A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants
Phase: PHASE2
Conditions: SARS-CoV-2
Sponsor: ModernaTX, Inc.

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
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CLINICAL STUDY PROTOCOL 
Protocol Title: 
A Phase 2/3 Study to Evaluate the Immunogenicity and Safety 
of mRNA Vaccine Boosters for SARS-CoV-2 Variants 
Protocol Number: 
mRNA-1273-P205 
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: 19745 
Amendment Number  
11 
Date of Amendment 11 
10 Oct 2023 
Date of Amendment 10 
23 Mar 2023 
Date of Amendment 9 
30 Sep 2022 
Date of Amendment 8 
01 Aug 2022 
Date of Amendment 7 
26 Apr 2022 
Date of Amendment 6 
17 Mar 2022 
Date of Amendment 5 
10 Feb 2022 
Date of Amendment 4 
04 Jan 2022 
Date of Amendment 3 
15 Sep 2021 
Date of Amendment 2 
26 Jul 2021 
Date of Amendment 1 
23 Jun 2021 
Date of Original Protocol 
21 May 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 Pharmaceuticals for Human Use, E6(R2) Good 
Clinical Practice (GCP) Guidance. 
NCT #: NCT04927065
PPD
PPD
PPD

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
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PROTOCOL APPROVAL – SPONSOR SIGNATORY  
Study Title: 
A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of 
mRNA Vaccine Boosters for SARS-CoV-2 Variants 
Protocol Number: 
mRNA-1273-P205 
Amendment Number: 
11 
Date of Amendment: 
10 Oct 2023 
 
Protocol accepted and approved by: 
 
 
 
See eSignature and date signed on 
last page of the document 
 
 
 
 
 
 
ModernaTX, Inc. 
200 Technology Square 
Cambridge, MA 02139 
Telephone: 
 
 
Date 
 
 
PPD
PPD
PPD

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
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DECLARATION OF INVESTIGATOR  
I have read and understood all sections of the protocol entitled “A Phase 2/3 Study to Evaluate 
the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants” and the 
most recent version of the mRNA-1273 Investigator’s Brochure (IB). 
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 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. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE  
DOCUMENT HISTORY 
Document 
Date 
Amendment 11 
10 Oct 2023 
Amendment 10 
23 Mar 2023 
Amendment 9 
30 Sep 2022 
Amendment 8 
01 Aug 2022 
Amendment 7 
26 Apr 2022 
Amendment 6 
17 Mar 2022 
Amendment 5 
10 Feb 2022 
Amendment 4 
04 Jan 2022 
Amendment 3 
15 Sep 2021 
Amendment 2 
26 Jul 2021 
Amendment 1 
23 Jun 2021 
Original Protocol 
21 May 2021 
Amendment 11, 10 Oct 2023: Current Amendment 
This amendment is considered to be non-substantial because it neither impacts the safety or 
physical/mental integrity of participants nor the scientific value of the study. 
Overall Rationale for Amendment 11: 
The main purpose of this amendment is to update the Clinical Study Protocol (CSP) in 
accordance with the updated FDA guidance on emergency use authorization for vaccines to 
prevent COVID-19 (FDA 2022). 
The immunogenicity objectives and endpoints outlined in the CSP amendment 10 are no longer 
applicable. Therefore, these objectives and endpoints were removed from the CSP. 
The amendment also removes the antibody response comparisons between different vaccines 
because each modified vaccine targets a specific VOC that is no longer in circulation. Hence, 
comparing antibody responses between such vaccines is deemed not clinically meaningful or 
relevant. 
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 Summary of Changes. 
The Medical Monitor was changed. 
Updated to reflect the 
Medical Monitor Personnel, 
and changes within the body 
of the protocol amendment. 
Protocol Synopsis 
Changes made based on the revisions in 
the body of the protocol amendment. 
Updated to reflect the 
changes within the body of 
the protocol amendment 

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mRNA-1273-P205 Protocol Amendment 11 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1: Study 
Rationale; Section 2.0: 
Objectives and Endpoints; 
Section 3.1: General 
Design; Section 7.2: 
Immunogenicity 
Assessments; Section 8.2: 
Statistical Hypotheses; 
Section 8.3: Sample Size 
Determination; 
Section 8.5.3: 
Immunogenicity Analyses; 
Section 8.5.5 Exploratory 
Analyses for Parts A.1, B, 
C, and D 
Removed the following objectives and 
endpoints, related to immunogenicity: 
• 
Primary antibody response of a 
single booster dose against 
variants contained in the vaccine 
compared to the antibody 
response against ancestral 
SARS-CoV-2 after mRNA-1273 
priming series (mRNA-1273-
P301 [COVE] study). 
• 
Secondary antibody response 
comparisons between booster 
dose against variants and 
priming series of mRNA-1273 
against ancestral SARS-CoV-2. 
• 
Exploratory antibody response 
comparisons between booster 
dose against virus variants and 
priming series of mRNA-1273 
against the same variants. 
• 
Exploratory antibody response 
comparisons between booster 
vaccines against same viral 
strains. 
Added the exploratory objectives and 
endpoints related to the immune 
response generated by 
mRNA-1273.211, mRNA-1273, 
mRNA-1273.617.2, and 
mRNA-1273.213 booster dose against 
the original SARS-CoV-2 virus and 
different variants, at selected 
timepoints. 
Also removed corresponding sections 
related to these endpoints in the 
statistical methods, sample size 
calculation, immunogenicity 
assessments and analyses and 
exploratory analyses. Section 8.5.5 
Subgroup Analyses was added in the 
place of Section 8.5.5 Exploratory 
Analyses. 
Removed the 
immunogenicity objectives 
and endpoints that are no 
longer applicable for the 
immunogenicity assessment 
based on updated FDA 
guidance on modified 
vaccine. 
 
Removed the antibody 
response comparisons 
between different vaccines 
because each modified 
vaccine targets a specific 
VOC that is no longer in 
circulation. Hence, 
comparing antibody 
responses between such 
vaccines is deemed not 
clinically meaningful or 
relevant. 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 8.4: Analysis Sets 
The Modified Intent-to-Treat (mITT) 
Set was removed. 
Per-Protocol (PP) Set for 
Immunogenicity was renamed to Per-
Protocol Immunogenicity Set (PPIS) 
and will be used as the primary analysis 
set for Parts A.1, B, C, D and J. 
PP Set for Immunogenicity –  
SARS-CoV-2 negative (PPSI-Neg) was 
renamed to PP Immunogenicity Set–
SARS-CoV-2 negative (PPIS-Neg) and 
will be the primary analysis set for 
analyses of immunogenicity for Parts 
A.2, F (Cohort 1), F (Cohort 2), G, and 
H. 
To clarify analysis set to be 
used for immunogenicity 
analysis. 
Section 8.5.3: 
Immunogenicity Analyses 
for Part J 
ANCOVA model used to compare 
antibody response between treatment 
arms was removed 
Removed statistical 
comparisons because there is 
no hypothesis testing between 
two treatment groups. 
 

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
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PROTOCOL SYNOPSIS  
Name of Sponsor/Company: ModernaTX, Inc. 
Name of Investigational Product: mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, 
mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, 
and mRNA-1273.231 for injection 
Name of Active Ingredient: mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-
1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and 
mRNA-1273.231 
Protocol Title: A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA 
Vaccine Boosters for SARS-CoV-2 Variants  
Protocol Number: mRNA-1273-P205 
Study Period (years): Approximately 12 months 
Phase of Development: Phase 2/3 
Estimated Date First Participant Enrolled: May 2021 
Estimated Date Last Participant Completed: Dec 2023 
Total Number of Sites: Approximately 25 sites in the United States or its territories 
Objectives and Endpoints: 
This study consists of 9 parts: A (1, 2), B, C, D, E, F, G, H, and J. The objectives and 
endpoints in each part are described in the tables below; Part E objectives and endpoints are 
described in a site-specific protocol amendment and are not covered in this global protocol 
amendment. 
Part A.1: 50 µg mRNA-1273.211 and 100 µg mRNA-1273.211 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity 
of mRNA-1273.211 
• 
Solicited local and systemic reactogenicity 
adverse reactions (ARs) during a 7-day 
follow-up period after vaccination 
• 
Unsolicited adverse events (AEs) during the 
28-day follow-up period after vaccination 
• 
Serious AEs (SAEs), medically attended AEs 
(MAAEs), AEs leading to withdrawal and AEs 
of special interest (AESI) from Day 1 to end of 
study (EoS) 
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.211 at selected timepoints 
post boost 
• 
Immune response of mRNA-1273.211 against 
ancestral SARS-CoV-2 and SARS-CoV-2 
variants including B.1.351 at selected timepoint 
post boost by GMT, GMFR and SRR 

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• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
Centers for Disease Control (CDC) criteria: 
the presence of one of the CDC-listed 
symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive reverse transcriptase 
polymerase chain reaction (RT-PCR) test 
on a respiratory sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Part A.2: Second booster dose 50 µg mRNA-1273.214: Participants who received mRNA-
1273.211 50 µg as a first booster dose in Part A.1 
Objectives 
Endpoints 
Primary 
• 
To evaluate the immunogenicity of 
mRNA-1273.214 (50 µg) as a second 
booster dose in participants who 
previously received a first booster dose 
of mRNA-1273.211 (50 µg) 
• 
GMT ratio and SRR difference of 
mRNA-1273.214 (50 µg) as a second booster 
dose against the ancestral SARS-CoV-2 and 
against SARS-CoV-2 variants (including 
Omicron) compared to mRNA-1273.211 (50 µg) 
against the ancestral SARS-CoV-2 and against 
SARS-CoV-2 variants as the first booster dose 
(Day 29, Day 181)  
• 
To assess the safety and reactogenicity 
of the mRNA-1273.214 (50 µg) given as 
a second booster dose in participants 
who previously received a first booster 
dose of mRNA-1273.211 (50 µg) 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS 
Secondary 
• 
To evaluate the immunogenicity of 
mRNA-1273.214 (50 µg) as a second 
• 
Antibody response of the mRNA-1273.214 
(50 µg) against the ancestral SARS-CoV-2 and 

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booster dose in participants who 
previously received a first booster dose 
of mRNA-1273.211 (50 µg) 
against SARS-CoV-2 variants (including 
Omicron) by GMT and SRR at multiple time 
points after the mRNA-1273.214 booster dose 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment 
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 isolates to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Part B: 100 µg mRNA-1273 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity 
of mRNA-1273 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273 at selected timepoints post 
boost 
• 
Immune response of mRNA-1273 against the 
ancestral SARS-CoV-2 and against SARS-
CoV-2 variants at selected timepoints post boost 
by GMT, GMFR, and SRR 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 

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Part C: 50 µg mRNA-1273.617.2 and 100 µg mRNA-1273.617.2 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity 
of mRNA-1273.617.2 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.617.2 at selected 
timepoints post boost 
• 
Immune response of mRNA-1273.617.2 against 
the ancestral SARS-CoV-2 and against 
SARS-CoV-2 variants including B.1.617.2 at 
selected timepoints post boost by GMT, GMFR, 
and SRR 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 

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− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Part D: 50 µg mRNA-1273.213 and 100 µg mRNA-1273.213 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity 
of mRNA-1273.213 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.213 at selected timepoints 
post boost 
• 
Immune response of mRNA-1273.213 against 
the ancestral SARS-CoV-2 and against 
SARS-CoV-2 variants including B.1.351 and 
B.1.617.2 at selected timepoints post boost 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment 
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 

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sequence 
vaccine sequence 
Part F - Cohort 1: 50 µg mRNA-1273.529: Participants who previously received 100 µg 
mRNA-1273 primary series and have not received a mRNA-1273 booster dose 
previously. 
Objectives 
Endpoints 
Primary 
• 
To demonstrate non-inferiority of the 
antibody response against the Omicron 
variant (B.1.1.529) of a first booster 
dose of mRNA-1273.529 compared to a 
first booster dose of mRNA-1273 
(50 µg) based on GMT ratio and SRR 
difference 
• 
To demonstrate superiority of the 
antibody response against the Omicron 
variant (B.1.1.529) of a first booster 
dose of mRNA-1273.529 compared to a 
first booster dose of mRNA-1273 
(50 µg) based on GMT ratio. 
• 
Day 29 post boost GMT ratio of Omicron-
specific GMT of mRNA-1273.529 over the 
Omicron-specific GMT of mRNA-1273 
(historical mRNA-1273 booster dose control) 
• 
Day 29 SRR difference between 
mRNA-1273.529 against Omicron and 
mRNA-1273 against Omicron 
• 
To evaluate the safety and reactogenicity 
of mRNA-1273.529 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Secondary 
• 
To evaluate the immunogenicity of a 
mRNA-1273.529 dose compared to a 
mRNA-1273 administered as a first 
booster dose at selected timepoints post 
boost 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the Omicron variant at 
selected timepoint post boost 
• 
SRR difference between mRNA-1273.529 
against the Omicron variant and mRNA-1273 
against the Omicron variant 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the ancestral SARS-CoV-2 
and other variants at selected timepoints post 
boost 
• 
SRR difference between mRNA-1273.529 
against the ancestral SARS-CoV-2 and other 
variants and mRNA-1273 against the ancestral 
SARS-CoV-2 and other variants 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 

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− Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− Secondary case definition based on the CDC 
criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
− Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
• 
To characterize the cellular immune 
response of the mRNA-1273.529 
booster dose against the ancestral 
SARS-CoV-2 and against variants 
• 
T-cell and B-cell response after the 
mRNA-1273.529 booster 
Part F - Cohort 2: Second booster dose 50 µg mRNA-1273.529 or 50 µg mRNA-1273 
dose: Participants who previously received 100 µg mRNA-1273 primary series and a 
booster dose of 50 µg mRNA-1273 
Objectives 
Endpoints 
Primary 
• 
To demonstrate non-inferiority of the 
antibody response against the Omicron 
variant (B.1.1.529) of a second booster 
dose of mRNA-1273.529 compared to a 
second booster dose of mRNA-1273 
(50 µg) based on GMT ratio and SRR 
difference 
• 
To demonstrate superiority of the 
antibody response against the Omicron 
variant (B.1.1.529) of a second booster 
dose of mRNA-1273.529 compared to a 
second booster dose of mRNA-1273 
(50 µg) based on GMT ratio 
• 
Day 29 postboost GMT ratio of Omicron-
specific GMT of mRNA-1273.529 over the 
Omicron-specific GMT of mRNA-1273 
• 
Day 29 SRR difference between 
mRNA-1273.529 against Omicron and 
mRNA-1273 against Omicron 

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• 
To evaluate the safety and 
reactogenicity of mRNA-1273.529 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Secondary 
• 
To evaluate the immunogenicity of 
mRNA-1273.529 booster compared to 
mRNA-1273 booster administered as a 
second booster dose at selected 
timepoints post boost 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the Omicron variant at 
selected timepoints post boost 
• 
SRR difference between mRNA-1273.529 
against the Omicron variant and mRNA-1273 
against the Omicron variant 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the ancestral SARS-CoV-2 
and other variants at selected timepoints post 
boost 
• 
SRR difference between mRNA-1273.529 
against the ancestral SARS-CoV-2 and other 
variants and mRNA-1273 against the ancestral 
SARS-CoV-2 and other variants 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 

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• 
To characterize the cellular immune 
response of mRNA-1273.529 as a 
booster against SARS-CoV-2 and other 
variants 
• 
T-cell and B-cell response after the 
mRNA-1273.529 booster 
Part G: Second booster dose 50 µg mRNA-1273.214: Participants who received 100 µg 
mRNA-1273 primary series and a booster dose of 50 µg mRNA-1273 
Objectives 
Endpoints 
Primary  
• 
To demonstrate non-inferiority of the 
antibody response of a second booster 
dose of mRNA-1273.214 compared to 
mRNA-1273 (50 µg) when administered 
as a second booster dose against the 
Omicron variant (B.1.1.529) based on 
GMT ratio and SRR difference at 
Day 29 or Day 91 
• 
To demonstrate superiority of the 
antibody response of a second booster 
dose of mRNA-1273.214 compared to 
mRNA-1273 (50 µg) administered as a 
second booster dose against the 
Omicron variant (B.1.1.529) based on 
GMT ratio at Day 29 or Day 91  
• 
To demonstrate non-inferiority of the 
antibody response of a second booster 
dose of mRNA-1273.214 compared to 
mRNA-1273 (50 µg) when administered 
as a second booster dose against the 
ancestral SARS-CoV-2 based on GMT 
ratio at Day 29 or Day 91 
• 
GMT ratio of Omicron-specific GMT of 
mRNA-1273.214 over the Omicron-specific 
GMT of mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273) at Day 29 and Day 91 
• 
SRR difference between mRNA-1273.214 
against Omicron variant and mRNA-1273 
against Omicron variant at Day 29 and Day 91 
• 
GMT ratio of ancestral SARS-CoV-2 GMT of 
mRNA-1273.214 over ancestral SARS-CoV-2 
GMT of mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273) at Day 29 and Day 91 
• 
To evaluate the safety and 
reactogenicity of mRNA-1273.214 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Key Secondary 
• 
To demonstrate non-inferiority based 
on the SRR against ancestral SARS-
CoV-2 of a second booster dose of 
mRNA-1273.214 compared to a second 
booster dose of mRNA-1273 (50 µg) at 
Day 29 or Day 91 
• 
SRR difference between mRNA-1273.214 
against ancestral SARS-CoV-2 and mRNA-1273 
against ancestral SARS-CoV-2 at Day 29 and 
Day 91 
Secondary 
• 
To evaluate the immunogenicity of 
• 
GMT ratio of mRNA-1273.214 and 

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mRNA-1273.214 booster compared to 
mRNA-1273 booster administered as a 
second booster dose at selected 
timepoints post boost 
mRNA-1273 against the Omicron variant at 
selected timepoints post boost 
• 
SRR difference between mRNA-1273.214 
against the Omicron variant and mRNA-1273 
against the Omicron variant at selected 
timepoints post boost 
• 
GMT ratio of mRNA-1273.214 and 
mRNA-1273 against ancestral SARS-CoV-2 and 
other variants at selected timepoints post boost 
• 
SRR difference between mRNA-1273.214 
against ancestral SARS-CoV-2 and other 
variants and mRNA-1273 against ancestral 
SARS-CoV-2 and other variants at selected 
timepoints post boost 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
• 
To characterize the cellular immune 
response of mRNA-1273.214 as a 
booster against SARS-CoV-2 and other 
variants 
• 
T-cell and B-cell response after the 
mRNA-1273.214 booster 
Part H: Second booster dose of 50 µg mRNA-1273.222  
Objectives 
Endpoints 
Primary  

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• 
To demonstrate non-inferiority of the 
antibody response of a second booster 
dose of mRNA-1273.222 50 µg 
compared to mRNA-1273 50 µg when 
administered as a second booster dose 
against Omicron BA.4/5 based on GMT 
ratio and SRR difference at Day 29 
• 
To demonstrate superiority of the 
antibody response of a second booster 
dose of mRNA-1273.222 compared to 
mRNA-1273 (50 µg) administered as a 
second booster dose against the 
Omicron BA.4/5 based on GMT ratio at 
Day 29 
• 
To demonstrate non-inferiority of the 
antibody response of mRNA-1273.222 
50 µg compared to mRNA-1273 50 µg 
when administered as a second booster 
dose against the ancestral SARS-CoV-2 
D614G based on GMT ratio and SRR 
difference at Day 29 
• 
GMT ratio of Omicron BA.4/5 GMT of 
mRNA-1273.222 over the Omicron BA.4/5 
GMT of mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273) at Day 29 
• 
SRR difference between mRNA-1273.222 
against Omicron BA.4/5 and mRNA-1273 
against Omicron BA.4/5 at Day 29 
• 
GMT ratio of the ancestral SARS-CoV-2 D614G 
GMT of mRNA-1273.222 over the ancestral 
SARS-CoV-2 D614G GMT of mRNA-1273 at 
Day 29 
• 
SRR difference between mRNA-1273.222 and 
mRNA-1273 against the ancestral SARS-CoV-2 
D614G at Day 29 
• 
To evaluate the safety and 
reactogenicity of mRNA-1273.222 
50 µg 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after injection 
• 
Unsolicited AEs during the 28-day follow-up 
period after injection 
• 
SAEs, MAAEs, AEs leading to withdrawal, and 
AESI from Day 1 to EoS 
Secondary 
• 
To evaluate the immunogenicity of 
mRNA-1273.222 50 µg as a second 
booster dose against the ancestral 
SARS-CoV-2 (and other variants) 
compared to a second booster dose of 
mRNA-1273 50 µg at selected 
timepoints post boost 
• 
GMT ratio of mRNA-1273.222 50 µg and 
mRNA-1273 50 µg against ancestral 
SARS-CoV-2 (and other variants) at selected 
timepoints post boost 
• 
SRR difference between mRNA-1273.222 50 µg 
and mRNA-1273 50 µg against ancestral 
SARS-CoV-2 and variants of concern at selected 
timepoints post boost 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of 1 of the 
CDC-listed symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 

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and a positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
antinucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Part J - Booster dose of mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg): 
Participants who previously received a primary series of mRNA vaccine, a first booster 
dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA 
vaccine against SARS-CoV-2 
Objectives 
Endpoints 
Primary  
• 
To evaluate the immunogenicity of 
mRNA-1273.815 (50 µg) and 
mRNA-1273.231 (50 µg) against 
SARS-CoV-2 Omicron BA.4/BA.5, 
BQ.1.1, and XBB.1.5 subvariants at 
Day 15 and Day 29 
• 
Antibody response of mRNA-1273.815 (50 µg) 
and mRNA-1273.231(50 µg) against 
SARS-CoV-2 Omicron BA.4/BA.5, BQ.1.1, 
and XBB.1.5 subvariants by GMT, geometric 
mean fold rise (GMFR), and SRR at Day 15 and 
Day 29 
• 
To evaluate the safety and 
reactogenicity of mRNA-1273.815 
(50 µg) and mRNA-1273.231 (50 µg) 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after injection 
• 
Unsolicited AEs during the 28-day follow-up 
period after injection 
• 
SAEs, MAAEs, AEs leading to withdrawal, and 
AESI from Day 1 to Day 181 (EoS) 
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.815 (50 µg) and mRNA-
1273.231 (50 µg) against SARS-CoV-2 
variants at selected timepoints  
• 
Antibody response of mRNA-1273.815 (50 µg) 
and mRNA-1273.231(50 µg) against 
SARS-CoV-2 variants by GMT, GMFR, and 
SRR at selected timepoints  
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− Secondary case definition based on the CDC 
criteria: the presence of 1 of the CDC-listed 
symptoms 
(https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html) 
and a positive RT-PCR test on a respiratory 

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sample 
− Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
antinucleocapsid antibody after a negative 
test at time of enrollment  
Overall Study Design: 
This is an open-label, Phase 2/3 study to evaluate the immunogenicity, safety, and 
reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, 
mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and 
mRNA-1273.231 administered as booster doses. 
Part A.1 
Part A.1 will evaluate the immunogenicity, safety, and reactogenicity of 2 dose levels of the 
mRNA-1273.211 vaccine candidate when administered as a single booster dose to adult 
participants of the mRNA-1273-P301 (COVE) study who have previously received 2 doses of 
mRNA-1273 as a primary series. Two dose levels (50 or 100 µg total mRNA content) of the 
mRNA-1273.211 booster will be evaluated in this study. Enrollment will begin with the 
mRNA-1273.211 50 µg dose arm, followed by the enrollment of the mRNA-1273.211 100 µg 
dose arm. See the Investigator’s Brochure (IB) for further details. 
Part A.2 
Part A.2 will evaluate the immunogenicity, safety, and reactogenicity of the mRNA-1273.214 
vaccine candidate when administered as a second booster dose to adult participants of the 
mRNA-1273-P205 study who have previously received 2 doses of mRNA-1273 as a primary 
series and a first booster dose of 50 µg of the mRNA-1273.211 in Part A.1 of this study. 
Part B 
Part B will evaluate the immunogenicity, safety, and reactogenicity of the mRNA-1273 
vaccine when administered as a single booster dose to adult participants of the 
mRNA-1273-P301 (COVE) study who have previously received 2 doses of mRNA-1273 as a 
primary series. Enrollment of Part B will begin upon completion of enrollment of Part A.1 of 
the study. See the IB for further details. 
Part C 
Part C will evaluate the immunogenicity, safety, and reactogenicity of 2 dose levels (50 or 
100 µg) of the mRNA-1273.617.2 vaccine when administered as a single booster dose to 
adults who have previously received 2 doses of mRNA-1273 as a primary series in Study 
mRNA-1273-P301 (COVE) or under the Emergency Use Authorization (EUA). Enrollment of 
Part C 100 µg dose level will begin upon completion of enrollment of Part B of the study. 
Enrollment of the 50-µg dose arm will begin after completion of the 100 µg dose level arm in 
both Part C and Part D. See the IB for further details. 
Part D 
Part D will evaluate the immunogenicity, safety, and reactogenicity of 2 dose levels (50 or 
100 µg) of the mRNA-1273.213 vaccine when administered as a single booster dose to adults 
who have previously received 2 doses of mRNA-1273 as a primary series in Study 
mRNA-1273-P301 (COVE) or under the EUA. Enrollment of Part D 50 µg dose level arm will 
begin upon completion of enrollment of Part C 100µg dose level arm of the study. Part D 

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50 µg dose arm enrollment will begin after completion of the 100µg dose arm enrollment and 
may run in parallel with Part C 50 µg dose arm enrollment. See the IB for further details. 
Part E 
Part E consists of a group described in a site-specific protocol amendment and will not be 
discussed in this global protocol amendment. 
Part F 
Part F will consist of 2 cohorts: Cohort 1 – adults who have previously received 2 doses of 
mRNA-1273 as primary series and Cohort 2- adults who have previously received 2 doses of 
100 µg mRNA-1273 as a primary series and a single booster dose of 50 µg mRNA-1273, in 
Study mRNA-1273-P301 (COVE) or under the EUA. 
Cohort 1 will evaluate the immunogenicity, safety, and reactogenicity of 50 µg of the 
mRNA1273.529 vaccine candidate when administered as a single booster dose to adults who 
have previously received 2 doses of mRNA-1273 as a primary series. 
Cohort 2 will evaluate the immunogenicity, safety and reactogenicity of 50 µg of the 
mRNA-1273.529 and of 50 µg of the mRNA-1273 vaccine candidate when administered as a 
second booster dose to adults who have previously received 2 doses of 100 µg mRNA-1273 as 
a primary series and a single booster dose of 50 µg mRNA-1273. 
Enrollment of the mRNA-1273.529 Cohort 1 will run in parallel with the mRNA-1273.529 in 
Cohort 2. Enrollment of the 50-µg mRNA-1273 arm in Cohort 2 will begin upon completion 
of enrollment of the mRNA-1273.529 Cohort 2 arm and may run in parallel with the 
enrollment of the mRNA-1273.529 Cohort 1 arm. For Cohort 1, the results of the 
mRNA1273.529 vaccine candidate administered as a booster will be compared to the 
immunogenicity induced after a booster dose of mRNA-1273 from the external historical 
comparator arm (details will be provided in statistical analysis plan [SAP]). For Cohort 2, the 
results of the mRNA-1273.529 vaccine candidate administered as the second booster dose will 
be compared to the immunogenicity induced after the second booster dose of mRNA-1273. 
Part G 
Enrollment of the mRNA-1273.214 50 µg second boost arm will begin upon completion of 
enrollment of the mRNA-1273 50 ug arm in Cohort 2 of Part F. Enrollment of the 
mRNA-1273.214 50 µg second boost arm may run in parallel with the enrollment of the 
mRNA-1273.529 Cohort 1 arm of Part F. Part G will evaluate the immunogenicity, safety, and 
reactogenicity of 50 µg of the mRNA1273.214 vaccine candidate when administered as a 
second booster dose to adults who have previously received 2 doses of 100 µg mRNA-1273 as 
a primary series and a single booster dose of 50 µg mRNA-1273. The results of the 
mRNA-1273.214 vaccine candidate administered as the second booster dose will be compared 
to the immunogenicity induced after the second booster dose of mRNA-1273 (Part F, 
Cohort 2, 50 µg mRNA-1273). 
Part H 
Part H will evaluate the immunogenicity, safety, and reactogenicity of 50 µg of the 
mRNA-1273.222 vaccine candidate when administered as a second booster dose to adults who 
have previously received 2 doses of 100 µg mRNA-1273 as a primary series and a single 
booster dose of 50 µg mRNA-1273. The immunogenicity of the mRNA-1273.222 candidate 
administered as the second booster dose will be compared to the immunogenicity of the 
second booster dose of mRNA-1273 (Part F, Cohort 2, 50 µg mRNA-1273). 

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Part J 
Part J of the study will evaluate immunogenicity, safety, and reactogenicity of 
mRNA-1273.815 (50 µg) and mRNA-1273.231 (50 µg) administered as a booster to adults 
who previously received a primary series of mRNA vaccine, a first booster dose of a 
monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against 
SARS-CoV-2. Participants will be randomized in a 1:1 ratio to receive either mRNA-1273.815 
(50 µg) or mRNA-1273.231 (50 µg). 
Overall, study Parts A.1, B, C, and D will assess antibody response of a single booster dose of 
the mRNA vaccines in each study. 
Study Part F Cohort 1 will assess whether a single booster dose of the mRNA-1273.529 as the 
first booster dose elicits a similar or superior antibody response to the B.1.1.529 compared to a 
single booster dose of mRNA-1273, using an external historical comparator; Study Part F 
Cohort 2 will assess whether a single booster dose of the mRNA-1273.529 as a second booster 
dose elicits a similar or superior antibody response to the B.1.1.529 compared to a single 
booster dose of mRNA-1273 as a second booster dose.  
Study Part G will assess whether a single booster dose of the mRNA-1273.214 as a second 
booster dose elicits a similar or superior antibody response to the B.1.1.529 compared to a 
single booster dose of mRNA-1273 as a second booster dose (Part F, Cohort 2, 50 µg 
mRNA-1273). 
Study Part A.2 will evaluate the immunogenicity, safety, and reactogenicity of the 
mRNA-1273.214 vaccine candidate when administered as a second booster dose to 
participants who rolled over from Part A.1. 
Study Part H will assess whether a single booster dose of the mRNA-1273.222 50 µg as a 
second booster dose elicits a superior antibody response against Omicron BA.4/5 compared to 
a single booster dose of mRNA-1273 as a second booster dose (Part F, Cohort 2, 50 µg 
mRNA-1273). 
Part J will evaluate whether mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg) 
administered as a booster will elicit antibody response against Omicron subvariants 
BA.4/BA.5, and XBB.1.5 in adults who previously received a primary series of mRNA 
vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a 
bivalent mRNA vaccine against SARS-CoV-2. 
Study Arms 
Study Part 
Study Arm 
Dose1 
N 
Part A.1 
mRNA-1273.211 
50 µg 
~300 
mRNA-1273.211 
100 µg 
~584 
Part A.22 
mRNA-1273.214 
50 µg 
~300 
Part B 
mRNA-1273 
100 µg 
~300 
Part C 
mRNA-1273.617.2 
50 µg 
~584 
mRNA-1273.617.2 
100 µg 
~584 
Part D 
mRNA-1273.213 
50 µg 
~584 
mRNA-1273.213 
100 µg 
~584 
Part F (Cohort 1) 
mRNA-1273.529 
50 µg 
~375 
Part F (Cohort 2) 
mRNA-1273.529 
50 µg 
~375 

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mRNA-1273 
50 µg 
~375 
Part G 
mRNA-1273.214 
50 µg 
~375 
Part H (2nd booster) 
mRNA-1273.222 
50 µg 
~500 
Part J (3rd booster)3, 4 
mRNA-1273.815 
50 µg 
~50 
mRNA-1273.231 
50 µg 
~50 
1. Dose is total mRNA. 
2. Participants rolled over from Part A.1 to Part A.2. 
3. Participants may be rolled over from Part H. 
4. Participants will be randomized in a 1:1 ratio to receive either mRNA-1273.815 or mRNA-1273.231. 
Participants in Parts A.1, B, C, D, F, and G will have up to 7 visits; 6 visits if screening and 
dosing are performed on the same day. Study vaccine (mRNA-1273.211, mRNA-1273, 
mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, or mRNA-1273.214) will be 
administered as a single dose on Day 1. Additional safety and/or immunogenicity study visits 
will occur on Days 15, 29, 91 (Parts F and G only), 181, and 366 (EoS). Study visits will 
include scheduled safety phone calls at Day 8, every 2 weeks from Day 43 to Day 169 and 
from Day 209 to Day 349 to collect AEs, MAAEs, AESI, AEs leading to withdrawal, SAEs, 
pregnancies, and information about concomitant medications and receipt of non-study 
vaccinations.  
Participants in Part A.1 who choose to continue in Part A.2 will have 6 additional visits; 5 if 
screening and dosing are performed on the same day. Study vaccine (mRNA-1273.214 
[50 µg]) will be administered as a single dose on Day 1. Additional safety and/or 
immunogenicity study visits will occur on Days 15, 29, 91, and 181 (EoS). Study visits will 
include scheduled safety phone calls at Day 8, and every 2 weeks from Day 43 to Day 169 to 
collect AEs, MAAEs, AESI, AEs leading to withdrawal, SAEs, pregnancies, and information 
about concomitant medications and receipt of non-study vaccinations. 
Participants in Part H will have up to 6 visits; 5 visits if screening and dosing are performed on 
the same day. Study vaccine (mRNA-1273.222 [50 µg]) will be administered as a single dose 
on Day 1. Additional safety and/or immunogenicity study visits will occur on Days 15, 29, 91, 
and 181(EoS). Study visits will include scheduled safety phone calls at Day 8, and every 
2 weeks from Day 43 to Day 169 to collect AEs, MAAEs, AESI, AEs leading to withdrawal, 
SAEs, pregnancies, and information about concomitant medications and receipt of non-study 
vaccinations. 
Participants in Part J may include participants who have previously participated in Part H of 
this study. Participants in Part J will have up to 6 visits; 5 visits if screening and dosing are 
performed on the same day. Study vaccine (mRNA-1273.815 or mRNA-1273.231) will be 
administered as a single dose on Day 1. Additional safety and/or immunogenicity study visits 
will occur on Days 15, 29, 91, and 181 (EoS). Study visits will include scheduled safety phone 
calls at Day 8, and every 2 weeks from Day 43 to Day 169 to collect AEs, MAAEs, AESI, 
AEs leading to withdrawal, SAEs, pregnancies, and information about concomitant 
medications and receipt of non-study vaccinations. For participants who have previously 
participated in Part H of this study, the total number of visits completed in the study overall 
will be 10-12 depending on whether screening and dosing are performed on the same day. 
At the dosing visit on Day 1, participants will be instructed how to document and report 
solicited ARs within a provided electronic diary (eDiary). Solicited ARs will be assessed for 
7 days (the day of injection and the following 6 days), and unsolicited AEs will be assessed for 

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28 days after injection; SAEs, MAAEs, AEs leading to withdrawal, pregnancies, and AESI 
will be assessed throughout the study. All participants will be tested for the presence of 
SARS-CoV-2 antibodies at baseline and at Day 29 (primary immunogenicity endpoint). 
Participants in Part J will also be tested for the presence of SARS-CoV-2 antibodies at Day 15 
(primary immunogenicity endpoint). Additional blood draws will be collected on Day 91 
(Parts A.2, F, G, H, and J only), Day 181, and Day 366 (Parts A.1, B, C, D, F, and G only). In 
addition, active surveillance for intercurrent or breakthrough SARS-CoV-2 infection will 
occur throughout the study and reported as AEs (confirmed symptomatic infections will be 
reported as MAAEs if not SAEs). Participants with signs and symptoms meeting the CDC 
case definition for COVID-19 (21 Feb 2021 or most recent 
[https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html]) will be 
asked to contact the site and undergo prompt assessment which will include RT-PCR testing 
(of a respiratory sample) to assess symptomatic COVID-19. Participants with any clinical or 
radiographic evidence of pneumonia will also undergo RT-PCR testing. Suspected COVID-19 
cases will also be tested using a multiplex assay to assess for non–SARS-CoV-2 causes of 
upper or lower respiratory tract infection. Participants will have blood samples collected at 
scheduled study site visits during the study for immunogenicity assessments or other medical 
concerns according to the investigator’s judgment. 
Participants may experience AEs, to include symptoms of COVID-19, that necessitate an 
unscheduled visit. There may also be situations in which the investigator asks a participant to 
report for an unscheduled visit following the report of an AE. 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 should be completed for each unscheduled visit. 
In addition, participants may have blood samples collected at unscheduled visits for acute 
respiratory symptoms. 
Peripheral blood mononuclear cells (PBMCs) may be collected for a subset of participants at 
selected sites at baseline (Day 1) and at Days 15, 29, and 91 to characterize the T-cell and 
B-cell responses against SARS-CoV-2 and variants. 
Participants will be enrolled to receive 50 or 100 µg dose of mRNA-1273.211 (Part A.1), 
100 µg mRNA-1273 (Part B), 50 or 100 µg mRNA-1273.617.2 (Part C), 50 or 100 µg 
mRNA-1273.213 (Part D), 50 µg mRNA-1273.529 or 50 µg mRNA-1273 (Part F), 50 µg 
mRNA-1273.214 (Part G and Part A.2), 50 µg mRNA-1273.222 (Part H), or 50 µg 
mRNA-1273.815 or 50 µg mRNA-1273.231 (Part J). The interim analysis will be conducted 
based on safety and immunogenicity data collected through Day 15 or Day 29. The interim 
analysis may be conducted either after all participants in Parts A.1, A.2, B, C, D, F, G, H, or J 
have completed their Day 15 or Day 29 visit assessments and/or subsequent timepoint visits 
(eg, Day 91 for Parts F, G, and H) or combined after the last participant in any of the study 
parts (Parts A.1, A.2, B, C, D, F, G, H, or J) or dose arm, or pre-specified subset of dose arm 
has completed their Day 15 or Day 29 visit assessments. The final study analysis after 
12 months of follow-up will be completed for all participants in Parts A.1, B, C, D, F, and G. 
The final study analysis after 6 months of follow-up will be completed for all participants in 
Parts A.2, H, and J. 
Safety Oversight: No safety monitoring committee or data safety monitoring board is planned 
for this study. 

