condition that may be detected during the screening process. In addition, 
in the absence of specific arrangements, the Sponsor, the CRO, and the study site are not 
financially responsible for further treatment of the disease under study. 
10.2.5. 
Recruitment Procedures 
Advertisements to be used for the recruitment of study participants, and any other written 
information regarding this study to be provided to the participant, should be submitted to the 
Sponsor for approval. All documents must be approved by the IRB. 
10.2.6. 
Informed Consent Process 
The informed consent document(s) must meet the requirements of 21 CFR 50, local regulations, 
ICH guidelines, Health Insurance Portability and Accountability Act, where applicable, and the 
IRB or study site. All consent documents will be approved by the appropriate IRB. The actual ICF 
used at each study site may differ, depending on local regulations and IRB requirements. However, 
all versions of the ICF must contain the standard information found in the sample ICF provided 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 187 
by the Sponsor. Any change to the content of the ICF must be approved by the Sponsor and the 
IRB prior to the ICF being used. 
If new information becomes available that may be relevant to the participant’s willingness to 
continue participation in the study, this will be communicated to them in a timely manner. Such 
information will be provided via a revised ICF or an addendum to the original ICF. 
The investigator or his/her representative will explain the nature of the study to the participant and 
answer all questions regarding the study. 
The investigator is responsible for ensuring that the participant fully understands the nature and 
purpose of the study. Information should be given in both oral and written form whenever possible. 
No participant should be obliged to participate in the study. The participant must be informed that 
participation is voluntary. Participants must be given ample opportunity to inquire about details of 
the study. The information must make clear that refusal to participate in the study or withdrawal 
from the study at any stage is without any prejudice to the participant’s subsequent care. 
The participant must be allowed sufficient time to decide whether they wish to participate in the 
study. 
The participant must be made aware of, and give consent to, direct access to his/her source medical 
records by study monitors, auditors, the IRB, and regulatory authorities. The participant should be 
informed that such access will not violate participant confidentiality or any applicable regulations. 
The participant should also be informed that he/she is authorizing such access by signing the ICF. 
A copy of the ICF(s) must be provided to the participant. 
A participant who is rescreened is not required to sign another ICF if the rescreening occurs within 
28 days from the previous ICF signature date (within the initial Screening Period). 
The ICF will also explain that excess serum from immunogenicity testing may be used for future 
research, which may be performed at the discretion of the Sponsor to further characterize the 
immune response to SARS-CoV-2, additional assay development, and the immune response across 
CoVs. 
All participants (healthy and SOT recipients) must sign the most current site-approved ICF. 
10.2.7. 
Protocol Amendments 
No change or amendment to this protocol may be made by the investigator or the Sponsor after 
the protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) 
has (have) been agreed upon by the investigator or the Sponsor. Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the investigator and the Sponsor. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 188 
IRB approval is required prior to the implementation of an amendment, unless overriding safety 
reasons warrant immediate action, in which case the IRB(s) will be promptly notified. 
Any modifications to the protocol or the ICF, which may impact the conduct of the study, potential 
benefit of the study, or participant safety, including changes of study objectives, study design, 
participant population, sample sizes, study procedures, or significant administrative aspects, will 
require a formal amendment to the protocol. Such an amendment will be released by the Sponsor, 
agreed upon by the investigator(s), and approved by the relevant IRB(s) prior to implementation. 
A signed and dated statement that the protocol, any subsequent relevant amended documents, and 
the ICF have been approved by relevant IRB(s) must be provided to the Sponsor before the study 
is initiated. 
Administrative changes of the protocol are minor corrections and/or clarifications that have no 
effect on the way the study is to be conducted. These administrative changes will be released by 
the Sponsor, agreed upon by the investigators, and notified to the IRB(s). 
10.2.8. 
Protocol Deviations 
The noncompliance may be either on the part of the participant, the investigator, or the study site 
staff. As a result of protocol deviations, corrective actions are to be developed by the study site 
and implemented promptly. 
It is the responsibility of the study site investigator to use continuous vigilance to identify and 
report protocol deviations to the Sponsor or its designee. All protocol deviations must be addressed 
in study source documents and reported to study monitor. Protocol deviations must be sent to the 
reviewing IRB per their policies. The study site investigator is responsible for knowing and 
adhering to the reviewing IRB requirements. 
10.2.9. 
Data Protection 
Participants will be assigned a unique identifier by the Sponsor. Any participant records or datasets 
that are transferred to the Sponsor will contain the identifier only; participant names or any 
information that would make the participant identifiable will not be transferred. 
The participant must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. 
The participant must be informed that his/her medical records may be examined by clinical quality 
assurance auditors or other authorized personnel appointed by the Sponsor, by appropriate IRB 
members, and by inspectors from regulatory authorities. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 189 
Individual participant medical information obtained as a result of this study is considered 
confidential, and disclosure to third parties is prohibited. Information will be accessible to 
authorized parties or personnel only. Medical information may be given to the participant’s 
physician or to other appropriate medical personnel responsible for the participant’s well-being. 
Each participant will be asked to complete a form allowing the investigator to notify the 
participant’s primary health care provider of his/her participation in this study. 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain participant confidentiality. All records will be kept in a secure storage 
area with limited access. Clinical information will not be released without the written permission 
of the participant, except as necessary for monitoring and auditing by the Sponsor, its designee, 
the relevant regulatory authority, or the IRB. 
The investigator and all employees and coworkers involved with this study may not disclose or 
use for any purpose other than performance of the study any data, record, or other unpublished, 
confidential information disclosed to those individuals for the purpose of the study. Prior written 
agreement from the Sponsor or its designee must be obtained for the disclosure of any confidential 
information to other parties. 
10.2.10. 
Sample Retention and Future Biomedical Research 
The retention period of laboratory samples will be 20 years, or as permitted by local regulations, 
to address further scientific questions related to mRNA-1273 or antirespiratory virus immune 
response. In addition, identifiable samples can be destroyed at any time at the request of the 
participant. During the study, or during the retention period, in addition to the analysis outlined in 
the study endpoints, exploratory analysis may be conducted using other Ab-based methodologies 
on any remaining blood or serum samples, including samples from participants who are screened 
but are not subsequently enrolled. These analyses will extend the search for other potentially 
relevant biomarkers to investigate the effect of mRNA-1273, as well as to determine how changes 
in biomarkers may relate to exposure and clinical outcomes. A decision to perform such 
exploratory research may arise from new scientific findings related to the drug class or disease, as 
well as reagent and assay availability. 
10.2.11. 
Dissemination of Clinical Study Data 
The Sponsor shares information about clinical trials and results on publicly accessible websites, 
based on international and local legal and regulatory requirements, and other clinical trial 
disclosure commitments established by pharmaceutical industry associations. These websites 
include clinicaltrials.gov, EU clinical trial register (eu.ctr), as well as some national registries. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 190 
In addition, results from clinical trials are required to be submitted to peer-reviewed journals 
following internal company review for accuracy, fair balance, and intellectual property. For those 
journals that request sharing of the analyzable data sets that are reported in the publication, 
interested researchers are directed to submit their request to clinicalstudydatarequest.com. 
Individual participant data and supporting clinical documents are available for request at 
clinicalstudydatarequest.com. While making information available, the privacy of participants in 
clinical studies sponsored by the Sponsor is assured. Details on data sharing criteria and process 
for requesting access can be found at this web address: clinicalstudydatarequest.com. 
10.2.12. 
Data Quality Assurance and Quality Control 
Data collection is the responsibility of the clinical study staff at the study site under the supervision 
of the study site investigator. The investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
• All participant data relating to the study will be recorded in the eCRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The 
investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the eCRF. 
• The investigator must maintain accurate documentation (source data) that supports 
the information entered in the eCRF. 
• The investigator must permit study-related monitoring, audits, IRB review, and 
regulatory agency inspections and provide direct access to source data documents. 
• Monitoring details describing strategy (eg, risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical Risk 
Based Monitoring), methods, responsibilities, and requirements, including handling 
of noncompliance issues and monitoring techniques (central, remote, or on site 
monitoring), are provided in the Clinical Monitoring Plan. 
