A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
Phase: PHASE2
Conditions: SARS-CoV-2 Infection, COVID19
Sponsor: BioNTech SE

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
 Final Protocol Amendment 5, 13 January 2023 
 
PFIZER CONFIDENTIAL 
Page 1 
 
 
This document and accompanying materials contain confidential information belonging to Pfizer. Except 
as otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) 
or use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified. 
 
 
 
 
A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, 
TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE 
BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE 
 
Study Sponsor: 
BioNTech SE 
Study Conducted By: 
Pfizer 
Study Intervention Number: 
PF-07302048 
Study Intervention Name: 
BNT162b2 RNA-Based COVID-19 
Vaccine 
US IND Number: 
19736 
EudraCT Number: 
2021-001290-23 
ClinicalTrials.gov ID: 
NCT04895982 
Protocol Number: 
C4591024 
Phase: 
2b 
Brief Title Phase 2b, Open-Label Study to Evaluate Safety, Tolerability, and 
Immunogenicity of Vaccine Candidate BNT162b2 in Immunocompromised Participants 
≥2 Years of Age 
 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
 Final Protocol Amendment 5, 13 January 2023 
 
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Document History 
 
Document 
Version Date 
Original protocol 
16 April 2021 
Protocol amendment 1 
24 June 2021 
Protocol amendment 2 
05 August 2021 
Protocol amendment 3 
15 September 2021 
Protocol amendment 4 
21 January 2022 
Protocol amendment 5 
13 January 2023 
 
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative 
clarification letter. 
Protocol Amendment Summary of Changes Table 
Amendment 5 (13 January 2023) 
Overall Rationale for the Amendment: 
 
Section # and Name 
Description of Change 
Brief Rationale 
Sections 1.1 Overall Design, 
1.1 Number of Participants, 
and 4.1 Overall Design 
• Updated the number of 
participants in each 
group based on actual 
recruitment figures 
• Due to the challenging 
recruitment of 
immunocompromised 
participants in this study, 
a decision was made to 
stop recruiting new 
participants 
Section 5.4 Screen Failures 
• Included content from 
the PACL dated 
25 October 2022 to 
clarify the definition of 
screen failures 
• This is to align with the 
protocol template 
wording for screen 
failure 
Sections 8.9.8 Visit 8 – 
Vaccination 4 (91 to 189 
Days After Visit 5), 
8.9.9 Visit 9 – 1-Month 
Follow-Up Visit (After 
Vaccination 4) (28 to 35 
Days After Visit 8), 
8.9.10 Visit 10 – 6-Month 
Follow-Up Visit (After 
Vaccination 4) (175 to 189 
Days After Visit 8), 
• Included content from 
the PACL dated 
05 October 2022 to 
clarify the requirements 
for study procedures 
after protocol 
amendment 4 
• This is to ensure 
participants can continue 
to perform study 
activities, as appropriate, 
if they do not consent to 
a fourth dose 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
 Final Protocol Amendment 5, 13 January 2023 
 
PFIZER CONFIDENTIAL 
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Section # and Name 
Description of Change 
Brief Rationale 
1.3 Schedule of Activities, 
and 7.1 Discontinuation of 
Study Intervention 
Sections 8 Study 
Assessments and 
Procedures, 
9.3.4 Exploratory 
Endpoint(s)/Estimand(s) 
Analysis, and 
1.3 Schedule of Activities 
• Removed further blood 
draws for participants 
who have consented to 
PBMC sampling 
• Only 1 participant to 
date has been enrolled in 
the PBMC subset due to 
the challenges with 
study enrollment overall; 
with too few participants 
to make a meaningful 
analysis, further 
collection of blood for 
PBMC assessment is not 
required 
Section 8.9.8 Visit 8 – 
Vaccination 4 (91 to 189 
Days After Visit 5) 
• Included content from 
the PACL dated 
19 May 2022 to correct a 
typographical error 
• This is to reflect the 
accurate study 
procedures listed in 
Section 1.3 Schedule of 
Activities 
Section 8.11.1 Potential 
COVID-19/MIS-C Illness 
Visit (Optimally Within 3 
Days After Potential 
COVID-19 Illness Onset) 
• Included content from 
the PACL dated 
09 March 2022 to clarify 
nasal swab collection for 
participants in study 
sites in Mexico 
• This is to clarify that 
participants will not 
self-collect nasal swabs 
in Mexico 
Section 9.3.1 General 
Considerations 
• Added the following 
wording: Analyses for 
certain cohorts may be 
combined if the number 
of participants is small 
• This is in case of low 
recruitment 
Section 9.4.1 Analysis 
Timing 
• Streamlined the text in 
this section 
• This is to clarify the 
language 