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Safety monitoring for this study will include study team members, inclusive of, at a minimum, 
the Sponsor medical monitor, Sponsor safety physician (from Pharmacovigilance), and 
contract research organization medical monitor. The study team will conduct ongoing safety 
reviews during the study and will be responsible to monitor for safety concerns during the 
study as described in the Safety Management Plan. 
An independent cardiac event adjudication committee 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.  
Study Duration: Approximately 12 months for each participant in Parts A.1, B, C, D, F, and 
G. Approximately 6 months for each participant in Parts A.2, H, and J. 
Number of Participants: 
Part A.1: 
Approximately 300 participants will receive a single booster dose of mRNA-1273.211 50 µg, 
to achieve 270 evaluable participants in the 50-µg dose study arm. Approximately 
584 participants will receive a single booster dose of mRNA-1273.211 100 µg, to achieve 
526 evaluable participants in the 100-µg study arm. 
Part A.2 
Approximately 300 participants will receive a second booster dose of mRNA-1273.214 50 µg. 
Part B: 
Approximately 300 participants will receive a single booster dose of mRNA-1273 100 µg, to 
achieve 270 evaluable participants in Part B of the study. 
Part C: 
Approximately 584 participants will receive a single booster dose of mRNA-1273-617.2 
50 µg, to achieve 526 evaluable participants in the 50 µg dose study arm. Approximately 
584 participants will receive a single booster dose of mRNA-1273.617.2 100 µg, to achieve 
526 evaluable participants in the 100 µg dose study arm. 
Part D: 
Approximately 584 participants will receive a single booster dose of mRNA-1273.213 50 µg, 
to achieve 526 evaluable participants in the 50-µg dose study arm. Approximately 
584 participants will receive a single booster dose of mRNA-1273.213 100 µg, to achieve 
526 evaluable participants in the 100-µg dose study arm. 
Part F: 
Cohort 1: 
Approximately 375 participants will receive a single booster dose of mRNA-1273.529 50 µg, 
to achieve 300 evaluable participants in the 50-µg dose study arm. 
Cohort 2: 
Approximately 375 participants will receive a second booster dose of mRNA-1273.529 50 µg. 
In addition, approximately 375 participants will receive a second booster dose of mRNA-1273 
50 µg to achieve 300 evaluable participants in each arm (sequential enrollment for the 
2 groups in Cohort 2). 
Part G: 
Approximately 375 participants will receive a second booster dose of mRNA-1273.214 50 µg, 
to achieve 300 evaluable participants in mRNA-1273.214 50 µg arm. 

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Part H: 
Approximately 500 participants will receive a second booster dose of mRNA-1273.222 50 µg 
to achieve 300 evaluable participants. 
Part J: 
Approximately 100 participants will be randomized in a 1:1 ratio to receive a single booster 
dose of mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg). 
Study Eligibility Criteria 
Inclusion Criteria: 
Each participant must meet all of the following criteria to be enrolled in this study: 
1. Male or female, at least 18 years of age at the time of consent (Screening Visit). 
2. Investigator’s assessment that participant understands and is willing and physically 
able to comply with protocol-mandated follow-up, including all procedures. 
3. Participant has provided written informed consent for participation in this study, 
including all evaluations and procedures as specified in this protocol. 
4. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal 
ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as 
amenorrhea for ≥ 12 consecutive months prior to screening [Day 0] without an 
alternative medical cause). A follicle-stimulating hormone level may be measured at 
the discretion of the investigator to confirm postmenopausal status. 
5. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all of the following criteria: 
• Has a negative pregnancy test on the day of vaccination (Day 1). 
• Has practiced adequate contraception or has abstained from all activities that could 
result in pregnancy for at least 28 days prior to Day 1. 
• Has agreed to continue adequate contraception through 3 months following 
vaccination. 
• Is not currently breastfeeding. 
Adequate female contraception is defined as consistent and correct use of a Food and 
Drug Administration (FDA)-approved contraceptive method in accordance with the 
product label. 
6. Participant must have been either previously enrolled in the mRNA-1273-P301 
(COVE) study, must have received 2 doses of mRNA-1273 in that study, with his/her 
second dose at least 6 months prior to enrollment in mRNA-1273-P205, and must be 
currently enrolled and compliant in that study (ie, has not withdrawn or discontinued 
early); or participant must have received 2 doses of mRNA-1273 under the EUA with 
their second dose at least 6 months prior to enrollment in mRNA-1273 P205; or have 
received a 2 dose primary series of mRNA-1273 followed by a 50 µg booster dose of 
mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA at least 3 months 
prior to enrollment in mRNA-1273-P205; and able to provide proof of vaccination 
status at the time of screening (Day 1); or for enrollment in Part A.2, participant must 
be currently enrolled and compliant in Part A.1 of the mRNA-1273-P205 study and 

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must have received their first booster dose of mRNA-1273.211 50 µg; or for 
enrollment in Part J, participant must meet at least one of the following criteria: 
• Completed enrollment in Part H of the mRNA-1273-P205 study; or 
• Received a 2-dose primary series of mRNA-1273 (100 µg) followed by a 50 µg 
booster dose of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under 
EUA, followed by a 50 µg booster dose of mRNA-1273.222 under EUA at least 
3 months prior to enrollment in Part J of mRNA-1273-P205; or 
• Previously received a 2-dose primary series of mRNA vaccine against 
SARS-CoV-2 followed by a booster dose of a monovalent mRNA vaccine, 
followed by a second booster dose of a bivalent mRNA vaccine.  
Participants in Part J must also provide proof of vaccination status at the time of screening 
(Day 0 or Day 1). 
Exclusion Criteria: 
Participants meeting any of the following criteria at the Screening Visit, unless noted 
otherwise, will be excluded from the study: 
1. Had significant exposure to someone with SARS-CoV-2 infection or coronavirus 
disease 2019 (COVID-19) in the past 14 days, as defined by the CDC as a close 
contact of someone who has COVID-19). 
2. Has known history of SARS-CoV-2 infection within 3 months prior to enrollment. 
3. Is acutely ill or febrile (temperature ≥ 38.0°C [100.4°F]) less than 72 hours prior to or 
at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled 
and will retain their initially assigned participant number. 
4. Currently has symptomatic acute or unstable chronic disease requiring medical or 
surgical care, to include significant change in therapy or hospitalization for worsening 
disease, at the discretion of the investigator. 
5. 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. 
6. Has a current or previous diagnosis of immunocompromising condition to include 
human immunodeficiency virus, immune-mediated disease requiring 
immunosuppressive treatment, or other immunosuppressive condition. 
7. Has received systemic immunosuppressants or immune-modifying drugs for > 14 days 
in total within 6 months prior to screening (for corticosteroids ≥ 10 mg/day of 
prednisone equivalent) or is anticipating the need for immunosuppressive treatment at 
any time during participation in the study. 
8. Has known or suspected allergy or history of anaphylaxis, urticaria, or other significant 
AR to the vaccine or its excipients. 
9. Has a documented history of myocarditis or pericarditis within 2 months prior to 
Screening Visit (Day 0). 
10. Coagulopathy or bleeding disorder considered a contraindication to intramuscular (IM) 
injection or phlebotomy. 
11. Has received or plans to receive any licensed vaccine ≤ 28 days prior to the injection 
(Day 1) or a licensed vaccine within 28 days before or after the study injection, with 

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the exception of influenza vaccines, which may be given 14 days before or after receipt 
of a study vaccine. 
12. Has received systemic immunoglobulins or blood products within 3 months prior to the 
Screening Visit (Day 0) or plans for receipt during the study. 
13. Has donated ≥ 450 mL of blood products within 28 days prior to the Screening Visit or 
plans to donate blood products during the study. 
14. Plans to participate in an interventional clinical trial of an investigational vaccine or 
drug while participating in this study. 
15. Is an immediate family member or household member of study personnel, study site 
staff, or Sponsor personnel. 
16. Is currently experiencing an SAE in Study mRNA-1273-P301 (COVE) at the time of 
screening for this study.  
Study Treatments 
Investigational Product, Dosage, and Mode of Administration: 
Part A.1 (mRNA-1273.211) 
mRNA-1273.211 is a multivalent product that contains 2 mRNAs: CX-024414 encoding for 
the prefusion stabilized spike protein (S-2P) of Wuhan-Hu-1 and CX-027367 encoding for the 
S-2P of B.1.351, in a 1:1 ratio. mRNA-1273.211 consists of the mRNA formulated in a 
mixture of 4 lipids common to the Sponsor’s mRNA vaccine platform: SM-102, cholesterol, 
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and 1-monomethoxypolyethyleneglycol-
2,3-dimyristylglycerol with polyethylene glycol of average molecular weight 2000 
(PEG-2000-DMG). 
mRNA-1273.211 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 
mRNA-1273.211 will be administered at 50 and 100 µg dose levels. Doses will be 
administered by IM injection according to the procedures specified in the mRNA-1273-P205 
Pharmacy Manual. Preferably, the vaccine should be administered into the nondominant arm. 
Part A.2 (mRNA-1273.214) 
mRNA-1273.214 contains CX-024414, the mRNA that encodes for the prefusion stabilized 
spike glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the 
mRNA that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 variant. mRNA-1273.214 
consists of each mRNA formulated in a mixture of 4 lipids common to the Sponsor’s mRNA 
vaccine platform: SM-102, cholesterol, DSPC, and PEG2000-DMG. 
The formulated mRNA are mixed in a 1:1 ratio. mRNA-1273.214 injection will be provided as 
a sterile liquid for injection, white to off-white dispersion in appearance, at a concentration of 
0.1 mg/ML 
. 
mRNA-1273 will be administered at a 50 µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part B (mRNA-1273) 
mRNA-1273 contains mRNA CX-024414 encoding for the S-2P of Wuhan-Hu-1. 
mRNA-1273 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC and 1 PEG-2000-DMG. 
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mRNA-1273 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 
mRNA-1273 will be administered at a 100 µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part C (mRNA-1273.617.2) 
mRNA-1273.617.2 contains mRNA CX-029444 encoding for the S-2P of B.1.617.2. 
mRNA-1273.617.2 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC and PEG-2000-DMG. 
mRNA-1273.617.2 injection will be provided as a sterile liquid for injection, white to 
off-white dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 
mRNA-1273.617.2 will be administered at 50 µg and 100 µg dose level. Doses will be 
administered by IM injection according to the procedures specified in the mRNA-1273-P205 
Pharmacy Manual. Preferably, the vaccine should be administered into the nondominant arm. 
Part D (mRNA-1273.213) 
mRNA-1273.213 is a multivalent product that contains 2 mRNAs: CX-029444 encoding for 
the S-2P of B.1.617.2 and CX-027367 encoding for the S-2P of B.1.351, in a 1:1 ratio. 
mRNA-1273.213 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC and PEG-2000-DMG. 
mRNA-1273.213 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 
mRNA-1273.213 will be administered at 50 µg and 100 µg dose level. Doses will be 
administered by IM injection according to the procedures specified in the mRNA-1273-P205 
Pharmacy Manual. Preferably, the vaccine should be administered into the nondominant arm. 
Part F (mRNA-1273.529) 
mRNA-1273.529 contains mRNA CX-031302 encoding for the S-2P of B.1.1.529. 
mRNA-1273.529 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC and PEG-2000-DMG. 
mRNA-1273.529 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 
mRNA-1273.529 will be administered at a 50 µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part G (mRNA-1273.214) 
mRNA-1273.214 contains CX-024414, the mRNA that encodes for the prefusion stabilized 
spike glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the 
mRNA that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 variant. mRNA-1273.214 
consists of each mRNA formulated in a mixture of 4 lipids common to the Sponsor’s mRNA 
vaccine platform: SM-102, cholesterol, DSPC, and PEG2000-DMG. 
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The formulated mRNA are mixed in a 1:1 ratio. mRNA-1273.214 injection will be provided as 
a sterile liquid for injection, white to off-white dispersion in appearance, at a concentration of 
0.1 mg/ML 
 
mRNA-1273 will be administered at a 50 µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part H (mRNA-1273.222) 
mRNA-1273.222 contains CX-024414, the mRNA that encodes for the prefusion stabilized 
spike glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-034476, the 
mRNA that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 subvariants BA.4/BA.5. 
mRNA-1273.222 consists of each mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC, and PEG2000-DMG. 
The formulated mRNA are mixed in a 1:1 ratio. mRNA-1273.222 injection will be provided as 
a sterile liquid for injection, white to off-white dispersion in appearance, at a concentration of 
0.1 mg/mL 
 
mRNA-1273.222 will be administered at a 50 µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part J (mRNA-1273.815 and mRNA-1273.231) 
mRNA-1273.815 contains CX-038839, the monovalent mRNA that encodes for the S-2P of 
the SARS-CoV-2 Omicron subvariants XBB.1.5/XBB.1.9.1. mRNA-1273.231 contains 
CX-034476, the mRNA that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 Omicron 
subvariants BA.4/BA.5, and CX-038839, the mRNA that encodes for the S-2P of the 
SARS-CoV-2 subvariants XBB.1.5/XBB.1.9.1. The formulated mRNA in mRNA-1273.231 
are mixed in a 1:1 ratio. Both mRNA-1273.815 and mRNA-1273.231 consist of mRNA 
formulated in a mixture of 4 lipids common to the Sponsor’s mRNA vaccine platform: 
SM-102, cholesterol, DSPC, and PEG2000-DMG. 
mRNA-1273.815 and mRNA-1273.231 will be administered at a 50 µg dose level. Doses will 
be administered by IM injection according to the procedures specified in the 
mRNA-1273-P205 Pharmacy Manual. Preferably, the vaccine should be administered into the 
nondominant arm. 
mRNA-1273.231 and mRNA-1273.815 injections will be provided as a sterile liquid for 
injection, white to off-white dispersion in appearance, at a concentration of 0.1 mg/mL  
 
Procedures and Assessments: 
Safety Assessments: 
Safety assessments will include monitoring and recording of the following for each 
participant: 
• Solicited local and systemic ARs that occur during the 7 days following 
vaccination (ie, the day of injection and 6 subsequent days). Solicited ARs will be 
recorded daily using eDiaries. 
• Unsolicited AEs observed or reported during the 28 days following vaccination (ie, 
the day of injection and 27 subsequent days). 
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• AEs leading to withdrawal from Day 1 through EoS or withdrawal from the study. 
• MAAEs from vaccination on Day 1 through EoS or withdrawal from the study. 
• AESI from vaccination on Day 1 through EoS or withdrawal from the study. 
• SAEs from vaccination on Day 1 through EoS or withdrawal from the study. 
• Vital sign measurements before and after vaccination. 
• Physical examination findings (if performed). 
• 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. 
The incidence and severity of the above events will be monitored by an independent safety 
team (IST) on a regular basis. 
Immunogenicity Assessments: 
Blood samples for immunogenicity assessments will be collected at the time points indicated 
in the SoE. 
Statistical Methods: 
Parts A.1, A.2, B, C, and D: 
There is no hypothesis testing for Parts A.1, A.2, B, C, and D. 
Part F: 
Cohort 1: 
50 µg mRNA-1273.529 booster dose (as a first booster dose) will be assessed with respect to 
mRNA-1273 booster dose (as a first booster dose) using an external comparator (details 
regarding the external historical comparator will be included in the SAP). 
For the primary immunogenicity objectives, there are 3 hypotheses to be tested: 
A. H11: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 
1.5. 
B. H12: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
superior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
(based on GMR and SRR difference) is demonstrated. 

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Cohort 2: 
50 µg mRNA-1273.529 as the second booster dose will be compared to 50 µg mRNA-1273 as 
the second booster dose. 
For the primary immunogenicity objective, there are 3 hypotheses to be tested: 
A. H11: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 
compared to mRNA-1273 against the variant B.1.1.529 at Day 29 with a 
non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
(based on GMR and SRR difference) is demonstrated. 
Part G: 
50 µg mRNA-1273.214 as the second booster dose will be compared to 50 µg mRNA-1273 as 
the second booster dose (active control arm in Part F, Cohort 2) 
For the primary immunogenicity objective, there are 8 hypotheses (4 hypotheses at Day 29 and 
4 hypotheses at Day 91). 
A. H11: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 29 
compared to mRNA-1273 against the variant B.1.1.529 at Day 29 with a 
non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 
is non-inferior to the second booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against ancestral 
SARS-CoV-2 at Day 29 compared to mRNA-1273 against ancestral SARS-CoV-2 at 
Day 29 with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29. 
E. H15: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
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compared to mRNA-1273 against the variant B.1.1.529 at Day 91 with a 
non-inferiority margin of 1.5. 
F. H16: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the difference in SRR at Day 91 with a non-inferiority margin of 10%. 
G. H17: 50 µg mRNA-1273.214, as a second booster dose, against the ancestral 
SARS-CoV-2 is non-inferior to the second booster dose of (50 µg) mRNA-1273 
against ancestral SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against 
ancestral SARS-CoV-2 at Day 91 compared to mRNA-1273 against ancestral 
SARS-CoV-2 at Day 91 with a non-inferiority margin of 1.5. 
H. H18: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 91 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 91. 
For the primary immunogenicity objective, an alpha of 0.05 (two-sided) will be allocated to 
the 2 time points (Day 29 and Day 91). Day 29 and Day 91 will each have an alpha of 0.025 
(two-sided) for hypotheses testing. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
based on GMR, SRR difference, and non-inferiority against the ancestral SARS-CoV-2 based 
on GMR are demonstrated at Day 29 or Day 91. 
For the key secondary immunogenicity objective, there are 2 hypotheses to be tested (Day 29 
and 91 will each have an alpha of 0.025 [two-sided] for hypotheses testing): 
A. H19: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 
is non-inferior to the booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2 based on the difference in SRR at Day 29 with a non-inferiority margin 
of 10%. 
B. H110: 50 µg mRNA-1273.214, as a second booster dose, against ancestral 
SARS-CoV-2 is non-inferior to the booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 based on the difference in SRR at Day 91 with a 
non-inferiority margin of 10%. 
Part H: 
50 µg mRNA-1273.222 given as a second booster dose will be compared to 50 µg 
mRNA-1273 given as a second booster dose (in Part F, Cohort 2). 
For the primary immunogenicity objective, there are 5 hypotheses to be tested as shown 
below:  
A. H11: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against Omicron 
BA.4/5 based on the GMT ratio of mRNA-1273.222 against Omicron BA.4/5 at 
Day 29 compared to mRNA-1273 against Omicron BA.4/5 at Day 29 with a non-
inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against Omicron 
BA.4/5 based on the difference in SRR at Day 29 with a non-inferiority margin of 5%. 

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C. H13: 50 µg mRNA-1273.222, as a second booster dose, against ancestral SARS-CoV-2 
D614G is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 D614G based on the GMT ratio of mRNA-1273.222 against 
ancestral SARS-CoV-2 D614G at Day 29 compared to mRNA-1273 against ancestral 
SARS-CoV-2 D614G at Day 29 with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.222, as a second booster dose, against ancestral SARS-CoV-2 
D614G is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 D614G based on the difference in SRR at Day 29 with a 
non-inferiority margin of 10%. 
E. H15: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
superior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the GMT ratio of mRNA-1273.222 against Omicron BA.4/5 at Day 29 
compared to mRNA-1273 against Omicron BA.4/5 at Day 29. 
Part J:  
No formal hypothesis testing will be performed. 
Sample Size: 
Part A.1 
With approximately 300 and 584 participants exposed to 50 and 100 µg of mRNA-1273.211, 
respectively, there is at least 90% probability to observe one participant at each dose level 
reporting an AE if the true rate of AEs is 1%. 
Part A.2 
We anticipate approximately 300 participants will be enrolled in Part A.2, there is no 
statistical hypothesis testing in Part A.2. 
Part B 
With approximately 300 participants exposed to 100 µg of mRNA-1273, there is at least 90% 
probability to observe one participant reporting an AE if the true rate of AEs is 1%. 
Part C 
With approximately 584 participants exposed to each dose of mRNA-1273.617.2, there is at 
least 90% probability in each group to observe one participant reporting an AE if the true rate 
of AEs is 1%. 
Part D 
With approximately 584 participants exposed to each dose of mRNA-1273.213, there is at 
least 90% probability in each group to observe one participant reporting an AE if the true rate 
of AEs is 1%. 
Part F 
mRNA-1273.529 in each cohort will be assessed at a 2-sided type I error rate of 5%. 
Cohort 1: 
The target enrollment is approximately 375 participants for 50 µg mRNA-1273.529. Assuming 
20% of participants will be excluded from the PP Set for Immunogenicity-SARS-CoV2 
negative, with approximately 300 participants in 50 µg mRNA-1273.529 and 300 participants 
in 50 µg mRNA-1273 (external comparator) in the PP Set for Immunogenicity-SARS-CoV-2 
negative, there is approximately 89% global power for the primary immunogenicity objectives 
with alpha level of 0.05 (2-sided). The assumptions are: the true GMR (mRNA-1273.529 
booster vs. 50 µg mRNA-1273 booster) against the variant (B.1.1.529) is 1.5, the standard 

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deviation of the log-transformed titer is 1.5, and the non-inferiority margin for GMR is 1.5; the 
true SRR against B.1.1.529 after a single booster dose of 50 µg mRNA-1273.529 is 90% 
(same assumption for 50 µg mRNA-1273), and non-inferiority margin for SRR difference is 
10%. With approximately 375 participants exposed to 50 µg mRNA-1273.529, there is at least 
90% probability in this group to observe 1 participant reporting an AE if the true rate of AEs is 
1%. 
There may be an urgency to perform the Day 29 analysis as early as possible and depending 
on the testing capability of assays of antibodies against B.1.1.529, the Sponsor may decide 
using an external arm with less than 300 participants. Such decision will be documented in 
SAP prior to the planned Day 29 analysis. 
Cohort 2: 
The target enrollment is approximately 750 participants for 50 µg mRNA-1273.529 and 50 µg 
mRNA-1273 (1:1 ratio). Assuming 20% of participants will be excluded from the PP Set for 
Immunogenicity – SARS-CoV-2 negative, with approximately 300 participants each in 
50 µg mRNA-1273.529 and 50 µg mRNA-1273 in the PP Set for Immunogenicity and 
SARS-CoV-2 negative, there is approximately 89% global power to demonstrate the primary 
immunogenicity objectives of alpha level of 0.05 (2-sided). The assumptions are: the true 
GMR (mRNA-1273.529 as the second booster vs 50 µg mRNA-1273 as the second booster) 
against the variant (B.1.1.529) is 1.5, the standard deviation of the log-transformed titer is 1.5, 
and the non-inferiority margin for GMR is 1.5; the true SRR against B.1.1.529 after 
mRNA-1273 as a second booster dose is 90% (same assumption for both 50 µg 
mRNA-1273.529 and 50 µg mRNA-1273), and non-inferiority margin for SRR difference is 
10%. 
With approximately 375 participants exposed to each group, there is at least 90% probability 
in each group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part G 
The target enrollment is approximately 375 participants for 50 µg mRNA-1273.214. 
Hypotheses testing will be performed at Day 29 and Day 91, alpha of 0.025 (2-sided) will be 
allocated equally to each one of the 2 time points. Assuming 20% of participants will be 
excluded from the PP Set for Immunogenicity – SARS-CoV-2 negative, with approximately 
300 participants in 50 µg mRNA-1273.214 and 300 participants in 50 µg mRNA-1273 (Part F, 
Cohort 2-50 µg mRNA-1273) in the PP Set for Immunogenicity and SARS-CoV-2 negative, 
there is approximately 71% global power to demonstrate the primary immunogenicity 
objectives with alpha of 0.025 (2-sided) at each time point. The assumptions are: the true 
GMR (mRNA-1273.214 second booster vs 50 µg mRNA-1273 second booster) against the 
variant (B.1.1.529) is 1.5, the true GMR against ancestral SARS-CoV-2 is 1, the standard 
deviation of the log-transformed titer is 1.5, and the non-inferiority margin for GMR is 1.5, the 
true SRR against B.1.1.529 after mRNA-1273.214 as a second booster dose is 90% (same 
assumption for both 50 µg mRNA-1273.214 and 50 µg mRNA-1273), and non-inferiority 
margin for SRR difference is 10%. 
With approximately 375 participants exposed to 50 µg mRNA-1273.214, there is at least 90% 
probability in this group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part H 
The target enrollment is approximately 500 participants for 50 µg mRNA-1273.222. Assuming 
40% of participants will be excluded from the PP Set for Immunogenicity – SARS-CoV-2 

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negative (due to a SARS-CoV-2 infection prebooster), with approximately 300 participants in 
50 µg mRNA-1273.222 and 260 participants in 50 µg mRNA-1273 (Part F, Cohort 2-50 µg 
mRNA-1273) in the PP Set for Immunogenicity and SARS-CoV-2 negative, there is 
approximately 60% power to demonstrate the primary immunogenicity objectives with an 
alpha of 0.05 (2-sided) at Day 29. The assumptions are: the true GMR (mRNA-1273.222 
second booster vs. mRNA-1273 second booster) against Omicron BA.4/5 is 1.5, GMR 
(mRNA-1273.222 second booster vs. mRNA-1273 second booster) against ancestral 
SARS-CoV-2 D614G is 1, the standard deviation of the log-transformed titer is 1.5, and the 
non-inferiority margin for GMR is 1.5. The true SRR against Omicron BA.4/5 after 
mRNA-1273.222 as a second booster dose is 95% (same assumption for 50 µg mRNA-1273), 
and non-inferiority margin for SRR difference against Omicron BA.4/5 is 5%. The true SRR 
against ancestral SARS-CoV-2 D614G after mRNA-1273.222 as a second booster dose is 95% 
(same assumption for 50 µg mRNA-1273), and the non-inferiority margin for SRR difference 
against ancestral SARS-CoV-2 D614G is 10%. 
With approximately 500 participants exposed to 50 µg mRNA-1273.222, there is at least 90% 
probability in this group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part J 
The sample size for Part J is not driven by statistical assumptions for formal hypothesis 
testing. The number of proposed participants is considered sufficient to provide a descriptive 
summary of the safety and immunogenicity of each treatment arm. 
The target enrollment is approximately 100 participants who will be randomized in a 1:1 ratio 
to receive either mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg). 
Analysis Sets: 
Analysis sets are described below (same definitions across Part A [1, 2], B, C, D, F, G, H, and 
J when applicable): 
Set 
Description 
Full Analysis Set (FAS) 
The FAS consists of all participants who receive IP. 
Per-Protocol Immunogenicity 
Set (PPIS) 
The PPIS consists of all participants in the FAS who received the 
planned dose of study vaccination and no major protocol deviations 
that impact key or critical data. 
The PPIS will be used as the primary analysis set for Parts A.1, B, 
C, D and J. 
Per-Protocol Immunogenicity 
Set – SARS-CoV-2 Negative 
(PPIS-Neg) 
Participants in the PPIS-Neg who have no serologic or virologic 
evidence of SARS-CoV-2 infection at baseline, ie, who are 
SARS-CoV-2 negative, defined by both negative RT-PCR test for 
SARS-CoV-2 and negative serology test based on bAb specific to 
SARS-CoV-2 nucleocapsid. 
PPIS-Neg will be the primary analysis set for analyses of 
immunogenicity for Parts A.2, F (Cohort 1), F (Cohort 2), G, and H. 
Solicited Safety Set 
The Solicited Safety Set consists of all participants who receive IP 
and contribute any solicited AR data. 
The Solicited Safety Set will be used for the analyses of solicited 
ARs. Participants will be included in the study arm corresponding to 
the dose of IP that they actually received. 

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Safety Set 
The Safety Set consists of all participants who receive IP. The 
Safety Set will be used for all analyses of safety except for the 
solicited ARs. Participants will be included in the study arm 
corresponding to the dose of IP that they actually received. 
Per-Protocol Set for Efficacy 
The PP Set for Efficacy consists of all participants in the FAS who 
receive the planned dose of study vaccination, who are 
SARS-CoV-2 negative at baseline (ie, have a negative RT-PCR test 
for SARS-CoV-2 and a negative serology test based on bAb specific 
to SARS-CoV-2 nucleocapsid at baseline), and have no major 
protocol deviations that impact key or critical data. 
Safety Analyses: 
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 provided by study arm. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters 
including solicited ARs (local and systemic ARs), unsolicited AEs, treatment-related AEs, 
severe AEs, SAEs, MAAEs, AESI, AEs leading to withdrawal, vital sign measurements, and 
physical examination findings. 
The number and percentage of participants with any solicited local AR, with any solicited 
systemic AR, with any solicited AR during the 7-day follow-up period after vaccination, and 
with Grade 3 or higher solicited AR will be provided. A 2-sided 95% exact confidence interval 
(CI) using the Clopper-Pearson method will be provided for the percentage of participants 
with any solicited AR. 
The number and percentage of participants with unsolicited AEs, treatment-related AEs, 
severe AEs, SAEs, MAAEs, AESI, and AEs leading to withdrawal will be summarized. 
Unsolicited AEs will be presented by Medical Dictionary for Regulatory Activities 
(MedDRA) system organ class and preferred term. Unsolicited AEs will be coded according to 
the MedDRA Dictionary for Adverse Reaction Terminology. 
The number of events of solicited ARs, unsolicited AEs/SAEs, MAAEs, AEs leading to 
withdrawal, and AESI will be reported in summary tables accordingly. Pregnancy outcomes 
will also be summarized. 
Immunogenicity Analyses: 
Parts A.1, B, C, and D 
There is no hypothesis testing for Parts A.1, B, C, and D. 
Part A.2 
There is no hypothesis testing for Part A.2. 
For Part A.2 participants, Day 29 and Day 181 immune response after mRNA-1273.214 
(50 µg) as a second booster dose will be compared with their own Day 29 and Day 181 
immune response of mRNA-1273.211 (50 µg) received as the first booster dose. GMT ratios 
will be calculated by back transforming the mean of paired differences of antibody titer data 
on the logarithmic scale between Day 29 and Day 181 post mRNA-1273.214 and Day 29 and 
Day 181 of antibody titer data post mRNA-1273.211. CIs for the GMT ratio will be based on 
t-distribution of the log-transformed values then back-transformed to the original scale for 
presentation. Seroresponse rates at Day 29 and Day 181 post mRNA-1273.214 will be 
compared with their seroresponse rates at Day 29 and Day 181 post mRNA-1273.211. The 

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difference in seroresponse rates and its corresponding 95% CI based on adjusted Wald method 
will be provided. 
Part F: 
Cohort 1: 
50 µg mRNA-1273.529 booster dose (first booster dose) will be assessed with respect to 
mRNA-1273 booster dose (first booster dose) using an external comparator (details regarding 
the external historical control will be included in the SAP). For the primary immunogenicity 
objectives, there are 3 hypotheses to be tested. 
A. H11: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 at Day 29 
compared to mRNA-1273 against the variant B.1.1.529 at Day 29 with a 
non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
superior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
An ANCOVA model will be performed to assess the difference in immune response between 
mRNA-1273.529 and mRNA-1273 (using external comparator) as the first booster dose. For 
immune response against the B.1.1.529 strain, in the ANCOVA model, antibody titers at 
Day 29 postbooster against the B.1.1.529 strain will be a dependent variable, and a group 
variable (mRNA-1273.529 and mRNA-1273) will be the fixed effect, adjusting for age groups 
(< 65, ≥ 65 years) and prebooster antibody titer level, if applicable. 
The GMT will be estimated by the GLSM from the model and its corresponding 95% will be 
provided for each group. The GMR (ratio of GMTs) for mRNA-1273.529 with respect to 
mRNA-1273 will be estimated by the ratio of GLSM from the model and the corresponding 
95% CIs will be provided. The 95% CI for GMR will be used to assess the between group 
difference in immune response against the B.1.1.529 strain for mRNA-1273.529 at Day 29 
compared to the mRNA-1273. 
The number and percentage (rate) of participants achieving seroresponse at Day 29 will be 
summarized with 95% CI calculated using the Clopper-Pearson method for each group. The 
difference of SRR between mRNA-1273.529 and mRNA-1273 will be calculated with 95% CI 
based on Miettinen-Nurminen method. The non-inferiority in SRR of mRNA-1273.529 
compared to mRNA-1273 will be considered demonstrated if the lower bound of the 95% of 
the SRR difference is > -10% based on the non-inferiority margin of 10%. 
The primary immunogenicity objective (against the B.1.1.529) is considered met if 
non-inferiority is demonstrated based on GMR and SRR difference, specifically: 
• The lower bound of the 95% CI of the GMT ratio between mRNA1273.529 against the 
variant (B.1.1.529) at Day 29 as compared to 50 µg mRNA1273 against B.1.1.529 at 
Day 29 is > 0.667 based on the non-inferiority margin of 1.5 

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• The lower bound of the 95% CI of the SRR difference (50 µg mRNA-1273.529 against 
the variant B.1.1.529 at Day 29–- 50 µg mRNA-1273 against B.1.1.529 at Day 29) is 
>-10% 
• If non-inferiority is demonstrated (based on GMT ratio and SRR difference), the lower 
bound of 95% CI of the GMT ratio will be compared to 1, if it’s greater than 1, then 
superiority is demonstrated. 
Cohort 2: 
The same analyses methods described in Part F Cohort 1 will be used for Cohort 2. 
A. H11: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 
compared to mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-
inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29. 
The primary immunogenicity objective (against the B.1.1.529) is considered met if non-
inferiority is demonstrated based on GMR and SRR difference, specifically: 
• The lower bound of the 95% CI of the GMT ratio between mRNA1273.529 against the 
variant (B.1.1.529) at Day 29 as compared to 50 µg mRNA1273 against B.1.1.529 at 
Day 29 is > 0.667 based on the non-inferiority margin of 1.5. 
• The lower bound of the 95% CI of the SRR difference (50 µg mRNA-1273.529 against 
the variant B.1.1.529 at Day 29–- 50 µg mRNA-1273 against B.1.1.529 at Day 29) is 
>-10%. 
• If non-inferiority is demonstrated (based on GMT ratio and SRR difference), the lower 
bound of 95% CI will be compared to 1, if it’s greater than 1, then superiority is also 
demonstrated. 
Part G: 
50 µg mRNA-1273.214 as the second booster dose will be compared to 50 µg mRNA-1273 as 
the second booster dose (active control arm in Part F, Cohort 2) 
For the primary immunogenicity objective, there are 4 hypotheses to be tested at Day 29 and 4 
hypotheses to be tested at Day 91. 
A. H11: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 
compared to mRNA-1273 against the variant B.1.1.529 at Day 29 with a 
non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 

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C. H13: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 
is non-inferior to the second booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2based on the GMT ratio of mRNA-1273.214 against ancestral SARS-
CoV-2 at Day 29 compared to mRNA-1273 against ancestral SARS-CoV-2 at Day 29 
with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29. 
E. H15: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the GMT ratio of mRNA-1273.214against the variant B.1.1.529 at Day 91 
compared to mRNA-1273 against the variant B.1.1.529 at Day 91 with a 
non-inferiority margin of 1.5. 
F. H16: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 
based on the difference in SRR at Day 91 with a non-inferiority margin of 10%. 
G. H17: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 
is non-inferior to the second booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against ancestral 
SARS-CoV-2 at Day 91 compared to mRNA-1273 against ancestral SARS-CoV-2 at 
Day 91 with a non-inferiority margin of 1.5. 
H. H18: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 91 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 91. 
The analyses method described in Part F Cohort 1 will be used for Part G. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
based on GMR and SRR difference, and non-inferiority against ancestral SARS-CoV-2 based 
on GMR are demonstrated at Day 29 or at Day 91. 
For the primary immunogenicity objective, the non-inferiority of mRNA-1273.214 as 
compared to mRNA-1273 against the B.1.1.529 and the non-inferiority of mRNA-1273.214 as 
compared to mRNA-1273 against ancestral SARS-CoV-2 at Day 29 will be assessed using a 
non-inferiority margin of 1.5 at 2-sided alpha of 0.025, and the non-inferiority of 
mRNA-1273.214 as compared to mRNA-1273 against B.1.1.529 based on SRR using a 
non-inferiority margin of 10% at 2-sided alpha of 0.025.  
Superiority of mRNA-1273.214 as compared to mRNA-1273 against the B.1.1.529 strain will 
be evaluated at Day 29. Once the non-inferiority of mRNA-1273.214 as compared to 
mRNA-1273 against B.1.1.529 and against ancestral SARS-CoV-2 at Day 29 is demonstrated, 
the 97.5% CI of GMR (mRNA-1273.214 vs mRNA-1273) will be used to assess superiority of 
mRNA-1273.214 as compared to mRNA-1273. If the lower bound of the GMR > 1 at Day 29, 
superiority of mRNA-1273.214 compared to mRNA-1273 against B.1.1.529 will be 
considered demonstrated. 
Hypotheses testing at Day 91 will be performed in the same manner; first test 3 non-inferiority 
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(two-sided). Once non-inferiority is demonstrated for both B.1.1529 and the ancestral 
SARS-CoV-2, then superiority testing against B.1.1.529 at alpha of 0.025 level (two-sided) 
will also be performed. 
For the key secondary objective, there are 2 hypotheses to be tested (Day 29 and Day 91 each 
with alpha level of 0.025, 2-sided): 
A. H19: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 
is non-inferior to the booster dose of (50 µg) mRNA-1273 against ancestral SARS-
CoV-2 based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
B. H110: 50 µg mRNA-1273.214, as a second booster dose, against ancestral 
SARS-CoV-2 is non-inferior to the booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 based on the difference in SRR at Day 91 with a 
non-inferiority margin of 10%. 
If the lower bound of the 97.5% CI of the SRR difference (50 µg mRNA-1273.214 against 
ancestral SARS-CoV-2–- 50 µg mRNA-1273 against ancestral SARS-CoV-2) is >-10% at 
Day 29 or Day 91, then the key secondary objective will be considered met. 
In the event that an early assessment of the 1273.214 data is needed due to public health 
concerns, a two-staged approach might be used. Specifically, a subset of participants’ (ie, 
50 first enrolled participants) serum samples will first be tested against ancestral SARS-CoV-2 
and variants of concern. For the Day 29 and Day 91 immunogenicity analyses, all participants’ 
immune data will be used in the formal interim analysis to evaluate the primary 
immunogenicity objective. 
Part H: 
The primary immunogenicity objective will be assessed in the per-protocol immunogenicity, 
SARS-CoV-2 negative set.  
The analyses methods described in Part F Cohort 1 will be used for Part H. 
The primary immunogenicity objective is considered met if non-inferiority against Omicron 
BA.4/5 and ancestral SARS-CoV-2 D614G based on GMR and SRR difference at Day 29 is 
demonstrated. 
Non-inferiority against Omicron BA.4/5: 
• The lower bound of the 95% CI of the GMT ratio between mRNA-1273.222 against 
Omicron BA.4/5 at Day 29 as compared to 50 µg mRNA-1273 against BA.4/5 at 
Day 29 is > 0.667 based on the non-inferiority margin of 1.5.  
• The lower bound of the 95% CI of the SRR difference (50 µg mRNA-1273.222 against 
Omicron BA. 4/5 at Day 29–- 50 µg mRNA-1273 against BA.4/5 at Day 29) is >-5%.  
Non-inferiority against ancestral SARS-CoV-2 D614G: 
• The lower bound of the 95% CI of the GMT ratio between mRNA-1273.222 against 
ancestral SARS-CoV-2 D614G at Day 29 as compared to 50 µg mRNA-1273 against 
ancestral SARS-CoV-2 D614G at Day 29 is > 0.667 based on the non-inferiority 
margin of 1.5.  
• The lower bound of the 95% CI of the SRR difference (50 µg mRNA-1273.222 against 
ancestral SARS-CoV-2 D614G at Day 29–- 50 µg mRNA-1273 against ancestral 
SARS-CoV-2 D614Gat Day 29) is >-10%.  