• The Sponsor or designee is responsible for the data management of this study, 
including quality checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals (eg, 
CRO). 
• Study monitors will perform ongoing source data verification to confirm that data 
entered into the eCRF by authorized study site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 191 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator for a period of at least 2 years after the last 
marketing application approval or, if not approved, 2 years following the 
discontinuance of the test article for investigation. If this requirement differs from any 
local regulations, the local regulations will take precedence unless the local retention 
policy is less than 2 years. No records may be destroyed during the retention period 
without the written approval of the Sponsor. No records may be transferred to another 
location or party without written notification to the Sponsor. 
Quality assurance includes all the planned and systematic actions that are established to ensure 
that the clinical study is performed and the data are generated, documented (recorded), and 
reported according to ICH GCP and local/regional regulatory standards. 
A quality assurance representative from the Sponsor or a qualified designee, who is independent 
of and separated from routine monitoring, may periodically arrange inspections/audits of the 
clinical study by reviewing the data obtained and procedural aspects. These inspections may 
include onsite inspections/audits and source data checks. Direct access to source documents is 
required for the purpose of these periodic inspections/audits. 
10.2.13. 
Data Collection and Management 
This study will be conducted in compliance with ICH CGP guidelines. This study will also be 
conducted in accordance with the most recent version of the Declaration of Helsinki. 
This study will use electronic data collection to collect data directly from the study site using 
eCRFs. The investigator is responsible for ensuring that all sections of each eCRF are completed 
promptly and correctly and that entries can be verified against any source data. 
Study monitors will perform source document verification to identify inconsistencies between the 
eCRFs and source documents. Discrepancies will be resolved in accordance with the principles of 
GCP. Detailed study monitoring procedures are provided in the Clinical Monitoring Plan. 
Adverse events will be coded with MedDRA. Concomitant medications will be coded using the 
WHO Drug Dictionary. 
10.2.14. 
Source Documents 
Source documents are original documents or certified copies and include, but are not limited to, 
eDiaries, medical and hospital records, screening logs, ICFs, telephone contact logs, and 
worksheets. Source documents provide evidence for the existence of the participant and 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 192 
substantiate the integrity of the data collected. Source documents are filed at the investigator’s 
study site. 
Data reported on the CRF or entered in the eCRF that are transcribed from source documents must 
be consistent with the source documents or the discrepancies must be explained. The investigator 
may need to request previous medical records or transfer records, depending on the study. Also, 
current medical records must be available. 
The Sponsor or its designee requires that the investigator prepare and maintain adequate and 
accurate records for each participant treated with the vaccine. Source documents, such as any 
hospital, clinic, or office charts, and the signed ICFs are to be included in the investigator’s files 
with the participant’s study records. 
10.2.15. 
Retention of Records 
The principal investigator must maintain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 
the discontinuance of the test article for investigation. If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is > 2 years. 
If it becomes necessary for the Sponsor or the regulatory authority to review any documentation 
relating to the study, the investigator must permit access to such records. No records will be 
destroyed without the written consent of the Sponsor, if applicable. It is the responsibility of the 
Sponsor to inform the investigator when these documents no longer need to be retained. 
10.2.16. 
Study and Site Closure 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IRBs, the regulatory authorities, and any CRO(s) used in the study of the reason 
for termination or suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the participants and should ensure appropriate participant 
therapy and/or follow-up. 
The Sponsor or designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. 
The investigator may initiate study site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or investigator may include, but are 
not limited to: 
• Continuation of the study represents a significant medical risk to participants 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 193 
• Failure of the investigator to comply with the protocol, the requirements of the IRB or 
local health authorities, the Sponsor’s procedures, or GCP guidelines 
• Inadequate recruitment of participants by the investigator 
• Discontinuation of further mRNA-1273 development 
Study sites will be closed upon study completion. A study site is considered closed when all 
required documents and study supplies have been collected and a study site closure visit has been 
performed. 
10.2.17. 
Publication Policy 
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. 
This allows the Sponsor to protect proprietary information and to provide comments. 
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual study site data. In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee of 
Medical Journal Editors authorship requirements. 
The clinical study plan and the results of the study will be published on www.ClinicalTrials.gov 
in accordance with 21 CFR 50.25(c). The results of and data from this study belong to the Sponsor. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 194 
10.3. 
APPENDIX 3: Contraceptive Guidance 
Adequate female contraception is defined as consistent and correct use of an FDA approved 
contraceptive method in accordance with the product label. For example: 
• Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction 
with spermicide 
• Intrauterine device 
• Prescription hormonal contraceptive taken or administered via oral (pill), transdermal 
(patch), subdermal, or IM route 
• Sterilization of a female participant’s monogamous male partner prior to entry into 
the study 
Note that periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and 
withdrawal are not acceptable methods of contraception. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 195 
10.4. 
APPENDIX 4: Toxicity Grading Scale Tables 
Table 11: Severity Grading of Laboratory Abnormalities 
Serum Chemistrya  
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially 
Life-threatening 
(Grade 4)b 
Creatinine (mg/dL) 
1.5 – 1.7 
1.8 – 2.0 
2.1 – 2.5 
> 2.5 or requires 
dialysis 
ALP; increase by factor  
1.1 – 2.0 × 
ULN 
2.1 – 3.0 × 
ULN 
3.1 – 10 × 
ULN 
> 10 × ULN 
Liver function tests – 
ALT and AST; 
increase by factor  
1.1 – 2.5 x 
ULN 
2.6 – 5.0 × 
ULN 
5.1 – 10 × 
ULN 
> 10 × ULN 
Bilirubin – when 
accompanied by any 
increase in liver 
function test; increase 
by factor  
1.1 – 1.25 × 
ULN 
1.26 – 1.5 × 
ULN 
1.51 – 1.75 × 
ULN 
> 1.75 × ULN 
Bilirubin – when liver 
function test is normal; 
increase by factor  
1.1 – 1.5 × 
ULN 
1.6 – 2.0 × 
ULN 
2.0 – 3.0 × 
ULN 
> 3.0 × ULN 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate 
aminotransferase; ULN = upper limit of the normal range. 
a The laboratory values provided in the tables serve as guidelines and are dependent upon 
institutional normal parameters. Institutional normal reference ranges should be provided to 
demonstrate that they are appropriate. 
b The clinical signs or symptoms associated with laboratory abnormalities might result in 
characterization of the laboratory abnormalities as potentially life-threatening (Grade 4). For 
example, a low sodium value that falls within a Grade 3 parameter (125 – 129 mEq/L) should 
be recorded as a Grade 4 hyponatremia event if the participant had a new seizure associated 
with the low sodium value. 
Source: Guidance for industry – Toxicity Grading Scale for Heathy Adult and Adolescent 
Volunteers Enrolled in Preventative Vaccine Clinical Trials; tables for laboratory abnormalities 
(DHHS 2007). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 196 
Table 12: Severity Grading of Vital Sign Abnormalities 
Vital Signsa  
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially 
Life-threatening 
(Grade 4)b 
Tachycardia (beats per 
minute) 
101 – 115 
116 – 130 
> 130 
ER visit or 
hospitalization 
for arrhythmia 
Bradycardia (beats per 
minute)b 
50 – 54 
45 – 49 
< 45 
ER visit or 
hospitalization 
for arrhythmia 
Hypertension (systolic) 
(mm Hg) 
141 – 150 
151 – 155 
> 155 
ER visit or 
hospitalization 
for malignant 
hypertension 
Hypertension 
(diastolic) (mm Hg) 
91 – 95 
96 – 100 
> 100 
ER visit or 
hospitalization 
for malignant 
hypertension 
Hypotension (systolic) 
(mm Hg)  
85 – 89 
80 – 84 
< 80 
ER visit or 
hospitalization 
for hypotensive 
shock 
Respiratory rate 
(breaths per minute) 
17 – 20 
21 – 25 
> 25 
Intubation 
Abbreviation: ER = emergency room. 
Note that fever is classified under systemic reactions for grading purposes. 
a Participant should be at rest for all vital sign measurements. 
b When resting heart rate is between 60 – 100 beats per minute. Use clinical judgment when 
characterizing bradycardia among some healthy participant populations, for example, 
conditioned athletes. 
Source: Guidance for industry – Toxicity Grading Scale for Heathy Adult and Adolescent 
Volunteers Enrolled in Preventative Vaccine Clinical Trials; tables for clinical abnormalities 
(DHHS 2007). 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 197 
10.5. 
APPENDIX 5: Adverse Event of Special Interest Terms 
Investigators should report all events which fall into the following categories as an AESI per the 
reporting processes specified in Section 7.5.5. The AESIs in Table 13 are medical concepts that 
may be related to COVID-19 or are of interest in COVID-19 vaccine safety surveillance. Even if 
any of these events occur in the setting of a COVID infection, the event should still be reported as 
an AESI, if it is one of the medical concepts in Table 13. 
Table 13: Adverse Events of Special Interest 
Medical Concept 
Additional Notes 
Anosmia, Ageusia 
• New onset COVID associated or idiopathic events 
without other etiology excluding congenital etiologies 
or trauma 
Subacute thyroiditis 
• Including but not limited to events of: atrophic 
thyroiditis, autoimmune thyroiditis, immune-mediated 
thyroiditis, silent thyroiditis, thyrotoxicosis, and 
thyroiditis 
Acute pancreatitis 
 