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 Final Protocol Amendment 5, 13 January 2023 
 
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TABLE OF CONTENTS 
LIST OF TABLES ..................................................................................................................... 9 
1. PROTOCOL SUMMARY ................................................................................................... 10 
1.1. Synopsis ................................................................................................................... 10 
1.2. Schema..................................................................................................................... 17 
1.3. Schedule of Activities .............................................................................................. 18 
2. INTRODUCTION ................................................................................................................ 22 
2.1. Study Rationale ........................................................................................................ 22 
2.2. Background .............................................................................................................. 22 
2.2.1. Clinical Overview ....................................................................................... 25 
2.3. Benefit/Risk Assessment ......................................................................................... 25 
2.3.1. Risk Assessment ......................................................................................... 27 
2.3.2. Benefit Assessment ..................................................................................... 30 
2.3.3. Overall Benefit/Risk Conclusion ................................................................ 30 
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ............................................................ 30 
4. STUDY DESIGN ................................................................................................................. 32 
4.1. Overall Design ......................................................................................................... 32 
4.2. Scientific Rationale for Study Design ..................................................................... 34 
4.2.1. Diversity of Study Population ..................................................................... 35 
4.3. Justification for Dose ............................................................................................... 35 
4.4. End of Study Definition ........................................................................................... 36 
5. STUDY POPULATION ...................................................................................................... 36 
5.1. Inclusion Criteria ..................................................................................................... 36 
5.2. Exclusion Criteria .................................................................................................... 38 
5.3. Lifestyle Considerations .......................................................................................... 40 
5.3.1. Contraception .............................................................................................. 40 
5.4. Screen Failures ......................................................................................................... 40 
5.5. Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention ........................... 40 
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY .................................. 41 
6.1. Study Intervention(s) Administered ......................................................................... 42 
6.1.1. Administration ............................................................................................. 42 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
 Final Protocol Amendment 5, 13 January 2023 
 
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6.2. Preparation, Handling, Storage, and Accountability .............................................. 42 
6.2.1. Preparation and Dispensing ........................................................................ 43 
6.3. Measures to Minimize Bias: Randomization and Blinding .................................... 44 
6.3.1. Allocation to Study Intervention ................................................................ 44 
6.4. Study Intervention Compliance .............................................................................. 44 
6.5. Dose Modification .................................................................................................. 44 
6.6. Continued Access to Study Intervention After the End of the Study ..................... 44 
6.7. Treatment of Overdose ........................................................................................... 44 
6.8. Concomitant Therapy ............................................................................................. 45 
6.8.1. Prohibited During the Study ...................................................................... 45 
6.8.2. Permitted During the Study ....................................................................... 46 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ........................................................................... 46 
7.1. Discontinuation of Study Intervention .................................................................... 46 
7.2. Participant Discontinuation/Withdrawal From the Study ...................................... 47 
7.2.1. Withdrawal of Consent .............................................................................. 48 
7.3. Lost to Follow-Up .................................................................................................. 48 
8. STUDY ASSESSMENTS AND PROCEDURES .............................................................. 49 
8.1. Efficacy and/or Immunogenicity Assessments ....................................................... 50 
8.1.1. SARS-CoV-2–Related Cases ..................................................................... 51 
8.1.2. Multisystem Inflammatory Syndrome in Children .................................... 53 
8.1.3. Immunogenicity ......................................................................................... 54 
8.1.4. Biological Samples .................................................................................... 54 
8.2. Safety Assessments ................................................................................................. 55 
8.2.1. Physical Examinations ............................................................................... 55 
8.2.2. Vital Signs .................................................................................................. 56 
8.2.3. Clinical Safety Laboratory Assessments .................................................... 56 
8.2.4. Electronic Diary ......................................................................................... 56 
8.2.4.1. Grading Scales .......................................................................... 57 
8.2.4.2. Local Reactions ........................................................................ 57 
8.2.4.3. Systemic Events ........................................................................ 59 
8.2.4.4. Fever ......................................................................................... 60 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
 Final Protocol Amendment 5, 13 January 2023 
 