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If non-inferiority is demonstrated based on GMT ratio and SRR difference against Omicron 
BA. 4/5 and ancestral SARS-CoV-2 D614G then the lower bound of 95% CI of the GMT ratio 
will be compared to 1, and if it is higher than 1 then superiority will also be demonstrated. 
Part J: 
No formal hypothesis testing will be performed for Part J and all safety and immunogenicity 
analyses will be descriptive. The primary immunogenicity objective will be assessed using the 
Per-Protocol Set for Immunogenicity. Comparisons on immunogenicity response between the 
mRNA-1273.815 and mRNA-1273.231 treatment arms may be performed. 
Immunogenicity endpoints applicable to all study parts: 
SARS-CoV-2-specific bAb and nAb are assessed at multiple timepoints in each part of this 
study. 
For each of the antibodies of interest, eg, levels of SARS-CoV-2–specific bAb and 
SARS-CoV-2–specific nAb, the GMT or level with corresponding 95% CI at each time point, 
and GMFR of post-baseline/baseline titers or levels with corresponding 95% CI at each 
post-baseline time point will be provided for each 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. The following descriptive statistics will also be provided at each time point: 
number of participants (n), median, minimum, and maximum. 
The mixed effect model repeated measure (MMRM) will be used to analyze all postbooster 
measures for between-booster comparison when applicable, the model will include treatment 
group, analysis visit, treatment by visit interaction, and adjusting for age groups and 
prebooster titer levels. An unstructured covariance structure will be used to model the 
within-participant errors. The GMT will be estimated from the model and its corresponding 
95% CI will be provided for each group at each postboost timepoint. The GMR (ratio of 
GMTs) will be estimated from the model and the corresponding 95% CI will be provided at 
each postboost timepoint. 
The SRR of each arm against ancestral SARS-CoV-2 and variants, defined as the percentage 
of participants achieving seroresponse against ancestral SARS-CoV-2 and variants 
respectively, will be provided for each arm with the 95% CI calculated using the 
Clopper-Pearson method. 
The primary definition of seroresponse is defined as ≥ 4 × LLOQ for those with pre-dose 1 of 
primary series baseline < LLOQ; ≥ 4-foldrise for those with pre-dose 1 of primary series 
baseline ≥ LLOQ. The secondary definition of seroresponse is defined as ≥ 4 × LLOQ for 
those with prebooster baseline < LLOQ; ≥ 4-foldrise for those with prebooster ≥ LLOQ. SRR 
will be summarized using both definitions for all the study parts. 
Efficacy Analysis 
This study is not designed to assess efficacy. Descriptive summaries of symptomatic 
COVID-19 disease, asymptomatic SARS-CoV-2 infection, as well as SARS-CoV-2 infection 
regardless of symptoms will be provided for each arm. 
Planned Analyses 
Interim Analyses 
The interim analysis will be conducted based on safety and immunogenicity data collected 
through Day 15 or Day 29. The interim analysis may be conducted either after all participants 
in Parts A.1, A.2, B, C, D, F, G, H, or J have completed their Day 15 or Day 29 visit 
assessments and/or subsequent timepoint visits (eg, Day 91 for Parts F, G, H, and J) or 

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combined after the last participant of each study part (Parts A.1, A.2, B, C, D, F, G, H, or J), 
dose arm, or pre-specified subset of dose arm has completed their Day 15 or Day 29 visit 
assessments. 
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 clinical study 
report (CSR), including individual listings. The final CSR will include full analyses of all 
safety and immunogenicity through Day 366 (Month 12) for Parts A.1, B, C, D, F, and G and 
through D181 (Month 6) for Parts A.2, H, and J. 
 
 

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TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL ..................................................................................................1 
PROTOCOL APPROVAL – SPONSOR SIGNATORY ................................................................2 
DECLARATION OF INVESTIGATOR .........................................................................................3 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................4 
PROTOCOL SYNOPSIS ................................................................................................................7 
TABLE OF CONTENTS ...............................................................................................................43 
LIST OF TABLES .........................................................................................................................48 
LIST OF FIGURES .......................................................................................................................48 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ..................................................49 
GLOSSARY OF TERMS ..............................................................................................................52 
1. 
INTRODUCTION ......................................................................................................54 
1.1. 
Study Rationale ...........................................................................................................54 
1.1.1. 
mRNA-1273 ...............................................................................................................56 
1.1.2. 
mRNA-1273.211 ........................................................................................................56 
1.1.3. 
mRNA-1273.617.2 .....................................................................................................56 
1.1.4. 
mRNA-1273.213 ........................................................................................................56 
1.1.5. 
mRNA-1273.529 ........................................................................................................56 
1.1.6. 
mRNA-1273.214 ........................................................................................................56 
1.1.7. 
mRNA-1273.222 ........................................................................................................56 
1.1.8. 
mRNA-1273.815 ........................................................................................................56 
1.1.9. 
mRNA-1273.231 ........................................................................................................56 
1.2. 
Nonclinical Studies .....................................................................................................57 
1.3. 
Clinical Studies ...........................................................................................................57 
1.4. 
Benefit/Risk Assessment ............................................................................................57 
1.4.1. 
Known Potential Benefits ...........................................................................................57 
1.4.2. 
Risks from Study Participation and Their Mitigation .................................................58 
1.4.3. 
Overall Benefit/Risk Conclusion ................................................................................59 
2. 
OBJECTIVES AND ENDPOINTS ............................................................................60 
3. 
STUDY DESIGN .......................................................................................................72 
3.1. 
General Design ...........................................................................................................72 
3.2. 
Scientific Rationale for Study Design ........................................................................77 

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3.3. 
Justification for Dose, Control Product, and Choice of Study Population .................77 
3.4. 
End of Study Definition ..............................................................................................78 
4. 
STUDY POPULATION .............................................................................................79 
4.1. 
Inclusion Criteria ........................................................................................................80 
4.2. 
Exclusion Criteria .......................................................................................................81 
4.3. 
Lifestyle Restrictions ..................................................................................................82 
4.4. 
Screen Failures ............................................................................................................82 
5. 
STUDY TREATMENT ..............................................................................................83 
5.1. 
Investigational Products Administered .......................................................................83 
5.2. 
Randomization and Blinding ......................................................................................85 
5.3. 
Preparation/Handling/Storage/Accountability ............................................................85 
5.3.1. 
Preparation of Study Vaccine .....................................................................................85 
5.3.2. 
Study Vaccine Administration ....................................................................................87 
5.3.3. 
Study Vaccine Delivery and Receipt ..........................................................................87 
5.3.4. 
Study Vaccine Packaging and Labeling .....................................................................87 
5.3.5. 
Study Vaccine Storage ................................................................................................89 
5.3.6. 
Study Vaccine Accountability ....................................................................................90 
5.3.7. 
Study Vaccine Handling and Disposal .......................................................................90 
5.3.8. 
Unblinding ..................................................................................................................90 
5.4. 
Study Intervention Compliance ..................................................................................90 
5.5. 
Prior and Concomitant Medications ...........................................................................90 
5.5.1. 
Prior Medications and Therapies ................................................................................90 
5.5.2. 
Concomitant Medications and Therapies ...................................................................91 
5.5.3. 
Concomitant Medications and Vaccines that May Lead to the Elimination of a 
Participant from Per-Protocol Analyses .....................................................................91 
5.6. 
Intervention After the End of the Study .....................................................................92 
6. 
DELAY OR DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL .......................................93 
6.1. 
Criteria for Delay of Vaccine Administration ............................................................93 
6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination .................................93 
6.2. 
Participant Discontinuation/Withdrawal from the Study ...........................................93 
6.3. 
Lost to Follow-up .......................................................................................................94 
7. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................96 

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7.1. 
Safety Assessments and Procedures ...........................................................................96 
7.1.1. 
Use of Electronic Diaries ............................................................................................97 
7.1.2. 
Safety Telephone Call .................................................................................................99 
7.1.3. 
Laboratory Assessments .............................................................................................99 
7.1.4. 
Vital Sign Measurements ............................................................................................99 
7.1.5. 
Physical Examinations ..............................................................................................100 
7.1.6. 
Assessment for SARS-CoV-2 Infection ...................................................................100 
7.2. 
Immunogenicity Assessments ..................................................................................101 
7.3. 
Efficacy Assessments ...............................................................................................102 
7.4. 
Safety Definitions and Related Procedures ..............................................................103 
7.4.1. 
Adverse Event ...........................................................................................................103 
7.4.2. 
Serious Adverse Events ............................................................................................103 
7.4.3. 
Solicited Adverse Reactions .....................................................................................104 
7.4.4. 
Medically Attended Adverse Events ........................................................................106 
7.4.5. 
Adverse Event of Special Interest .............................................................................107 
7.4.6. 
Recording and Follow-up of Pregnancy ...................................................................109 
7.4.7. 
Eliciting and Documenting Adverse Events .............................................................110 
7.4.8. 
Assessment of Intensity ............................................................................................110 
7.4.9. 
Assessment of Causality ...........................................................................................111 
7.4.10. 
Reporting Adverse Events ........................................................................................111 
7.4.11. 
Reporting SAEs ........................................................................................................111 
7.4.12. 
Time Period and Frequency for Collecting AE, AESI, and SAE Information .........112 
7.4.13. 
Method of Detecting AEs and SAEs ........................................................................113 
7.4.14. 
Follow-up of AEs and SAEs .....................................................................................113 
7.4.15. 
Regulatory Reporting Requirements for SAEs .........................................................113 
7.5. 
Safety Monitoring .....................................................................................................114 
7.6. 
Treatment of Overdose .............................................................................................114 
7.7. 
Pharmacokinetics ......................................................................................................114 
7.8. 
Pharmacodynamics ...................................................................................................114 
7.9. 
Biomarkers ................................................................................................................114 
7.10. 
Health Economics .....................................................................................................114 
8. 
STATISTICAL ANALYSIS PLAN .........................................................................115 
8.1. 
Blinding and Responsibility for Analyses ................................................................115 

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8.2. 
Statistical Hypotheses ...............................................................................................115 
8.3. 
Sample Size Determination ......................................................................................118 
8.4. 
Analysis Sets .............................................................................................................120 
8.5. 
Statistical Methods ....................................................................................................121 
8.5.1. 
Baseline Characteristics and Demographics .............................................................121 
8.5.2. 
Efficacy Analysis ......................................................................................................121 
8.5.3. 
Immunogenicity Analyses ........................................................................................122 
8.5.4. 
Safety Analyses ........................................................................................................128 
8.5.5. 
Subgroup Analyses ...................................................................................................129 
8.6. 
Planned Analyses ......................................................................................................130 
8.6.1. 
Interim Analysis ........................................................................................................130 
8.6.2. 
Final Analyses ..........................................................................................................130 
9. 
REFERENCES .........................................................................................................131 
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................133 
10.1. 
APPENDIX 1: Schedule of Events ...........................................................................134 
10.2. 
APPENDIX 2: Study Governance Considerations ...................................................147 
10.2.1. 
Regulatory and Ethical Considerations ....................................................................147 
10.2.2. 
Study Monitoring ......................................................................................................147 
10.2.3. 
Audits and Inspections ..............................................................................................148 
10.2.4. 
Financial Disclosure .................................................................................................149 
10.2.5. 
Recruitment Procedures ............................................................................................149 
10.2.6. 
Informed Consent/Assent Process ............................................................................149 
10.2.7. 
Protocol Amendments ..............................................................................................150 
10.2.8. 
Protocol Deviations ..................................................................................................150 
10.2.9. 
Data Protection .........................................................................................................151 
10.2.10. 
Sample Retention and Future Biomedical Research ................................................151 
10.2.11. 
Safety Oversight .......................................................................................................151 
10.2.12. 
Dissemination of Clinical Study Data ......................................................................152 
10.2.13. 
Data Quality Assurance and Quality Control ...........................................................152 
10.2.14. 
Data Collection and Management ............................................................................153 
10.2.15. 
Source Documents ....................................................................................................153 
10.2.16. 
Retention of Records ................................................................................................153 

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10.2.17. 
Study and Site Closure..............................................................................................154 
10.2.18. 
Publication Policy .....................................................................................................154 
10.3. 
APPENDIX 3: Contraceptive Guidance ...................................................................156 
10.4. 
APPENDIX 4: Adverse Events of Special Interest Terms .......................................158 
10.5. 
APPENDIX 5: Protocol Amendment History ..........................................................160 
10.5.1. 
Amendment 10, 23 Mar 2023 ...................................................................................160 
10.5.2. 
Amendment 9, 30 Sep 2022 ......................................................................................163 
10.5.3. 
Amendment 8, 01 Aug 2022 .....................................................................................165 
10.5.4. 
Amendment 7, 26 Apr 2022 .....................................................................................165 
10.5.5. 
Amendment 6, 17 Mar 2022 .....................................................................................166 
10.5.6. 
Amendment 5, 10 Feb 2022 ......................................................................................168 
10.5.7. 
Amendment 4, 04 Jan 2022 ......................................................................................169 
10.5.8. 
Amendment 3, 15 Sep 2021 ......................................................................................172 
10.5.9. 
Amendment 2, 26 Jul 2021 .......................................................................................174 
10.5.10. 
Amendment 1, 23 Jun 2021 ......................................................................................178 
 
 
 

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LIST OF TABLES  
Table 1: 
Part A.1 – 50 µg mRNA-1273.211 and 100 µg mRNA-1273.211 .............................60 
Table 2: 
Part A.2 – Second booster dose 50 µg mRNA-1273.214: Participants who 
received an mRNA-1273.211 50 µg as a first booster dose in Part A.1 .....................61 
Table 3: 
Part B – 100 µg mRNA-1273 .....................................................................................62 
Table 4: 
Part C – 50 µg mRNA-1273.617.2 and 100 µg mRNA-1273.617.2 ..........................62 
Table 5: 
Part D – 50 µg mRNA-1273.213 and 100 µg mRNA-1273.213 ................................63 
Table 6: 
Part F – Cohort 1 (first booster dose): Participants Who Previously Received 
100 µg mRNA-1273 Primary Series and Have Not Received a Booster Dose 
Previously (50 and 100 µg mRNA-1273.529) ............................................................64 
Table 7: 
Part F–- Cohort 2 (second booster dose): Participants Who Previously 
Received 100 µg mRNA-1273 Primary Series Plus 1 Booster Dose of 50 µg 
mRNA-1273 (50 µg mRNA-1273.529 and 50 µg mRNA-1273) ...............................66 
Table 8: 
Part G – Second Booster Dose 50 µg mRNA-1273.214: Participants Who 
Received 100 µg mRNA-1273 Primary Series and a Booster Dose of 50 µg 
mRNA-1273 ...............................................................................................................67 
Table 9: 
Part H - Second Booster Dose 50 µg mRNA-1273.222: Participants Who 
Received 100 µg mRNA-1273 Primary Series and a Booster Dose of 50 µg 
mRNA-1273 ...............................................................................................................69 
Table 10: Part J –- Booster dose of mRNA-1273.815 (50 µg) or mRNA-1273.231 
(50 µg): Participants who previously received a primary series of mRNA 
vaccine, a first booster dose of a monovalent mRNA vaccine, and a second 
booster dose of a bivalent mRNA vaccine against SARS-CoV-2 ..............................70 
Table 11: Study Arms .................................................................................................................74 
Table 12: Blood and Nasopharyngeal Swab Sampling for Parts A.1, B, C, D, F, and G .........102 
Table 13: Blood and Nasopharyngeal Swab Sampling for Parts A.2, H, and J ........................102 
Table 14: Solicited Adverse Reactions and Grades ..................................................................105 
Table 15: Analysis Sets .............................................................................................................121 
Table 16: Analysis Strategy for Safety Parameters ..................................................................129 
Table 17: Schedule of Events for Parts A.1, B, C, D, F, and G ................................................134 
Table 18: Schedule of Events for Part A.2 ...............................................................................138 
Table 19: Schedule of Events for Part H ..................................................................................141 
Table 20: Schedule of Events for Part J ....................................................................................144 
 
LIST OF FIGURES  
Figure 1: 
Statistical Hypotheses Testing Strategy for Part G...................................................125 
Figure 2: 
Statistical Hypotheses Testing for Part H .................................................................127 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS  
The following abbreviations and terms are used in this study protocol. 
Abbreviation or Specialist Term 
Definition 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
AR 
adverse reaction 
ARDS 
acute respiratory distress syndrome 
AST 
aspartate aminotransferase 
bAb 
binding antibody 
CDC 
US Centers for Disease Control and Prevention 
CEAC 
Cardiac Event Adjudication Committee 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CoV 
coronavirus 
COVID-19 
coronavirus disease 2019 
CRO 
contract research organization 
CSP 
clinical study protocol 
CSR 
clinical study report 
DSPC 
1,2-distearoyl-sn-glycero-3-phosphocholine 
ECG or EKG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eDiary 
electronic diary 
EoS 
end of study 
EUA 
Emergency Use Authorization 
FAS 
Full Analysis Set 
FDA 
United States Food and Drug Administration 
FSH 
follicle-stimulating hormone 

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Abbreviation or Specialist Term 
Definition 
GCP 
Good Clinical Practice 
GLSM 
geometric least square mean 
GMFR 
geometric mean fold rise 
GMR 
ratio of geometric mean titers 
GMT 
geometric mean titer 
HCP 
healthcare practitioner 
HIPAA 
Health Insurance Portability and Accountability Act 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IM 
intramuscular 
IP 
investigational product 
IRB 
institutional review board 
LLOQ 
lower limit of quantitation 
LNP 
lipid nanoparticle 
LTFU 
lost to follow-up 
MAAE 
medically attended adverse event 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed effect model repeated measure 
mRNA 
messenger RNA 
nAb 
neutralizing antibody 
NP 
nasopharyngeal 
PBMC 
peripheral blood mononuclear cells 
PEG-2000-DMG 
1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol 
with polyethylene glycol of average molecular weight 2000 
PP 
per-protocol 
RBD 
receptor-binding domain 
RT-PCR 
reverse transcriptase polymerase chain reaction 

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Abbreviation or Specialist Term 
Definition 
S 
spike 
S-2P 
prefusion stabilized spike protein 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS 
severe acute respiratory syndrome 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SoE 
schedule of events 
SRR 
seroresponse rate 
USP 
United States Pharmacopoeia 
VOC 
variants of concern 
WHO 
World Health Organization 
 

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GLOSSARY OF TERMS  
Term/Concept  
Definition  
Adequate female 
contraception  
Consistent and correct use of a FDA-approved contraceptive method 
in accordance with the product label.  
Adverse event (AE)  
Any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related.  
Adverse event of special 
interest (AESI)  
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.  
A list of the AESI pertinent to this study is provided in Section 10.4 
(Appendix 4).  
Adverse reaction (AR)  
Any AE for which there is a reasonable possibility that the vaccine 
caused the AE. 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.  
Solicited ARs are defined in Section 7.4.3.  
Anaphylaxis  
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.  
Characteristics of anaphylaxis are provided in Section 7.4.4.  
Asymptomatic SARS-CoV-2 
infection  
Asymptomatic SARS-CoV-2 infection is defined as a positive 
RT-PCR test on a respiratory sample in the absence of symptoms or a 
positive serologic test for anti-nucleocapsid antibody after a negative 
test at time of enrollment.  
COVID-19 symptoms  
Fever (temperature ≥ 38.0°C [100.4°F]) or chills  
Cough  
Shortness of breath and/or difficulty  
Fatigue  
Muscle or body aches  
Headache  
New loss of taste and/or smell  
Sore throat, congestion, or runny nose  
Nausea or vomiting  
Diarrhea  
Phase 3 Study (mRNA-1273-
P301) definition of COVID-
19  
The participant must have experienced at least TWO of the following 
systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore 
throat, 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 

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Term/Concept  
Definition  
breathing, OR clinical or radiographical evidence of pneumonia; AND 
The participant must have at least one NP swab, nasal swab, or saliva 
sample (or respiratory sample, if hospitalized) positive for SARS-
CoV-2 by RT-PCR.  
End of Study  
Completion of the last visit of the last participant in the study or last 
scheduled procedure, as shown in the SoE (Table 17, Table 18, 
Table 19, and Table 20) for the last participant in the study. 
Lost to follow-up  
A participant who repeatedly fails to return for scheduled visits 
without stating an intention to withdraw consent and is unable to be 
contacted by the study site.  
Medically attended adverse 
event (MAAE)  
An AE that leads to an unscheduled visit to a healthcare provider.  
Nonchildbearing potential  
Surgically sterile (history of bilateral tubal ligation, bilateral 
oophorectomy, hysterectomy) or postmenopausal (defined as 
amenorrhea for ≥ 12 consecutive months prior to screening without an 
alternative medical cause).  
Screen failures  
Participants who consent to participate in the clinical study but are not 
subsequently assigned to treatment.  
Serious adverse event (SAE)  
An AE is considered an SAE, if, in the view of either the investigator 
or Sponsor, it results in any of the following outcomes (see 
Section 7.4.2 for further details of each criterion):  
Death  
Is life-threatening  
Inpatient hospitalization or prolongation of existing hospitalization  
Persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions  
Congenital anomaly or birth defect  
Medically important event.  
Symptomatic COVID-19  
The presence of one of the CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory sample.  
Unsolicited AE  
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, 7 days after 
vaccination).  
Women of childbearing 
potential  
Women of childbearing potential are those who are considered fertile 
following menarche and until becoming postmenopausal unless 
permanently sterile (see Section 10.3, Appendix 3).  
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; 
MAAE = medically attended adverse event; RT-PCR = reverse transcriptase polymerase chain reaction; 
SAE = serious adverse event.  

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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 and severe acute 
respiratory syndrome (SARS). An outbreak of a novel coronavirus (COVID-19, later designated 
SARS-CoV-2) initially emerged in Wuhan, Hubei Province, China in December 2019. The 
World Health Organization (WHO) declared COVID-19 a pandemic on 11 Mar 2020 with more 
than 157 million cases and 3.2 million deaths by 09 May 2021 (WHO 2021). 
ModernaTX, Inc. (the Sponsor)’s scalable messenger RNA (mRNA)/lipid nanoparticle (LNP) 
technology platform allowed for a rapid response to the pandemic and was used to develop 
mRNA-1273, a novel LNP-encapsulated mRNA-based vaccine against SARS-CoV-2. 
mRNA-1273 contains a single mRNA (CX-024414) that encodes for the full-length 
SARS-CoV-2 spike (S) protein of the Wuhan-Hu-1 SARS-CoV-2 virus, modified with 2 proline 
substitutions within the heptad repeat 1 domain (S-2P) to stabilize the spike protein into a 
prefusion conformation. Having achieved the primary endpoint in a pivotal Phase 3 study 
conducted in persons at high risk for SARS-CoV-2 infection, in December 2020, mRNA-1273 
was granted EUA for the prevention of COVID-19 for individuals 18 years of age and older 
based on the demonstration of efficacy and safety in a Phase 3 pivotal trial and was subsequently 
licensed in the US (31 January 2022) (Baden et al 2021). 
Over the course of the pandemic, SARS-CoV-2 variants have emerged and are likely to continue 
to emerge, some of which may prove to have some level of escape from immunity associated 
with previous infection or vaccination. Recently, newer variants have raised concern, due to 
reports of increased infectivity or reduction in the ability of convalescent sera or sera from 
vaccinated participants to neutralize these emergent strain variants. Mutations occurring in the 
receptor-binding domain (RBD) are of particular concern, as this site includes the dominant 
neutralization epitopes on the S protein and these mutations could impact the effectiveness of 
antibodies elicited by infection or vaccination in neutralizing the virus (Greaney et al 2021). 
These recent evolutionary events indicate that SARS-CoV-2 has the capacity to develop more 
efficient transmission between human hosts (Martin et al 2021) and vaccination strategies to 
control the virus need to be responsive to this evolution. A SARS-CoV-2 variant, B.1.1.7, rapidly 
spread from southeast England around the globe. Relative to the Wuhan viral isolate, B.1.1.7 
includes 8 mutations located in the S protein, including the N501Y mutation occurring in the 
RBD. Early analyses indicate that B.1.1.7 has a substantial fitness advantage over other currently 
circulating lineages. The B.1.351 variant emerged in South Africa, and the P.1 lineage has 
recently been reported in Brazil. There are at least 11 mutations located in the S protein, 3 of 
which (K417N, E484K, and N501Y) are found in the RBD. More recently SARS-CoV-2 variants 
emerged in India, and the B.1.617.2 variant (Delta variant) containing 2 mutations in the RBD 
(L452R and T478K) is currently circulating globally. In vitro characterization of sera from 
individuals recently vaccinated with the 2-dose regimen of the Moderna COVID-19 Vaccine at 
the 100 µg dose showed that the Moderna COVID-19 Vaccine produced neutralizing titers 
against key emerging variants tested, including B.1.1.7, B.1.351, and B.1.617.2 (Wang et al 
2021, Wu et al 2021a, Choi A et al 2021). The studies showed no significant reduction in 
neutralizing titers against the B.1.1.7 relative to the ancestral Wuhan-Hu-1 strain and a 2.1-fold 

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reduction versus B.1.617.2; however, a greater than six-fold reduction in neutralizing titers was 
observed against the B.1.351 variant relative to the Wuhan-Hu-1. Evidence from adenovirus 
vector SARS-CoV-2 vaccines based on the Wuhan-Hu-1 sequence suggests reduced vaccine 
efficacy against moderate to severe COVID-19 in South Africa where the B.1.351 variant is 
circulating (Madhi et al 2021, Sadoff et al 2021). 
In November 2021, the SARS-CoV-2 Omicron variant (B.1.1.529; BA.1) was detected in South 
Africa and currently epidemiological information about its spread in other regions is being 
evaluated. The Omicron variant has significant antigenic change with a potential growth 
advantage. In addition, it contains potential antibody escape site mutations (such as K417N, 
T478K, E484A, and N501Y). After the emergency of the BA.1 sublineage, other Omicron 
sublineages (BA.2, BA.4, BA.5, and XBB.1.5) with additional potential antibody escape site 
mutations have been detected in multiple geographies. 
There is an urgent need for vaccination strategies that induce broader protection against variants 
of concern (VOC), to decrease morbidity and mortality. In addition, it is currently not known 
whether breakthrough infections could occur long-term due to waning antibody titers 
(Doria-Rose et al 2021, Pegu A et al). Based on the experience of mRNA-1273 and leveraging 
the flexible nature of the mRNA technology, Moderna is evaluating multiple mRNA vaccines to 
address emerging variants. 
Overall, study Parts A.1, B, C, and D will assess antibody response of a single booster dose of 
the mRNA vaccines in each study part. Study Part F Cohort 1 will assess whether a single 
booster dose of the mRNA-1273.529 as the first booster dose will elicit a similar or superior 
antibody response to the B.1.1.529 compared to a single booster dose of mRNA-1273, using an 
external comparator; Study Part F Cohort 2 will assess whether a single booster dose of the 
mRNA-1273.529 as a second booster dose will elicit a similar or superior antibody response to 
the B.1.1.529 compared to a single booster dose of mRNA-1273 as a second booster dose. Study 
Part G will assess whether a single booster dose of the mRNA-1273.214 as a second booster 
dose will elicit a similar or superior antibody response to the B.1.1.529 compared to a single 
booster dose of mRNA-1273 as a second booster dose (Part F, Cohort 2, 50 µg mRNA-1273). 
Study Part A.2 will assess whether a second booster dose with mRNA-1273.214 (50 µg) in 
individuals who have previously received the mRNA-1273.211 (50 µg) booster will elicit a 
robust immune response against SARS-CoV-2. Study Part H will assess whether a single booster 
dose of the mRNA-1273.222 50 µg as a second booster dose elicits a superior antibody response 
against Omicron BA.4/5 compared to a single booster dose of mRNA-1273 as a second booster 
dose (Part F, Cohort 2, 50 µg mRNA-1273). Part J will assess whether a booster dose of 
mRNA-1273.815 or mRNA-1273.231 will elicit a robust immune response against SARS-CoV-2 
Omicron BA.4/BA.5, BQ.1.1, and XBB.1.5 variants in individuals who previously received a 
primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a 
second booster dose of a bivalent mRNA vaccine against SARS-CoV-2. 
Background and Overview 
The Sponsor has developed a rapid response, proprietary vaccine platform based on mRNA 
delivery system. The platform is based on the principle and observations that cells in vivo can 
take up mRNA, translate it, and then express 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. 

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1.1.1. 
mRNA-1273  
The Sponsor is using its mRNA-based platform to develop a novel LNP-encapsulated 
mRNA-based vaccine against SARS-CoV-2 (mRNA-1273). mRNA-1273 encodes for the 
full-length S protein of SARS-CoV-2, modified to introduce 2 proline residues to stabilize the 
S protein (S-2P) in a prefusion conformation. 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 (Corbett et al 2020). It has been confirmed that the stabilized 
SARS-CoV-2 S2P antigen presents in the correct prefusion conformation (Wrapp et al 2020). 
1.1.2. 
mRNA-1273.211  
mRNA-1273.211 is a multivalent product that contains 2 mRNAs: CX-024414 encoding for the 
S-2P of Wuhan-Hu-1 and CX-027367 encoding for the S-2P of B.1.351, in a 1:1 ratio. 
1.1.3. 
mRNA-1273.617.2  
mRNA-1273.617.2 contains mRNA CX-029444 encoding for the S-2P of B.1.617.2. 
1.1.4. 
mRNA-1273.213  
mRNA-1273.213 is a multivalent product that contains 2 mRNAs: CX-029444 encoding for the 
S-2P of B.1.617.2 and CX-027367 encoding for the S-2P of B.1.351, in a 1:1 ratio. 
1.1.5. 
mRNA-1273.529  
mRNA-1273.529 contains mRNA CX-031302 encoding for the S-2P of B.1.1.529. 
1.1.6. 
mRNA-1273.214  
mRNA-1273.214 contains CX-024414, the mRNA that encodes for the prefusion stabilized spike 
glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the mRNA 
that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 variant. 
1.1.7. 
mRNA-1273.222  
mRNA-1273.222 contains CX-024414, the mRNA that encodes for the prefusion stabilized spike 
glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-034476, the mRNA 
that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 subvariants BA.4/BA.5. 
1.1.8. 
mRNA-1273.815  
mRNA-1273.815 contains CX-038839, the monovalent mRNA that encodes for the S-2P of the 
SARS-CoV-2 Omicron subvariants XBB.1.5/XBB.1.9.1. 
1.1.9. 
mRNA-1273.231  
mRNA-1273.231 contains CX-034476 and CX-038839, the bivalent mRNA that encodes for the 
S-2P of the SARS-CoV-2 B.1.1.529 Omicron subvariants BA.4/BA.5 and XBB.1.5/XBB.1.9.1. 

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1.2. 
Nonclinical Studies  
The Sponsor has conducted preclinical studies to evaluate modified vaccines. The 
immunogenicity of mRNA-1273.351 (a monovalent product containing mRNA CX-027367) and 
a 1:1 mix of mRNA-1273 and mRNA-1273.351 was evaluated in BALB/c mice. Both vaccines 
were evaluated as a 2-dose primary series in mice, and mRNA-1273.351 was also evaluated as a 
booster dose in animals previously vaccinated with 2 doses of mRNA-1273. The results 
demonstrated that a primary vaccination series of mRNA-1273.351 was effective at increasing 
nAb titers against the B.1.351 variant, while a 1:1 mix of mRNA-1273 and mRNA-1273.351 was 
most effective at providing broad cross-variant neutralization. Studies also demonstrated that a 
third dose of mRNA-1273.351 significantly increased both Wuhan-Hu-1 and B.1.351-specific 
neutralization titers (Wu et al 2021b). 
Additional studies are being performed in mice, golden Syrian hamsters, and rhesus macaques to 
further evaluate mRNA-1273, mRNA-1273.351, and mRNA-1273.211 as both a primary series 
vaccine and as a single booster dose in animals previously vaccinated with a primary 
mRNA-1273 vaccine series. These studies are to determine the immunogenicity of the primary 
series or booster vaccines and to evaluate protection from challenge with wild-type and variant 
viruses. These data will be reported once studies have been completed. A vaccine that contains 
the spike protein sequence of the B.1.617.2 vaccine has been developed, mRNA-1273.617.2. The 
immunogenicity of this vaccine is being evaluated as a monovalent product and as a component 
in a multivalent formulation, mixed with mRNA-1273 or mRNA-1273.351. Additional animal 
studies are currently being conducted with mRNA vaccines that target different Omicron 
variants. 
1.3. 
Clinical Studies  
The Sponsor has previously evaluated modified Beta variant-matched booster vaccines in the 
completed Phase 2a clinical study (NCT04405076) and the Sponsor is currently evaluating 
several modified vaccines (containing spike sequences of the Beta, Delta, and Omicron variants) 
in the present study, mRNA-1273-P205. 
1.4. 
Benefit/Risk Assessment  
1.4.1. 
Known Potential Benefits  
The following benefits may accrue to participants that will receive the mRNA-1273.211, 
mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, 
mRNA-1273.222, mRNA-1273.815, or mRNA-1273.231 booster vaccine candidates: 
• The mRNA-1273.211 vaccine candidate may be an effective vaccine against 
COVID-19 VOC and may provide an effective immune response against ancestral 
SARS-CoV-2. 
• The mRNA-1273.617.2 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 
• The mRNA-1273.213 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 

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• The mRNA-1273.529 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 
• The mRNA-1273.214 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 
• The mRNA-1273.222 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 
• The mRNA-1273.815 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 
• The mRNA-1273.231 vaccine candidate may be an effective vaccine against 
COVID-19 VOC. 
• 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 VOC, a 
current pandemic disease. 
1.4.2. 
Risks from Study Participation and Their Mitigation  
The safety profile of mRNA-1273 is largely based on data from the pivotal Phase 3 Study 
mRNA-1273-P301 (COVE). 
Solicited ARs were reported more frequently among vaccine participants than among placebo 
participants. The most frequently reported ARs after any dose in the vaccine group were pain at 
the injection site, fatigue, headache, myalgia and chills. The most common solicited local AR 
was pain. Solicited systemic ARs were reported more frequently by vaccine participants after 
dose 2 (fatigue, 65.3%, headache, 58.6%, myalgia, 58% and arthralgia, 42.8%) than after dose 1 
(fatigue, 37,2%, headache, 32.7%, myalgia, 22.7% and arthralgia,16.6%). Grade 3 systemic ARs 
were also reported more frequently after dose 2 than after dose 1. 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. 
Unsolicited AEs that occurred within 28 days following each vaccination were reported by 
23.9% of participants who received mRNA-1273 and 21.6% of participants who received 
placebo. 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% vs. 0.6%). All of the lymphadenopathy events are similar to the axillary 
swelling/tenderness in the injected arm reported as solicited ARs. Several participants reported 
injection site reactions after Day 7 that were characterized by erythema, induration and often 
pruritus. Consultation with a dermatopathologist suggested that these were most likely dermal 
hypersensitivity and were unlikely to represent a long-term safety concern. 

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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. 
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. Currently available information on Bell’s palsy is insufficient 
to determine a causal relationship with the vaccine. 
SAEs were reported at the same rates in participants who received mRNA-1273 and placebo 
from the first dose until the last observation. 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. 
There were no other notable patterns or numerical imbalances between study arms for specific 
categories of AEs (including other neurologic, neuro-inflammatory, and thrombotic events) that 
would suggest a causal relationship to mRNA-1273. 
In the Post-Authorization setting, anaphylaxis has been reported following mRNA-1273 
administration. In addition, 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 shortly 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. Healthcare professionals should be alert to the signs 
and symptoms of myocarditis and pericarditis. Safety will be monitored throughout the study 
(Section 7.4). 
1.4.3. 
Overall Benefit/Risk Conclusion  
The evolving antigenic variation of SARS-CoV-2 underscores the urgent need for vaccination 
strategies that induce broader protection, specifically against VOC with attendant risk of viral 
escape. ModernaTX, Inc. is developing monovalent and multivalent mRNA vaccines (including 
mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231) that are similar to 
the mRNA-1273 vaccine, but in which the mRNA encodes for mutations included in the 
S protein of both ancestral SARS-CoV-2 (Wuhan-Hu-1) and VOC to enhance protection against 
COVID-19 caused by SARS-CoV-2 variants. 