• Including but not limited to events of: autoimmune 
pancreatitis, immune-mediated pancreatitis, ischemic 
pancreatitis, edematous pancreatitis, pancreatitis, acute 
pancreatitis, hemorrhagic pancreatitis, necrotizing 
pancreatitis, viral pancreatitis, and subacute pancreatitis 
• Excluding known etiologic causes of pancreatitis 
(alcohol, gallstones, trauma, recent invasive procedures) 
Appendicitis  
• Include any event of appendicitis  
Rhabdomyolysis 
• New onset rhabdomyolysis without known etiology 
such as excessive exercise or trauma 
Acute respiratory distress 
syndrome (ARDS) 
• Including but not limited to new events of ARDS and 
respiratory failure.  
Coagulation disorders 
• Including but not limited to thromboembolic and 
bleeding disorders, disseminated intravascular 
coagulation, pulmonary embolism, and deep vein 
thrombosis  
Acute cardiovascular injury 
• Including but not limited to myocarditis, pericarditis, 
microangiopathy, coronary artery disease, arrhythmia, 
stress cardiomyopathy, heart failure, or acute 
myocardial infarction 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 198 
Medical Concept 
Additional Notes 
Acute kidney injury 
• Include events with idiopathic or autoimmune etiologies 
• Exclude events with clear alternate etiology (trauma, 
infection, tumor, or iatrogenic causes such as 
medications or radiocontrast etc) 
• Include all cases that meet the following criteria 
o Increase in serum creatinine by ≥ 0.3 mg/dL 
(≥ 26.5 µmol/L) within 48 hours; 
OR 
o Increase in serum creatinine to ≥ 1.5 times 
baseline, known or presumed to have 
occurred within prior 7 days 
OR 
o Urine volume ≤ 0.5 mL/kg/hour for 6 hours 
Acute liver injury 
• Include events with idiopathic or autoimmune etiologies 
• Exclude events with clear alternate etiology (trauma, 
infection, tumor, etc) 
• Include all cases that meet the following criteria: 
o > 3-fold elevation above the upper normal 
limit for ALT or AST 
OR 
o > 2-fold elevation above the upper normal 
limit for total serum bilirubin or gamma 
glutamyltransferase or ALP 
Dermatologic findings  
• Chilblain-like lesions 
• Single organ cutaneous vasculitis 
• Erythema multiforme 
• Bullous rashes 
• Severe cutaneous adverse reactions including but not 
limited to: Stevens-Johnson Syndrome (SJS), Toxic 
Epidermal Necrolysis (TEN), Drug Reaction with 
Eosinophilia and Systemic Symptoms (DRESS) and 
fixed-drug eruptions 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 199 
Medical Concept 
Additional Notes 
Multisystem inflammatory 
disorders  
• Multisystem inflammatory syndrome in adults (MIS-A) 
• Multisystem inflammatory syndrome in children (MIS-
C) 
• Kawasaki’s disease 
Thrombocytopenia 
• Platelet counts < 150 × 109 
• Including but not limited to immune thrombocytopenia, 
platelet production decreased, thrombocytopenia, 
thrombocytopenic purpura, thrombotic 
thrombocytopenic purpura, or hemolysis, elevated liver 
enzymes, low platelet count syndrome 
Acute aseptic arthritis 
 