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2. 
OBJECTIVES AND ENDPOINTS  
This study consists of 9 parts: A (1, 2), B, C D, E, F, G, H, and J. The objectives and endpoints 
in each part are described in the tables below, Part E objectives and endpoints are described in a 
site-specific protocol amendment and are not covered in this global protocol amendment. The 
objectives and endpoints for Parts A (1, 2), B, C, and D are described below in Table 1, Table 2, 
Table 3, Table 4, and Table 5, respectively, the objectives and endpoints for Part F (Cohorts 1 
and 2) are described in Table 6 and Table 7, the objectives and endpoints for Part G are 
described in Table 8, the objectives and endpoints for Part H are described in Table 9, and the 
objectives and endpoints for Part J are described in Table 10. 
Table 1: 
Part A.1 – 50 µg mRNA-1273.211 and 100 µg mRNA-1273.211 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity 
of mRNA-1273.211 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS 
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.211 at selected timepoints 
post boost 
• 
Immune response of mRNA-1273.211 against 
ancestral SARS-CoV-2 and SARS-CoV-2 
variants including B.1.351 at selected timepoints 
post boost by GMT, GMFR and SRR 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the CDC 
criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment 
• 
To evaluate the genetic and/or 
phenotypic relationships of isolated 
SARS-CoV-2 strains to the vaccine 
sequence 
• 
Characterize the SARS-CoV-2 genomic sequence 
of viral isolates and compare with the vaccine 
sequence 

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Table 2: 
Part A.2 – Second booster dose 50 µg mRNA-1273.214: Participants who 
received an mRNA-1273.211 50 µg as a first booster dose in Part A.1 
Objectives 
Endpoints 
Primary 
• 
To evaluate the immunogenicity of 
mRNA-1273.214 (50 µg) as a second 
booster dose in participants who 
previously received a first booster dose of 
mRNA-1273.211 (50 µg) 
GMT ratio and SRR difference of 
mRNA-1273.214 (50 µg) as a second booster 
dose against the ancestral SARS-CoV-2 and 
against SARS-CoV-2 variants (including 
Omicron) compared to mRNA-1273.211 (50 µg) 
against the ancestral SARS-CoV-2 and against 
SARS-CoV-2 variants as the first booster dose 
(Day 29, Day 181) 
• 
To assess the safety and reactogenicity of 
the mRNA-1273.214 (50 µg) given as a 
second booster dose in participants who 
previously received a first booster dose of 
mRNA-1273.211 (50 µg) 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS 
Secondary 
• 
To evaluate the immunogenicity of 
mRNA-1273.214 (50 µg) as a second 
booster dose in participants who 
previously received a first booster dose of 
mRNA-1273.211 (50 µg) 
• 
Antibody response of the mRNA-1273.214 
(50 µg) against the ancestral SARS-CoV-2 and 
against SARS-CoV-2 variants (including 
Omicron) by GMT and SRR at multiple time 
points after the mRNA-1273.214 booster dose 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study. 
− 
Secondary case definition based on the CDC 
criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample. 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment.  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 
isolates to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic sequence 
of viral isolates and compare with the vaccine 
sequence 

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Table 3: 
Part B – 100 µg mRNA-1273 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS 
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273 at selected timepoints post 
boost 
• 
Immune response of mRNA-1273 against the 
ancestral SARS-CoV-2 and against SARS-
CoV-2 variants at selected timepoints post boost 
by GMT, GMFR, and SRR 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study. 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample. 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment.  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 
strains to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Table 4: 
Part C – 50 µg mRNA-1273.617.2 and 100 µg mRNA-1273.617.2 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.617.2 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS 

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Objectives 
Endpoints 
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.617.2 at selected timepoints 
post boost 
• 
Immune response of mRNA-1273.617.2 against 
the ancestral SARS-CoV-2 and against 
SARS-CoV-2 variants including B.1.617.2 at 
selected timepoints post boost by GMT, GMFR, 
and SRR 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a negative 
test at time of enrollment 
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 
strains to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Table 5: 
Part D – 50 µg mRNA-1273.213 and 100 µg mRNA-1273.213 
Objectives 
Endpoints 
Primary 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.213 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Exploratory 
• 
To evaluate the immunogenicity of 
mRNA-1273.213 at selected timepoints 
post boost 
• 
Immune response of mRNA-1273.213 against 
the ancestral SARS-CoV-2 and against 
SARS-CoV-2 variants including B.1.351 and 
B.1.617.2 at selected timepoints post boost 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 

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Objectives 
Endpoints 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample 
• 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of symptoms 
or a positive serologic test for anti-nucleocapsid 
antibody after a negative test at time of 
enrollment  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 
strains to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with 
the vaccine sequence 
Table 6: 
Part F – Cohort 1 (first booster dose): Participants Who Previously Received 
100 µg mRNA-1273 Primary Series and Have Not Received a Booster Dose 
Previously (50 and 100 µg mRNA-1273.529) 
Objectives 
Endpoints 
Primary 
• 
To demonstrate non-inferiority of the 
antibody response against the Omicron 
variant (B.1.1.529) of a first booster dose of 
mRNA-1273.529 compared to a first booster 
dose of mRNA-1273 (50 µg) based on GMT 
ratio and SRR difference 
• 
To demonstrate superiority of the antibody 
response against the Omicron variant 
(B.1.1.529) of a first booster dose of 
mRNA-1273.529 compared a first booster 
dose of mRNA-1273 (50 µg) based on GMT 
ratio 
• 
Day 29 postboost GMT ratio of Omicron-
specific GMT of mRNA-1273.529 over the 
Omicron-specific GMT of mRNA-1273 
(historical mRNA-1273 booster dose control) 
• 
Day 29 SRR difference between 
mRNA-1273.529 against Omicron and 
mRNA-1273 against Omicron 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.529 
• 
Solicited local and systemic reactogenicity 
ARs during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal 
and AESI from Day 1 to EoS  

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Objectives 
Endpoints 
Secondary 
• 
To evaluate the immunogenicity of a 
mRNA-1273.529 dose compared to a 
mRNA-1273 administered as a first booster 
dose at selected timepoints post boost 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the Omicron variant at 
selected timepoints post boost 
• 
SRR difference between mRNA-1273.529 
against the Omicron variant and mRNA-1273 
against the Omicron variant 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the ancestral 
SARS-CoV-2 and other variants at selected 
timepoints post boost 
• 
SRR difference between mRNA-1273.529 
against the ancestral SARS-CoV-2 and other 
variants and mRNA-1273 against the 
ancestral SARS-CoV-2 and other variants 
Exploratory 
• 
To assess for symptomatic and asymptomatic 
SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a 
negative test at time of enrollment  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 strains 
to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with 
the vaccine sequence 
• 
To characterize the cellular immune response 
of the mRNA-1273.529 booster dose against 
the ancestral SARS-CoV-2 and against 
variants 
• 
T-cell and B-cell response after the 
mRNA-1273.529 booster 

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Table 7: 
Part F–- Cohort 2 (second booster dose): Participants Who Previously 
Received 100 µg mRNA-1273 Primary Series Plus 1 Booster Dose of 50 µg 
mRNA-1273 (50 µg mRNA-1273.529 and 50 µg mRNA-1273) 
Objectives 
Endpoints 
Primary 
• 
To demonstrate non-inferiority of the 
antibody response against the Omicron 
variant (B.1.1.529) of a second booster dose 
of mRNA-1273.529 compared to a second 
booster dose of mRNA-1273 (50 µg) based 
on GMT ratio and SRR difference 
• 
To demonstrate superiority of the antibody 
response against the Omicron variant 
(B.1.1.529) of a second booster dose of 
mRNA-1273.529 compared to a second 
booster dose of mRNA-1273 (50 µg) based on 
GMT ratio 
• 
Day 29 postboost GMT ratio of Omicron-
specific GMT of mRNA-1273.529 over the 
Omicron-specific GMT of mRNA-1273 
• 
Day 29 SRR difference between 
mRNA-1273.529 against Omicron and 
mRNA-1273 against Omicron 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.529 
• 
Solicited local and systemic reactogenicity 
ARs during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal 
and AESI from Day 1 to EoS  
Secondary 
• 
To evaluate the immunogenicity of mRNA-
1273.529 booster compared to mRNA-1273 
booster administered as a second booster dose 
at selected timepoints post boost 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the Omicron variant at 
selected timepoints post boost 
• 
SRR difference between mRNA-1273.529 
against the Omicron variant and mRNA-1273 
against the Omicron variant 
• 
GMT ratio of mRNA-1273.529 and 
mRNA-1273 against the ancestral 
SARS-CoV-2 and other variants at selected 
timepoints post boost 
• 
SRR difference between mRNA-1273.529 
against the ancestral SARS-CoV-2 and other 
variants and mRNA-1273 against the 
ancestral SARS-CoV-2 and other variants 
Exploratory 
• 
To assess for symptomatic and asymptomatic 
SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 

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Objectives 
Endpoints 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
anti-nucleocapsid antibody after a 
negative test at time of enrollment  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 strains 
to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with 
the vaccine sequence 
• 
To characterize the cellular immune response 
of mRNA-1273.529 as a booster against 
SARS-CoV-2 and other variants 
• 
T-cell and B-cell response after the 
mRNA-1273.529 booster 
Table 8: 
Part G – Second Booster Dose 50 µg mRNA-1273.214: Participants Who 
Received 100 µg mRNA-1273 Primary Series and a Booster Dose of 50 µg 
mRNA-1273 
Objectives 
Endpoints 
Primary (see Figure 1) 
• 
To demonstrate non-inferiority of the 
antibody response of a second booster dose 
of mRNA-1273.214 compared to 
mRNA-1273 (50 µg) when administered as 
a second booster dose against the Omicron 
variant (B.1.1.529) at Day 29 or Day 91 
based on GMT ratio and SRR difference at 
Day 29 or Day 91 
• 
To demonstrate superiority of the antibody 
response of a second booster dose of 
mRNA-1273.214 compared to mRNA-1273 
(50 µg) administered as a second booster 
dose against the Omicron variant 
(B.1.1.529) based on GMT ratio at Day 29 
or Day 91 
• 
To demonstrate non-inferiority of the 
antibody response of a second booster dose 
of mRNA-1273.214 compared to 
mRNA-1273 (50 µg) when administered as 
a second booster dose against ancestral 
SARS-CoV-2 based on GMT ratio at 
Day 29 or Day 91 
• 
GMT ratio of Omicron-specific GMT of 
mRNA-1273.214 over the Omicron-specific 
GMT of mRNA-1273 (Part F, Cohort 2, 
50 µg mRNA-1273) at Day 29 and Day 91 
• SRR difference between mRNA-1273.214 
against Omicron variant and mRNA-1273 
against Omicron variant at Day 29 and 
Day 91 
• 
GMT ratio of ancestral SARS-CoV-2 GMT of 
mRNA-1273.214 over ancestral SARS-CoV-2 
GMT of mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273) at Day 29 or Day 91 

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Objectives 
Endpoints 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.214 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after 
vaccination 
• 
Unsolicited AEs during the 28-day follow-up 
period after vaccination 
• 
SAEs, MAAEs, AEs leading to withdrawal and 
AESI from Day 1 to EoS  
Key Secondary 
• 
To demonstrate non-inferiority based on the 
SRR against ancestral SARS-CoV-2 of a 
second booster dose of mRNA-1273.214 
compared to a second booster dose of 
mRNA-1273 (50 µg) at Day 29 or Day 91 
• 
SRR difference between mRNA-1273.214 
against ancestral SARS-CoV-2 and 
mRNA-1273 against ancestral SARS-CoV-2 at 
Day 29 and Day 91 
Secondary 
• 
To evaluate the immunogenicity of 
mRNA-1273.214 booster compared to 
mRNA-1273 booster administered as a 
second booster dose at selected timepoints 
post boost 
• 
GMT ratio of mRNA-1273.214 and 
mRNA-1273 against the Omicron variant at 
selected timepoints post boost 
• 
SRR difference between mRNA-1273.214 
against the Omicron variant and mRNA-1273 
against the Omicron variant at selected 
timepoints post boost 
• 
GMT ratio of mRNA-1273.214 and 
mRNA-1273 against ancestral SARS-CoV-2 
and other variants at selected timepoints post 
boost 
• 
SRR difference between mRNA-1273.214 
against ancestral SARS-CoV-2 and other 
variants and mRNA-1273 against ancestral 
SARS-CoV-2 and other variants at selected 
timepoints post boost 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of one of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCRtest on a respiratory 
sample 
• 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of symptoms 
or a positive serologic test for anti-nucleocapsid 

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Objectives 
Endpoints 
antibody after a negative test at time of 
enrollment  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 
strains to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with 
the vaccine sequence 
• 
To characterize the cellular immune 
response of mRNA-1273.214 as a booster 
against SARS-CoV-2 and other variants 
• 
T-cell and B-cell response after the 
mRNA-1273.214 booster 
Table 9: 
Part H - Second Booster Dose 50 µg mRNA-1273.222: Participants Who 
Received 100 µg mRNA-1273 Primary Series and a Booster Dose of 50 µg 
mRNA-1273 
Objectives 
Endpoints 
Primary  
• 
To demonstrate non-inferiority of the 
antibody response of a second booster dose 
of mRNA-1273.222 50 µg compared to 
mRNA-1273 50 µg when administered as a 
second booster dose against Omicron 
BA.4/5 based on GMT ratio and SRR 
difference at Day 29  
• 
To demonstrate superiority of the antibody 
response of a second booster dose of 
mRNA-1273.222 compared to mRNA-1273 
(50 µg) administered as a second booster 
dose against the Omicron BA.4/5 based on 
GMT ratio at Day 29 
• 
To demonstrate non-inferiority of the 
antibody response of mRNA-1273.222 
50 µg compared to mRNA-1273 50 µg 
when administered as a second booster dose 
against the ancestral SARS-CoV-2 D614G 
based on GMT ratio and SRR difference at 
Day 29 
• 
GMT ratio of Omicron BA.4/5 GMT of 
mRNA-1273.222 over the Omicron BA.4/5 
GMT of mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273) at Day 29 
• 
SRR difference between mRNA-1273.222 
against Omicron BA.4/5 and mRNA-1273 
against Omicron BA.4/5 at Day 29 
• 
GMT ratio of the ancestral SARS-CoV-2 D614G 
GMT of mRNA-1273.222 over the ancestral 
SARS-CoV-2 D614G GMT of mRNA-1273 at 
Day 29 
• 
SRR difference between mRNA-1273.222 and 
mRNA-1273 against the ancestral SARS-CoV-2 
D614G at Day 29 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.222 50 µg 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after injection 
• 
Unsolicited AEs during the 28-day follow-up 
period after injection 
• 
SAEs, MAAEs, AEs leading to withdrawal, and 
AESI from Day 1 to EoS 
Secondary 
• 
To evaluate the immunogenicity of 
mRNA-1273.222 50 µg as a second booster 
dose against the ancestral SARS-CoV-2 
(and other variants) compared to a second 
• 
GMT ratio of mRNA-1273.222 50 µg and 
mRNA-1273 50 µg against ancestral 
SARS-CoV-2 (and other variants) at selected 
timepoints post boost 

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Objectives 
Endpoints 
booster dose of mRNA-1273 50 µg at 
selected timepoints post boost 
• 
SRR difference between mRNA-1273.222 
50 µg and mRNA-1273 50 µg against ancestral 
SARS-CoV-2 and variants of concern at 
selected timepoints post boost 
Exploratory 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of 1 of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
antinucleocapsid antibody after a negative 
test at time of enrollment  
• 
To evaluate the genetic and/or phenotypic 
relationships of isolated SARS-CoV-2 
strains to the vaccine sequence 
• 
Characterize the SARS-CoV-2 genomic 
sequence of viral isolates and compare with the 
vaccine sequence 
Table 10: 
Part J –- Booster dose of mRNA-1273.815 (50 µg) or mRNA-1273.231 
(50 µg): Participants who previously received a primary series of mRNA 
vaccine, a first booster dose of a monovalent mRNA vaccine, and a second 
booster dose of a bivalent mRNA vaccine against SARS-CoV-2 
Objectives 
Endpoints 
Primary  
• 
To evaluate the immunogenicity of mRNA-
1273.815 (50 µg) and mRNA-1273.231 
(50 µg) against SARS-CoV-2 Omicron 
BA.4/BA.5, BQ.1.1, and XBB.1.5 
subvariants at Day 15 and Day 29 
• 
Antibody response of mRNA-1273.815 (50 µg) 
and mRNA-1273.231 (50 µg) against 
SARS-CoV-2 Omicron BA.4/BA.5, BQ.1.1, 
and XBB.1.5 subvariants by GMT, GMFR, and 
SRR at Day 15 and Day 29 
• 
To evaluate the safety and reactogenicity of 
mRNA-1273.815 (50 µg) and 
mRNA-1273.231 (50 µg) 
• 
Solicited local and systemic reactogenicity ARs 
during a 7-day follow-up period after injection 
• 
Unsolicited AEs during the 28-day follow-up 
period after injection 
• 
SAEs, MAAEs, AEs leading to withdrawal, and 
AESI from Day 1 to Day 181 (EoS) 

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Objectives 
Endpoints 
Exploratory 
• 
To evaluate the immunogenicity of mRNA-
1273.815 (50 µg) and mRNA-1273.231 
(50 µg) against SARS-CoV-2 variants at 
selected timepoints 
• 
Antibody response of mRNA-1273.815 (50 µg) 
and mRNA-1273.231 (50 µg) against 
SARS-CoV-2 variants by GMT, GMFR, and 
SRR at selected timepoints 
• 
To assess for symptomatic and 
asymptomatic SARS-CoV-2 infection 
• 
Laboratory-confirmed symptomatic or 
asymptomatic SARS-CoV-2 infection will be 
defined in participants: 
− 
Primary case definition per the 
mRNA-1273-P301 (COVE) study 
− 
Secondary case definition based on the 
CDC criteria: the presence of 1 of the 
CDC-listed symptoms (CDC 2022) and a 
positive RT-PCR test on a respiratory 
sample 
− 
Asymptomatic SARS-CoV-2 infection is 
defined as a positive RT-PCR test on a 
respiratory sample in the absence of 
symptoms or a positive serologic test for 
antinucleocapsid antibody after a negative 
test at time of enrollment  
 

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3. 
STUDY DESIGN  
3.1. 
General Design  
This is an open-label, Phase 2/3 study to evaluate the immunogenicity, safety, and reactogenicity 
of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, 
mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231, administered as 
booster doses. 
Part A.1 
Part A.1 will evaluate the immunogenicity, safety, and reactogenicity of 2 dose levels of the 
mRNA-1273.211 vaccine candidate when administered as a single booster dose to adult 
participants of the mRNA-1273-P301 (COVE) study who have previously received 2 doses of 
mRNA-1273 as a primary series. Two dose levels (50 or 100 µg total mRNA content) of the 
mRNA-1273.211 booster will be evaluated in this study. Enrollment will begin with the 
mRNA-1273.211 50 µg dose arm, followed by the enrollment of the mRNA-1273.211 100 µg 
dose arm. See the IB for further details. 
Part A.2  
Part A.2 will evaluate the immunogenicity, safety, and reactogenicity of the mRNA-1273.214 
vaccine candidate when administered as a second booster dose to adult participants of the 
mRNA-1273-P205 study who have previously received 2 doses of mRNA-1273 as a primary 
series and a first booster dose (50 µg total mRNA content) of the mRNA-1273.211 in Part A.1 of 
this study. 
Part B 
Part B will evaluate the immunogenicity, safety, and reactogenicity of the mRNA-1273 vaccine 
when administered as a single booster dose to adult participants of the mRNA-1273-P301 
(COVE) study who have previously received 2 doses of mRNA-1273 as a primary series. 
Enrollment of Part B will begin upon completion of enrollment of Part A.1 of the study. See the 
IB for further details. 
Part C 
Part C will evaluate the immunogenicity, safety, and reactogenicity of 2 dose levels (50 or 100 
µg) of the mRNA-1273.617.2 vaccine when administered as a single booster dose to adults who 
have previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 
(COVE) or under the EUA. Enrollment of Part C 100 µg dose level will begin upon completion 
of enrollment of Part B of the study. Enrollment of the 50-µg dose arm will begin after 
completion of the 100 µg dose level arm in both Part C and Part D. See the IB for further details. 
Part D 
Part D will evaluate the immunogenicity, safety, and reactogenicity of 2 dose levels (50 or 
100 µg) of the mRNA-1273.213 vaccine when administered as a single booster dose to adults 
who have previously received 2 doses of mRNA-1273 as a primary series in Study 
mRNA-1273-P301 (COVE) or under the EUA. Enrollment of Part D 100µg dose level arm will 
begin upon completion of enrollment of Part C 100µg dose level arm of the study. Part D 50 µg 

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dose arm enrollment will begin after completion of the 100 µg dose arm enrollment and may run 
in parallel with Part C 50 µg dose arm enrollment. See the IB for further details. 
Part E 
Part E consisted of a group described in a site-specific protocol amendment and will not be 
discussed in this global protocol amendment. 
Part F 
Part F will consist of 2 cohorts: Cohort 1–- adults who have previously received 2 doses of 
mRNA-1273 as primary series and Cohort 2- adults who have previously received 2 doses of 
100 µg mRNA-1273 as a primary series and a single booster dose of 50 µg mRNA-1273, in 
Study mRNA-1273-P301 (COVE) or under the EUA. 
Cohort 1 will evaluate the immunogenicity, safety, and reactogenicity of 50 µg of the 
mRNA1273.529 vaccine candidate when administered as a single booster dose to adults who 
have previously received 2 doses of mRNA-1273 as a primary series. 
Cohort 2 will evaluate the immunogenicity, safety and reactogenicity of 50 µg of the 
mRNA-1273.529 and of 50 µg of the mRNA-1273 vaccine candidate when administered as a 
second booster dose to adults who have previously received 2 doses of 100 µg mRNA-1273 as a 
primary series and a single booster dose of 50 µg mRNA-1273. 
Enrollment of the mRNA-1273.529 Cohort 1 will run in parallel with the mRNA-1273.529 in 
Cohort 2. Enrollment of the 50-µg mRNA-1273 arm in Cohort 2 will begin upon completion of 
enrollment of the mRNA-1273.529 Cohort 2 arm and may run in parallel with the enrollment of 
the mRNA-1273.529 Cohort 1 arm. For Cohort 1, the results of the mRNA1273.529 vaccine 
candidate administered as a booster will be compared to the immunogenicity induced after a 
booster dose of mRNA1273 from the external historical comparator arm. (details will be 
provided in the SAP). For Cohort 2, the results of the mRNA1273.529 vaccine candidate 
administered as the second booster dose will be compared to the immunogenicity induced after 
the second booster dose of mRNA-1273. 
Part G 
Enrollment of the mRNA-1273.214 50 µg second boost arm will begin upon completion of 
enrollment of the mRNA-1273 50 µg arm in Cohort 2 of Part F. Enrollment of the 
mRNA-1273.214 50 µg second boost arm may run in parallel with the enrollment of the 
mRNA-1273.529 Cohort 1 arm of Part F. Part G will evaluate the immunogenicity, safety, and 
reactogenicity of 50 µg of the mRNA1273.214 vaccine candidate when administered as a second 
booster dose to adults who have previously received 2 doses of 100 µg mRNA-1273 as a primary 
series and a single booster dose of 50 µg mRNA-1273. The results of the mRNA-1273.214 
vaccine candidate administered as the second booster dose will be compared to the 
immunogenicity induced after the second booster dose of mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273). 
Part H 
Part H will evaluate the immunogenicity, safety, and reactogenicity of 50 µg of the 
mRNA-1273.222 vaccine candidate when administered as a second booster dose to adults who 
have previously received 2 doses of 100 µg mRNA-1273 as a primary series and a single booster 

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dose of 50 µg mRNA-1273. The immunogenicity of the mRNA-1273.222 candidate 
administered as the second booster dose will be compared to the immunogenicity of the second 
booster dose of mRNA-1273 (Part F, Cohort 2, 50 µg mRNA-1273). 
Part J 
Part J of the study will evaluate immunogenicity, safety, and reactogenicity of mRNA-1273.815 
(50 µg) and mRNA-1273.231 (50 µg) administered as a booster to adults who previously 
received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA 
vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2. 
Participants will be randomized in a 1:1 ratio to receive either mRNA-1273.815 (50 µg) or 
mRNA-1273.231 (50 µg). 
Overall, study Parts A.1, B, C, and D will assess antibody response of a single booster dose of 
the mRNA vaccines in each study part. Study Part F Cohort 1 will assess whether a single 
booster dose of the mRNA-1273.529 as the first booster dose elicits a similar or superior 
antibody response to the B.1.1.529 compared to a single booster dose of mRNA-1273, using an 
external historical comparator; Study Part F Cohort 2 will assess whether a single booster dose of 
the mRNA-1273.529 as a second booster dose elicits a similar or superior antibody response to 
the B.1.1.529 compared to a single booster dose of mRNA-1273 as a second booster dose. Study 
Part G will assess whether a single booster dose of the mRNA-1273.214 as a second booster 
dose elicits a similar or superior antibody response to the B.1.1.529 compared to a single booster 
dose of mRNA-1273 as a second booster dose (Part F, Cohort 2, 50 µg mRNA-1273). 
Study Part A.2 will evaluate the immunogenicity, safety, and reactogenicity of the 
mRNA-1273.214 vaccine candidate when administered as a second booster dose to participants 
who rolled over from Part A.1. 
Study Part H will assess whether a single booster dose of the mRNA-1273.222 50 µg as a second 
booster dose elicits a superior antibody response against Omicron BA.4/5 compared to a single 
booster dose of mRNA-1273 as a second booster dose (Part F, Cohort 2, 50 µg mRNA-1273). 
Part J will evaluate whether mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg) administered 
as a booster will elicit antibody response against Omicron subvariants BA.4/BA.5, BQ.1.1, and 
XBB.1.5 in adults who previously received a primary series of mRNA vaccine, a first booster 
dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine 
against SARS-CoV-2. 
Table 11: 
Study Arms 
Study Part 
Study Arm 
Dose1 
N 
Part A.1 
mRNA-1273.211 
50 µg 
~300 
mRNA-1273.211 
100 µg 
~584 
Part A.22 
mRNA-1273.214 
50 µg 
~300 
Part B 
mRNA-1273 
100 µg 
~300 
Part C 
mRNA-1273.617.2 
50 µg 
~584 
mRNA-1273.617.2 
100 µg 
~584 

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Study Part 
Study Arm 
Dose1 
N 
Part D 
mRNA-1273.213 
50 µg 
~584 
mRNA-1273.213 
100 µg 
~584 
Part F (Cohort 1) 
mRNA-1273.529 
50 µg 
~375 
Part F (Cohort 2) 
mRNA-1273.529 
50 µg 
~375 
mRNA-1273 
50 µg 
~375 
Part G 
mRNA-1273.214 
50 µg 
~375 
Part H 
mRNA-1273.222 
50 µg 
~500 
Part J (3rd booster)3, 4 
mRNA-1273.815 
50 µg 
~50 
mRNA-1273.231 
50 µg 
~50 
1. 
Dose is total mRNA. 
2. 
Participants rolled over from Part A.1 to Part A.2. 
3. 
Participants may be rolled over from Part H. 
4. 
Participants will be randomized in a 1:1 ratio to receive either mRNA-1273.815 or mRNA-1273.231. 
The SoEs are provided in Table 17, Table 18, Table 19, and Table 20. Participants in Parts A.1, 
B, C, D, F, and G will have up to 7 visits; 6 visits if screening and dosing are performed on the 
same day. Study vaccine (mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, 
mRNA-1273.213, mRNA-1273.529, or mRNA-1273.214) will be administered as a single dose 
on Day 1. Additional safety and/or immunogenicity study visits will occur on Days 15, 29, 91 
(Part F and G only), 181, and 366 (EoS). Study visits will include scheduled safety phone calls at 
Day 8, every 2 weeks from Day 43 to Day 169 and from Day 209 to Day 349 to collect AEs, 
MAAEs, AESI, AEs leading to withdrawal, SAEs, pregnancies, and information about 
concomitant medications and receipt of non-study vaccinations. 
Participants in Part A.1 who choose to continue in Part A.2 will have 6 additional visits; 5 if 
screening and dosing are performed on the same day. Study vaccine (mRNA-1273.214 [50 µg]) 
will be administered as a single dose on Day 1. Additional safety and/or immunogenicity study 
visits will occur on Days 15, 29, 91, and 181 (EoS). Study visits will include scheduled safety 
phone calls at Day 8, and every 2 weeks from Day 43 to Day 169 to collect AEs, MAAEs, AESI, 
AEs leading to withdrawal, SAEs, pregnancies, and information about concomitant medications 
and receipt of non-study vaccinations. 
Participants in Part H will have up to 6 visits; 5 visits if screening and dosing are performed on 
the same day. Study vaccine (mRNA-1273.222 50 µg) will be administered as a single dose on 
Day 1. Additional safety and/or immunogenicity study visits will occur on Days 15, 29, 91, and 
181 (EoS). Study visits will include scheduled safety phone calls at Day 8, and every 2 weeks 
from Day 43 to Day 169 to collect AEs, MAAEs, AESI, AEs leading to withdrawal, SAEs, 
pregnancies, and information about concomitant medications and receipt of non-study 
vaccinations. 
Participants in Part J may include participants who have previously participated in Part H of this 
study. Participants in Part J will have up to 6 visits; 5 visits if screening and dosing are 
performed on the same day. Study vaccine (mRNA-1273.815 or mRNA-1273.231) will be 
administered as a single dose on Day 1. Additional safety and/or immunogenicity study visits 
will occur on Days 15, 29, 91, and 181 (EoS). Study visits will include scheduled safety phone 

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calls at Day 8, and every 2 weeks from Day 43 to Day 169 to collect AEs, MAAEs, AESI, AEs 
leading to withdrawal, SAEs, pregnancies, and information about concomitant medications and 
receipt of non-study vaccinations. For participants who have previously participated in Part H of 
this study, the total number of visits completed in the study overall will be 10-12 depending on 
whether screening and dosing are performed on the same day. 
At the dosing visit on Day 1, participants will be instructed how to document and report solicited 
ARs within a provided electronic diary (eDiary). Solicited ARs will be assessed for 7 days (the 
day of injection and the following 6 days), and unsolicited AEs will be assessed for 28 days after 
injection; SAEs, MAAEs, AEs leading to withdrawal, pregnancies and AESI will be assessed 
throughout the study. All participants will be tested for the presence of SARS-CoV-2 antibodies 
at baseline and at Day 29 (primary immunogenicity endpoint). Participants in Part J will also be 
tested for the presence of SARS-CoV-2 antibodies at Day 15 (primary immunogenicity 
endpoint). Additional blood draws will be collected on Day 91 (Parts A.2, F, G, H, and J only), 
Day 181, and Day 366 (Parts A.1, B, C, D, F, and G only). In addition, active surveillance for 
intercurrent or breakthrough SARS-CoV-2 infection will occur throughout the study and 
reported as AEs (confirmed symptomatic infections will be reported as MAAEs if not SAEs). 
Participants with signs and symptoms meeting the CDC case definition for COVID-19 
(21 February 2021 or most recent [CDC 2020]) will be asked to contact the site and undergo 
prompt assessment which will include RT-PCR testing (of a respiratory sample) to assess 
symptomatic COVID-19. Participants with any clinical or radiographic evidence of pneumonia 
will also undergo RT-PCR testing. Suspected COVID-19 cases will also be tested using a 
multiplex assay to assess for non–SARS-CoV-2 causes of upper or lower respiratory tract 
infection (Table 12 and Table 13). Participants will have blood samples collected at scheduled 
study site visits during the study for immunogenicity assessments or other medical concerns 
according to the investigator’s judgment. 
Participants may experience AEs, to include symptoms of COVID-19, that necessitate an 
unscheduled visit. There may also be situations in which the investigator asks a participant to 
report for an unscheduled visit following the report of an AE. 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 should be completed for each unscheduled visit. In 
addition, participants may have blood samples collected at unscheduled visits for acute 
respiratory symptoms. 
Peripheral blood mononuclear cells (PBMCs) may be collected for a subset of participants at 
selected sites at baseline (Day 1) and at Days 15, 29, and 91 to characterize the T-cell and B-cell 
responses against SARS-CoV-2 and variants. 
Participants will be enrolled to receive 50 or 100 µg dose of mRNA-1273.211 (Part A.1), 100 µg 
mRNA-1273 (Part B), 50 µg or 100 µg mRNA-1273.617.2 (Part C), 50 µg or 100 µg 
mRNA-1273.213 (Part D), 50 µg mRNA-1273.529 or 50 µg mRNA-1273 (Part F), 50 µg 
mRNA-1273.214 (Part G and Part A.2), 50 µg mRNA-1273.222 (Part H), or 50 µg 
mRNA-1273.815 or 50 µg mRNA-1273.231 (Part J). The interim analysis will be conducted 
based on safety and immunogenicity data collected through Day 15 or Day 29. The interim 
analysis may be conducted either after all participants in Parts A.1, A.2, B, C, D, F, G, H, or J 
have completed their Day 15 or Day 29 visit assessments and/or subsequent timepoint visits (eg, 
Day 91 for Parts F and G, and H) or combined after the last participant in any of the study parts 

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(Parts A.1, A.2, B, C, D, F, G, H or J), dose arm or pre-specified subset of dose arm has 
completed their Day 15 or Day 29 visit assessments. The final study analysis after 12 months of 
follow-up will be completed for all participants in Parts A.1, B, C, D, F, and G. The final study 
analysis after 6 months of follow-up will be completed for all participants in Parts A.2, H, and J. 
3.2. 
Scientific Rationale for Study Design  
This study is designed as an open-label study. 
With SARS-CoV-2 expected to be circulating in the general population during the study, all 
participants will provide pre-injection and post-injection blood samples for analysis of antibodies 
to non-vaccine antigens through 12 months after study injection, or 6 months after study 
injection for Parts A.2, H, and J. In addition, participants will have NP swab samples collected 
before vaccination on Day 1, on Day 29, and also on Day 91 (Parts A.2, F, G, H, and J only), 
Day 181, and Day 366 (EoS) (Parts A.1, B, C, D, F, and G only). Furthermore, in case of any 
signs or symptoms or MAAEs suggesting SARS-CoV-2 infection in a participant, an additional 
NP swab sample and blood sample will be collected 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. 
Since it is possible that participants are naturally exposed to SARS-CoV-2 through community 
exposure, the NP swab samples collected before study injection and the serologic assays 
performed for antibody responses to non-vaccine antigen(s), may help to discriminate between 
natural infection and vaccine-induced antibody responses, should such discrimination be needed. 
3.3. 
Justification for Dose, Control Product, and Choice of Study 
Population  
The dose of the ancestral SARS-CoV-2 vaccine (mRNA-1273) was clinically evaluated at dose 
levels of 25, 50, 100, and 250 µg in a 2-dose series in a Phase 1 dose-ranging study, with the 
100-µg dose level selected for the pivotal Phase 3 trial. Therefore, the dose of 100 µg will be 
used as the booster dose in Part B of this study (monovalent mRNA1273 booster). In addition, 
the dose of 50 µg and100 µg will be used for the monovalent mRNA1273.617.2 booster (Part C). 
In Part D, the bivalent mRNA-1273-213 50 µg and 100µg dose will be used as a booster. In 
Part F, the monovalent mRNA-1273.529 50 µg will be used as a first booster dose after 
mRNA-1273 primary series at least 6 months post-second dose, or as a second booster dose at 
least 3 months after mRNA-1273 50 µg booster. In Part G and Part A.2, the multivalent 
mRNA-1273.214 booster candidate will be administered at the 50-µg dose level as a second 
booster dose. In Part H the multivalent mRNA-1273.222 booster candidate will be administered 
at the 50-µg dose level as a second booster dose. In Part J, the multivalent booster candidates 
mRNA-1273.815 and mRNA-1273.231 will be administered at a dose of 50 µg. 
In the mRNA-1273-P201 study, mRNA-1273 administered as a single booster dose of 50 µg was 
well-tolerated and demonstrated significant boosting of neutralizing antibody responses to 
SARS-CoV-2 in a pseudovirus neutralization assay (Wu et al 2021b). 
This study will screen and enroll healthy adults, 18 years of age and above, who have previously 
received 2 doses of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA (Parts 
A.1, B, C, and D); or who have previously received 2 doses of mRNA-1273 and a booster dose 

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of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA (Parts F, G, and H); or 
who have previously received 2 doses of mRNA-1273 in the mRNA-1273-P301 (COVE) study 
or under EUA and have received a booster dose of mRNA-1273.211 50 µg in Part A.1 of this 
study (Part A.2); or who previously received a primary series of mRNA vaccine, a first booster 
dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine 
against SARS-CoV-2 (Part J).  
3.4. 
End of Study Definition  
A participant is considered to have completed the study if he or she has completed all phases of 
the study including the last scheduled procedure as shown in the SoE (Table 17) for Parts A.1, B, 
C, D, F and G), unless they choose to participate in Part A.2. A participant who chooses to enroll 
in Part A.2 is considered to have completed the study if he or she has completed all phases of the 
study including the last scheduled procedure as shown in the SoE (Table 18). A participant in 
Part H is considered to have completed the study if he or she has completed all phases of the 
study including the last scheduled procedure as shown in the SoE (Table 19), unless they choose 
to participate in Part J. A participant who chooses to enroll in Part J is considered to have 
completed the study if he or she has completed all phases of the study including the last 
scheduled procedure as shown in the SoE (Table 20). 
The EoS is defined as completion of the last visit of the last participant in the study or last 
scheduled procedure, as shown in the SoE (Table 17, Table 18, Table 19, and Table 20, 
whichever is later), for the last participant in the study. 

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4. 
STUDY POPULATION  
Part A.1: 
Approximately 300 participants will receive a single booster dose of mRNA-1273.211 50 µg, to 
achieve 270 evaluable participants in the 50-µg dose study arm. Approximately 584 participants 
will receive a single booster dose of mRNA-1273.211 100 µg, to achieve 526 evaluable 
participants in the 100 µg dose study arm. 
Part A.2: 
Approximately 300 participants will receive a second booster dose of mRNA-1273.214 50 µg. 
Part B: 
Approximately 300 participants will receive a single booster dose of mRNA-1273 100 µg, to 
achieve 270 evaluable participants in Part B of the study. 
Part C: 
Approximately 584 participants will receive a single booster dose of mRNA-1273.617.2 50 µg, 
to achieve 526 evaluable participants in the 50-µg dose study arm. Approximately 
584 participants will receive a single booster dose of mRNA-1273.617.2 100 µg, to achieve 
526 evaluable participants in the 100-µg dose study arm. 
Part D: 
Approximately 584 participants will receive a single booster dose of mRNA-213 50 µg, to 
achieve 526 evaluable participants in the 50-µg dose study arm. Approximately 584 participants 
will receive a single booster dose of mRNA-1273.213 100 µg, to achieve 526 evaluable 
participants in the 100 µg dose study arm. 
Part F: 
In Cohort 1, approximately 375 participants will receive a single booster dose of 
mRNA-1273.529 50 µg after receiving a primary series of mRNA-1273 vaccine to achieve 
300 evaluable participants in the mRNA-1273.529 50 µg dose study arm. 
In Cohort 2, approximately 375 participants will receive a single booster dose of 
mRNA-1273.529 50 µg after receiving a primary series of mRNA-1273 vaccine and a single 
booster dose of mRNA-1273 50 µg to achieve 300 evaluable participants in the mRNA-1273.529 
50 µg study arm. Approximately 375 participants will receive a single booster dose of 
mRNA-1273 50 µg after receiving a primary series of mRNA-1273 vaccine and a single booster 
dose of mRNA1273 50 µg to achieve 300 evaluable participants in the mRNA-1273 50 µg study 
arm. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
Part G: 
Approximately 375 participants will receive a single booster dose of mRNA-1273.214 50 µg 
after receiving a primary series of mRNA-1273 vaccine and a single booster dose of 
mRNA-1273 50 µg, to achieve 300 evaluable participants. 

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Part H: 
Approximately 500 participants will receive a second booster dose of mRNA1273.222 50 µg to 
achieve 300 evaluable participants. 
Part J: 
Approximately 100 participants will be randomized in a 1:1 ratio to receive a single booster dose 
of mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg). 
4.1. 
Inclusion Criteria  
Each participant must meet all of the following criteria to be enrolled in this study: 
1. Male or female, at least 18 years of age at the time of consent (Screening Visit). 
2. Investigator’s assessment that participant understands and is willing and physically able 
to comply with protocol-mandated follow-up, including all procedures. 
3. Participant has provided written informed consent for participation in this study, 
including all evaluations and procedures as specified in this protocol. 
4. Female participants of nonchildbearing potential may be enrolled in the study. 
Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal 
ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as 
amenorrhea for ≥ 12 consecutive months prior to screening [Day 0] without an alternative 
medical cause). A follicle-stimulating hormone (FSH) level may be measured at the 
discretion of the investigator to confirm postmenopausal status. 
5. Female participants of childbearing potential may be enrolled in the study if the 
participant fulfills all of the following criteria: 
• Has a negative pregnancy test on the day of vaccination (Day 1). 
• Has practiced adequate contraception (Section 10.3) or has abstained from all 
activities that could result in pregnancy for at least 28 days prior to Day 1. 
• Has agreed to continue adequate contraception through 3 months following 
vaccination. 
• Is not currently breastfeeding. 
Adequate female contraception is defined as consistent and correct use of a United States 
FDA-approved contraceptive method in accordance with the product label (Section 10.3). 
6. Participant must have been either previously enrolled in the mRNA-1273-P301 (COVE) 
study, must have received 2 doses of mRNA-1273 in that study, with his/her second dose 
at least 6 months prior to enrollment in mRNA-1273-P205, and must be currently 
enrolled and compliant in that study (ie, has not withdrawn or discontinued early); or 
participant must have received 2 doses of mRNA-1273 under the EUA with their second 
dose at least 6 months prior to enrollment in mRNA-1273-P205; or have received a 2 
dose primary series of mRNA-1273 followed by a 50 µg booster dose of mRNA-1273 in 
the mRNA-1273-P301 (COVE) study or under EUA at least 3 months prior to enrollment 
in mRNA-1273-P205; and able to provide proof of vaccination status at the time of 

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screening (Day 1); or for enrollment in Part A.2, participant must be currently enrolled 
and compliant in Part A.1 of the mRNA-1273-P205 study and must have received their 
first booster dose of mRNA-1273.211 50 µg; or for enrollment in Part J, participant must 
meet at least one of the following criteria: 
• Completed enrollment in Part H of the mRNA-1273-P205 study; or 
• Received a 2-dose primary series of mRNA-1273 (100 µg) followed by a 50 µg 
booster dose of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA, 
followed by a 50 µg booster dose of mRNA-1273.222 under EUA at least 3 months 
prior to enrollment in Part J of mRNA-1273-P205; or 
• Previously received a 2-dose primary series of mRNA vaccine against SARS-CoV-2 
followed by a booster dose of a monovalent mRNA vaccine, followed by a second 
booster dose of a bivalent mRNA vaccine. 
Participants in Part J must also provide proof of vaccination status at the time of screening 
(Day 0 or Day 1). 
4.2. 
Exclusion Criteria  
Participants meeting any of the following criteria at the Screening Visit, unless noted otherwise, 
will be excluded from the study: 
1. Had significant exposure to someone with SARS-CoV-2 infection or coronavirus disease 
2019 (COVID-19) in the past 14 days, as defined by the CDC as a close contact of 
someone who has had COVID-19. 
2. Has known history of SARS-CoV-2 infection within 3 months prior to enrollment. 
3. Is acutely ill or febrile (temperature ≥ 38.0°C/[100.4°F]) less than 72 hours prior to or at 
the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled and 
will retain their initially assigned participant number. 
4. Currently has symptomatic acute or unstable chronic disease requiring medical or 
surgical care, to include significant change in therapy or hospitalization for worsening 
disease, at the discretion of the investigator. 
5. 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. 
6. Has a current or previous diagnosis of immunocompromising condition to include human 
immunodeficiency virus, immune-mediated disease requiring immunosuppressive 
treatment, or other immunosuppressive condition. 
7. Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in 
total within 6 months prior to screening (for corticosteroids ≥ 10 mg/day of prednisone 
equivalent) or is anticipating the need for immunosuppressive treatment at any time 
during participation in the study. 
8. Has known or suspected allergy or history of anaphylaxis, urticaria, or other significant 
AR to the vaccine or its excipients. 

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9. Has a documented history of myocarditis or pericarditis within 2 months prior to 
Screening Visit (Day 0). 
10. Coagulopathy or bleeding disorder considered a contraindication to intramuscular (IM) 
injection or phlebotomy. 
11. Has received or plans to receive any licensed vaccine ≤ 28 days prior to the injection 
(Day 1) or a licensed vaccine within 28 days before or after the study injection, with the 
exception of influenza vaccines, which may be given 14 days before or after receipt of a 
study vaccine. 
12. Has received systemic immunoglobulins or blood products within 3 months prior to the 
Screening Visit (Day 0) or plans for receipt during the study. 
13. Has donated ≥ 450 mL of blood products within 28 days prior to the Screening Visit or 
plans to donate blood products during the study. 
14. Plans to participate in an interventional clinical trial of an investigational vaccine or drug 
while participating in this study. 
15. Is an immediate family member or household member of study personnel, study site staff, 
or Sponsor personnel. 
16. Is currently experiencing an SAE in Study mRNA-1273-P301 (COVE) at the time of 
screening for this study. 
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 assigned to treatment. 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 the time 
informed consent was obtained to the time of withdrawal. 

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5. 
STUDY TREATMENT  
5.1. 
Investigational Products Administered  
The term “investigational product (IP)” refers to mRNA-1273, mRNA-1273.211, 
mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, 
mRNA-1273.815, or mRNA-1273.231 vaccine administered in this study. 
Part A.1 (mRNA-1273.211) 
mRNA-1273.211 is a multivalent product that contains 2 mRNAs: CX-024414 encoding for the 
S-2P of Wuhan-Hu-1 and CX-027367 encoding for the S-2P of B.1.351, in a 1:1 ratio. 
mRNA-1273.211 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-
phosphocholine (DSPC), and 1-monomethoxypolyethyleneglycol-2,3-dimyristylglycerol with 
polyethylene glycol of average molecular weight 2000 (PEG-2000-DMG). 
mRNA-1273.211 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL (0.8 mL fill volume) 
 
 mRNA-1273.211 
will be administered at a 50 and 100 µg dose levels. 
Part A.2 (mRNA-1273.214) 
mRNA-1273.214 contains CX-024414, the mRNA that encodes for the prefusion stabilized spike 
glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the mRNA 
that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 variant. mRNA-1273.214 consists of 
each mRNA formulated in a mixture of 4 lipids common to the Sponsor’s mRNA vaccine 
platform: SM-102, cholesterol, DSPC, and PEG2000-DMG. 
The formulated mRNAs are mixed in a 1:1 ratio. mRNA-1273.214 injection will be provided as 
a sterile liquid for injection, white to off-white dispersion in appearance, at a concentration of 
0.1 mg/ML 
 
mRNA-1273 will be administered at a 50-µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part B (mRNA-1273) 
mRNA-1273 contains mRNA CX-024414 encoding for the S-2P of Wuhan-Hu-1. mRNA-1273 
consists of the mRNA formulated in a mixture of 4 lipids common to the Sponsor’s mRNA 
vaccine platform: SM-102, cholesterol, DSPC, and PEG-2000-DMG. 
mRNA-1273 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL (0.8 mL fill volume) 
 
 mRNA-1273 will be 
administered at a 100-µg dose level. 
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Part C (mRNA-1273.617.2) 
mRNA-1273.617.2 contains mRNA CX-029444 encoding for the S-2P of B.1.617.2. 
mRNA-1273.617.2 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC, and PEG-2000-DMG. 
mRNA-1273.617.2 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL (0.8 mL fill volume) 
 
 mRNA-1273.617.2 
will be administered at 50 µg and 100 µg dose level. 
Part D (mRNA-1273.213) 
mRNA-1273.213 is a multivalent product that contains 2 mRNAs: CX-029444 encoding for the 
S-2P of B.1.617.2 and CX-027367 encoding for the S 2P of B.1.351, in a 1:1 ratio. 
mRNA-1273.213 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC and PEG 2000 DMG. 
mRNA-1273.213 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 mRNA-1273.213 will be administered 
at 50 µg and 100 µg dose level. 
Part F (mRNA-1273.529 and mRNA-1273) 
mRNA-1273.529 contains mRNA CX-031302 encoding for the S-2P of B.1.1.529. 
mRNA-1273.529 consists of the mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC and PEG 2000 DMG. 
mRNA-1273.529 injection will be provided as a sterile liquid for injection, white to off-white 
dispersion in appearance, at a concentration of 0.2 mg/mL 
 
 
mRNA-1273.529 will be administered at 50 µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273 P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part G (mRNA-1273.214) 
mRNA-1273.214 contains CX-024414, the mRNA that encodes for the prefusion stabilized spike 
glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the mRNA 
that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 variant. mRNA-1273.214 consists of 
each mRNA formulated in a mixture of 4 lipids common to the Sponsor’s mRNA vaccine 
platform: SM-102, cholesterol, DSPC, and PEG2000-DMG. 
The formulated mRNAs are mixed in a 1:1 ratio. mRNA-1273.214 injection will be provided as 
a sterile liquid for injection, white to off-white dispersion in appearance, at a concentration of 
0.1 mg/ML 
 
mRNA-1273.214 will be administered at a 50-µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273 P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
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Part H (mRNA-1273.222) 
mRNA-1273.222 contains CX-024414, the mRNA that encodes for the prefusion stabilized spike 
glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-034476, the mRNA 
that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 subvariants BA.4/BA.5. 
mRNA-1273.222 consists of each mRNA formulated in a mixture of 4 lipids common to the 
Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC, and PEG2000-DMG. 
The formulated mRNA are mixed in a 1:1 ratio. mRNA-1273.222 injection will be provided as a 
sterile liquid for injection, white to off-white dispersion in appearance, at a concentration of 
0.1 mg/mL 
 
mRNA-1273.222 will be administered at a 50-µg dose level. Doses will be administered by IM 
injection according to the procedures specified in the mRNA-1273-P205 Pharmacy Manual. 
Preferably, the vaccine should be administered into the nondominant arm. 
Part J (mRNA-1273.815 and mRNA-1273.231) 
mRNA-1273.815 contains CX-038839, the mRNA that encodes for the S-2P of the 
SARS-CoV-2 subvariants XBB.1.5/XBB.1.9.1 mRNA-1273.231 contains CX-034476, the 
mRNA that encodes for the S-2P of the SARS-CoV-2 B.1.1.529 subvariants BA.4/BA.5, and 
CX-038839, the mRNA that encodes for the S-2P of the SARS-CoV-2 subvariants 
XBB.1.5/XBB.1.9.1. The formulated mRNA in mRNA-1273.231 are mixed in a 1:1 ratio. Both 
mRNA-1273.815 and mRNA-1273.231 consist of mRNA formulated in a mixture of 4 lipids 
common to the Sponsor’s mRNA vaccine platform: SM-102, cholesterol, DSPC, and 
PEG2000-DMG. 
mRNA-1273.231 and mRNA-1273.815 injections will be provided as a sterile liquid for 
injection, white to off-white dispersion in appearance, at a concentration of 0.1 mg/mL 
 
 
mRNA-1273.815 and mRNA-1273.231 will be administered at a 50 µg dose level. Doses will be 
administered by IM injection according to the procedures specified in the mRNA-1273-P205 
Pharmacy Manual. 
5.2. 
Randomization and Blinding  
This is an open-label study, no blinding will be performed. Randomization will be performed for 
participants in Part J. 
5.3. 
Preparation/Handling/Storage/Accountability  
5.3.1. 
Preparation of Study Vaccine  
Part A.1 
The mRNA-1273.211 vaccine candidate will have a fill volume of 0.8 mL and contain 
mRNA-1273.211 at the dose of 50 and 100 µg (dose volume 0.5 mL). Vaccine preparation 
instructions are detailed in the mRNA-1273-P205 Pharmacy Manual. 
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Part A.2 
The mRNA-1273.214 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.214 
at the dose of 50 µg (dose volume 0.5 mL). Vaccine preparation instructions are detailed in the 
mRNA-1273-P205 Pharmacy Manual. 
Part B 
The mRNA-1273 vaccine will have a fill volume of 6.3 mL and contains mRNA-1273 at the 
dose of 100 µg (dose volume 0.5 mL). Vaccine preparation instructions are detailed in the 
mRNA-1273-P205 Pharmacy Manual. 
Part C 
The mRNA-1273.617.2 vaccine will have a fill volume of 0.8 mL and contains 
mRNA-1273.617.2 at the dose of 50 µg (dose volume 0.25 mL) and 100 µg (dose volume 
0.5 mL). Vaccine preparation instructions are detailed in the mRNA-1273-P205 Pharmacy 
Manual. 
Part D 
The mRNA-1273.213 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.213 
at the dose of 50 µg (dose volume 0.25 mL) and 100 µg (dose volume 0.5 mL). Vaccine 
preparation instructions are detailed in the mRNA-1273-P205 Pharmacy Manual. 
Part F 
The mRNA-1273.529 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.529 
at the dose of 50 µg (dose volume 0.25 mL). The mRNA-1273 vaccine will have a fill volume of 
6.3 mL and contains mRNA-1273 at the dose of 50 ug (dose volume 0.25 mL). Vaccine 
preparation instructions are detailed in the mRNA-1273-P205 Pharmacy Manual. 
Part G 
The mRNA-1273.214 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.214 
at the dose of 50 µg (dose volume 0.5 mL). Vaccine preparation instructions are detailed in the 
mRNA-1273-P205 Pharmacy Manual. 
Part H 
The mRNA-1273.222 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.222 
at the dose of 50 µg (dose volume 0.5 mL). Vaccine preparation instructions are detailed in the 
mRNA-1273-P205 Pharmacy Manual. 
Part J 
The mRNA-1273.815 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.815 
at the dose of 50 µg (dose volume 0.5 mL). Vaccine preparation instructions are detailed in the 
mRNA-1273-P205 Pharmacy Manual. 
The mRNA-1273.231 vaccine will have a fill volume of 0.8 mL and contains mRNA-1273.231 
at the dose of 50 µg (dose volume 0.5 mL). Vaccine preparation instructions are detailed in the 
mRNA-1273-P205 Pharmacy Manual. 

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5.3.2. 
Study Vaccine Administration  
mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, 
mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, or mRNA-1273.231 will be administered 
as an IM injection into the deltoid muscle on Day 1. Preferably, vaccine should be administered 
into the nondominant arm. 
On Day 1, participants will be monitored for a minimum of 30 minutes after vaccination. 
Assessments will include vital sign measurements and monitoring for local or systemic ARs as 
shown in the SoE (Table 17, Table 18, Table 19, and Table 20). 
The study site 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 a 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 IP. 
• Confirming the appropriate labeling of the IP, so that it complies with the legal 
requirements of the United States. 
The investigator is responsible for acknowledging the receipt of the IP by a designated staff 
member at the site, which includes the following: 
• Confirming that the IP 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 IP for use. 
• Ensuring the appropriate dose of IP is properly prepared using aseptic technique. 
Further description of the IP and instructions for the receipt, storage, preparation, administration, 
accountability, and destruction of IP are described in the mRNA-1273-P205 Pharmacy Manual. 
5.3.4. 
Study Vaccine Packaging and Labeling  
Part A.1 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.211. Sterile mRNA-1273.211 is packaged in 2R glass vials with a 0.8-mL fill 
volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The Sponsor or Sponsor’s designee will supply the 0.9% sodium chloride injection for use as a 
diluent to mRNA-1273.211. The 0.9% sodium chloride bears a commercial label and does not 
contain study-specific identification. 
The IP 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 

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Practice guidelines, International Council for Harmonisation (ICH) GCP Guideline, guidelines 
for Quality System Regulations, and applicable regulations. 
Part A.2 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.214. Sterile mRNA-1273.214 is packaged in 2R glass vials with a 0.8-mL fill 
volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part B 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273. Sterile mRNA-1273 is packaged in 10R glass vials with a 6.3-mL fill volume. 
The IP will have all required labeling per regulations and will be supplied to the pharmacy in an 
unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part C 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.617.2. Sterile mRNA-1273.617.2 is packaged in 2R glass vials with a 0.8-mL 
fill volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part D 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.213. Sterile mRNA-1273.213 is packaged in 2R glass vials with a 0.8-mL fill 
volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part F 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.529 and mRNA-1273. Sterile mRNA-1273.529 is packaged in 2R glass vials 
with a 0.8-mL fill volume. Sterile mRNA-1273 is packaged in 10R glass vials with a 6.3-mL fill 

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volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part G 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.214. Sterile mRNA-1273.214 is packaged in 2R glass vials with a 0.8-mL fill 
volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part H 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.222. Sterile mRNA-1273.222 is packaged in 2R glass vials with a 0.8-mL fill 
volume. The IP will have all required labeling per regulations and will be supplied to the 
pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
Part J 
The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities 
of mRNA-1273.815 and mRNA-1273.231. Sterile mRNA-1273.815 and mRNA-1273.231 will 
be packaged in 2R glass vials with a 0.8-mL fill volume. The IP will have all required labeling 
per regulations and will be supplied to the pharmacy in an unblinded manner. 
The IP will be packaged and labeled in accordance with the standard operating procedures of the 
Sponsor or of its designee, CFR Title 21 Good Manufacturing Practice guidelines, ICH GCP 
Guideline, guidelines for Quality System Regulations, and applicable regulations. 
5.3.5. 
Study Vaccine Storage  
mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, 
mRNA-1273.214, and mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 must be stored 
at -60°C to -90°C (-76°F to -130°F), and mRNA-1273 must be stored at -25°C to -15°C (-13°F 
to 5°F). All study vaccines must 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). The freezer should have 
automated temperature recording and a 24-hour alert system in place that allows for rapid 
response in case of or refrigerator malfunction. There must be an available backup freezer. The 
freezer must be connected to a backup generator. In addition, IP accountability study staff are 
required to keep a temperature log to establish a record of compliance with these storage 
conditions. The site is responsible for reporting any IP that was not temperature-controlled 

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during shipment or storage. Such IP will be retained for inspection by the monitor and disposed 
of according to approved methods. 
The 0.9% sodium chloride injection (USP) should be stored at 20ºC to 25ºC (68ºF to 77ºF) in a 
restricted access area. 
5.3.6. 
Study Vaccine Accountability  
It is the investigator’s responsibility that the IP accountability study staff maintain accurate 
records in an IP accountability log of receipt of all IP, site IP inventory, IP dispensing, IP 
injections, and return to the Sponsor or alternative disposition of used and unused IP vials. 
A site monitor will review the inventory and accountability log during site visits and at the 
completion of the study. Additional details are found in the mRNA-1273-P205 Pharmacy 
Manual. 
5.3.7. 
Study Vaccine Handling and Disposal  
A site monitor will reconcile the IP inventory during the conduct and at the end of the study for 
compliance. Once fully reconciled at the site at the end of the study, the IP should be destroyed 
on site, if site procedures allow, or returned to a destruction depot per instruction of the Sponsor. 
Additional details are found in the mRNA-1273-P205 Pharmacy Manual. 
5.3.8. 
Unblinding  
This is an open-label study. 
5.4. 
Study Intervention Compliance  
All doses of IP 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 staff will 
confirm that the participant has received the entire dose of IP. If a participant does not receive IP 
or does not receive all of the planned dose, the reason for the missed dose will be recorded. Data 
will be reconciled with site accountability records to assess compliance. 
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 specified in the SoE (Table 17, 
Table 18, Table 19, and Table 20). If a participant does not complete a visit within the time 
window, that visit will be classified as a missed visit and 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. 

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5.5.2. 
Concomitant Medications and Therapies  
At study site, study staff must question the participant regarding any medications taken and 
non-study vaccinations received by the participant and record the following information in the 
eCRF: 
• All non-study vaccinations administered within the period starting 28 days before the 
study injection. 
• Seasonal influenza vaccine administered for the current influenza season (typically 
October through April in the Northern Hemisphere). 
• All concomitant medications and non-study vaccinations taken through 28 days after 
vaccination. 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 used to prevent or treat COVID-19 or its symptoms. 
• Any concomitant medications relevant to or for the treatment of an SAE or an 
MAAE. 
• The participant 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 vaccination, 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 (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 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 Analyses  
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 evaluability in the per-protocol 
(PP) analysis (analysis sets are described in Section 8.4): 
• Any investigational or nonregistered product (drug or vaccine) other than the IP used 
during the study period. 
• Immunosuppressants or other immune-modifying drugs administered chronically (ie, 
more than 14 days in total) during the study period. For corticosteroids, this will mean 
that prednisone ≥ 10 mg/day or the equivalent is not permitted. Inhaled, nasal, and 
topical steroids are allowed. 

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• Long-acting immune-modifying drugs administered at any time during the study 
period (eg, infliximab). 
• An authorized or licensed vaccine administered during the period from 28 days before 
through 28 days after vaccination, except for any licensed influenza vaccine that was 
administered 14 days before or after vaccination. 
• Immunoglobulins and/or any blood products administered during the study period. 
In addition, any participant confirmed to have received or plans to receive a non-study 
COVID-19 vaccine, either licensed or under EUA, may also not be included in the PP analysis. 
5.6. 
Intervention After the End of the Study  
Any SAE occurring after the end of the study and considered to be caused by the study vaccine 
must be reported to the Sponsor. 

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6. 
DELAY OR DISCONTINUATION OF STUDY INTERVENTION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL  
6.1. 
Criteria for Delay of Vaccine Administration  
6.1.1. 
Individual Participant Criteria for Delay of Study Vaccination  
Body temperature must be measured before vaccination. 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 be injected at a later date within the time window specified in the SoE (Table 17, 
Table 18, Table 19, and Table 20), 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. 
Afebrile participants with minor illnesses can be vaccinated at the discretion of the investigator. 
Participants with a fever of 38.0°C (100.4°F) or higher 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 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. 
Participant Discontinuation/Withdrawal from the Study  
Participants who withdraw or are withdrawn from the study will not be replaced. 
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. 
A participant who chooses not to receive the second booster dose of mRNA-1273.214 in 
Part A.2 of the study will NOT be considered to have discontinued treatment and can remain in 
the study in Part A.1 and will complete all scheduled visits and assessments. 
Participants receiving a second or subsequent non-study COVID-19 booster vaccine can remain 
in the study for safety evaluation. The investigator will request that the participant complete all 
scheduled study visits. Blood and NP samples will not be collected in participants who have 
received subsequent non-study COVID-19 booster vaccines. If a participant meets the criteria for 
an illness visit (Section 7.1.6), NP samples will be collected during the illness visit per protocol. 
If participant desires to withdraw from the study because of an AE, the investigator will attempt 
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 

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participant or by the investigator, as well as which of the following possible reasons was 
responsible for withdrawal: 
• AE (specify) 
• AESI (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 and AESI) 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 withdrawing from the study may request destruction of any samples taken and not 
tested, and the investigator must document this in the 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 10.2.6). 
The Sponsor will continue to retain and use all research results 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). 
6.3. 
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 site 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. 
• 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 and, if 

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necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts (eg, dates of telephone calls and 
registered 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. 

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7. 
STUDY ASSESSMENTS AND PROCEDURES  
Before performing any study procedures, all potential participants will sign an informed consent 
form (ICF) (as detailed in Section 10.2.6). Participants will undergo study procedures at the time 
points specified in the SoE (Table 17, Table 18, Table 19, and Table 20). 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 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 2023), investigators may convert study site visits 
to home visits or telemedicine visits with the approval of the Sponsor. Such action should be 
taken to protect the safety and well-being of 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 the SoE (Table 17, Table 18, Table 19, and 
Table 20). 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 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 a part of the participant’s routine clinical management and 
obtained before signing of the ICF may be utilized for screening or baseline purposes 
provided that the procedures meet the protocol-specified criteria and are performed 
within the time frame defined in the SoE (Table 17, Table 18, Table 19, and 
Table 20). 
• The Screening Visit and Day 1 visit may be completed on the same day. 
7.1. 
Safety Assessments and Procedures  
Safety assessments will include monitoring and recording of the following for each participant, 
according to the SoE (Table 17, Table 18, Table 19, and Table 20): 
• Solicited local and systemic ARs (Section 7.4.3) that occur during the 7 days 
following vaccination (ie, the day of injection and 6 subsequent days). Solicited ARs 
will be recorded daily using eDiaries (Section 7.1.1). 

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• Unsolicited AEs observed or reported during the 28 days following vaccination (ie, 
the day of injection and 27 subsequent days). Unsolicited AEs are defined in 
Section 7.4.1. 
• AEs leading to withdrawal from Day 1 through EoS. 
• MAAEs from vaccination on Day 1 through EoS or withdrawal from the study. 
• AESI from vaccination on Day 1 through EoS or withdrawal from the study. 
• SAEs from vaccination on Day 1 through EoS or withdrawal from the study. 
• Vital sign measurements before and after vaccination (Section 7.1.4). 
• Physical examination findings (if performed) (Section 7.1.5). 
• 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 (Section 7.4.6). 
The incidence and severity of the above events will be monitored by an IST on a regular basis. 
Participants who receive a non-study second booster dose (or any subsequent doses, if available 
in the future), after having received all prior booster doses in the study, can remain in the study 
for safety follow-up. 
7.1.1. 
Use of Electronic Diaries  
At the time of consent, the participants must confirm they will be willing to complete an eDiary 
using either an application downloaded to their smartphone or using a device that will be 
provided at the time of enrollment. Before enrollment on Day 1, the participant will be instructed 
to download the eDiary application or will be provided an eDiary device to record solicited ARs 
(Section 7.4.3) on Day 1. 
On Day 1 (dosing day), 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. 
On Day 1 (dosing day), participants will record data into the eDiary starting approximately 
30 minutes after the 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. 
Participants will record the following data in the eDiary: 
• Solicited local and systemic reactogenicity ARs, as defined in Section 7.4.3, that 
occur on the day of vaccination and during the 7 days after vaccination (ie, the day of 
injection and 6 subsequent days). Any solicited AR that is ongoing beyond Day 7 will 
be reported in the eDiary until it has resolved, and not to exceed 28 days after 
vaccination. ARs recorded in the eDiary beyond Day 7 should be reviewed by the 

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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. 
• Other measurements, as applicable, for solicited local ARs (injection site erythema 
and swelling/induration) will be performed using the ruler provided by the study site. 
• Any medications taken to treat or prevent pain or fever on Day 1 or for the next 
6 days. 
The eDiary will be the only source document allowed for solicited systemic or local 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 site visits (including a 
solicited AR) that is not already captured in the eDiary will be described in the source documents 
as a verbally reported event. Any AR reported in this manner must be described as an unsolicited 
event and therefore entered on the AE eCRF. 
Study site staff will review eDiary data with participants during the safety call 7 days after 
vaccination. 
The eDiary will also be used every 2 weeks from Day 36 to Day 162, and from Day 202 to 
Day 342 (Parts A.1, B, C, D, F, and G only) or every 2 weeks from Day 36 to Day 162 
(Parts A.2, H, and J only), to capture the occurrence of MAAEs, AESI, SAEs, and AEs leading 
to withdrawal. 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 exposure to someone with known COVID-19 or SARS-CoV-2 infection. 
• Any experience of symptoms of COVID-19. 
• Any MAAEs, AESI, or SAEs. 
If an eDiary record results in identification of relevant safety events or of symptoms of 
COVID-19, a follow-up safety call will be triggered. 
Apart from the safety telephone calls described in Section 7.1.2, each participant will complete a 
questionnaire in an eDiary as shown in the SoE (Table 17, Table 18, Table 19, and Table 20). 
The eDiary responses will be reviewed by study site personnel and may result in a follow-up 
safety call by the site to the participant. 

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7.1.1.1. 
Ancillary Supplies for Participant Use  
Study sites will distribute Sponsor-provided oral thermometers and rulers for use by participants 
to assess body temperature and injection site reactions, respectively, for recording solicited ARs 
in the eDiaries. 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 Call  
A safety telephone call is a telephone call made to the participant by a trained site personnel. 
This call will follow an approved script, which will facilitate the collection of relevant safety 
information. There will be a safety telephone call on Day 8 for each participant to discuss their 
health and review their eDiary. Subsequent safety calls by the site to each participant will occur 
every 2 weeks from Day 43 to Day 169, and from Day 209 to Day 349 (Parts A.1, B, C, D, F, 
and G only) (Table 17) and every 2 weeks from Day 43 to Day 169 for Parts A.2 (Table 18), 
H (Table 19), and J (Table 20). The participant will be interviewed according to the script about 
the occurrence of AEs, MAAEs, AESI, SAEs, AEs leading to withdrawal, concomitant 
medications associated with those events, and any non-study vaccinations (Section 7.4.7). In 
addition, study personnel will collect information on known participant exposure to someone 
with COVID-19 or SARS-CoV-2 infection and on the participant’s experience of COVID-19 
symptoms. All safety information collected from the telephone call must be documented in the 
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 call may be 
triggered if an eDiary record results in identification of a relevant safety event. 
7.1.3. 
Laboratory Assessments  
No routine safety laboratory assessments are planned for this study. 
A point-of-care urine pregnancy test will be performed at Day 1 before vaccination. At any time, 
a pregnancy test either via blood or point-of-care urine can be performed, at the discretion of the 
investigator. If not documented in a female participant’s medical records, an FSH test may be 
performed at the Screening Visit, as necessary and at the discretion of the investigator, to 
confirm postmenopausal status. 
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 
indicated in the SoE (Table 17, Table 18, Table 19, and Table 20). Vital signs are to be collected 
pre- and post-dosing on the day of injection (Day 1) only. When applicable, vital sign 
measurements should be performed before blood collection. 
Participants who are febrile (body temperature ≥ 38.0°C [100.4°F]) before injection on Day 1 
must be rescheduled within the relevant window period to receive the injection. Afebrile 
participants with minor illnesses may be vaccinated at the discretion of the investigator. 

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7.1.5. 
Physical Examinations  
A full physical examination, including height and weight, will be performed at Day 1 as 
indicated in the SoE (Table 17, Table 18, Table 19, and Table 20). 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 and extremities. Any 
clinically significant finding identified during a study visit should be reported as an MAAE. 
Symptom-directed physical examinations may be performed at other time points at the discretion 
of the investigator. On the day of vaccination, before injection, the arm receiving the injection 
should be examined and the associated lymph nodes should be evaluated. 
7.1.6. 
Assessment for SARS-CoV-2 Infection  
Participants will have NP samples collected for SARS-CoV-2 testing at time points specified in 
the SoE (Table 17, Table 18, Table 19, and Table 20). 
A study illness visit or a consultation will be arranged within 24 hours or as soon as possible to 
collect an NP swab (Table 12 and Table 13) to ascertain the presence of SARS-CoV-2 via 
RT-PCR if a participant experiences any of the following (the presence of any one of these 
symptoms lasting at least 48 hours [except for fever and/or respiratory symptoms]): 
• Signs or symptoms of SARS-CoV-2 infection as defined by the CDC (CDC 2020), 
including: 
- 
Fever (temperature ≥ 38.0°C [100.4°F]) or chills (of any duration, including 
≤ 48 hours) 
- 
Cough (of any duration, including ≤ 48 hours) 
- 
Shortness of breath and/or difficulty breathing (of any duration, including 
≤ 48 hours) 
- 
Fatigue 
- 
Muscle or body aches 
- 
Headache 
- 
New loss of taste and/or smell 
- 
Sore throat, congestion, or runny nose 
- 
Nausea or vomiting 
- 
Diarrhea 
• MAAE suggesting a SARS-CoV-2 infection 
• Clinical or radiographical evidence of pneumonia 
Additionally, clinical information will be carefully collected to evaluate the severity of the 
clinical case. All findings will be recorded in the eCRF. 
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, 

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investigators should use their clinical judgment to decide whether an NP swab should be 
collected. The collection of an NP swab prior to the Day 1 and Day 29 vaccination can help 
ensure that cases of COVID-19 are not overlooked. Any study participant reporting respiratory 
symptoms during the 7-day period after vaccination should be evaluated for COVID-19. 
If scheduled, a study site illness visit may include additional assessments such as medical 
history, physical examination, and blood sampling for clinical laboratory testing. The NP swab 
sample may be tested by multiplex RT-PCR for respiratory viruses besides SARS-CoV-2 to 
evaluate the severity of the clinical case. Radiologic imaging studies may be conducted. Blood 
samples will be collected at all illness visits for potential future immunologic assessment of 
SARS-CoV-2 infection. 
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 (CLIA)-certified or CLIA-certified waiver 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. 
Symptomatic COVID-19 is defined by the presence of one of the CDC-listed symptoms 
(CDC 2020) and a positive RT-PCR test on a respiratory sample. Asymptomatic SARS-CoV-2 
infection is defined as a positive RT-PCR test on a respiratory sample in the absence of 
symptoms or a positive serologic test for antinucleocapsid antibody after a negative test result at 
the time of enrollment, with the serologic assay detecting previously resolved SARS-CoV-2 
infections that may have occurred between visits, and the RT-PCR to detect active viral infection 
at the time of a visit. If participants are confirmed to have SARS-CoV-2 infection and are 
symptomatic or asymptomatic, the investigator will notify the participants’ primary care 
physicians of the diagnosis and the local public health authorities as required per local 
regulations. 
If the participant had known exposure to COVID-19 (eg, exposure to someone with a confirmed 
case of COVID-19), it will be captured in the COVID-19 exposure form, and the participant will 
continue to follow all remaining study assessments as scheduled. Likewise, participants with a 
confirmed case of COVID-19 will continue to follow all remaining study assessments as 
scheduled. 
Any confirmed symptomatic COVID-19 infection occurring in participants will be captured as 
an MAAE along with relevant concomitant medications and details about severity, seriousness, 
and outcome. 
7.2. 
Immunogenicity Assessments  
Blood samples for immunogenicity assessments will be collected at the time points indicated in 
the SoE (Table 17, Table 18, Table 19, and Table 20). 
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 

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sample collected will be recorded in the eCRF. 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), 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 CoV. 
Nasopharyngeal swab samples to be collected are also shown (Table 12 and Table 13). 
Table 12: 
Blood and Nasopharyngeal Swab Sampling for Parts A.1, B, C, D, F, and G 
Sample Name 
D1 
(Baseline) 
D15 
D29 
D91 
(Part F and 
Part G 
only) 
D181 
D366 
UNS / 
Illness 
Anti-SARS-CoV-2 
1 
 
1 
1 
1 
1 
1 
Immunogenicity 
1 
1 
1 
1 
1 
1 
1 
RT-PCR/Sequencing 
1 
 
1 
1 
1 
 
1 
BioFire 2.1 
 
 
 
 
 
 
1 
PBMC may be 
collected for a subset of 
participants at selected 
sites 
1 
1 
1 
1 
 
 
 
Abbreviations: D =day; N/A = not applicable; NP = nasopharyngeal; PBMC = Peripheral Blood Mononuclear Cells; 
RT-PCR = reverse transcriptase polymerase chain reaction; SST = serum separator tube; UNS = unscheduled visit. 
Table 13: 
Blood and Nasopharyngeal Swab Sampling for Parts A.2, H, and J 
Sample Name 
D1 
(Baseline) 
D15 
D29 
D91 
D181 
UNS / 
Illness 
Anti-SARS-CoV-2 
1 
 
1 
1 
1 
1 
Immunogenicity 
1 
1 
1 
1 
1 
1 
RT-PCR/Sequencing 
1 
 
1 
1 
1 
1 
BioFire 2.1 
 
 
 
 
 
1 
Abbreviations: D =day; N/A = not applicable; NP = nasopharyngeal; PBMC = Peripheral Blood Mononuclear Cells; 
RT-PCR = reverse transcriptase polymerase chain reaction; SST = serum separator tube; UNS = unscheduled visit. 
7.3. 
Efficacy Assessments  
Vaccine efficacy will not be formally assessed in this study, but active surveillance for 
COVID-19 and SARS-CoV-2 infection through weekly contact and blood draws (see Table 17, 
Table 18, Table 19, and Table 20), will be performed. 

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7.4. 
Safety Definitions and Related Procedures  
7.4.1. 
Adverse Event  
An AE is defined as any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. 
Events Meeting the Adverse Event Definition 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after vaccination even though they may have 
been present before the start of the study. 
Events NOT Meeting the Adverse Event Definition 
• Procedures planned before study entry (eg, hospitalization for preplanned surgical 
procedure). 
• 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 7.4.3). 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, 7 days after vaccination). Any unsolicited AE which began during 
mRNA-1273-P301 (COVE) but is ongoing at the time of enrollment in this study, should be 
documented as medical history. 
7.4.2. 
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 IP. 
• 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 

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hospital or emergency ward for at least one 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 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. 
7.4.3. 
Solicited Adverse Reactions  
The term “reactogenicity” refers to the occurrence and intensity of selected signs and symptoms 
(ARs) occurring after IP 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 during the 7 days after vaccination (ie, the day of injection and 6 subsequent days). 
Severity grading of reactogenicity will occur automatically based on participant entry into the 
eDiary according to the grading scales presented in Table 14 modified from the Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials (DHHS 2007). 
If a solicited local or systemic AR continues beyond 7 days after dosing, the participant will be 
prompted daily to capture solicited local or systemic AR in the eDiary until resolution. ARs 
recorded in eDiaries beyond Day 7 should be reviewed by the study staff either via phone call or 
at the next study visit. All solicited ARs (local and systemic) will be considered causally related 
to dosing. 

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Table 14: 
Solicited Adverse Reactions and Grades 
Reaction 
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
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 
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 

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Reaction 
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Nausea/vomiting 
None 
No 
interference 
with activity 
or 1-2 
episodes/ 
24 hours 
Some interference 
with activity or 
> 2 episodes/24 ho
urs 
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 – 38.4°C 
100.4 – 
101.1°F 
38.5 – 38.9°C 
101.2 – 102.0°F 
39.0 – 
40.0°C 
102.1 – 
104.0°F 
> 40.0°C 
> 104.0°F 
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 provider (HCP), to 
be recorded as an MAAE (Section 7.4.4). 
• 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 post-injection. 
• Solicited local or systemic AR that otherwise meets the definition of an SAE. 
7.4.4. 
Medically Attended Adverse Events  
An 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 follow-up, COVID-19 
[Section 7.1.6]) 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 MAAEs. 
Unsolicited AEs will be captured on the AE page of the eCRF. 
All confirmed COVID-19 cases will be recorded as MAAEs. 
All suspected cases of anaphylaxis should be recorded as MAAEs and reported as an SAE, based 
on the criteria for a medically important event, 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 per Section 7.4.11. The investigator will submit any updated 
anaphylaxis case data to the Sponsor within 24 hours of it being available. For reporting 

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purposes, a participant who displays signs or symptoms consistent with anaphylaxis (as follows) 
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 the following: 
• Sudden onset AND 
• Rapid progression of signs and symptoms AND 
• Involves 2 or more organ systems, as follows: 
− Skin/mucosal: urticaria (hives), generalized erythema, angioedema, generalized 
pruritus with skin rash, generalized prickle sensation, and red and itchy eyes. 
− Cardiovascular: measured hypotension, clinical diagnosis of uncompensated 
shock, loss of consciousness or decreased level of consciousness, and evidence of 
reduced peripheral circulation. 
− 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, and 
rhinorrhea. 
− Gastrointestinal: diarrhea, abdominal pain, nausea, and vomiting. 
7.4.5. 
Adverse Event 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. Section 10.4 
(Appendix 4) provides a list of AESI pertinent to this study. All AESI 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, or the SAE Fax line 
(Section 7.4.11). 
Myocarditis and/or Pericarditis  
Very rare events of myocarditis and/or pericarditis have been reported after vaccination with the 
mRNA-1273 vaccine. All suspected cases of probable and confirmed myocarditis, pericarditis, or 
myopericarditis should be reported as an AESI even if it does not meet criteria per the CDC case 
definition. The event should also be reported as an SAE, if it 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 7.4.2. The investigator will submit any updated 

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myocarditis, pericarditis, or myopericarditis case data to the Sponsor within 24 hours of it being 
available. For reporting purposes, any events suspicious for myocarditis, pericarditis, or 
myopericarditis should be reported as an AESI. The CDC case definition is displayed below as 
guidance (Gargano et al, 2021). These definitions are intended to serve as a guide to help 
reporting of suspected cases of myocarditis, pericarditis, or myopericarditis, but the diagnosis of 
suspected cases are left to the investigator’s clinical judgment. 
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: 
≥ 1 new finding of: 
• Troponin level above upper limit of normal (any type of troponin) 
• Abnormal electrocardiogram (ECG or EKG) or rhythm monitoring findings 
consistent with myocarditis 
− To meet the ECG or rhythm monitoring criterion, a probable case must include at 
least one of: 
o ST segment or T-wave abnormalities 
o Paroxysmal or sustained atrial, supraventricular, or ventricular arrhythmias 
o AV nodal conduction delays or intraventricular conduction defects 
• Abnormal cardiac function or wall motion abnormalities on echocardiogram 
• cMRI finding consistent with myocarditis (Ferreira et al, 2018) 
AND 
• No other identifiable cause of the symptoms and findings 
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 

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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 exam 
• New ST-elevation or PR-depression on EKG 
• New or worsening pericardial effusion on echocardiogram or MRI 
Case Definition of Myopericarditis  
Participants who meet criteria for both myocarditis and pericarditis may be described under 
myopericarditis. 
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 probably or confirmed 
cases of myocarditis or pericarditis will be referred to the Sponsor, who 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. 
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. 
7.4.6. 
Recording and Follow-up of Pregnancy  
Female participants who have a positive pregnancy test at screening should not be enrolled; 
participants who have a positive pregnancy test at any time during the study should receive no 
further dosing with IP 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) will be considered as SAEs. 
Pregnancies occurring in participants after enrollment must be reported to Sponsor or designee 
within 24 hours of the site learning of its occurrence, using the SAE Mailbox, or the SAE Fax 
line (Section 7.4.11). 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 

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awareness) report to the Sponsor any pregnancy resulting in an abnormal outcome according to 
the procedures described for SAEs. 
7.4.7. 
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 vaccination. Other (unsolicited) 
AEs will be collected from Day 1 through 28 days after vaccination. 
The MAAEs, AESI, AE leading to withdrawal, AESI, and SAEs will be collected from 
participants as specified in the SoE (Table 17, Table 18, Table 19, and Table 20) until the end of 
their participation in the study. Any AEs occurring before receipt of IP will be analyzed 
separately from AEs occurring after receipt of the study vaccine. 
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 non-study vaccinations. 
In addition to participant observations, physical examination findings, or other documents 
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 6.3). 
7.4.8. 
Assessment of Intensity  
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 7.4.2), NOT when it is rated as severe. 
The severity (or intensity) 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 Preventive 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 7.4.3. 
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. 