• New onset aseptic arthritis without clear alternate 
etiology (eg, gout, osteoarthritis, and trauma) 
New onset of or worsening of 
neurologic disease 
• Including but not limited to: 
o Guillain-Barre Syndrome 
o Acute disseminated encephalomyelitis 
o Peripheral facial nerve palsy (Bell’s palsy) 
o Transverse myelitis 
o Encephalitis/Encephalomyelitis 
o Aseptic meningitis 
o Febrile seizures 
o Generalized seizures/convulsions 
o Stroke (hemorrhagic and nonhemorrhagic) 
o Narcolepsy 
Anaphylaxis  
• Anaphylaxis as defined per protocol 
• Follow reporting procedures per protocol 
Other syndromes 
• Fibromyalgia 
• Postural Orthostatic Tachycardia Syndrome 
• Chronic Fatigue Syndrome (includes myalgic 
encephalomyelitis and Post-Viral Fatigue Syndrome) 
• Myasthenia gravis 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 200 
10.6. 
APPENDIX 6: Protocol Amendment History 
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents. 
10.6.1. 
Amendment 3: 23 Aug 2021 
Amendment 3, 23 Aug 2021 
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Main Rationale for the Amendment 
The main rationale for this amendment is to enroll participants who had a kidney or liver solid 
organ transplant (SOT) who previously received 2 doses of mRNA-1273 outside of the study in 
order for them to receive a third dose as part of the study. 
The Summary of Changes table provided below describes the major changes made in 
Amendment 3 relative to Protocol Amendment 2, including the sections modified and the 
corresponding rationales. The synopsis of Amendment 3 has been modified to correspond to 
changes in the body of the protocol. Minor grammar and formatting corrections were made 
throughout the document to enhance clarity and readability (which did not affect the conduct of 
the study). 
Summary of Changes in Protocol Amendment 3 
Section # and Name 
Description of Change 
Brief Rationale 
Title Page, Protocol 
Approval Page, 
Protocol Amendment 
Summary of Changes, 
and Header 
Updated protocol version and 
date. 
Added Protocol Amendment 
Summary of Changes for 
Amendment 3 and moved the 
Summary of Changes for 
Amendment 2 to Appendix 6: 
Protocol Amendment History.  
To reflect the new version and 
date of protocol.  
Section 1.1 Study 
Rationale and 
Section 3.2 Scientific 
Rationale for Study 
Design 
Added recently published studies 
to this section. 
To reflect the most recent 
published literature. 
Section 1.2.2 Clinical 
Studies 
Added a summary of the 
ongoing clinical studies in the 
program. 
 