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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 
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 
intensity 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. 
7.4.9. 
Assessment of Causality  
The investigator’s assessment of an AE’s relationship to IP 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 IP 
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 IP. Participant did not 
receive the IP OR temporal sequence of the AE onset relative to administration of the IP is not 
reasonable OR the AE is more likely explained by another cause than the IP. 
Related: There is a reasonable possibility of a relationship to the IP. There is evidence of 
exposure to the IP. The temporal sequence of the AE onset relative to the administration of the IP 
is reasonable. The AE is more likely explained by the IP than by another cause. 
7.4.10. 
Reporting Adverse Events  
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to IP 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 type of event, time of onset, investigator-specified 
assessment of severity (impact on activities of daily living) and relationship to IP, 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 of screening 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. 
7.4.11. 
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. 

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Any AE considered serious by the investigator or that meets SAE criteria (Section 7.4.2) must be 
reported to the Sponsor immediately (within 24 hours of becoming aware of the SAE) via the 
EDC system. The investigator will assess whether there is a reasonable possibility that the IP 
caused the SAE. The Sponsor will be responsible for notifying the relevant regulatory authorities 
of any SAE as outlined in 21 US CFR Parts 312 and 320. The investigator is responsible for 
notifying the 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: Drugsafety@modernatx.com  
• SAE Fax Line (USA and Canada): +1-617-649-3910 
Regulatory reporting requirements for SAEs are described in Section 7.4.15. 
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 IP or study procedures, or that caused 
the participant to discontinue the study. 
7.4.12. 
Time Period and Frequency for Collecting AE, AESI, and SAE Information  
Medical occurrences that begin before IP 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. 
AEs 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 AEs will be collected from the day of injection through 6 days after vaccination. Other 
(unsolicited) AEs will be collected from the day of injection through 28 days after vaccination. 
Serious AEs (including AESI) will be collected from the start of IP dosing until the last day of 
study participation. 
All SAEs and AESI will be recorded and reported to the Sponsor or designee immediately and 
under no circumstance should this exceed 24 hours of becoming aware of the event via the EDC 
system. If a site receives a report of a new SAE or AESI from a study participant or receives 
updated data on a previously reported SAE or AESI and the eCRF has been taken offline, then 
the site can report this information on a paper SAE or AESI form using the SAE Mailbox or the 
SAE Fax line (Section 7.4.11). 
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 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 

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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 IP or study participation, the investigator must promptly notify the Sponsor. 
7.4.13. 
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 intensity 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 study arm or 
suspected causal relationship to IP. 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 
AE occurrences. 
7.4.14. 
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 6.3. 
7.4.15. 
Regulatory Reporting Requirements for 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. 
• 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. 

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7.5. 
Safety Monitoring  
No safety monitoring committee or data safety monitoring board is planned for this study. 
Safety monitoring for this study will include study team members, inclusive of, at a minimum, 
the Sponsor medical monitor, Sponsor safety physician (from Pharmacovigilance), and CRO 
medical monitor. The study team will conduct ongoing safety reviews during the study and will 
be responsible to monitor for safety concerns during the study as described in the Safety 
Management Plan. 
An Independent 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. 
7.6. 
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). 
7.7. 
Pharmacokinetics  
Pharmacokinetic parameters are not evaluated in this study. 
7.8. 
Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
7.9. 
Biomarkers  
Immunogenicity assessments are described in Section 7.2. Biomarkers are not evaluated in this 
study. 
7.10. 
Health Economics  
Health economics are not evaluated in this study. 

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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 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 related statistical methods after the study has begun, 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 CSR for the study. Ad hoc exploratory analyses, if any, 
will be clearly identified in the CSR. 
8.1. 
Blinding and Responsibility for Analyses  
This is an open-label study. For Part J, participants will be randomized in a 1:1 ratio to receive 
one of 2 treatments. Randomization will not be blinded. 
8.2. 
Statistical Hypotheses  
Parts A.1, A.2, B, C, and D: 
There is no hypothesis testing for Parts A.1, A.2, B, C, and D. 
Part F (Cohort 1): 
50 µg mRNA-1273.529 booster dose (as a first booster dose) will be assessed with respect to 
mRNA-1273 booster dose (as a first booster dose) using an external comparator (details will be 
provided in SAP). 
For the primary immunogenicity objectives, there are 3 hypotheses to be tested: 
A. H11: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
superior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the GMT 
ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
based on GMR and SRR difference is demonstrated. 
Part F (Cohort 2): 
50 µg mRNA-1273.529 as the second booster dose will be compared to 50 µg mRNA-1273 as 
the second booster dose. 
For the primary immunogenicity objective, there are 3 hypotheses to be tested: 

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A. H11: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 
1.5. 
B. H12: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
based on GMR and SRR difference is demonstrated. 
Part G: 
50 µg mRNA-1273.214 as the second booster dose will be compared to 50 µg mRNA-1273 as 
the second booster dose (active control arm in Part F, Cohort 2) 
For the primary objective on immune response, there are 8 hypotheses (4 hypotheses at Day 29 
and 4 hypotheses at Day 91). 
A. H11: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 
1.5. 
B. H12: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against the ancestral 
SARS-CoV-2 at Day 29 compared to mRNA-1273 against the ancestral SARS-CoV-2 at 
Day 29 with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
E. H15: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 91 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 91 with a non-inferiority margin of 
1.5. 

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F. H16: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the difference in SRR at Day 91 with a non-inferiority margin of 10%. 
G. H17: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against ancestral 
SARS-CoV-2 at Day 91 compared to mRNA-1273 against ancestral SARS-CoV-2 at 
Day 91 with a non-inferiority margin of 1.5 
H. H18: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 91 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 91. 
For the primary immunogenicity objective, an alpha of 0.05 (two-sided) will be allocated to the 
2 time points (Day 29 and Day 91). Day 29 and Day 91 will each have an alpha of 0.025 
(two-sided) for hypotheses testing. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
based on GMR, SRR difference. and non-inferiority against ancestral SARS-CoV-2 based on 
GMR are demonstrated at Day 29 or Day 91. 
For the key secondary immunogenicity objective, there are 2 hypotheses to be tested (Day 29 and 
Day 91 will each have alpha of 0.025 [two-sided] for hypotheses testing): 
A. H19: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against ancestral SARS-CoV-2 
based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
B. H110: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against ancestral SARS-CoV-2 
based on the difference in SRR at Day 91 with a non-inferiority margin of 10%. 
Part H: 
50 µg mRNA-1273.222 given as a second booster dose will be compared to 50 µg mRNA-1273 
given as a second booster dose (in Part F, Cohort 2). 
For the primary immunogenicity objective, there are 5 hypotheses to be tested as shown in 
Figure 2:  
A. H11: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the GMT ratio of mRNA-1273.222 against Omicron BA.4/5 at Day 29 
compared to mRNA-1273 against Omicron BA.4/5 at Day 29 with a non-inferiority 
margin of 1.5. 
B. H12: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the difference in SRR at Day 29 with a non-inferiority margin of 5%. 

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C. H13: 50 µg mRNA-1273.222, as a second booster dose, against ancestral SARS-CoV-2 
D614G is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 D614G based on the GMT ratio of mRNA-1273.222 against 
ancestral SARS-CoV-2 D614G at Day 29 compared to mRNA-1273 against ancestral 
SARS-CoV-2 D614G at Day 29 with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.222, as a second booster dose, against ancestral SARS-CoV-2 
D614G is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 D614G based on the difference in SRR at Day 29 with a 
non-inferiority margin of 10%. 
E. H15: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
superior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the GMT ratio of mRNA-1273.222 against Omicron BA.4/5 at Day 29 
compared to mRNA-1273 against Omicron BA.4/5 at Day 29. 
Part J: 
No formal hypothesis testing will be performed for Part J and all safety and immunogenicity 
analyses will be descriptive. 
The primary immunogenicity objective will be assessed using the Per-Protocol Set for 
Immunogenicity. Comparisons on immunogenicity response between the mRNA-1273.815 and 
mRNA-1273.231 treatment arms may be performed. 
8.3. 
Sample Size Determination  
Part A.1 
With approximately 300 and 584 participants exposed to 50 and 100 µg of mRNA-1273.211, 
respectively, there is at least 90% probability to observe 1 participant at each dose level reporting 
an AE if the true rate of AEs is 1%. 
Part A.2 
We anticipate approximately 300 participants will be enrolled in Part A.2, there is no statistical 
hypothesis testing in Part A.2. 
Part B 
With approximately 300 participants exposed to 100 µg of mRNA-1273, there is at least 90% 
probability to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part C 
With approximately 584 participants exposed to each dose of mRNA-1273.617.2, there is at least 
90% probability in each group to observe 1 participant reporting an AE if the true rate of AEs is 
1%. 
Part D 
With approximately 584 participants exposed to each dose of mRNA-1273.213, there is at least 
90% probability in each group to observe 1 participant reporting an AE if the true rate of AEs is 
1%. 

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Part F 
mRNA-1273.529 in each cohort will be assessed at a 2-sided type I error rate of 5%. 
Cohort 1: 
The target enrollment is approximately 375 participants for 50 µg mRNA-1273.529. Assuming 
20% of participants will be excluded from the PP Set for Immunogenicity-SARS-CoV2 negative, 
with approximately 300 participants in 50 µg mRNA-1273.529 and 300 participants in 50 µg 
mRNA-1273 (external comparator) in the PP Set for Immunogenicity-SARS-CoV-2 negative, 
there is approximately 89% global power for the primary immunogenicity objectives with alpha 
level of 0.05 (2-sided). The assumptions are: the true GMR (mRNA-1273.529 booster vs. 50 µg 
mRNA-1273 booster) against the variant (B.1.1.529) is 1.5, the standard deviation of the 
log-transformed titer is 1.5, and the non-inferiority margin for GMR is 1.5; the true SRR against 
B.1.1.529 after a single booster dose of 50 µg mRNA-1273.529 is 90% (same assumption for 
50 µg mRNA-1273), and non-inferiority margin for SRR difference is 10%. 
With approximately 375 participants exposed to 50 µg mRNA-1273.529, there is at least 90% 
probability in this group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
There may be an urgency to perform the Day 29 analysis as early as possible and depending on 
the testing capability of assays of antibodies against B.1.1.529, the Sponsor may decide using an 
external arm with less than 300 participants. Such decision will be documented in SAP prior to 
the planned Day 29 analysis. 
Cohort 2: 
The target enrollment is approximately 750 participants for 50 µg mRNA-1273.529 and 50 µg 
mRNA-1273 (1:1 ratio). Assuming 20% of participants will be excluded from the PP Set for 
Immunogenicity – SARS-CoV-2 negative, with approximately 300 participants each in 50 µg 
mRNA-1273.529 and 50 µg mRNA-1273 in the PP Set for Immunogenicity and SARS-CoV-2 
negative, there is approximately 89% global power to demonstrate the primary immunogenicity 
objectives of alpha level of 0.05 (2-sided). The assumptions are: the true GMR 
(mRNA-1273.529 as the second booster vs 50 µg mRNA-1273 as the second booster) against the 
variant (B.1.1.529) is 1.5, the standard deviation of the log-transformed titer is 1.5, and the 
non-inferiority margin for GMR is 1.5; the true SRR against B.1.1.529 after 50 µg 
mRNA-1273.529 as a second booster dose is 90% (same assumption for 50 µg 1273), and 
non-inferiority margin for SRR difference is 10%. 
With approximately 375 participants exposed to each group, there is at least 90% probability in 
each group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part G 
The target enrollment is approximately 375 participants for 50 µg mRNA-1273.214. Hypotheses 
testing will be performed at Day 29 and Day 91, alpha of 0.025 (2-sided) will be allocated 
equally to each one of the 2 time points. Assuming 20% of participants will be excluded from the 
PP Set for Immunogenicity – SARS-CoV-2 negative, with approximately 300 participants in 
50 µg mRNA-1273.214 and 300 participants in 50 µg mRNA-1273 (Part F, Cohort 2, 50 µg 
mRNA-1273) in the PP Set for Immunogenicity and SARS-CoV-2 negative, there is 
approximately 71% global power to demonstrate the primary immunogenicity objectives with 
alpha of 0.025 (2-sided) at each time point. The assumptions are: the true GMR 

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(mRNA-1273.214 second booster vs. 50 µg mRNA-1273 second booster) against the variant 
(B.1.1.529) is 1.5, the true GMR against ancestral SARS-CoV-2 is 1, the standard deviation of 
the log-transformed titer is 1.5, and the non-inferiority margin for GMR is 1.5, the true SRR 
against B.1.1.529 after mRNA-1273.214 as a second booster dose is 90% (same assumption for 
both 50 µg mRNA-1273.214 and 50 µg mRNA-1273), and non-inferiority margin for SRR 
difference is 10%. 
With approximately 375 participants exposed to 50 µg mRNA-1273.214, there is at least 90% 
probability in this group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part H 
The target enrollment is approximately 500 participants for 50 µg mRNA-1273.222. Assuming 
40% of participants will be excluded from the PP Set for Immunogenicity – SARS-CoV-2 
negative (due to a SARS-CoV-2 infection prebooster), with approximately 300 participants in 
50 µg mRNA-1273.222 and 260 participants in 50 µg mRNA-1273 (Part F, Cohort 2-50 µg 
mRNA-1273) in the PP Set for Immunogenicity and SARS-CoV-2 negative, there is 
approximately 60% power to demonstrate the primary immunogenicity objectives with an alpha 
of 0.05 (2-sided) at Day 29. The assumptions are: the true GMR (mRNA-1273.222 second 
booster vs. mRNA-1273 second booster) against Omicron BA.4/5 is 1.5, GMR 
(mRNA-1273.222 second booster vs. mRNA-1273 second booster) against ancestral 
SARS-CoV-2 D614G is 1, the standard deviation of the log-transformed titer is 1.5, and the non-
inferiority margin for GMR is 1.5. The true SRR against Omicron BA.4/5 after mRNA-1273.222 
as a second booster dose is 95% (same assumption for 50 µg mRNA-1273), and non-inferiority 
margin for SRR difference against Omicron BA.4/5 is 5%. The true SRR against ancestral 
SARS-CoV-2 D614G after mRNA-1273.222 as a second booster dose is 95% (same assumption 
for 50 µg mRNA-1273), and the non-inferiority margin for SRR difference against ancestral 
SARS-CoV-2 D614G is 10%. 
With approximately 500 participants exposed to 50 µg mRNA-1273.222, there is at least 90% 
probability in this group to observe 1 participant reporting an AE if the true rate of AEs is 1%. 
Part J 
8.4. 
Analysis Sets  
The analysis sets are described in Table 15, same definitions across Parts A (1, 2), B, C, D, F, G, 
H, and J when applicable. 
The sample size for Part J is not driven by statistical assumptions for formal hypothesis testing. 
The number of proposed participants is considered sufficient to provide a descriptive summary 
of the safety and immunogenicity of each treatment arm. 
The target enrollment is approximately 100 participants who will be randomized in a 1:1 ratio to 
receive either mRNA-1273.815 (50 µg) or mRNA-1273.231 (50 µg). 

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Table 15: 
Analysis Sets 
Set 
Description 
Full Analysis Set (FAS) 
The FAS consists of all participants who receive IP.  
Per-Protocol Immunogenicity 
Set (PPIS) 
The PPIS consists of all participants in the FAS who received the 
planned dose of study vaccination and no major protocol deviations 
that impact key or critical data. 
The PPIS will be used as the primary analysis set for analyses of 
immunogenicity for Parts A.1, B, C, D and J. 
Per-Protocol Immunogenicity 
Set-SARS-CoV-2 Negative 
(PPIS-Neg) 
Participants in the PPIS-Neg who have no serologic or virologic 
evidence of SARS-CoV-2 infection at baseline, ie, who are SARS-
CoV-2 negative, defined by both negative RT-PCR test for SARS-
CoV-2 and negative serology test based on bAb specific to SARS-
CoV-2 nucleocapsid. 
PPIS-Neg will be the primary analysis set for analyses of 
immunogenicity for Parts A.2, F (Cohort 1), F (Cohort 2), G, and H. 
Solicited Safety Set 
The Solicited Safety Set consists of all participants who receive IP 
and contribute any solicited AR data. 
The Solicited Safety Set will be used for the analyses of solicited 
ARs. Participants will be included in the study arm corresponding to 
the dose of IP that they actually received. 
Safety Set 
The Safety Set consists of all participants who receive IP. The Safety 
Set will be used for all analyses of safety except for the solicited ARs. 
Participants will be included in the study arm corresponding to the 
dose of IP that they actually received. 
Per-Protocol Set for Efficacy 
The PP Set for Efficacy consists of all participants in the FAS who 
receive the planned dose of study vaccination, who are SARS-CoV-2 
negative at baseline (ie, have a negative RT-PCR test for 
SARS-CoV-2 and a negative serology test based on bAb specific to 
SARS-CoV-2 nucleocapsid at baseline), and have no major protocol 
deviations that impact key or critical data. 
8.5. 
Statistical Methods  
8.5.1. 
Baseline Characteristics and Demographics  
Demographic variables (eg, age, gender, race, ethnicity, height, weight, and body mass index) 
and baseline characteristics will be summarized by study arm. For study parts with more than 
one dose, data will be summarized for each arm and for dose levels of the same vaccine type 
combined. Summary statistics (mean, standard deviation for continuous variable, and number 
and percentage for categorical variables) will be provided. 
8.5.2. 
Efficacy Analysis  
This study is not designed to assess efficacy. Descriptive summaries of symptomatic COVID-19 
disease, asymptomatic SARS-CoV-2 infection, as well as SARS-CoV-2 infections regardless of 
symptoms will be provided for each study arm. analyses will be performed using PP Set for 
Efficacy. 

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8.5.3. 
Immunogenicity Analyses  
There is no hypothesis testing for Parts A.1, B, C, and D. 
The primary analysis population for immunogenicity will be the PPIS for Immunogenicity 
analysis for Parts A.1, A.2, B, C, D and J. PPIS-Neg will be the primary analysis for 
immunogenicity analyses for Parts F (Cohort 1), F (Cohort 2), G, and H. Each arm will be 
evaluated separately. 
8.5.3.1. 
Analysis for the Primary Immunogenicity Objective  
8.5.3.1.1. Analysis for the Primary Immunogenicity Objective for Parts A.1, B, C, and D  
Immune response of each booster arm against ancestral SARS-CoV-2 and SARS-CoV-2 
variants, the GMT, geometric mean fold rise and seroresponse rate will be calculated at the time 
points where the immune response is assessed. 
8.5.3.1.2. Analysis for the Primary Immunogenicity Objective for Part A.2  
There is no hypothesis testing for Part A.2. 
For Part A.2 participants, Day 29 and Day 181 immune response after mRNA-1273.214 (50 µg) 
as a second booster dose will be compared with their own Day 29 and Day 181 immune response 
of mRNA-1273.211 (50 µg) received as the first booster dose. GMT ratios will be calculated by 
back transforming the mean of paired differences of antibody titer data on the logarithmic scale 
between Day 29 and Day 181 post mRNA-1273.214 and Day 29 and Day 181 of antibody titer 
data post mRNA-1273.211. CIs for the GMT ratio will be based on t-distribution of the 
log-transformed values then back-transformed to the original scale for presentation. 
Seroresponse rates at Day 29 and Day 181 post mRNA-1273.214 will be compared with their 
seroresponse rates at Day 29 and Day 181 post mRNA-1273.211. The difference in seroresponse 
rates and its corresponding 95% CI based on adjusted Wald method will be provided. 
8.5.3.1.3. Analysis for the Primary Immunogenicity Objective for Part F  
Cohort 1: 
The 50-µg mRNA-1273.529 booster dose (first booster dose) will be assessed with respect to the 
mRNA-1273 booster dose (first booster dose) using an external comparator (details regarding the 
external historical control will be included in the SAP). For the primary immunogenicity 
objective, there are 3 hypotheses to be tested. 
A. H11: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is non-
inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the 
difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a single booster dose, against the variant B.1.1.529 is 
superior to the booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on the GMT 
ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 

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An ANCOVA model will be performed to assess the difference in immune response between 
mRNA-1273.529 and mRNA-1273 (using external comparator) as the first booster dose. For 
immune response against the B.1.1.529 strain, in the ANCOVA model, antibody titers at Day 29 
postbooster against the B.1.1.529 strain will be a dependent variable, and a group variable 
(mRNA-1273.529 and mRNA-1273) will be the fixed effect, adjusting for age groups (< 65, 
≥ 65 years) and prebooster antibody titer level, if applicable. 
The GMT will be estimated by the GLSM from the model and its corresponding 95% will be 
provided for each group. The GMR (ratio of GMTs) for mRNA-1273.529 with respect to 
mRNA-1273 will be estimated by the ratio of GLSM from the model and the corresponding 95% 
CIs will be provided. The 95% CI for GMR will be used to assess the between group difference 
in immune response against the B.1.1.529 strain for mRNA-1273.529 at Day 29 compared to the 
mRNA-1273. 
The number and percentage (rate) of participants achieving seroresponse at Day 29 will be 
summarized with 95% CI calculated using the Clopper-Pearson method for each group. The 
difference of SRR between mRNA-1273.529 and mRNA-1273 will be calculated with 95% CI 
based on Miettinen-Nurminen method. The non-inferiority in SRR of mRNA-1273.529 
compared to mRNA-1273 will be considered demonstrated if the lower bound of the 95% of the 
SRR difference is > -10% based on the non-inferiority margin of 10%. 
The primary immunogenicity objective (against the B.1.1.529) is considered met if non-
inferiority is demonstrated based on GMR and SRR difference, specifically: 
• The lower bound of the 95% CI of the GMT ratio between mRNA1273.529 against 
the variant (B.1.1.529) at Day 29 as compared to 50 µg mRNA1273 against B.1.1.529 
at Day 29 is > 0.667 based on the non-inferiority margin of 1.5 
• The lower bound of the 95% CI of the SRR difference (50 µg mRNA-1273.529 
against the variant B.1.1.529 at Day 29–- 50 µg mRNA-1273 against B.1.1.529 at 
Day 29) is >-10% 
• If non-inferiority is demonstrated (based on GMT ratio and SRR difference), the 
lower bound of 95% CI of the GMT ratio will be compared to 1, if it’s greater than 1, 
then superiority is demonstrated. 
Cohort 2 
A. H11: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 
1.5. 
B. H12: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.529, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 

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the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
The primary immunogenicity objective (against the B.1.1.529) is considered met if non-
inferiority is demonstrated based on GMR and SRR difference, specifically: 
• The lower bound of the 95% CI of the GMT ratio between mRNA1273.529 against 
the variant (B.1.1.529) at Day 29 as compared to 50 µg mRNA1273 against B.1.1.529 
at Day 29 is > 0.667 based on the non-inferiority margin of 1.5. 
• The lower bound of the 95% CI of the SRR difference (50 µg mRNA-1273.529 
against the variant B.1.1.529 at Day 29–- 50 µg mRNA-1273 against B.1.1.529 at 
Day 29) is >-10%. 
• If non-inferiority is demonstrated (based on GMT ratio and SRR difference), the 
lower bound of 95% CI of GMT ratio will be compared to 1, if it’s greater than 1, 
then superiority is demonstrated. 
8.5.3.1.4. Analysis for the Primary Immunogenicity Objective for Part G  
50 µg mRNA-1273.214 as the second booster dose will be compared to 50 µg mRNA-1273 as 
the second booster dose (active control arm in Part F, Cohort 2) 
For the primary immunogenicity objective, there are 8 hypotheses (4 hypotheses at Day 29 and 
4 hypotheses at Day 91). Figure 1 depicts the hypotheses testing strategy. 
A. H11: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the GMT ratio of mRNA-1273.529 against the variant B.1.1.529 at Day 29 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 29 with a non-inferiority margin of 
1.5. 
B. H12: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
C. H13: 50 µg mRNA-1273.214, as a second booster dose, against the ancestral 
SARS-CoV-2 is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against ancestral 
SARS-CoV-2 at Day 29 compared to mRNA-1273 against ancestral SARS-CoV-2 at 
Day 29 with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 29 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 29. 
E. H15: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 91 compared 
to mRNA-1273 against the variant B.1.1.529 at Day 91 with a non-inferiority margin of 
1.5. 

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F. H16: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based 
on the difference in SRR at Day 91 with a non-inferiority margin of 10%. 
G. H17: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against ancestral 
SARS-CoV-2 based on the GMT ratio of mRNA-1273.214 against ancestral 
SARS-CoV-2 at Day 91 compared to mRNA-1273 against ancestral SARS-CoV-2 at 
Day 91 with a non-inferiority margin of 1.5. 
H. H18: 50 µg mRNA-1273.214, as a second booster dose, against the variant B.1.1.529 is 
superior to the second booster dose of (50 µg) mRNA-1273 against B.1.1.529 based on 
the GMT ratio of mRNA-1273.214 against the variant B.1.1.529 at Day 91 compared to 
mRNA-1273 against the variant B.1.1.529 at Day 91. 
Figure 1: 
Statistical Hypotheses Testing Strategy for Part G  
 
For the primary immunogenicity objective, an alpha of 0.05 (two-sided) will be allocated to the 
2 time points. Day 29 and Day 91 will each have an alpha of 0.025 (two-sided) for hypotheses 
testing.  
The analyses method described in Part F Cohort 1 will be used for Part G. 
The primary immunogenicity objective is considered met if non-inferiority against B.1.1.529 
based on GMR, SRR difference, and non-inferiority against ancestral SARS-CoV-2 based on 
GMR are demonstrated at Day 29 or Day 91. 
Day 29: alpha = 0.025 (2-sided) 
• The lower bound of the 97.5% CI of the GMT ratio between mRNA-1273.214 against 
the variant (B.1.1.529) at Day 29 as compared to 50 µg mRNA-1273 against 
B.1.1.529 at Day 29 is > 0.667 based on the non-inferiority margin of 1.5. 

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• The lower bound of the 97.5% CI of the SRR difference (50 µg mRNA-1273.214 
against the variant B.1.1.529 at Day 29–- 50 µg mRNA-1273 against B.1.1.529 at 
Day 29) is >-10%. 
• The lower bound of the 97.5% CI of the GMT ratio between mRNA-1273.214 against 
ancestral SARS-CoV-2 at Day 29 as compared to 50 µg mRNA-1273 against 
ancestral SARS-CoV-2 at Day 29 is > 0.667 based on the non-inferiority margin of 
1.5. 
• If non-inferiority is demonstrated for both B.1.1.529 (based on GMR and SRR) and 
ancestral SARS-CoV-2 (based on GMR), the lower bound of 97.5% CI of GMR will 
be compared to 1, if it’s greater than 1, then superiority against B.1.1.529 is 
demonstrated. 
Day 91: alpha=0.025 (2-sided) 
Hypotheses testing at Day 91 will be performed in the same manner, first test 2 non-inferiority 
hypotheses (2 against the B.1.1.529 strain and one against ancestral SARS-CoV-2) at alpha of 
0.025 level (two-sided). Once non-inferiority is demonstrated for both B.1.1529 and ancestral 
SARS-CoV-2, then superiority testing against the B.1.1.529 at alpha of 0.025 level (two-sided) 
will be performed. 
For the key secondary objective, there are 2 hypotheses to be tested (Day 29 and Day 91 each 
with alpha level of 0.025, 2-sided): 
A. H19: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against ancestral SARS-CoV-2 
based on the difference in SRR at Day 29 with a non-inferiority margin of 10%. 
B. H110: 50 µg mRNA-1273.214, as a second booster dose, against ancestral SARS-CoV-2 is 
non-inferior to the booster dose of (50 µg) mRNA-1273 against ancestral SARS-CoV-2 
based on the difference in SRR at Day 91 with a non-inferiority margin of 10%. 
If the lower bound of the 97.5% CI of the SRR difference (50 µg mRNA-1273.214 against 
ancestral SARS-CoV-2–- 50 µg mRNA-1273 against ancestral SARS-CoV-2) is >-10% at 
Day 29 or Day 91, then the key secondary objective will be considered met. 
In the event that an early assessment of the 1273.214 data is needed due to public health 
concerns, a two-staged approach will be used. Specifically, a subset of participants’ (ie, 50 first 
enrolled participants) serum samples will first be tested against ancestral SARS-CoV-2 and 
various VOCs. For the Day 29 and Day 91 immunogenicity analyses, all participants’ immune 
data will be used in the formal analysis to evaluate the primary immunogenicity objective. 
8.5.3.1.5. Analysis for the Primary Immunogenicity Objective for Part H  
The primary immunogenicity objective will be assessed using PPIS-Neg, descriptive summaries 
of antibody GMTs, GMFR, and SRR will be provided (refer to Section 8.5.3.2 for analysis 
methods). 

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For the primary immunogenicity objective, there are 5 hypotheses to be tested as shown in 
Figure 2: 
A. H11: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the GMT ratio of mRNA-1273.222 against Omicron BA.4/5 at 
Day 29 compared to mRNA-1273 against Omicron BA.4/5 at Day 29 with a 
non-inferiority margin of 1.5. 
B. H12: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
non-inferior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the difference in SRR at Day 29 with a non-inferiority margin of 5%. 
C. H13: 50 µg mRNA-1273.222, as a second booster dose, against ancestral SARS-CoV-2 
D614G is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 D614G based on the GMT ratio of mRNA-1273.222 against 
ancestral SARS-CoV-2 D614G at Day 29 compared to mRNA-1273 against ancestral 
SARS-CoV-2 D614G at Day 29 with a non-inferiority margin of 1.5. 
D. H14: 50 µg mRNA-1273.222, as a second booster dose, against ancestral SARS-CoV-2 
D614G is non-inferior to the second booster dose of (50 µg) mRNA-1273 against 
ancestral SARS-CoV-2 D614G based on the difference in SRR at Day 29 with a 
non-inferiority margin of 10%. 
E. H15: 50 µg mRNA-1273.222, as a second booster dose, against Omicron BA.4/5 is 
superior to the second booster dose of (50 µg) mRNA-1273 against Omicron BA.4/5 
based on the GMT ratio of mRNA-1273.222 against Omicron BA.4/5 at 
Day 29 compared to mRNA-1273 against Omicron BA.4/5 at Day 29. 
Figure 2: 
Statistical Hypotheses Testing for Part H  
 
The analyses methods described in Part F Cohort 1 will be used for Part H. 
The primary immunogenicity objective is considered met if non-inferiority against BA.4/5 and 
ancestral SARS-CoV-2 D614G based on GMR, SRR difference at Day 29 are demonstrated. 

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8.5.3.1.6. Analysis for the Primary Immunogenicity Objective for Part J  
No formal hypothesis testing will be performed for Part J and all safety and immunogenicity 
analyses will be descriptive. 
The primary immunogenicity objective will be assessed using the PPIS. 
8.5.3.2. 
Other Analyses of Immunogenicity Applicable to All Study Parts 
SARS-CoV-2-specific bAb and nAb are assessed at multiple timepoints in each part of this 
study. 
For each of the antibodies of interest, eg, levels of SARS-CoV-2–specific bAb and 
SARS-CoV-2-specific nAb, the GMT or level with corresponding 95% CI at each time point, 
and GMFR of post-baseline/baseline titers or levels with corresponding 95% CI at each post-
baseline time point will be provided for each 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. The following descriptive statistics will also be provided at each time point: 
number of participants (n), median, minimum, and maximum. 
The MMRM will be used to analyze all postbooster measures for between booster comparison 
when applicable, the model will include treatment group, analysis visit, treatment by visit 
interaction, and adjusting for age groups and prebooster titer levels. An unstructured covariance 
structure will be used to model the within-participant errors. The GMT will be estimated from 
the model and its corresponding 95% CI will be provided for each group at each postboost 
timepoint. The GMR (ratio of GMTs) will be estimated from the model and the corresponding 
95% CI will be provided at each postboost timepoint. 
The SRR of each arm against ancestral SARS-CoV-2 and variants, defined as the percentage of 
participants achieving seroresponse against ancestral SARS-CoV-2 and variants respectively, 
will be provided for each arm with the 95% CI calculated using the Clopper-Pearson method. 
The primary definition of seroresponse is defined as ≥ 4 × LLOQ for those with pre-dose 1 of 
primary series baseline < LLOQ; ≥ 4-foldrise for those with pre-dose 1 of primary series baseline 
≥ LLOQ. The secondary definition of seroresponse is defined as ≥ 4 × LLOQ for those with 
prebooster baseline < LLOQ; ≥ 4-foldrise for those with prebooster ≥ LLOQ. SRR will be 
summarized using both definitions for all the study parts. 
8.5.4. 
Safety Analyses  
All safety analyses are descriptive in nature and 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 provided by study arm. 
Safety and reactogenicity will be assessed by clinical review of all relevant parameters including 
solicited ARs (local and systemic ARs), unsolicited AEs, treatment-related AEs, severe AEs, 
SAEs, MAAEs, AESI, AEs leading to withdrawal, vital sign measurements, and physical 
examination findings.  
The number and percentage of participants with any solicited local AR, with any solicited 
systemic AR, with any solicited AR during the 7-day follow-up period after each vaccination, 
and with Grade 3 or higher solicited AR will be provided. A 2-sided 95% exact CI using the 

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Clopper-Pearson method will be provided for the percentage of participants with any solicited 
AR. 
The number and percentage of participants with unsolicited AEs, treatment-related AEs, severe 
AEs, SAEs, MAAEs, AESI, and AEs leading to withdrawal will be summarized. Unsolicited 
AEs will be presented by MedDRA system organ class and preferred term. Unsolicited AEs will 
be coded according to the MedDRA Dictionary for Adverse Reaction Terminology. 
The number of events of solicited ARs, unsolicited AEs/SAEs, MAAEs, AEs leading to 
withdrawal, and AESI will be reported in summary tables accordingly. Pregnancy outcomes will 
also be summarized. 
Table 16 summarizes the analysis strategy for safety parameters. For all other safety parameters, 
descriptive summary statistics will be provided. Further details will be described in the SAP. 
Table 16: 
Analysis Strategy for Safety Parameters  
Safety Endpoint 
Number and Percentage of 
Participants, Number of 
Events 
95% CI for 
Each Study 
Arm 
Any Solicited AR (overall and by local, systemic) 
X 
X 
Any Unsolicited AE 
X 
— 
Any SAE 
X 
— 
Any Unsolicited MAAE 
X 
— 
Any Unsolicited AESI 
X 
— 
Any Unsolicited Treatment-Related AE 
X 
— 
Any Treatment-Related SAE 
X 
— 
Any Unsolicited AE Leading to Withdrawal from Study 
Participation 
X 
— 
Any Severe Unsolicited AE 
X 
— 
Any Treatment-Related Severe Unsolicited AE 
X 
— 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; AR = adverse reaction; 
CI = confidence interval; MAAE = medically attended adverse event; SAE = serious adverse event. 
Notes: 95% CI using the Clopper-Pearson method, X = results will be provided. 
8.5.5. 
Subgroup Analyses  
Immunogenicity will be assessed in the following subgroups; however, subgroup analyses may 
not be performed for Part J due to small sample size: 
• Age (18 to < 65, and ≥ 65 years). 
• Sex (female, male). 
• Baseline/prebooster SARS-CoV-2 status (negative, positive) if there are enough 
numbers of prebooster positives. 
• Race and ethnicity group (non-Hispanic White, communities of color). 
Safety may be assessed for the same subgroups. 

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8.6. 
Planned Analyses  
8.6.1. 
Interim Analysis  
The interim analysis will be conducted based on safety and immunogenicity data collected 
through Day 15 or Day 29. The interim analysis may be conducted either after all participants in 
Parts A.1, A.2, B, C, D, F, G, H, or J have completed their Day 15 or Day 29 visit assessments 
and/or subsequent timepoint visits (eg, Day 91 for Parts F, G, H, and J) or combined after the last 
participant of each study part (Parts A.1, A.2, B, C, D, F, G, H, or J) dose arm, or pre-specified 
subset of the dose arm has completed their Day 15 or Day 29 visit assessments. 
8.6.2. 
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. The final CSR will include full analyses of all safety and immunogenicity 
through Day 366 (Month 12) for Parts A.1, B, C, D, F, and G and through D181 (Month 6) for 
Parts A.2, H, and J. 

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elicited antibodies to SARS-CoV-2 and circulating variants. bioRxiv. 2021; doi: 
10.1101/2021.01.15.426911. 
World Health Organization (WHO). Coronavirus disease 2019 (COVID-19) Weekly 
Epidemiological Update [Internet]. Geneva, Switzerland: WHO; 2021 May 9 [cited 2021 May 
12]. Available from: https://www.who.int/publications/m/item/weekly-epidemiological-update-
on-covid-19---11-may-2021. 
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. 
Wu K, Werner AP, Moliva JI, Koch M, Choi A, Stewart-Jones GBE, et al. Serum neutralizing 
activity elicited by mRNA-1273 vaccine. NEJM. 2021b Apr 15. doi: 10.1056/NEJMc2102179. 
Wu K, Choi A, Koch M, Elbashir S, Ma L, Lee D, et al. Variant SARS-CoV-2 mRNA vaccines 
confer broad neutralization as primary or booster series in mice. bioRxiv. 2021b. doi: 
0.1101/2021.04.13.439482. 

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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS  

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10.1. 
APPENDIX 1: Schedule of Events  
Table 17: 
Schedule of Events for Parts A.1, B, C, D, F, and G 
Visit Number 
Screening1 V1 
 
V2 
V3 
V3a 
 
 
V4 
 
 
V5 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) C 
SFU 
(eDiary) 
SFU (SC) C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
 
 
M12 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
(Parts F 
and G 
only) 
Every 
2 weeks 
D36– 
D1622 
Every 
2 weeks 
D43-
D169 
D181 
Every 
2 weeks 
D202– 
D3422 
Every 
2 weeks 
D209-
D349 
D366 
 
Window Allowance 
(Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
±2 
±3 
±14 
-- 
Days Since Booster 
Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
 
365 
-- 
Informed consent form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Study injection (including 
30-minute post-dosing 
observation period) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Confirm participant meets 
inclusion and exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination 
including vital signs3 
X 
X 
 
 
X 
X 
 
 
X 
 
 
X 
X 
Pregnancy testing 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Blood for SARS-CoV-2 
serology (antinucleocapsid 
antibody) 
 
X 
 
 
X 
X 
 
 
X 
 
 
X 
X 
Blood for immune response 
to vaccination (binding and 
neutralizing antibody)4 
 
X 
 
X 
X 
X 
 
 
X 
 
 
X 
X 

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Visit Number 
Screening1 V1 
 
V2 
V3 
V3a 
 
 
V4 
 
 
V5 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) C 
SFU 
(eDiary) 
SFU (SC) C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
 
 
M12 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
(Parts F 
and G 
only) 
Every 
2 weeks 
D36– 
D1622 
Every 
2 weeks 
D43-
D169 
D181 
Every 
2 weeks 
D202– 
D3422 
Every 
2 weeks 
D209-
D349 
D366 
 
Window Allowance 
(Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
±2 
±3 
±14 
-- 
Days Since Booster 
Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
 
365 
-- 
Nasopharyngeal swab 
sample for SARS-CoV-24 
 
X 
 
 
X 
X 
 
 
X 
 
 
X 
X5 
eDiary activation for 
recording solicited local 
and systemic reactogenicity 
adverse reactions (7 days) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Review of eDiary 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Follow-up safety calls6 
 
 
X 
 
 
 
 
X 
 
 
X 
 
 
Recording of unsolicited 
AEs 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Recording of MAAEs and 
concomitant medications 
relevant to or for the 
treatment of the MAAE7 
 
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 SAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of AESI 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

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Visit Number 
Screening1 V1 
 
V2 
V3 
V3a 
 
 
V4 
 
 
V5 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) C 
SFU 
(eDiary) 
SFU (SC) C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
 
 
M12 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
(Parts F 
and G 
only) 
Every 
2 weeks 
D36– 
D1622 
Every 
2 weeks 
D43-
D169 
D181 
Every 
2 weeks 
D202– 
D3422 
Every 
2 weeks 
D209-
D349 
D366 
 
Window Allowance 
(Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
±2 
±3 
±14 
-- 
Days Since Booster 
Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
 
365 
-- 
Recording of concomitant 
medications and non-study 
vaccinations8 
 
X 
X 
X 
X 
 
 
 
 
 
 
X 
 
Study completion 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PBMCs 
May be collected for a 
subset of participants at 
selected sites.  
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; 
eDiary = electronic diary; M = month; MAAE = medically attended adverse event; NP = nasopharyngeal; RT-PCR = reverse transcriptase polymerase chain 
reaction; PBMC = peripheral blood mononuclear cells; SAE = serious adverse event; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; 
SC = safety telephone call; SFU = safety follow-up; UNS = unscheduled visit; V = visit. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (DHHS 2023), 
investigators may convert study site visits to telemedicine visits with the approval of the Sponsor. 
1. 
The Screening Visit and Day 1 (vaccination) visit can be combined and occur on the same day. 
2. 
Safety follow-up via eDiary questionnaire will be performed every 2 weeks from at Day 36 to Day 162, and from Day 202 to Day 342. These study days are 
relative to Day 1 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. 
3. 
Physical examination: A full physical examination, including height and weight, will be performed on Day 1. Symptom-directed physical examinations may 
be performed at other time points at the discretion of the investigator. Any clinically significant finding identified during a study visit should be reported as 
an MAAE. Vital signs are to be collected pre- and post-dosing on the day of injection (Day 1) only. When applicable, vital sign measurements should be 
performed before blood collection. For participants who are febrile (body temperature ≥ 38.0°C [100.4°F]) before injection on Day 1, the visit must be 

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
Page 137 
rescheduled within the relevant window period to receive the injection. Afebrile participants with minor illnesses can be administered investigational product 
at the discretion of the investigator. 
4. 
The NP swab sample, collected prior to vaccination on Day 1, will be used to ascertain the presence of SARS-CoV-2 via RT-PCR. The NP swab sample will 
also be collected within 24 hours if participant experience signs and symptoms of SARS-CoV-2 infection. It is important to note that some of the symptoms 
of COVID-19 overlap with solicited local and systemic reactogenicity ARs, that are expected after vaccination with mRNA-1273.211 (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 vaccination can help ensure that cases of COVID-19 are not 
overlooked. Any study participant reporting respiratory symptoms during the 7-day period after vaccination should be evaluated for COVID-19. 
5. 
Nasopharyngeal swabs will be collected during the unscheduled/illness visit for testing for the presence of SARS-CoV-2 via RT-PCR and for assessing non-
SARS-CoV-2 causes of upper and lower respiratory tract infection. 
6. 
Trained site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, AEs leading to withdrawal, information on 
concomitant medications associated with those events, AESI, and any non-study vaccinations. In addition, study personnel will collect information on 
known participant exposure to someone with known COVID-19 or SARS-CoV-2 infection and on participant experience of COVID-19 symptoms. Sites will 
collect this information for eDiary days only if eDiary responses indicate the need for follow-up via telephone. 
7. 
All concomitant medications relevant to or for the treatment of an SAE or MAAE will be recorded from Day 1 through the end of study visit (Day 366). 
8. 
All concomitant medications and non-study vaccinations will be recorded through 28 days following injection. 
 
 

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mRNA-1273 
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Table 18: 
Schedule of Events for Part A.2 
Visit Number 
A.2 
Screening1 
V6 
 
V7 
V8 
V9 
 
 
V10 
A.2 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) 
C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
-- 
Study Visit Day  
D01 
D11,9 
D8 
D15 
D29 
D91 
Every 
2 weeks 
D36– 
D1622 
Every 
2 weeks 
D43-D169 
D181 
 
Window Allowance (Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
-- 
Days Since Booster Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
Informed consent form 
X 
 
 
 
 
 
 
 
 
 
Study injection (including 
30-minute post-dosing observation 
period) 
 
X 
 
 
 
 
 
 
 
 
Confirm participant meets 
inclusion and exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
Physical examination including 
vital signs3 
X 
X 
 
 
X 
X 
 
 
X 
X 
Pregnancy testing 
 
X 
 
 
 
 
 
 
 
 
Blood for SARS-CoV-2 serology 
(antinucleocapsid antibody) 
 
X 
 
 
X 
X 
 
 
X 
X 
Blood for immune response to 
vaccination (binding and 
neutralizing antibody)4 
 
X 
 
X 
X 
X 
 
 
X 
X 
Nasopharyngeal swab sample for 
SARS-CoV-24 
 
X 
 
 
X 
X 
 
 
X 
X5 

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Visit Number 
A.2 
Screening1 
V6 
 
V7 
V8 
V9 
 
 
V10 
A.2 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) 
C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
-- 
Study Visit Day  
D01 
D11,9 
D8 
D15 
D29 
D91 
Every 
2 weeks 
D36– 
D1622 
Every 
2 weeks 
D43-D169 
D181 
 
Window Allowance (Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
-- 
Days Since Booster Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
eDiary activation for recording 
solicited local and systemic 
reactogenicity adverse reactions 
(7 days) 
 
X 
 
 
 
 
 
 
 
 
Review of eDiary 
 
 
X 
 
 
 
 
 
 
 
Follow-up safety calls6 
 
 
X 
 
 
 
 
X 
 
 
Recording of unsolicited AEs 
 
X 
X 
X 
X 
 
 
 
 
 
Recording of MAAEs and 
concomitant medications relevant 
to or for the treatment of the 
MAAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of SAEs and 
concomitant medications relevant 
to or for the treatment of the SAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of AESI 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of concomitant 
medications and non-study 
vaccinations8 
 
X 
X 
X 
X 
 
 
 
X 
 
Study completion 
 
 
 
 
 
 
 
 
X 
 

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mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
Page 140 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; 
eDiary = electronic diary; 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; 
UNS = unscheduled visit; V = visit. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (DHHS 2023), 
investigators may convert study site visits to telemedicine visits with the approval of the Sponsor. 
1. 
The Screening Visit and Day 1 (vaccination) visit can be combined and occur on the same day. 
2. 
Safety follow-up via eDiary questionnaire will be performed every 2 weeks from Day 36 to Day 162. These study days are relative to Day 1 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. 
3. 
Physical examination: A full physical examination, including height and weight, will be performed on Day 1. Symptom-directed physical examinations may 
be performed at other timepoints at the discretion of the investigator. Any clinically significant finding identified during a study visit should be reported as 
an MAAE. Vital signs are to be collected pre- and post-dosing on the day of injection (Day 1) only. When applicable, vital sign measurements should be 
performed before blood collection. For participants who are febrile (body temperature ≥ 38.0°C [100.4°F]) before injection on Day 1, the visit must be 
rescheduled within the relevant window period to receive the injection. Afebrile participants with minor illnesses can be administered investigational product 
at the discretion of the investigator. 
4. 
The NP swab sample, collected prior to injection on Day 1, will be used to ascertain the presence of SARS-CoV-2 via RT-PCR. The NP swab sample will 
also be collected within 24 hours if participant experience signs and symptoms of SARS-CoV-2 infection. It is important to note that some of the symptoms 
of COVID-19 overlap with solicited local and systemic reactogenicity ARs, that are expected after vaccination with mRNA-1273.211 (eg, myalgia, 
headache, fever, 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 a NP swab prior to the Day 1 vaccination can help ensure that cases of COVID-19 are not 
overlooked. Any study participant reporting respiratory symptoms during the 7-day period after injection should be evaluated for COVID-19. 
5. 
Nasopharyngeal swabs will be collected during the unscheduled/illness visit for testing for the presence of SARS-CoV-2 via RT-PCR and for assessing non-
SARS-CoV-2 causes of upper and lower respiratory tract infection. 
6. 
Trained site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, AEs leading to withdrawal, information on 
concomitant medications associated with those events, AESI, and any non-study vaccinations. In addition, study personnel will collect information on 
known participant exposure to someone with known COVID-19 or SARS-CoV-2 infection and on participant experience of COVID-19 symptoms. Sites will 
collect this information for eDiary days only if eDiary responses indicate the need for follow-up via telephone. 
7. 
All concomitant medications relevant to or for the treatment of an SAE or MAAE will be recorded from Day 1 through the end of study visit (Day 181). 
8. 
All concomitant medications and non-study vaccinations will be recorded through 28 days following injection. 
9. 
If Part A.2 Day 1 falls within the visit window for Part A.1 D366, the study procedures listed for Part A.1 Day 366, Part A.2 Screening, and Part A.2 Day 1 
can be completed on the same day. All Part A.1 Day 366 samples will be collected prior to administration of mRNA-1273.214. Additional samples would 
not be collected for Part A.2 Day 1 if it occurs on the same day as Part A.1 Day 366. The samples collected pre-dose will be used for both Part A.1 Day 366 
and Part A.2 Day 1.  
 

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mRNA-1273-P205 Protocol Amendment 11 
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Page 141 
Table 19: 
Schedule of Events for Part H 
Visit Number 
H Screening1 
V1 
 
V2 
V3 
V3a 
 
 
V4 
H UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) 
C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
Every 
2 weeks 
D36- 
D1622 
Every 
2 weeks 
D43-D169 
D181 
 
Window Allowance (Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
-- 
Days Since Booster Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
Informed consent form 
X 
 
 
 
 
 
 
 
 
 
Study injection (including 
30-minute post-dosing observation 
period) 
 
X 
 
 
 
 
 
 
 
 
Confirm participant meets 
inclusion and exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
Physical examination including 
vital signs3 
X 
X 
 
 
X 
X 
 
 
X 
X 
Pregnancy testing 
 
X 
 
 
 
 
 
 
 
 
Blood for SARS-CoV-2 serology 
(antinucleocapsid antibody) 
 
X 
 
 
X 
X 
 
 
X 
X 
Blood for immune response to 
vaccination (binding and 
neutralizing antibody)4 
 
X 
 
X 
X 
X 
 
 
X 
X 
Nasopharyngeal swab sample for 
SARS-CoV-24 
 
X 
 
 
X 
X 
 
 
X 
X5 
eDiary activation for recording 
solicited local and systemic 
reactogenicity adverse reactions 
(7 days) 
 
X 
 
 
 
 
 
 
 
 

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mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
Page 142 
Visit Number 
H Screening1 
V1 
 
V2 
V3 
V3a 
 
 
V4 
H UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU (SC) 
C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
Every 
2 weeks 
D36- 
D1622 
Every 
2 weeks 
D43-D169 
D181 
 
Window Allowance (Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
-- 
Days Since Booster Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
Review of eDiary 
 
 
X 
 
 
 
 
 
 
 
Follow-up safety calls6 
 
 
X 
 
 
 
 
X 
 
 
Recording of unsolicited AEs 
 
X 
X 
X 
X 
 
 
 
 
 
Recording of MAAEs and 
concomitant medications relevant 
to or for the treatment of the 
MAAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of SAEs and 
concomitant medications relevant 
to or for the treatment of the SAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of AESI 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of concomitant 
medications and non-study 
vaccinations8 
 
X 
X 
X 
X 
 
 
 
X 
 
Study completion 
 
 
 
 
 
 
 
 
X 
 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; C = clinic visit; COVID-19 = coronavirus disease 2019; D = day; 
eDiary = electronic diary; 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; 
UNS = unscheduled visit; V = visit. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” (DHHS 2023), 
investigators may convert study site visits to telemedicine visits with the approval of the Sponsor. 

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
Page 143 
1. 
The Screening Visit and Day 1 (vaccination) visit can be combined and occur on the same day. 
2. 
Safety follow-up via eDiary questionnaire will be performed every 2 weeks from at Day 36 to Day 162. These study days are relative to Day 1 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. 
3. 
Physical examination: A full physical examination, including height and weight, will be performed on Day 1. Symptom-directed physical examinations may 
be performed at other timepoints at the discretion of the investigator. Any clinically significant finding identified during a study visit should be reported as 
an MAAE. Vital signs are to be collected pre- and post-dosing on the day of injection (Day 1) only. When applicable, vital sign measurements should be 
performed before blood collection. For participants who are febrile (body temperature ≥ 38.0°C [100.4°F]) before injection on Day 1, the visit must be 
rescheduled within the relevant window period to receive the injection. Afebrile participants with minor illnesses can be administered investigational product 
at the discretion of the investigator. 
4. 
The NP swab sample, collected prior to injection on Day 1, will be used to ascertain the presence of SARS-CoV-2 via RT-PCR. The NP swab sample will 
also be collected within 24 hours if a participant experiences signs and symptoms of SARS-CoV-2 infection. It is important to note that some of the 
symptoms of COVID-19 overlap with solicited local and systemic reactogenicity ARs, which are expected after vaccination with mRNA-1273.222 (eg, 
myalgia, headache, fever, 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 a NP swab prior to the Day 1 vaccination can help ensure that cases of COVID-19 
are not overlooked. Any study participant reporting respiratory symptoms during the 7-day period after injection should be evaluated for COVID-19. 
5. 
Nasopharyngeal swabs will be collected during the unscheduled/illness visit for testing for the presence of SARS-CoV-2 via RT-PCR and for assessing non-
SARS-CoV-2 causes of upper and lower respiratory tract infection. 
6. 
Trained site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, AEs leading to withdrawal, information on 
concomitant medications associated with those events, AESI, and any non-study vaccinations. In addition, study personnel will collect information on 
known participant exposure to someone with known COVID-19 or SARS-CoV-2 infection and on participant experience of COVID-19 symptoms. Sites will 
collect this information for eDiary days only if eDiary responses indicate the need for follow up via telephone. 
7. 
All concomitant medications relevant to or for the treatment of an SAE or MAAE will be recorded from Day 1 through the end of study visit (Day 181). 
8. 
All concomitant medications and non-study vaccinations will be recorded through 28 days following injection. 

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mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
Page 144 
Table 20: 
Schedule of Events for Part J 
Visit Number 
J 
Screening1 
V1 
 
V2 
V3 
V3a 
 
 
V4 
J 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU 
(SC) 
C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
Every 
2 weeks 
D36-
D1622 
Every 
2 weeks 
D43-
D169 
D181 
 
Window Allowance 
(Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
-- 
Days Since Booster 
Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
Informed consent form 
X 
 
 
 
 
 
 
 
 
 
Randomization for 
treatment assignment 
and study injection 
(including 30-minute 
post-dosing observation 
period) 
 
X 
 
 
 
 
 
 
 
 
Confirm participant 
meets inclusion and 
exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
Physical examination 
including vital signs3 
X 
X 
 
 
X 
X 
 
 
X 
X 
Pregnancy testing 
 
X 
 
 
 
 
 
 
 
 
Blood for SARS-CoV-2 
serology 
(antinucleocapsid 
antibody) 
 
X 
 
 
X 
X 
 
 
X 
X 
Blood for immune 
response to vaccination 
(binding and 
neutralizing antibody)4 
 
X 
 
X 
X 
X 
 
 
X 
X 
Nasopharyngeal swab 
sample for 
SARS-CoV-24 
 
X 
 
 
X 
X 
 
 
X 
X5 
eDiary activation for 
recording solicited local 
and systemic 
reactogenicity adverse 
reactions (7 days) 
 
X 
 
 
 
 
 
 
 
 
Review of eDiary 
 
 
X 
 
 
 
 
 
 
 

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Visit Number 
J 
Screening1 
V1 
 
V2 
V3 
V3a 
 
 
V4 
J 
UNS 
Type of Visit 
C 
C 
SC 
C 
C 
C 
SFU 
(eDiary) 
SFU 
(SC) 
C 
C 
Month Timepoint 
M0 
M0 
 
 
M1 
M3 
 
 
M6 
-- 
Study Visit Day  
D01 
D11 
D8 
D15 
D29 
D91 
Every 
2 weeks 
D36-
D1622 
Every 
2 weeks 
D43-
D169 
D181 
 
Window Allowance 
(Days) 
-7 
0 
+3 
±3 
-7 
±7 
±2 
±3 
±14 
-- 
Days Since Booster 
Injection 
 
0 
7 
14 
28 
90 
-- 
 
180 
-- 
Follow-up safety calls6 
 
 
X 
 
 
 
 
X 
 
 
Recording of unsolicited 
AEs 
 
X 
X 
X 
X 
 
 
 
 
 
Recording of MAAEs 
and concomitant 
medications relevant to 
or for the treatment of 
the MAAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of SAEs and 
concomitant 
medications relevant to 
or for the treatment of 
the SAE7 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of AESI and 
AEs leading to 
withdrawal from study 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Recording of 
concomitant 
medications and non-
study vaccinations8 
 
X 
X 
X 
X 
 
 
 
X 
 
Study completion 
 
 
 
 
 
 
 
 
X 
 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; C = clinic visit; COVID-
19 = coronavirus disease 2019; D = day; eDiary = electronic diary; 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; UNS = unscheduled visit; V = visit. 
Note: In accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 
Public Health Emergency” (DHHS 2023), investigators may convert study site visits to telemedicine visits with 
the approval of the Sponsor. 
1. 
The Screening Visit and Day 1 (vaccination) visit can be combined and occur on the same day. 
2. 
Safety follow-up via eDiary questionnaire will be performed every 2 weeks from at Day 36 to Day 162. These 
study days are relative to Day 1 vaccination. Adverse reactions recorded in the eDiary beyond Day 7 should be 
reviewed by the study site staff either during the next scheduled safety telephone call or at the next study site 
visit. 

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3. 
Physical examination: A full physical examination, including height and weight, will be performed on Day 1. 
Symptom-directed physical examinations may be performed at other timepoints at the discretion of the 
investigator. Any clinically significant finding identified during a study visit should be reported as an MAAE. 
Vital signs are to be collected pre- and post-dosing on the day of injection (Day 1) only. When applicable, vital 
sign measurements should be performed before blood collection. For participants who are febrile (body 
temperature ≥ 38.0°C [100.4°F]) before injection on Day 1, the visit must be rescheduled within the relevant 
window period to receive the injection. Afebrile participants with minor illnesses can be administered 
investigational product at the discretion of the investigator. 
4. 
The NP swab sample, collected prior to injection on Day 1, will be used to ascertain the presence of 
SARS-CoV-2 via RT-PCR. The NP swab sample will also be collected within 24 hours if a participant 
experiences signs and symptoms of SARS-CoV-2 infection. It is important to note that some of the symptoms 
of COVID-19 overlap with solicited local and systemic reactogenicity ARs, which are expected after 
vaccination with mRNA-1273.222 (eg, myalgia, headache, fever, 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 a NP swab prior to the Day 1 vaccination can help ensure 
that cases of COVID-19 are not overlooked. Any study participant reporting respiratory symptoms during the 7-
day period after injection should be evaluated for COVID-19. 
5. 
Nasopharyngeal swabs will be collected during the unscheduled/illness visit for testing for the presence of 
SARS-CoV-2 via RT-PCR and for assessing non-SARS-CoV-2 causes of upper and lower respiratory tract 
infection. 
6. 
Trained site personnel will call all participants to collect information relating to any AEs, MAAEs, SAEs, 
AESI, AEs leading to withdrawal from study participation, information on concomitant medications associated 
with those events, AESI, and any non-study vaccinations. In addition, study personnel will collect information 
on known participant exposure to someone with known COVID-19 or SARS-CoV-2 infection and on 
participant experience of COVID-19 symptoms. Sites will collect this information for eDiary days only if 
eDiary responses indicate the need for follow up via telephone.  
7. 
All concomitant medications relevant to or for the treatment of an SAE or MAAE will be recorded from Day 1 
through the end of study visit (Day 181). 
8. 
All concomitant medications and non-study vaccinations will be recorded through 28 days following injection. 
 
 

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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 to: 
• 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. 
According to ICH GCP guideline, 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 and/or documents. In 

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addition, the study monitor will explain to and interpret for the investigator all regulations 
applicable to the clinical evaluation of an IP 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 IP 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 AEs and SAEs have been properly documented on eCRFs and confirm any 
SAEs have been forwarded to the SAE Mailbox, and 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 needs 
information or advice. 
10.2.3. 
Audits and Inspections  
The Sponsor, their designee(s), the IRB, or regulatory authorities will be allowed to conduct site 
visits to the investigational facilities for the purpose of monitoring or inspecting any aspect of the 
study. The investigator agrees to allow the Sponsor, their designee(s), the IRB, or regulatory 
authorities to inspect the IP storage area, IP stocks, IP records, participant charts and study 
source documents, and other records relative to study conduct. 
Authorized representatives of the Sponsor, a regulatory authority, and the IRB may visit the 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 data were recorded, 
analyzed, and accurately reported according to the protocol, ICH GCP (R2), 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. 

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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/Assent Process  
The informed consent document(s) must meet the requirements of 21 CFR 50, local regulations, 
ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, 
where applicable, and the IRB or study center. All consent documents will be approved by the 
appropriate IRB. The actual ICF used at each center may differ, depending on local regulations 
and IRB requirements. However, all versions must contain the standard information found in the 
sample ICF provided by the Sponsor. Any change to the content of the ICF must be approved by 
the Sponsor and the IRB prior to the form 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, their relatives, guardians, or (if applicable) legal 
representatives 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. 
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 

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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 CoV. 
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. Institutional review board 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 may affect 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 amendment will be 
released by the Sponsor, agreed 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 to 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 by the investigators, and notified to the IRB(s). 
10.2.8. 
Protocol Deviations  
Noncompliance may be either on the part of the participant, the investigator, or the study site 
staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations to the Sponsor or its designee. All deviations must be addressed in study source 
documents and reported to the study monitor. Protocol deviations must be sent to the reviewing 
IRB per their policies. The site investigator is responsible for knowing and adhering to the 
reviewing IRB requirements. 

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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 which 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. 
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-1273.211 or anti-respiratory 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 measures of 
adaptive immunity to SARS-CoV-2 to include humoral and cellular immune assay 
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-1273.211 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. 
Safety Oversight  
Safety monitoring for the study is described in Section 7.5. 

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10.2.12. 
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. 
10.2.13. 
Data Quality Assurance and Quality Control  
Data collection is the responsibility of the clinical study staff at the site under the supervision of 
the 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 onsite 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, CROs). 
- 
Study monitors will perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized 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 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 

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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 Sponsor or 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. 
10.2.14. 
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. 
AEs will be coded with MedDRA. Concomitant medications will be coded using WHO – Drug 
Reference List. 
10.2.15. 
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 
substantiate the integrity of the data collected. Source documents are filed at the investigator’s 
site. 
Data reported on the case report form 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 IP. 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. 
10.2.16. 
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 

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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. 
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. 
10.2.17. 
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 participant and should assure 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 
• 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-1273.211 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. 
10.2.18. 
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 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. 

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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. 

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10.3. 
APPENDIX 3: Contraceptive Guidance  
Definitions: Woman of Childbearing Potential 
Women of childbearing potential are those who are considered fertile following menarche and 
until becoming postmenopausal unless permanently sterile (see below). If fertility is unclear (eg, 
amenorrhea in adolescents or athletes) and a menstrual cycle cannot be confirmed before 
vaccination at Day 1, additional evaluation should be considered. 
Women in the following categories are not considered women of childbearing potential: 
1. Premenarchal 
2. Premenopausal, surgically sterile female with 1 of the following: 
a. Documented complete hysterectomy 
b. Documented surgical sterilization 
For individuals with permanent infertility due to an alternate medical cause other than the 
above (eg, Müllerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry. 
Note: Documentation can come from the site personnel’s review of the participant’s 
medical records, medical examination, or medical history interview. 
3. Postmenopausal female 
• A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. The following age-specific requirements apply: 
− Women < 50 years of age would be considered postmenopausal if they have been 
amenorrheic for 12 months or more following cessation of exogenous hormonal 
treatments and if they have luteinizing hormone and FSH levels in the 
postmenopausal range for the institution. 
− Women ≥ 50 years of age would be considered postmenopausal if they have been 
amenorrheic for 12 months or more, had radiation-induced menopause with last 
menses > 1 year ago, had chemotherapy-induced menopause with last menses 
> 1 year ago. 
• A high FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal replacement therapy (HRT). 
• Females on HRT and whose menopausal status is in doubt will be required to use one 
of the nonestrogen hormonal highly effective contraception methods if they wish to 
continue their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment. 
Contraception 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 

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• 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. 

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10.4. 
APPENDIX 4: Adverse Events of Special Interest Terms  
The Investigator’s medical judgment must be applied to assess an event as an AESI, as 
most AESI are based on medical concepts. The table below does not provide a 
comprehensive list of terms. 
The following table describes events/medical concepts that are of interest in COVID-19 vaccine 
safety surveillance. Some are specific to vaccines; however, some are of interest due to their 
occurrence in the context of concurrent or recent COVID-19. Events falling into the descriptions 
below should be reported as AESI, per protocol, even when they occur during/following COVID 
infection.  
Please note: COVID-19 itself is not an AESI. 
Medical Concept 
Medical Concept Descriptions/Guidance 
Anosmia, Ageusia 
New onset of anosmia or ageusia associated with COVID-19 or idiopathic etiology.  
DOES NOT INCLUDE anosmia or ageusia associated with sinus/nasal congestion, 
congenital, or traumatic etiologies  
Subacute thyroiditis 
Acute inflammatory disease of the thyroid (immune-mediated or idiopathic). 
DOES NOT INCLUDE new onset of chronic thyroiditis 
Acute pancreatitis 
New onset of pancreatitis in the absence of a clear, alternate etiology, such as 
alcohol, gallstones, trauma, recent invasive procedure, etc. 
Appendicitis 
Any event of appendicitis  
Rhabdomyolysis 
New onset of rhabdomyolysis in the absence of a clear, alternate etiology, such as 
drug/alcohol abuse, excessive exercise, trauma, etc. 
Acute respiratory 
distress syndrome 
(ARDS) 
New onset of ARDS/respiratory failure due to acute inflammatory lung injury. 
DOES NOT INCLUDE non-specific symptoms of shortness of breath or dyspnea, 
nor events with underlying etiologies of heart failure or fluid overload 
Coagulation disorders 
New onset of thrombosis, thromboembolic event, or non-traumatic 
hemorrhage/bleeding disorder (eg, stroke, DVT, pulmonary embolism, disseminated 
intravascular coagulation (DIC), etc.) 
Acute cardiovascular 
injury 
New onset of clinically confirmed, acute cardiovascular injury, such as myocarditis, 
pericarditis, arrhythmia confirmed by ECG (eg, atrial fibrillation, atrial flutter, 
supraventricular tachycardia), stress cardiomyopathy, heart failure, acute coronary 
syndrome, myocardial infarction, etc. 
DOES NOT INCLUDE transient sinus tachycardia/bradycardia, non-specific 
symptoms such as palpitations, racing heart, heart fluttering or pounding, irregular 
heartbeats, shortness of breath, chest pain/discomfort, etc. 
Acute kidney injury 
New onset of acute kidney injury or acute renal failure in the absence of a clear, 
alternate etiology, such as urinary tract infection/urosepsis, trauma, tumor, 
nephrotoxic medications/substances, etc.; 
Increase in serum creatinine by ≥ 0.3 mg/dl (or ≥26.5 µmol/l) within 48 hours; OR 
Increase in serum creatinine to ≥ 1.5 times baseline, known or presumed to have 
occurred within prior 7 days 

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Medical Concept 
Medical Concept Descriptions/Guidance 
Acute liver injury 
New onset in the absence of a clear, alternate etiology, such as trauma, tumor, 
hepatotoxic medications/substances, etc.: 
>3-fold elevation above the upper normal limit for ALT or AST; OR 
>2-fold elevation above the upper normal limit for total serum bilirubin or GGT or 
ALP 
Dermatologic findings 
Chilblain-like lesions 
Single organ cutaneous vasculitis 
Erythema multiforme 
Bullous rash 
Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, Toxic 
epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms 
(DRESS), fixed drug eruptions, and necrotic or exfoliative reactions 
Systemic inflammatory 
syndromes 
Multisystem inflammatory syndrome in adults (MIS-A) or children (MIS-C) 
Kawasaki’s disease 
Hemophagocytic lymphohistiocytosis (HLH) 
Thrombocytopenia 
Platelet count < 150 x 109/L (thrombocytopenia) 
New clinical diagnosis, or worsening, of thrombocytopenic condition, such as 
immune thrombocytopenia, thrombocytopenic purpura, or HELLP syndrome 
Acute aseptic arthritis 
Clinical syndrome characterized by acute onset of signs and symptoms of joint 
inflammation without recent trauma for a period of no longer than 6 weeks, synovial 
increased leukocyte count and the absence of microorganisms on Gram stain, 
routine culture and/or PCR. 
DOES NOT INCLUDE new onset of chronic arthritic conditions 
New onset, or 
worsening, of 
neurological disease 
Immune-mediated neurological disorders 
Guillain-Barre Syndrome 
Acute disseminated encephalomyelitis (ADEM) 
Peripheral facial nerve palsy (Bell’s palsy)  
Transverse myelitis 
Encephalitis/Encephalomyelitis 
Aseptic meningitis 
Seizures/convulsions/epilepsy 
Narcolepsy/hypersomnia 
Anaphylaxis  
Anaphylaxis associated with study drug administration 
Other syndromes 
Fibromyalgia  
Postural Orthostatic Tachycardia Syndrome  
Chronic Fatigue Syndrome  
Myalgic encephalomyelitis  
Post viral fatigue syndrome 
Myasthenia gravis 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
COVID = coronavirus disease; DVT = deep vein thrombosis; ECG = electrocardiogram; GGT = gamma-glutamyl 
transferase; HELLP = hemolysis, elevated liver enzymes, and low platelets 

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10.5. 
APPENDIX 5: Protocol Amendment History  
10.5.1. 
Amendment 10, 23 Mar 2023  
Main Rationale for the Amendment 
The main purpose of this amendment is to add a new part to the study, Part J, to evaluate the 
safety and immunogenicity of vaccine candidates to target antigenically divergent variants 
Omicron BA.4/BA.5, and Omicron XBB.1.5. 
The summary of changes table provided below describes the major changes made to Amendment 
10 relative to Amendment 9, including the sections modified and corresponding rationales. The 
synopsis of Amendment 10 has been modified to correspond to changes the body of the protocol. 
Minor copy edits and administrative updates were made throughout the protocol to align with 
new content and/or accuracy. 
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 Summary of Changes. 
Updated to reflect the new 
protocol version. Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Section 1.1 Study Rationale  Added rationale for Part J.  
Added Omicron XBB.1.5 as a new 
variant to be targeted and descriptions 
of new mRNA-1273.815 and mRNA-
1273.231 vaccine candidates. 
Updated to include the 
rationale for evaluating the 
immunogenicity and safety of 
new vaccine candidates 
against emerging Omicron 
variants.  
To provide background 
information on new vaccine 
candidates and their targeted 
severe acute respiratory 
syndrome coronavirus 2 
(SARS-CoV-2) variants. 
Section 1.2 Nonclinical 
Studies 
Added language informing that 
additional animal studies are currently 
being conducted with mRNA vaccines 
that target different Omicron variants. 
To update with developments 
in the ongoing mRNA-1273 
nonclinical program  
Section 1.4 Benefit/Risk 
Assessment 
Added new Omicron-targeting vaccine 
candidates. 
Clarified that the pivotal study on which 
the safety profile of mRNA-1273 is 
based is Study mRNA-1273-P301 
(COVE). 
To update Benefit/Risk 
section with the enhanced 
protection conferred by new 
Omicron-targeting vaccine 
candidates against 
coronavirus disease 2019 
(COVID-19) caused by 
emergent SARS-CoV-2 
variants. 

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Section # and Name 
Description of Change 
Brief Rationale 
To clearly reference the study 
on which the safety profile of 
mRNA-1273 is based. 
Section 2 Objectives and 
Endpoints 
Added objectives and endpoints of Part 
J of study. 
To ensure the 
immunogenicity and safety 
objectives and endpoints for 
the new Part of study (Part J) 
are clearly described. 
Section 3 Study Design 
Removed Day 8 from the list of 
additional safety and immunogenicity 
visits from all study parts. 
Added new vaccine candidates and 
description of study design of Part J. 
Added Part J to table describing 
treatment arms. Added information on 
number of visits conducted by 
participants in Part J. Added 
information on timing for blood draws 
from participants in Part J. Added 
information on dosing for participants 
in Part J. Added information on impact 
of Part J on timing for interim and final 
analysis. 
To accurately capture that 
Day 8 is a safety call in which 
on site safety and 
immunogenicity procedures 
cannot be performed.  
To capture the study design 
of Part J and the overall 
impact on the design, and 
analysis of the entire study. 
Section 3.2 Scientific 
Rationale for Study Design 
Updated with timing of blood and 
nasopharyngeal (NP) swab sample 
collection in Part J. 
To clarify the timing for 
blood and NP swab sampling 
is aligned with the timing of 
SARS-CoV-2 circulation 
during the study. 
Section 3.3 Justification for 
Dose, Control Product, and 
Choice of Study Population 
Updated dose of new multivalent 
booster candidates (50 µg). Added 
information on study population for 
Part J. 
To clarify the dose of new 
multivalent booster 
candidates will remain similar 
to prior booster candidates. 
To describe prior study 
participation and prior 
vaccination of Part J 
participants to enhance 
understanding of eligibility 
requirements. 
Section 3.4 End of Study 
Definition 
Added participation in Part J in the 
description of End of Study. 
To clarify prerequisites for 
study completion in 
participants who roll-over 
from Part H to Part J and 
general requirements for 
participants in Part J to 
complete all procedures in 

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Section # and Name 
Description of Change 
Brief Rationale 
Part J schedule of events 
(SoE).  
Section 4 Study Population 
Added Part J information which 
includes number of participants, prior 
vaccination, and booster dose to be 
administered. 
To include Part J population 
sample size and prior 
vaccination. 
Section 4.1 Inclusion 
Criteria 
Added eligibility criteria for 
participants in Part J of study. 
To ensure Part J-specific 
eligibility criteria are 
accurately described. 
Section 5.1 Investigational 
Products Administered 
Added new Omicron-targeting vaccine 
candidates. 
To ensure all investigational 
product (IP) used in this study 
is captured. 
Section 5.2 Randomization 
and Blinding 
Clarified that while randomization will 
occur for Part J participants, no blinding 
will occur in the study. 
To accurately capture 
randomization in Part J but 
clarify that study remains 
open-label 
Section 5.3. 
Preparation/Handling/ 
Storage/Accountability 
Added relevant information on new 
Omicron-targeting vaccine candidates 
To ensure completeness of 
Chemistry, Manufacturing, 
and Controls and Clinical 
Supply information on IP 
used in the study 
Section 5.4 Study 
Intervention Compliance 
Added link to Part J SoE in text 
describing visit windows 
To accurately capture 
Section 5.5.2 Concomitant 
Medications and Therapies 
Clarified that non-study vaccinations 
and medications which are not used to 
treat COVID-19 or it symptoms will be 
recorded if taken through 28 days after 
study vaccination. 
Clarified that concomitant medications 
relevant to or for the treatment of an 
serious adverse event (SAE) or a 
medically attended adverse event 
(MAAE) or to prevent or treat COVID-
19 or its symptoms will be recorded at 
any timepoint during the study. 
To distinguish between the 
timing for recording non-
study vaccinations and 
concomitant medications 
depending on whether or not 
they are used for the 
treatment of COVID-19 or it 
symptoms. 
Section 6.1.1 Individual 
Participant Criteria for 
Delay of Study Vaccination 
Added link to Part J SoE. 
To ensure Part J procedures 
are captured when describing 
delay of vaccination. 
Section 7 Study 
Assessments and 
Procedures 
Added links to Part J SoE. 
Revised polymerase chain reaction 
(PCR) sampling in Section 7.2 
Immunogenicity Assessments, to 
reverse transcriptase PCR (RT-PCR) 
and added Day 181 as sampling 
To ensure safety monitoring, 
eDiary use, timing for NP 
swab sampling, and timing 
for blood collection are 
captured for Part J 
participants. 

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Section # and Name 
Description of Change 
Brief Rationale 
timepoint for RT-PCR for all study 
parts. 
Removed SAE Hotline and all 
references to the SAE Hotline, updated 
SAE Mailbox e-mail address, and SAE 
Fax Line 
To ensure RT-PCR sampling 
is consistent with the SoE. 
To ensure SAE reporting 
mechanisms are up to date. 
Section 8.1 Blinding and 
Responsibility for Analyses 
Stated that randomization will occur for 
Part J participants. 
To clarify that while 
randomization will occur for 
Part J participants, treatment 
assignment will remain 
unblinded and the study will 
remain open-label. 
Section 8.2 Statistical 
Hypotheses 
Stated that no formal hypothesis testing 
will be conducted for Part J. 
To ensure hypothesis testing 
is accurately captured for all 
Parts of the study. 
Section 8.3 Sample Size 
Determination 
Added information on sample size 
determination for Part J of study. 
To ensure sample size 
determination for the entire 
study captures Part J. 
Section 8.5.3.2.1 Analysis 
for the Primary 
Immunogenicity Objective 
for Part J 
Added primary analysis information for 
Part J. 
To clarify analysis set and 
statistical models to be used 
for primary immunogenicity 
analysis. 
Section 8.5.6 
Stated that subgroup analysis may not 
be performed for Part J due to small 
sample size. 
To ensure subgroup analyses 
are accurately described for 
the appropriate Parts of the 
study. 
Section 8.6.1, Interim 
Analysis and Section 8.6.2 
Final Analyses 
Added impact of Part J on timing for 
interim and final analyses. 
To clarify that the timing of 
interim and final analyses is 
dependent on all parts of the 
study.  
Section 10.1 Appendix 1: 
Schedule of Events 
Added Table 20 Schedule of Events for 
Part J. 
To ensure procedures and 
events related to Part J of the 
study are captured in the 
protocol. 
10.5.2. 
Amendment 9, 30 Sep 2022  
Main Rationale for the Amendment 
The main purpose of this amendment is to update the statistical analyses of Part H (vaccine 
mRNA-1273.222) to include a primary immunogenicity objective of a comparison between the 
mRNA-1273.222 and mRNA-1273 groups of the antibody response against the ancestral 
SARS-CoV-2 D614G.  
The summary of changes table provided below describes the major changes made to 
Amendment 9 relative to Amendment 8, including the sections modified and corresponding 

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rationales. The synopsis of Amendment 9 has been modified to correspond to changes in the 
body of the protocol. Minor copy edits and administrative updates were made throughout the 
protocol to align with new content and/or for accuracy. 
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 Summary of Changes. 
Updated to reflect the new 
protocol version. Summary 
of Changes added to be in 
line with Moderna 
guidelines for protocol 
amendments. 
Synopsis; Section 2.0: 
Objectives and Endpoints 
Part H; Section 8.2: 
Statistical Hypotheses; 
Section 8.5.3.2.8: 
Analysis for the Primary 
Immunogenicity 
Objective for Part H 
Added evaluation of the neutralizing 
antibody response elicited by 
mRNA-1273.222 vs. mRNA-1273 
against the ancestral SARS-CoV-2 
D614G strain as a co-primary 
immunogenicity endpoint 
Because mRNA-1273.222 
is a bivalent vaccine with 
an antigenic component 
that also targets the 
ancestral SARS-CoV-2 
D614G strain, a 
comparison of the antibody 
responses against the 
ancestral SARS-CoV-2 
between the vaccine groups 
is now included in the 
primary immunogenicity 
objectives as a comparison. 
Synopsis; Section 8.0: 
Statistical Analysis Plan 
Revised the seroresponse rate 
success criteria against BA.4/5 for 
Part H using a 5% non-inferiority 
margin. 
This was updated based on 
the SRR data from another 
Omicron-containing 
bivalent vaccine, mRNA-
1273.214. 
Synopsis; 
Section 8.5.3.2: Analysis 
for Primary 
Immunogenicity  
Revised the GMR non-inferiority 
boundary for all study parts, from ≥ 
0.67 to > 0.667. 
This is a technical update 
of the GMR non-inferiority 
success criterion. 
Synopsis; Section 8.0: 
Statistical Analysis Plan 
Added evaluation of seroresponse 
based on secondary definition to 
Parts F (Cohort 2), G, and H. 
This update will enable use 
of both seroresponse rate 
definitions in the data 
analysis. 
Synopsis, Section 3.1: 
General Design; 
Section 4.0: Study 
Population; Section 8.3: 
Sample Size 
Determination 
In Part H, approximately 500 
(updated from 400) participants will 
receive a second booster dose of 
mRNA-1273.222 50 µg to achieve 
300 (updated from 240) evaluable 
subjects. 
The sample size increase 
will further accommodate 
statistical comparisons. 