To align with the current IB. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 201 
Section # and Name 
Description of Change 
Brief Rationale 
Added a reference to the 
investigator’s brochure for the 
latest safety and efficacy data. 
Section 2 Objectives 
and Endpoints 
The primary immunogenicity 
endpoint: neutralizing antibody 
(nAb) titers for 3-dose regimen 
was moved from a secondary 
endpoint to a primary endpoint 
and was also modified to include 
assessment of immunogenicity 
from both solid organ transplant 
(SOT) recipients previously 
vaccinated with 2 doses of 
Moderna COVID-19 vaccine 
under EUA and unvaccinated 
participants). 
 
Reactogenicity in the primary 
objective was separated out from 
the safety objective. 
 
Additional secondary endpoints 
were included to reflect the new 
arm. 
To implement the analysis of the 
new arm (participants who had an 
SOT who previously received 
2 Moderna COVID-19 vaccine 
doses). 
Section 2 Objectives 
and Endpoints 
Day 85 timepoint (dose 3) was 
added for nAb and binding 
antibody (bAb) geometric mean 
titer (GMT) and geometric mean 
fold rise (GMFR) assessments in 
the secondary endpoints (for 
unvaccinated SOT recipients 
who receive the 3-dose regimen). 
To enable longitudinal assessment 
of changes in nAb and bAb GMT 
and GMFR relative to dose 3 for 
unvaccinated SOT recipients who 
receive the 3-dose regimen. Blood 
sample collection for 
immunogenicity assessments are 
already being collected for 
Day 85. 
Section 3.1 General 
Study Design 
Added a table to represent the 
study arms and doses. 
To increase clarity in the study 
arms. 
Section 3.1 (General 
Design), 
Section 3.1.1.2 
(Treatment Period and 
Follow-up Period), 
US participants only stipulation 
for cell-mediated immunity 
exploratory assessments was 
removed. 
To simplify the protocol because 
this will be a US only study. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 202 
Section # and Name 
Description of Change 
Brief Rationale 
Section 7.4 Exploratory 
Assessments), and 
Section 10.1 
(Appendix 1: Schedule 
of Events – Table 6 and 
Table 7) 
Section 4 Study 
Population 
Removed sites in South America 
and Europe. 
To reflect the appropriate location 
of the study sites. 
Section 4.1.1 Inclusion 
Criteria for Transplant 
Recipients 
Updated Inclusion Criterion 1 to 
specifically state unvaccinated or 
previously vaccinated 
participants. 
Updated Inclusion Criterion 4 to 
clarify that previously vaccinated 
SOT recipients need to agree to 
continue adequate contraception 
“through 3 months following the 
third dose (Day 1).” 
To reflect new amendment to 
enroll SOT recipients who were 
previously vaccinated with 
2 doses of Moderna COVID-19 
vaccine. 
Section 4.2.1 Inclusion 
Criteria for Healthy 
Adults 
Updated Inclusion Criterion 1 to 
include a clarification that 
“unvaccinated” healthy 
participants are eligible to 
participate in the study. 
To clarify that the intent of 
Inclusion Criterion 1 for healthy 
adults is to enroll unvaccinated 
participants. 
Section 7.5.4.1 
Anaphylaxis 
Moved anaphylaxis to 
Section 7.5.5 Adverse Events of 
Special Interest. 
To improve clarity. 
Section 8.4.1 Interim 
Analyses 
Added into the interim analysis 
assessment of immunogenicity 
28 days after dose 3 for 
previously vaccinated SOT 
recipients. 
To implement the analysis of the 
new arm (participants who had an 
SOT who previously received 
2 Moderna COVID-19 vaccine 
doses). 
Section 8.4.1 Interim 
Analyses 
Removed the second interim 
analysis and added text regarding 
the possibility for another 
analysis. 
To include the possibility for 
another analysis. 
Section 9 (References) 
Updated reference list. 
To support the text added to the 
protocol. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 203 
Section # and Name 
Description of Change 
Brief Rationale 
Section 10.1 
Appendix 1 Schedule 
of Events Table 6 
Deleted “eDiary activation for 
recording solicited ARs 
(7 days)” at Day 57. 
To correct an error in the 
protocol. 
Section 10.1 
Appendix 1 Schedule 
of Events Table 6 
Moved the healthy participant 
statement for cell immune 
response (Footnote 13) from 
Table 7 to Table 6. 
To correct an error in the 
protocol. 
Section 10.1 
Appendix 1 Schedule 
of Events Table 7 
Added Footnotes “2” and “3” to 
Day 85 and Day 113. 
For “Days Since Most Recent 
Injection” for Day 85, changed 
from “0” to “Day 56/0”. 
Changed “42” to 42+” For Days 
Since Most Recent Injection. 
To improve clarity. 
Section 10.1 
Appendix 1 Schedule 
of Events Table 7 
Added “X” to Day 113 for the 
Convalescent visit. 
To correct an error in the 
protocol. 
Section 10.1 
Appendix 1 Schedule 
of Events Table 6, 
Table 7, and Table 8 
Separated lymph node 
assessment out of the physical 
examination footnote so it has its 
own row in each table 
To improve clarity. 
Global 
The protocol was updated 
throughout to include an 
additional arm in the study in 
order to enroll participants who 
had an SOT (kidney or liver) 
who previously received 
2 Moderna COVID-19 vaccine 
doses so they can receive a third 
vaccine dose. 
To reflect the new arm 
(participants who had an SOT 
who previously received 
2 Moderna COVID-19 vaccine 
doses). 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 204 
10.6.2. 
Amendment 2: 28 Jul 2021 
Amendment 2, 28 Jul 2021: 
This amendment was considered to be substantial based on the criteria set forth in Article 10(a) 
of Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Main Rationale for the Amendment: The main rationale for this amendment was to increase 
awareness of possible cases and to add a case definition for myocarditis and pericarditis as well 
as guidance for reporting and assessing suspected cases for this study, given the recent reports in 
the Emergency Use Authorization (EUA) experience of cases with a temporal association 
between COVID-19 messenger RNA (mRNA) vaccine administration and signs and symptoms 
of myocarditis and pericarditis. 
The Summary of Changes table provided below describes the major changes made in 
Amendment 2 relative to Protocol Amendment 1, including the sections modified and the 
corresponding rationales. The synopsis of Amendment 2 has been modified to correspond to 
changes in the body of the protocol. Minor grammar and formatting corrections were made 
throughout the document to enhance clarity and readability, and new references were added in 
support of the definition of myocarditis and pericarditis (which did not affect the conduct of the 
study). 
Summary of Changes in Protocol Amendment 2 
Section # and Name 
Description of Change 
Brief Rationale 
Title Page, Protocol 
Approval Page, 
Protocol Amendment 
Summary of Changes, 
and header 
Updated protocol version and 
date. 
Added Protocol Amendment 
Summary of Changes for 
Amendment 2 and moved the 
Summary of Changes for 
Amendment 1 to Appendix 6: 
Protocol Amendment History.  
Updated to reflect new version 
and date of protocol.  
Section 1.3.2 (Risks to 
Study Participants and 
Risk Mitigation) 
Added paragraph on rare reports 
of myocarditis and pericarditis 
occurring after vaccination with 
Moderna coronavirus disease 
2019 (COVID-19) vaccine under 
Emergency Use Authorization in 
adults 18 years and older. 
To reflect addendum made to 
Investigator’s Brochure. 
Section 3.1 (General 
Design), 
Section 3.1.1.2 
(Treatment Period and 
Removal of 1:1 enrollment of 
kidney and liver SOT recipients 
such that the study can enroll 
kidney or liver SOT recipients 
Site projections show higher 
number of kidney SOT recipients 
to liver SOT recipients (2:1). It 
should improve odds of enrolling 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 205 
Section # and Name 
Description of Change 
Brief Rationale 
Follow-up Period), 
Section 5.2 
(Randomization and 
Stratification), 
Section 7.4 Exploratory 
Assessments), 
Section 8.1 (Sample 
Size), and Section 10.1 
(Appendix 1: Schedule 
of Events – Table 6) 
until the 220 sample size cap is 
reached. 
quicker if the equal split for 
enrollment is eliminated. 
Section 3.1 (General 
Design - Figure 2) and 
Section 10.1 
(Appendix 1: Schedule 
of Events – Table 6) 
 