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10.5.3. 
Amendment 8, 01 Aug 2022  
Amendment 8, 01 Aug 2022 
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 purpose of this amendment is to introduce a new study part (part H) for the Omicron 
BA.4/5-containing bivalent vaccine candidate mRNA-1273.222.  
The summary of changes table provided below describes the major changes made to 
Amendment 8 relative to Amendment 7, including the sections modified and corresponding 
rationales. The synopsis of Amendment 8 has been modified to correspond to changes in the 
body of the protocol. Minor copy edits and administrative updates were made throughout the 
protocol to align with new content and/or for accuracy. 
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 Summary of Changes. 
Updated to reflect the new 
protocol version. Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Global 
New study part (H) added to the study 
protocol to evaluate the 
immunogenicity, safety, and 
reactogenicity of the mRNA-1273.222 
vaccine candidate. 
To evaluate the safety, 
reactogenicity, and 
immunogenicity of the 
mRNA-1273.222 candidate.  
Global 
Participant safety follow up shortened 
from 1 year to 6 months post study 
injection in Part A.2. 
It was determined that 6 
months post study injection 
provides adequate long-term 
safety follow up in 
participants who have already 
been followed for 1 year prior 
to the booster dose in Part 
A.2. 
10.5.4. 
Amendment 7, 26 Apr 2022  
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 purpose of this amendment is to introduce a sub-part in Part A of the study to offer the 
mRNA-1273.214 (50 µg) booster vaccine candidate (prototype/Omicron multivalent vaccine) as 
a second booster dose to participants who have previously received a first booster dose of 
mRNA-1273.211 (50 µg).  
The summary of changes table provided below describes the major changes made to 
Amendment 7 relative to Amendment 6, including the sections modified and corresponding 

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rationales. The synopsis of Amendment 7 has been modified to correspond to changes in the 
body of the protocol. Minor copy edits and administrative updates were made throughout the 
protocol to align with new content and/or for accuracy. 
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 Summary of Changes. 
Updated to reflect the new 
protocol version. Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Global 
New sub-part to Part A (Part A.2) being 
added to the study. 
Part A.2 evaluates the immunogenicity, 
safety, and reactogenicity of the 
mRNA-1273.214 vaccine candidate 
given as a second booster dose (50 µg) 
in Part A participants who have 
previously received 2 doses of mRNA-
1273 as a primary series and a single 
dose of mRNA-1273.211 (50 µg) as a 
booster dose. 
The Part A.2 primary 
objective is to evaluate the 
safety, reactogenicity and 
immunogenicity of the 
mRNA-1273.214 candidate 
as a second booster dose in 
participants who have 
previously received the 
mRNA-1273.211 50 µg 
booster candidate as a first 
booster dose.  
Synopsis, Section 4.1 
Inclusion Criteria 
Updated inclusion criterion #6 for Part 
A.2-specific requirements. 
Updated as part of the Part 
A.2 additions described 
above. 
Synopsis, Section 7.2 
Immunogenicity 
Assessments 
Added Part A.2 to the testing for 
serologic markers for SARS-CoV-2 
infection as measured by 
anti-nucleocapsid antibodies detected 
by immunoassay. 
Updated as part of the Part 
A.2 additions described 
above. 
Appendix 1: Schedule of 
Events, Table 15 
Updated the visit labels. 
This update to the table aligns 
with protocol amendment 
6 administrative memo #2, 
dated 01 Apr 2022. 
Appendix 4: Adverse 
Events of Special Interest 
Terms 
Updated the appendix language. 
Updated to reflect current 
language regarding adverse 
events of special interest.  
10.5.5. 
Amendment 6, 17 Mar 2022  
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 purpose of this amendment is to modify the statistical hypothesis testing by: 1) adding 
non-inferiority testing against the Omicron variant (B.1.1.529) and the ancestral SARS-CoV-2 
for multiple timepoints (Day 29, Day 91) based on geometric mean titer ratio and seroresponse 
rate (SRR) difference to the co-primary endpoints in Part G (booster vaccine candidate 

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mRNA-1273.214); 2) adding superiority testing against the Omicron variant for multiple 
timepoints (Day 29, Day 91) in Part G; 3) include the SRR difference in the primary endpoints 
for study parts F and G.  
The summary of changes table provided below describes the major changes made to 
Amendment 6 relative to Amendment 5, including the sections modified and corresponding 
rationales. The synopsis of Amendment 6 has been modified to correspond to changes in the 
body of the protocol. Minor copy edits and administrative updates were made throughout the 
protocol to align with new content and/or for accuracy. 
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 Summary of Changes. 
Updated to reflect the new 
protocol version. Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Protocol Synopsis 
Added sequential enrollment of dose 
levels to Part F Cohort 2. 
Updated to clarify the timing 
of enrollment of the 2 dose 
levels in Part F Cohort 2 
relative to one another. 
Synopsis, Section 2 
(Objectives and Endpoints), 
Section 8.2 (Statistical 
Hypotheses), Section 8.3 
(Sample Size 
Determination), Section 
8.5.3.2.5 (Analysis for the 
Primary Immunogenicity 
Objective for Part F), 
Section 8.5.3.2.6 (Analysis 
for the Primary 
Immunogenicity Objective 
for Part G), Section 8.6.1 
(Interim Analysis) 
 
Changed the primary objectives and 
endpoints of Part G to include 2 
timepoints (Day 29, Day 91) for 
hypothesis testing. 
Changed the SRR endpoint against 
Omicron from key secondary to a co-
primary endpoint for Parts F and G. 
Added hypothesis testing at 
Day 91 to evaluate the 
durability of the antibody 
response.  
SRR against Omicron will be 
evaluated as a co-primary 
endpoint; hypothesis testing 
for non-inferiority against 
Omicron will be based on 
GMT ratio and SRR 
difference and superiority 
will be based on GMT ratio. 
Section 3.1 (General 
Design) 
Deleted the final paragraph of this 
section. 
Removed text for clarity and 
to match updates to the 
protocol. 
Section 5.3.1 (Preparation 
of Study Vaccine) 
Part F and G corrected to reflect the 
correct volume of injections for mRNA-
1273 and mRNA-1273.214 
Updated to correct a 
typographical error. 
Section 5.3.4 (Study 
Vaccine Packaging and 
Labeling) 
Part F corrected to provide the correct 
volume of mRNA-1273 in the glass 
vials. 
Updated to correct a 
typographical error. 
Section 8.5.3.2.6 (Analysis 
for Primary 
Added a new heading for Part G. 
The heading was added for 
clarity to differentiate the 
analyses in Part F and Part G. 

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Section # and Name 
Description of Change 
Brief Rationale 
Immunogenicity Objective 
for Part G) 
Section 8.5.3.4 (Other 
Analysis of 
Immunogenicity) 
Removed reference to Day 29 
immunogenicity as a the timepoint of 
primary interest in the study.  
Updated to reflect the new 
Objectives and Endpoints. 
10.5.6. 
Amendment 5, 10 Feb 2022  
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 purposes of this amendment are: 
(i) to introduce mRNA-1273 (50 µg) arm, administered as a second booster dose, and to 
introduce non-inferiority and superiority hypothesis testing for the mRNA-1273.529 (50 
µg) Omicron variant booster vaccine candidate in Part F of the study 
(ii) to introduce Part G of the study to evaluate the mRNA-1273.214 (50 µg) multivalent 
booster vaccine candidate. 
The summary of changes table provided here describes the changes made in Amendment 5 
relative to Amendment 4, including the sections modified and the corresponding rationale. The 
synopsis of Amendment 5 has been modified to correspond to changes in the body of the 
protocol. Minor editorial and grammatical corrections were also made. 
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 Summary of Changes. 
Updated to reflect the new 
protocol version. Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Global 
Part G is being added to the study. 
Part G evaluates the immunogenicity, 
safety, and reactogenicity of 
mRNA-1273.214 vaccine candidate as a 
single booster dose (50 µg) in adults 
who have previously received 2 doses 
of mRNA-1273 as a primary series and 
a single dose of mRNA-1273 (50 µg) as 
a booster dose. 
The Part G primary 
objectives support non-
inferiority and superiority 
hypothesis testing for the 
mRNA-1273.214 booster 
candidate compared to the 
mRNA-1273 booster.  
Global 
Part F was updated: 
The 100 µg dose level of mRNA-
1273.529 was removed from Cohort 1 
and Cohort 2 of Part F. A 50 µg dose 
level of mRNA-1273 was added to 
The Part F primary objectives 
support non-inferiority and 
superiority hypothesis testing 
for the mRNA-1273.529 
booster candidate compared 
to the mRNA-1273 booster.  

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Section # and Name 
Description of Change 
Brief Rationale 
Cohort 2. The part F objectives and 
endpoints were also revised.  
Protocol Synopsis, Section 
2 (Objectives and 
Endpoints), Section 8.5 
(Statistical Methods) 
Updated the Objectives and Endpoints 
for Part F of the study. 
Updated to reflect the 
changes in the primary and 
secondary endpoints for Part 
F. 
Protocol Synopsis, Section 
3.1 (General Design), 
Section 3.3 (Justification 
for the Dose, Control 
Product, and Choice of 
Study Population), Section 
4.1 (Inclusion Criteria) 
Added language allowing subjects to 
have been given their mRNA-1273 
booster as part of the mRNA-1273-
P301 (COVE) study or under the EUA. 
Added for clarification that 
individuals who received 
their booster through Study 
mRNA-1273-P301 or through 
EUA are eligible to 
participate in the study. 
Protocol Synopsis, Section 
3.1 (General Design), 
Section 3.2 (Scientific 
Rationale for Study 
Design), Section 7.2 
(Immunogenicity 
Assessments), Section 10.1 
(Appendix 1: Schedule of 
Events) 
Addition of a Day 91 Visit for Part F 
and Part G. 
Added to allow serology 
draws, immunogenicity 
draws, and nasopharyngeal 
swab collection, at Day 91 in 
Part F and Part G. 
Section 1.1 (Study 
Rationale), Section 1.1.1 
(mRNA-1273), Section 
1.2.3 (Overall Benefit/Risk 
Conclusion), 
Language added to reference the 
approval of the mRNA-1273 primary 
series BLA. 
Updated to reflect licensure 
of the mRNA-1273 primary 
series.  
10.5.7. 
Amendment 4, 04 Jan 2022  
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 purposes of this amendment are: 
• To add the Omicron variant-specific vaccine candidate, mRNA-1273.529, (50 µg and 
100 µg) as first and second booster doses to the protocol in a new study part (Part F) 
• To update protocol based on updates (12 November 2021) made in the statistical analysis 
plan. 

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Summary of Major Changes in Protocol Amendment 4: 
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. 
Protocol Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments.  
Global  
Minor copy edits were made. 
Made for alignment with new 
content, readability and/or 
accuracy. 
Global  
Part F is being added to the study. 
Part F evaluates the immunogenicity, 
safety, and reactogenicity of 
mRNA-1273.529 vaccine candidate as 
a single booster dose (50 µg, 100 µg) in 
adults who have previously received 2 
doses of mRNA-1273 as a primary 
series (Cohort 1) or have received 2 
doses of mRNA-1273 as a primary 
series and a single dose of mRNA-1273 
(50 µg) as a booster dose (Cohort 2). 
The Part F primary objectives 
will enable a comparison 
between the Omicron-specific 
immune response elicited 
from a mRNA-1273.529 
booster dose with the 
ancestral SARS-CoV-2-
specific immune response 
elicited from the mRNA-1273 
primary series immunization 
(historical cohort). These 
immunogenicity objectives 
adhere to the regulatory 
guidance for variant vaccines.  
Protocol Synopsis, Section 
1.2.5 (mRNA-1273.529), 
Section 5.1 (Investigational 
Products Administered), 
Section 5.3.1 (Preparation 
of Study Vaccine), Section 
5.3.2 (Study Vaccine 
Administration), Section 
5.3.4 (Study Vaccine 
Packaging and Labeling), 
and Section 5.3.5 (Study 
Vaccine Storage) 
Part F language was added to discuss 
mRNA-1273.529 preparation and 
packaging/labeling. 
Part F language was added to 
include language related to 
the mRNA-1273.529 IP. 
Protocol Synopsis, Section 
2 (Objectives and 
Endpoints), Section 8.2 
(Statistical Hypothesis), 
Section 8.5.3.2 (Analysis 
for the Primary 
Immunogenicity Objective)  
Removed GMT ratio ≥1 point estimator 
requirement for 50 µg dose arms in 
multiple study parts. 
The point estimator of GMT 
ratio ≥1 for the 50-µg booster 
dose of the P205 vaccine 
candidates is being removed 
to align with the upversioned 
statistical analysis plan (SAP 
version 2). The SAP was 
upversioned after the interim 
analysis of Study P201B 
demonstrated non-inferior 

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Section # and Name 
Description of Change 
Brief Rationale 
immune responses, after the 
50-µg booster dose of 
mRNA-1273, compared to 
the mRNA-1273 primary 
series. 
Protocol Synopsis, Section 
2 (Objectives and 
Endpoints) 
Reference to viral sequencing changed 
from spike protein sequencing to 
genomic sequencing. 
Updated to reflect current 
practice of sequencing the 
entire viral genome rather 
than just the sequence of the 
spike protein. 
Protocol Synopsis, Section 
3.1 (General Design) 
Added discussion of Part E, a site-
specific study part that is not described 
in the global amendment. 
Added explanation to clarify 
the reason Part F follows Part 
D in this protocol 
amendment. 
Protocol Synopsis, Section 
3.1 (General Design), 
Section 10.4: Appendix 1 
(Schedule of Events) 
Added optional collection of PBMC 
samples.  
To allow for the collection, 
by some sites, of PBMC 
samples at specific visits. 
Protocol Synopsis, Section 
4.1 (Inclusion Criteria) 
Inclusion criterion 6 was changed to 
also allow for participants who have 
received a primary vaccine series of 
mRNA-1273 and a 50 µg mRNA-1273 
booster dose at least 3 months before 
enrollment to be included in the study. 
Addition to the inclusion 
criterion to allow for 
enrollment of participants in 
Cohort 2 of Part F of the 
study. 
Protocol Synopsis, Section 
4.2 (Exclusion Criteria) 
Exclusion criterion 2 was updated to 
reflect the new time frame for exclusion 
due to history of prior SARS-CoV-2 
infection.  
Updated to clarify the change 
to the exclusion criterion. 
Protocol Synopsis, Section 
4.2 (Exclusion Criteria) 
Exclusion criterion 9 updated to only 
exclude due to myocarditis or 
pericarditis within the last 2 months.  
Updated to reflect removal 
AESI as exclusionary except 
for myocarditis or pericarditis 
within the last 2 months. 
Protocol Synopsis, Section 
7.2 (Immunogenicity 
Assays) 
Added reference to viral genome 
sequencing of PCR positive samples. 
To clarify that viral genome 
sequencing is being carried 
out in alignment with 
exploratory endpoints. 
Protocol Synopsis, Section 
8.2 (Statistical Hypotheses), 
Section 8.5.3.2 (Analysis 
for the Primary 
Immunogenicity Objective) 
For study parts with both, 50 µg and 
100 µg doses, removed testing 
sequence for any interim and for the 
final analyses. 
Testing sequence was 
removed to align with the 
upversioned statistical 
analysis plan (SAP version 
2). The SAP was upversioned 
after the interim analysis of 
study P201 demonstrated 
non-inferior immune 
responses, after the 50-µg 

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Section # and Name 
Description of Change 
Brief Rationale 
booster dose of mRNA-1273, 
compared to the mRNA-1273 
primary series.  
Section 1.1 (Study 
Rationale) 
Background information regarding the 
Omicron (B.1.1.529) variant emergence 
and genotype added to the study 
rationale. 
To provide background and 
context for the addition of the 
mRNA-1273.529 variant 
vaccine to the study.  
Section 1.2.7 (Clinical 
Studies) 
Updated language to indicate that the 
Phase 2a study of mRNA-1273 
(NCT04405076) has been completed. 
To reflect completion of the 
study. 
Section 7.2 
(Immunogenicity 
Assessments) 
Deleted the “Draw Tube” and “Site 
Instructions” columns from Table 8. 
This information is already 
contained in the Laboratory 
Manual and Collections Flow 
Chart. 
Section 8.5.3.2 (Analysis 
for the Primary 
Immunogenicity Objective) 
Updated language to reflect the 
seroresponse definitions provided in the 
statistical analysis plan (SAP).  
To clarify the seroresponse 
definition based on pre-dose 1 
of primary series as the 
primary definition for 
seroresponse. 
10.5.8. 
Amendment 3, 15 Sep 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 purpose of this amendment is to add mRNA-1273.617.2 50 µg and mRNA-1273.213 
50 µg and 100 µg. 
Summary of Major Changes in Protocol Amendment 3: 
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. 
Protocol Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Global 
Minor copy edits were made. 
Made for alignment with new 
content, readability and/or 
accuracy. 
Synopsis 
Updated the estimated date of last 
participant and total number of sites. 
Changes made to reflect the 
addition of new study sites 
and additional parts to the 
study. 

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Section # and Name 
Description of Change 
Brief Rationale 
Synopsis, Section 2 
(Objectives and Endpoints), 
Section 3.1 (General 
Design), Section 3.3 
(Justification for Dose, 
Control Product, and 
Choice of Study 
Population), Section 4 
(Study Population), Section 
5.1 (Investigational 
Products Administered) 
Section 5.3.1 (Preparation 
of Study Vaccine), Section 
5.3.2 (Study Vaccine 
Administration), 
Section 5.3.5 (Study 
Vaccine Storage), Section 
8.6.1 (Interim Analyses), 
and Appendix 1, Table 10 
50 µg mRNA-1273.617.2 is being 
added to Part C which evaluates the 
immunogenicity, safety, and 
reactogenicity of mRNA-1273.617.2 
vaccine as a single booster dose (50 µg, 
100 µg) in adults who have previously 
received 2 doses of mRNA-1273 as a 
primary series. 
The Part C primary endpoints 
will enable a comparison 
between the immune response 
elicited from 
mRNA-1273.617.2 as a 
booster dose, against the 
B.1.617.2 variant, with the 
immune response elicited 
from mRNA-1273 after 
primary series immunization 
(historical cohort) against the 
parental viral strain. 
Part D is being added to Study P205. 
Part D evaluates the immunogenicity, 
safety, and reactogenicity of 
mRNA-1273.213 vaccine as a single 
booster dose (50 µg, 100 µg) in adults 
who have previously received 2 doses 
of mRNA-1273 as a primary series. 
The Part D primary endpoints 
will enable a comparison 
between the immune response 
elicited from mRNA-
1273.213 as a booster dose, 
against the B.1.617.2 and 
B.1.351 variants, with the 
immune response elicited 
from mRNA-1273 after 
primary series immunization 
(historical cohort) against the 
parental viral strain. 
Synopsis and Section 4.1 
(Inclusion Criteria) 
Criterion 6 was updated to include 
participants that received 2 doses of 
mRNA-1273 vaccine under the 
Emergency Use Authorization (EUA) 
with their second dose at least 6 months 
prior to enrollment in mRNA-1273-
P205, and able to provide proof of 
vaccination status at the time of 
screening (Day 1). 
Study participants might have 
received the primary series 
vaccination with an mRNA 
vaccine for the prevention of 
coronavirus disease 19 
(COVID-19) outside of 
mRNA-1273 studies. 
Synopsis and Section 4.2 
(Exclusion Criteria) 
Criterion 2 was updated to exclude 
participants with a known history of 
SARS-CoV-2 infection within the last 
18 months.  
Criterion was updated to 
allow enrollment of 
participants outside of those 
that participated in the 
mRNA-1273-P301 (COVE) 
study.  
Synopsis, Section 1.2.4 
(mRNA-1273.213), 
Section 5.1 (Investigational 
Products Administered), 
Section 5.3.1 (Preparation 
of Study Vaccine), and 
Section 5.3.4 (Study 
Part D (mRNA-1273.213) language 
was added to discuss mRNA-1273.213, 
preparation, and packaging/labeling. 
The Part D language was 
added to include the 
information related to the 
mRNA-1273.213 IP. 

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Section # and Name 
Description of Change 
Brief Rationale 
Vaccine Packaging and 
Labeling) 
Synopsis, Section 8.2 
(Statistical Hypotheses), 
Section 8.3 (Sample Size 
Determination), Section 
8.5.3.2 (Analysis for the 
Primary Immunogenicity 
Objective), Section 8.5.3.3 
(Analysis for Secondary 
Immunogenicity Objective), 
and Section 8.5.5 
(Exploratory Analyses) 
Part C 50 µg mRNA-1273.617.2 
hypotheses were added to reflect the 
addition of Part C Objectives. 
 
Part D hypotheses were added to reflect 
the addition of Part D Objectives. 
Study hypotheses were 
updated to reflect the addition 
of 50 µg mRNA-1273.617.2 
to Part C Objectives. 
 
Study hypotheses were 
updated to reflect addition of 
Part D.  
Section 1.3.1 (Known 
Potential Benefits) 
Known potential benefits was updated 
to include that mRNA-1273.213 
vaccine may be an effective vaccine 
against COIVD-19 variants of concern 
(VOC).  
Vaccine mRNA-1273.213 
includes variant-matched 
spike protein sequences, from 
circulating variants of 
concern 
Section 7.4.5 (Adverse 
Event of Special Interest) 
Added documentation for AESI and the 
definition of subclinical myocarditis. 
Added for alignment with 
approved verbiage across 
other clinical studies 
10.5.9. 
Amendment 2, 26 Jul 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 purpose of this amendment is to add mRNA-1273 and mRNA-1273.617.2 study arms 
of 100 µg and update the primary and secondary objectives and endpoints to reflect regulatory 
guidance. 
Summary of Major Changes in Protocol Amendment 2: 
Section # and Name 
Description of Change 
Brief Rationale 
Title Page, Protocol 
Approval Page, Declaration 
of Investigator, 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. 
Protocol Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments.  
Global  
Minor copy edits were made. 
Made for alignment with new 
content, readability and/or 
accuracy. 
Synopsis 
Updated the estimated date of last 
participant and total number of sites.  
Changes made to reflect the 
addition of new study sites 

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Section # and Name 
Description of Change 
Brief Rationale 
and additional parts to the 
study.  
Synopsis, Section 2 
(Objectives and Endpoints), 
Section 3.1 (General 
Design), Section 3.3 
(Justification for Dose, 
Control Product, and 
Choice of Study 
Population), and Section 4 
(Study Population) 
The study is now 3 open-label parts: A, 
B, and C. The objectives and endpoints 
were also broken up to address each of 
the below.  
 
Part A evaluates the immunogenicity, 
safety, and reactogenicity of 2 dose 
levels (50 µg and 100 µg) of 
mRNA-1273.211 vaccine administered 
as a single booster dose to adults who 
have previously received 2 doses of 
mRNA-1273 as a primary series. 
 
Part B evaluates the immunogenicity, 
safety, and reactogenicity of 
mRNA-1273 vaccine administered as a 
single booster dose (100 µg) to adults 
who have previously received 2 doses 
of mRNA-1273 as a primary series. 
 
Part C evaluates the immunogenicity, 
safety, and reactogenicity of 
mRNA-1273.617.2 vaccine as a single 
booster dose (100 µg) to adults who 
have previously received 2 doses of 
mRNA-1273 as a primary series.  
The study is now a 3-part 
study. Part A is the original 
study, including 2 dose levels 
of mRNA-1273.211 (50 and 
100 µg). Part B will include a 
new study arm of mRNA-
1273 100 µg. Part C will 
include a mRNA-1273.617.2 
100 µg study arm. 
 
The part B primary endpoints 
will enable a comparison 
between the immune response 
elicited from mRNA-1273 as 
a booster dose with the 
immune response elicited 
from mRNA-1273 after 
primary series immunization 
(historical cohort) using the 
prototype strain as basis for 
comparison. 
 
The part C primary endpoints 
will enable a comparison 
between the immune response 
elicited from mRNA-
1273.617.2 as a booster dose, 
against the B.1.617.2 variant, 
with the immune response 
elicited from mRNA-1273 
after primary series 
immunization (historical 
cohort) against the prototype 
viral strain.  
Synopsis and Section 2 
(Objectives and Endpoints) 
The Key Secondary objectives and 
endpoints were upgraded to co-primary 
endpoints for Part A of Amendment 2.  
Key secondary objectives and 
endpoints were updated to co-
primary to reflect 
considerations discussed with 
regulatory guidance. 
The updated co-primary 
objectives and endpoints will 
enable a comparison of the 
immune response to booster 
dose of mRNA-1273.211 
against the B.1.351 variant 

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Section # and Name 
Description of Change 
Brief Rationale 
with the immune response to 
priming doses of the 
prototype vaccine (historical 
control) against prototype 
strain. 
Synopsis and Section 2 
(Objectives and Endpoints) 
Symptomatic and asymptomatic 
SARS-CoV-2 infection terminology 
language was updated in the 
Exploratory Objectives: 
“An alternative definition of 
symptomatic COVID-19 that is 
identical to the one used in 
mRNA-1273-P301” was updated to 
Primary case definition per the 
mRNA-1273-P301 COVE study” 
The CDC definition was updated to 
Secondary case definition based on the 
CDC criteria. 
To align the naming 
convention across studies. 
Synopsis, Section 5.1 
(Investigational Products 
Administered), and 
Section 5.3.1 (Preparation 
of Study Vaccine) 
Part A (mRNA-1273.211) language 
was updated to correct concentration of 
mRNA-1273.211 from 0.5 mg/mL to 
0.2 mg/mL 
 
 
 
 
Part B (mRNA-1273) language was 
added to discuss mRNA-1273, 
preparation, and packaging/labeling. 
 
Part C (mRNA-1273.617.2) language 
was added to discuss mRNA-
1273.617.2, preparation, and 
packaging/labeling.  
Part A language was a 
correction. The Part B and C 
language was added to 
include the information 
related to the mRNA-1273 
and mRNA-1273.617.2 IP. 
Section 7.1.6 (Assessment 
of SARS-CoV-2 Infection) 
“Part A The blinded phase only” 
language was removed.  
This language applies to all 
parts and the study is 
open-label.  
Synopsis, Section 7.4.5 
(Adverse Events of Special 
Interest), and Section 7.5 
(Safety Monitoring) 
An adjudication committee will be 
utilized to review any suspected cases 
of myocarditis, pericarditis, and 
myopericarditis.  
An independent cardiac event 
adjudication committee will 
review any suspect cases of 
myocarditis, pericarditis, and 
myopericarditis. 
Synopsis, Section 8.2 
(Statistical Hypotheses), 
Section 8.3 (Sample Size 
Determination), 
Part A hypotheses were updated to 
from 2 Primary and 2 Key Secondary to 
4 Primary hypotheses. 
 
 Key secondary objectives 
and endpoints (part A) were 
updated to co-primary to 
reflect considerations 
CCI

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Section # and Name 
Description of Change 
Brief Rationale 
Section 8.5.4.2 (Analysis 
for the Primary 
Immunogenicity Objective) 
Part B hypotheses were added to reflect 
the Part B Objectives. 
 
Part C hypotheses were added to reflect 
the addition of Part C Objectives.  
discussed with regulatory 
guidance. Study hypotheses 
were updated accordingly. 
Synopsis and Section 8.3 
(Sample Size 
Determination) 
Part A additional power estimation was 
performed for 50 ug mRNA-1273.211 
(270 vs. 526 in PP Set for 
Immunogenicity).  
Updated plan to include all 
historical control patients in 
comparison of 
50 ug mRNA-1273.211 vs. 
historical control. 
Synopsis and Section 8.6.1 
(Interim Analysis) 
Section 8.6.1 was renamed from 
“Primary Analysis” to “Interim 
Analysis.” 
 
Language was also included to describe 
when the analysis may occur with the 
addition of Part B and C.  
Section heading and content 
was updated for clarity. 
Section 1.3.2 (Risks from 
Study Participation and 
Their Mitigation) 
Safety language related to myocarditis 
and pericarditis was added.  
Language was updated to 
reflect very rare reports of 
myocarditis/pericarditis after 
vaccination. 
Section 5.3.5 (Study 
Vaccine Storage)  
Language was added to indicate that 
mRNA-1273.617.2 must be stored 
at -60°C to -90°C (-76°F to -130°F), 
and mRNA-1273 must be stored at -
25°C to 15°C. 
Storage directions were added 
for mRNA-1273.617.2 and 
mRNA-1273 for clarity. 
Section 7.4.4 (Medically 
Attended Adverse Events) 
The following language was updated 
from “All MAAEs must be fully 
reported on the MAAE page of the 
eCRF” to  
“Unsolicited AEs will be captured on 
the AE page of the eCRF.”  
Language was updated to 
reflect actual process.  
Section 7.4.5 (Adverse 
Events of Special Interest) 
Myocarditis, pericarditis, and 
myopericarditis case definitions were 
added for investigator reference. 
The CDC definition of 
myocarditis and pericarditis 
(both are Adverse Events of 
Special Interest) was added to 
assist investigators with the 
evaluation of any suspect 
cases. 
Section 8.5.5 (Exploratory 
Analysis) 
Added 2 exploratory analyses. 
Exploratory analyses on immune 
response to selected virus strains may 
be performed to compare booster 
regimens (study arms). 
To assess product 
cross-protection against 
variant. 

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Section # and Name 
Description of Change 
Brief Rationale 
Other exploratory analyses to compare 
immune response of boosters against 
variants compared to the priming series 
of mRNA-1273 against the variant may 
be performed. 
10.5.10. 
Amendment 1, 23 Jun 2021  
Main Rationale for the Amendment: 
The main purpose of this amendment is to add an mRNA-1273.211 study arm of 100 µg and 
update the primary and secondary objectives and endpoints to reflect regulatory guidance. 
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. 
Protocol Summary of 
Changes added to be in line 
with Moderna guidelines for 
protocol amendments. 
Global 
Minor grammar and formatting 
corrections were made throughout the 
document. 
Updates were made for clarity 
and readability. 
Synopsis 
Estimated date last participant 
completed was updated to July 2022 
from May 2022. 
New study completion date is 
based on last participant in 
mRNA-1273.211 100 µg arm 
enrolled in July 2021. 
Synopsis, Section 1.1 
(Study Rationale), Section 2 
(Objectives and Endpoints), 
Section 3.1 (General 
Design), Section 3.3 
(Justification for Dose, 
Control Product, and 
Choice of Study 
Population), Section 4 
(Study Population), Section 
5.1 (Investigational 
Products Administered), 
Section 5.3.1 (Preparation 
of Study Vaccine), Section 
8.2 (Statistical Hypotheses), 
Section 8.3 (Sample Size 
Determination), and Section 
8.6.1 (Primary Analysis) 
An mRNA-1273.211 study arm of 
100 µg was added to the study.  
An mRNA-1273.211 
100 µg arm was added to 
evaluate the safety and 
immunogenicity of a higher 
booster dose. The 100 µg arm 
will be included in the study 
scientific hypothesis and 
objectives to demonstrate 
non-inferiority of the immune 
responses elicited by 
mRNA-1273.211 compared 
with the immune response 
elicited by mRNA-1273. 

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Section # and Name 
Description of Change 
Brief Rationale 
Synopsis and Section 2 
(Primary Objectives and 
Endpoints) 
The primary and secondary objectives 
and endpoints were updated. Key 
secondary objectives and endpoints 
were added before the secondary 
endpoint. 
Primary and secondary 
objectives and endpoints were 
updated to reflect 
considerations discussed with 
regulatory guidance. 
The updated primary 
endpoints will enable a 
comparison between the 
immune responses elicited 
from mRNA-1273.211 and 
mRNA-1273 (historical 
cohort) using the prototype 
strain as basis for 
comparison. 
The key secondary objective 
and endpoint will enable a 
comparison of immune 
response to booster dose of 
mRNA-1273.211 against the 
B1.1.351 variant with the 
immune response to priming 
doses of the prototype 
vaccine (historical control) 
against prototype strain. 
Synopsis and Section 2 
(Objectives and Endpoints) 
Secondary objectives and endpoints 
were modified to include comparisons 
of the immune response to a booster 
dose of mRNA-1273.211 with the 
response to priming doses of 
mRNA-1273 (historical control) against 
other variants of interest and concern 
(including B.1.1617.2). These 
objectives and endpoints were moved 
from exploratory and modified. 
 
Exploratory Endpoint language was 
also updated for clarity.  
Secondary endpoints were 
updated to perform a 
comparison of the immune 
response to the booster dose 
of mRNA-1273.211 against 
other viral variants of interest 
or concern, compared to the 
immune response to priming 
doses of the prototype 
vaccine (historical control) 
against the prototype strains.  
Synopsis and Section 3.1 
(Scientific Rationale for 
Study Design)  
Additional language was added to 
specify when the primary analysis will 
be completed.  
This language was added to 
clarify timing for primary 
analysis.  

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Section # and Name 
Description of Change 
Brief Rationale 
Synopsis, Section 3.1 
(General Design), Section 4 
(Study Population), and 
Section 8.3 (Sample Size 
Determination) 
Language was added to indicate that the 
100 µg study arm is expected to have 
approximately 584 participants, to 
achieve 526 evaluable participants. 
An mRNA-1273.211 100 µg 
arm was added to evaluate the 
safety and immunogenicity of 
a higher booster dose. The 
100 µg arm will be included 
in the study scientific 
hypothesis, and the study arm 
size was determined based on 
statistical calculations, in 
order to meet the study 
objectives. 
Synopsis, Section 1.1 
(Study Rationale), 
Section 8.2 (Statistical 
Hypotheses), and 
Section 8.5.4.2 (Analysis 
for the Primary 
Immunogenicity Objective) 
The primary hypotheses language was 
updated. 
The primary hypotheses 
language was updated to 
reflect the changes in the 
primary objectives as 
previously specified. 
Synopsis, Section 8.2 
(Statistical Hypotheses), 
and Section 8.5.4.3 
(Analysis for the Key 
Secondary Immunogenicity 
Objective) 
The hypotheses and supporting 
language for the key secondary 
objective were added. 
The Section 8.5.4.3 (Analysis for the 
Key Secondary and Secondary 
Immunogenicity Objective) was added. 
The hypotheses language for 
the key secondary was 
updated to reflect the changes 
in the key secondary 
objectives as previously 
specified. 
Synopsis and Section 
8.5.4.4 (Other Analysis of 
Immunogenicity) 
More information about other 
immunogenicity analyses was added. 
Information was added to 
align with the updated 
primary, key secondary and 
secondary endpoints. 
Synopsis and Section 8.3 
(Sample Size 
Determination) 
Sample size language and rationale was 
updated for clarity and language 
pertaining to the 100 µg study arm was 
added.  
mRNA-1273.211 100 µg arm 
was added to evaluate the 
safety and immunogenicity of 
a higher booster dose. The 
100 µg arm will be included 
in the study scientific 
hypothesis, and the study arm 
size was determined based on 
statistical calculations, in 
order to meet the study 
objectives. 

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Section # and Name 
Description of Change 
Brief Rationale 
Synopsis, Section 8.4 
(Analysis Sets), and Section 
8.5.2 (Efficacy Analysis) 
The Per-Protocol Set title was updated 
to include ‘for Immunogenicity’ and 
the description was updated. 
 
The Modified Intent-to-Treat Set, and 
the Per-Protocol Set for Efficacy were 
also added. 
 
Language was added to clarify that 
Efficacy analyses will be performed 
using Modified Intent-to-Treat Set and 
Per-Protocol Set.  
The modified intent-to-treat 
and per-protocol analysis sets 
were added to align with 
protocols across the 
SARS-CoV-2 program.  
Section 7.1.6 (Assessment 
for SARS-CoV-2 Infection) 
and Section 10.1 
(Appendix 1: Schedule of 
Events) - Footnote 4 
Language was added to discuss the use 
of clinical judgment to determine 
whether a nasopharyngeal swab 
collection is warranted due to 
symptoms of COVID-19 overlap with 
solicited systemic adverse reactions.  
This information was added 
to further support clinical 
evaluation of suspected 
COVID-19 events given 
some overlap between 
adverse reaction and 
symptoms of COVID-19.  
Section 7.2 
(Immunogenicity 
Assessments) - Table 3 
Blood and Nasopharyngeal 
Swab Sampling 
A 1 was added to the row 
PCR/Sequencing under the UNS/Illness 
column.  
This addition was to clarify 
that polymerase chain 
reaction testing would take 
place at acute 
illness/unscheduled visits to 
evaluate for SARS-CoV-2 
infection. 
Section 8.5.4.1 (Sampling 
of Historical Control: 
Participants from Study 
mRNA-1273-P301 
Immunogenicity Analysis) 
Section 8.5.4.1 (Sampling of Historical 
Control: Participants from Study 
mRNA-1273-P301 Immunogenicity 
Analysis) was added to provide further 
description of the historical control 
arm.  
Information regarding process 
for selecting samples from the 
historical controls of 
participants who received 
priming doses of 
mRNA-1273 in Study 
mRNA-1273-P301 is 
included. 
Section 8.5.4.2 (Analysis 
for the Primary 
Immunogenicity Objective) 
Section 8.5.4.2 (Analysis for the 
Primary Immunogenicity Objective) 
was added to provide further 
description of the primary 
immunogenicity objective and its 
parameters.  
Information was added to 
align with the updated 
primary objectives.  

ModernaTX, Inc. 
mRNA-1273-P205 Protocol Amendment 11 
mRNA-1273 
Confidential 
Page 182 
Section # and Name 
Description of Change 
Brief Rationale 
Section 8.5.4.3 (Analysis 
for the Key Secondary and 
Secondary Immunogenicity 
Objective)  
Section 8.5.4.3 (Analysis for the Key 
Secondary and Secondary 
Immunogenicity Objective) was added 
to provide further description of the key 
secondary and secondary 
immunogenicity objective and its 
parameters.  
Information was added to 
align with the updated key 
secondary and secondary 
objectives. 
Section 8.5.4.4 (Other 
Analysis of 
Immunogenicity) 
Section 8.5.4.4 (Other Analysis of 
Immunogenicity) was added to provide 
clarification on other immunogenicity 
analyses language.  
Clarifications were made 
within the immunogenicity 
analyses language to align 
with the modified objectives.  
 

Signature Page for VV-CLIN-009865 v2.0
Signature Page for VV-CLIN-009865 v2.0
2nd Approval
12-Oct-2023 14:52:13 GMT+0000
PPD