The Day 85 timepoint was added 
to describe blood sample 
collection for immunogenicity 
and assessment of Ab against 
nonvaccine antigen. 
 
Schedule of Events was 
corrected by adding ‘Blood for 
immunogenicity and assessment 
of Ab against nonvaccine 
antigen” at Day 85.  
To correct inconsistency in the 
protocol. Those participants 
receiving the 3-dose regimen 
should have blood drawn for 
immunogenicity and assessment 
of Ab against nonvaccine on the 
day of the third vaccination prior 
to dosing as stated in footnote 11 
of Table 6, protocol synopsis, and 
protocol Section 3.1. 
Section 3.1 (General 
Design), 
Section 3.1.1.2 
(Treatment Period and 
Follow-up Period), 
Section 7.4 Exploratory 
Assessments), and 
Section 10.1 
(Appendix 1: Schedule 
of Events – Table 5 and 
Table 6) 
US participants only stipulation 
was added to describe the cell-
mediated immunity exploratory 
assessments. 
To accurately reflect which sites 
will collect CMI exploratory 
assessments. 
Section 4 (Study 
Population) 
Changed the number of sites 
from “15-20” to “~20” sites. 
To accurately reflect the number 
of sites.  
Section 4.1.1 (Inclusion 
Criteria for Transplant 
Recipients) 
The inclusion criteria for 
transplant recipients were 
previously misnumbered, with a 
duplicate #2 and duplicate #3. 
Numbering was corrected to #1 
through #7. 
To correct an error in numbering. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 206 
Section # and Name 
Description of Change 
Brief Rationale 
Section 4.1.2 
(Exclusion Criteria for 
Transplant Recipients)  
The exclusion criteria for 
transplant recipients were 
previously misnumbered, 
skipping # 2 and #3. Numbering 
was corrected to #1 through #10. 
To correct an error in numbering. 
Section 4.2.2 
(Exclusion Criteria for 
Healthy Adults) 
The exclusion criteria for healthy 
adults were previously 
misnumbered, with a duplicate 
#4. Numbering was corrected to 
#1 through #10. 
To correct an error in numbering. 
Section 5.3.4 (Study 
Vaccine Packaging and 
Labeling) 
Added “or 8.0-mL” after 
“6.3-mL” 
To reflect the current fill volume 
options. 
Section 7.5.5 (Adverse 
Event of Special 
Interest)  
Added CDC case definitions for 
myocarditis and pericarditis. 
To provide guidance to the 
investigators regarding assessing 
and reporting myocarditis and 
pericarditis for this study 
population. 
Section 7.6.2 (Internal 
Safety Committee and 
Study Pause Rules) 
The study pause rules were 
clarified as follows: 
• Grade 3 systemic allergic 
reaction was intended to have 
the same severity grading of 
“severe” as stated in 
Section 7.5.9 of the protocol; 
therefore, “Grade 3” was 
modified to “severe” to 
maintain consistency of terms 
in the protocol. 
• “Definitely or possibly 
related” was intended to have 
the same causality assessment 
of “related” as stated in 
Section 7.5.10 of the protocol; 
therefore, “definitely or 
possibly related” was 
modified to “related” to 
To clarify that Grade 3 systemic 
allergic reaction was intended to 
have the same severity grading of 
“severe” as stated in protocol 
Section 7.5.9 Assessment of 
Severity. 
 
To clarify that “definitely or 
possibly related” was intended to 
have the same causality category 
of “related” as stated in protocol 
Section 7.5.10 Assessment of 
Causality. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 207 
Section # and Name 
Description of Change 
Brief Rationale 
maintain consistency of terms 
in the protocol. 
• Reactogenicity was described 
more clearly to include 
solicited local and systemic 
reactogenicity; therefore, 
“solicited local or systemic” 
was added. 
• Grade 4 AE was clarified to 
refer to the “laboratory and 
vital sign abnormalities per 
Section 10.4, Appendix 4”; 
therefore, a clarificatory 
sentence in parenthesis 
“(laboratory and vital sign 
abnormalities per 
Section 10.4, Appendix 4 
reported as AEs by the 
investigator)” was added to 
avoid confusion. 
Section 7.6.3 
(Independent Cardiac 
Event Adjudication 
Committee) 
Added Section 7.6.3, 
Independent Cardiac Event 
Adjudication Committee. 
To describe the proposed 
mechanism to assess risk of 
myocarditis and pericarditis in the 
study population (to address 
CBER request to describe how 
risk of myocarditis and 
pericarditis will be assessed in the 
study population receiving 
mRNA-1273). 
Section 8.4.1 (Interim 
Analyses) 
Added the following: A second 
interim analysis describing 
safety and immunogenicity data 
1 month after dose 3 may also be 
performed. 
To include the possibility for 
another interim analysis. 
Section 9 (References) 
Updated reference list. 
To support the text added to the 
protocol for myocarditis and 
pericarditis. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 208 
Section # and Name 
Description of Change 
Brief Rationale 
Section 10.1 
(Appendix 1: Schedule 
of Events – Table 5) 
Table 5 Schedule of Events was 
corrected by removing the 
pregnancy test at Day 57. 
Vital signs were separated out 
from the physical examination 
row. 
A pregnancy test is not warranted 
as there is no vaccine dose given 
at this visit. 
To ensure vital signs were not 
missed. 
Section 10.1 
(Appendix 1: Schedule 
of Events – Table 6) 
Participants Who Receive the 
3-Dose Regimen on Day 57, 
Study Visit #5, was corrected by 
removing an X for eDiary 
activation. 
 
 
 
Vital signs were separated out 
from the physical examination 
row. 
To correct an error in the 
protocol. There is no need to 
activate eDiaries at this visit as no 
vaccine dose is given at this visit. 
The next timepoint for eDiaries 
for those receiving the 3-dose 
regimen is at Day 85, Study 
Visit #6. 
To ensure vital signs were not 
missed. 
 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 209 
10.6.3. 
Amendment 1: 18 Jun 2021 
Overall Rationale for the Amendment 
The main purpose of this amendment was to change the design so that all the participants who are 
solid organ transplant (SOT) recipients will be offered the opportunity to receive a third dose of 
100 µg mRNA-1273 vaccine on Day 85. 
In addition, Amendment 1 incorporated 2 points from the Protocol Clarification Memorandum of 
15 April 2021: 
• Exclusion criterion #7 is modified to specify that the history of donor-specific 
antibody be clinically relevant according to the investigator’s judgment 
• Specified the number of kidney transplant recipients, liver transplant recipients, and 
healthy controls whose blood would be sampled for assessment of cellular immune 
response. In addition, due the addition of a third dose, the number of sampling days 
for cellular immune response is increased to three (Day 1, Day 36, and Day 92); and 
the number of transplant recipients (55 liver and 55 kidney) and healthy participants 
(20) with blood sample collection for evaluation of cellular immune response is 
increased. 
The Summary of Changes table provided below describes the major changes made in Amendment 
1 relative to the original protocol, including the sections modified and the corresponding rationales. 
The synopsis of Amendment 1 has been modified to correspond to changes in the body of the 
protocol. Minor grammar and formatting corrections were made throughout the document to 
enhance clarity and readability, and new references were added in support of the study rationale 
(which did not affect the conduct of the study) 
Summary of Major Changes in Protocol Amendment 1: 
Section # and Name 
Description of Change 
Brief Rationale 
Title Page, Protocol 
Approval Page, and 
Protocol Amendment 
Summary of Changes 
Updated protocol version and date. 
Added Protocol Amendment 
Summary of Changes.  
Updated to reflect new 
version and, date of 
protocol. A Protocol 
Summary of Changes 
section was added to be in 
line with Moderna 
guidelines. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 210 
Section # and Name 
Description of Change 
Brief Rationale 
Protocol Synopsis and 
Section 2 (Objectives and 
Endpoints) 
The primary safety and 
reactogenicity objective was revised 
to specify the evaluation of safety 
and reactogenicity of both a 2-dose 
and a 3-dose regimen of mRNA-
1273 vaccine. 
To implement the analysis 
of the new, 3-dose 
vaccination regimen. 
Protocol Synopsis and 
Section 2 (Objectives and 
Endpoints) 
The primary immunogenicity 
objective was revised to reflect a 
singular time point (Day 57). 
To evaluate a singular 
primary immunogenicity 
objective.  
Protocol Synopsis and 
Section 2 (Objectives and 
Endpoints) 
A new secondary objective was 
added, “To evaluate serum 
neutralizing antibody (nAb) 
responses to a third dose of 100 µg 
mRNA-1273.” 
 
A new secondary endpoint was 
added, “The geometric mean titer 
(GMT) value of SARS-CoV-2- 
specific nAb level at Day 113.” 
To implement the analysis 
of the new, 3-dose 
vaccination regimen. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 211 
Section # and Name 
Description of Change 
Brief Rationale 
Protocol Synopsis and 
Section 2 (Objectives and 
Endpoints) 
The secondary objectives to evaluate 
the persistence of the immune 
response to 100 µg mRNA-1273 
assessed by binding antibody (bAb) 
and nAb levels were revised to add 
evaluation of 3 doses of 100 µg 
mRNA-1273 through 1 year after 
dose 3. 
 
Secondary endpoints were revised to 
add, “The geometric mean (GM) 
value of anti-SARS-CoV-2 S-
specific bAb on Day 1, Day 29 (1 
month after dose 1), Day 57 (1 
month after dose 2), Day 113 (1 
month after dose 3), Day 265 (6 
months after dose 3), and Day 450 
(1 year after dose 3) 
Geometric mean fold rise (GMFR) 
of bAb relative to Day 1 on Day 29 
(1 month after dose 1), Day 57 (1 
month after dose 2), Day 113 (1 
month after dose 3), Day 265 (6 
months after dose 3), and Day 450 
(1 year after dose 3)”. 
To implement the analysis 
of the new, 3-dose 
vaccination regimen. 
Protocol Synopsis and 
Section 2 (Objectives and 
Endpoints) 
Secondary endpoints for solid organ 
transplant (SOT) recipients 
evaluating the incidence of 
asymptomatic SARS-CoV-2 
infection and coronavirus disease 
2019 (COVID 19), and the changes 
in liver and renal function and 
immunosuppressant medications 
after vaccination with mRNA-1273 
were revised to include endpoints 
after the third dose in addition to the 
endpoints after the second dose.  
To implement the analysis 
of the new, 3-dose 
vaccination regimen. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 212 
Section # and Name 
Description of Change 
Brief Rationale 
Protocol Synopsis and 
Section 2 (Objectives and 
Endpoints) 
Exploratory endpoints measuring T-
cell and B-cell responses by flow 
cytometry in a subset of participants 
were revised to increase the number 
of sampling days to three (Day 1, 
Day 36, and Day 92), to clarify the 
subset of participants as SOT 
recipients who receive 3 doses of 
mRNA-1273. 
To implement the analysis 
of the new, 3-dose 
vaccination regimen. 
Protocol Synopsis and 
Section 3.1 (General 
Design), 3.1.1 (Study 
Periods), 3.1.1.2 
(Treatment Period and 
Follow-up Period), 5.3.2 
(Administration of Study 
Vaccine), 10.1 
(APPENDIX 1: 
Schedules of Events) 
The General Design, Study Periods, 
Treatment Period and Follow-up 
Period, Administration of Study 
Vaccine, and schedules of events 
were updated to include participants 
who receive the 3-dose vaccine 
regimen. An additional schedule of 
events was added for the 3-dose 
regimen. 
To implement the addition 
of a 3-dose vaccination 
regimen. 
Protocol Synopsis and 
4.1.1 (Inclusion Criteria 
for Transplant Recipients) 
Inclusion criterion #2 was modified 
to specify that receipt of chronic 
immunosuppressive therapy for the 
prevention of allograft rejection be 
for a minimum of 6 months before 
signing consent. 
For consistency with 
inclusion criterion #1 
which specifies enrollment 
of kidney or a liver (single 
organ) transplant recipient 
who is at least 6 months 
after transplantation at the 
time of consent. 
Protocol Synopsis and 
4.1.2 (Exclusion Criteria 
for Transplant Recipients)  
Exclusion criterion #7 was modified 
to specify that the history of donor-
specific antibody be clinically 
relevant according to the 
investigator’s judgment. 
To clarify the intent of 
exclusion criterion #7. 
Protocol Synopsis and 7.4 
(Exploratory 
Assessments) 
Specified the number of kidney 
transplant recipients (55), liver 
transplant recipients (55), and 
healthy controls (20) whose blood 
would be sampled for assessment of 
cellular immune response. In 
addition, due the addition of a third 
dose, the number of sampling days 
for cellular immune response is 
increased to three (Day 1, Day 36, 
and Day 92). 
Amended the number of 
participants whose blood 
would be sampled and 
implemented the addition 
of a 3-dose vaccination 
regimen. 

ModernaTX, Inc. 
20 Dec 2021 
Protocol mRNA-1273-P304 Amendment 4 
mRNA-1273 
 
Confidential 
 
Page 213 
Section # and Name 
Description of Change 
Brief Rationale 
Protocol Synopsis and 
Section 7.6.2 (Internal 
Safety Committee and 
Study Pause Rules) 
Added a description of the internal 
safety team (IST) and added study 
pause rules to monitor safety and 
reactogenicity of 3-dose regimen in 
SOT recipients: 
Reactogenicity: Two Grade 4 
reactogenicities that are definitely or 
possibly related to the vaccine 
Hypersensitivity: Five SOT 
recipients, experiencing a Grade 3 
systemic allergic reaction that is 
definitely or possibly related to the 
vaccine 
Adverse Event: Three SAEs or 
Grade 4 AEs that are definitely or 
possibly related to the vaccine 
Fatal Outcome: One death that is 
definitely or possibly related to the 
vaccine. 
To describe the IST and 
study pause rules. 
Section 10.1 (Table 6) 
and Section 10.2.6 
Added an informed consent form to 
be completed by SOT participants 
who agree to receive a third dose of 
vaccine. 
To implement the addition 
of a 3-dose vaccination 
regimen. 
 

Signature Page for VV-CLIN-002168 v6.0
Signature Page for VV-CLIN-002168 v6.0
Approval
21-Dec-2021 23:25:54 GMT+0000
Approval
22-Dec-2021 14:11:06 GMT+0000
Approval
23-Dec-2021 20:49:38 GMT+0000
Approval
29-Dec-2021 17:05:19 GMT+0000
Approval
03-Jan-2022 17:24:55 GMT+0000
CCI
CCI
CCI
CCI
CCI