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8.2.4.5. Surveillance of Events That Could Represent Enhanced 
COVID-19 Disease ........................................................................... 61 
8.2.5. Pregnancy Testing ...................................................................................... 61 
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting ................. 61 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information ...... 61 
8.3.1.1. Reporting SAEs to Pfizer Safety .............................................. 62 
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF .................. 62 
8.3.2. Method of Detecting AEs and SAEs .......................................................... 63 
8.3.3. Follow-Up of AEs and SAEs ..................................................................... 63 
8.3.4. Regulatory Reporting Requirements for SAEs .......................................... 63 
8.3.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure .................................................... 64 
8.3.5.1. Exposure During Pregnancy ..................................................... 64 
8.3.5.2. Exposure During Breastfeeding ................................................ 66 
8.3.5.3. Occupational Exposure ............................................................. 66 
8.3.6. Cardiovascular and Death Events ............................................................... 66 
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs ............................................................................. 66 
8.3.8. Adverse Events of Special Interest ............................................................ 67 
8.3.8.1. Lack of Efficacy ....................................................................... 67 
8.3.9. Medical Device Deficiencies ..................................................................... 67 
8.3.10. Medication Errors ..................................................................................... 67 
8.4. Pharmacokinetics .................................................................................................... 68 
8.5. Genetics .................................................................................................................. 68 
8.6. Biomarkers .............................................................................................................. 69 
8.6.1. Specified Gene Expression (RNA) Research ............................................ 69 
8.6.2. Specified Protein Research ......................................................................... 69 
8.6.3. Specified Metabolomic Research ............................................................... 69 
8.7. Immunogenicity Assessments ................................................................................ 69 
8.8. Health Economics ................................................................................................... 69 
8.9. Study Procedures .................................................................................................... 69 
8.9.1. Visit 1 – Vaccination 1 (Day 1) ................................................................. 69 

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8.9.2. Visit 2 – Vaccination 2 (19 to 23 Days After Visit 1) ............................... 72 
8.9.3. Visit 3 – 1-Week Follow-Up Visit (After Vaccination 2) (6 to 8 Days 
After Visit 2) ................................................................................................... 74 
8.9.4. Visit 4 – 1-Month Follow-Up Visit (After Vaccination 2) (28 to 35 
Days After Visit 2) .......................................................................................... 75 
8.9.5. Visit 5 – Vaccination 3 (28 to 35 Days After Visit 2) ............................... 76 
8.9.6. Visit 6 – 1-Week Follow-Up Visit (After Vaccination 3) (6 to 8 Days 
After Visit 5) ................................................................................................... 78 
8.9.7. Visit 7 – 1-Month Follow-Up Visit (After Vaccination 3) (28 to 35 
Days After Visit 5) .......................................................................................... 79 
8.9.8. Visit 8 – Vaccination 4 (91 to 189 Days After Visit 5) ............................. 79 
8.9.9. Visit 9 – 1-Month Follow-Up Visit (After Vaccination 4) (28 to 35 
Days After Visit 8) .......................................................................................... 82 
8.9.10. Visit 10 – 6-Month Follow-Up Visit (After Vaccination 4) (175 to 
189 Days After Visit 8) ................................................................................... 83 
8.10. Unscheduled Visit for Fever or a Grade 3 or Suspected Grade 4 Reaction ......... 83 
8.11. COVID-19 Surveillance (All Participants) and MIS-C Surveillance 
(Participants <21 Years of Age) ................................................................................ 85 
8.11.1. Potential COVID-19/MIS-C Illness Visit (Optimally Within 3 Days 
After Potential COVID-19 Illness Onset) ....................................................... 86 
8.12. Additional Procedures for Monitoring of Potential Myocarditis or 
Pericarditis ................................................................................................................ 88 
8.13. Communication and the Use of Technology ........................................................ 89 
8.14. SARS-CoV-2 NAAT Results From Visit 1 and Subsequent Vaccination 
Visits and Potential COVID-19 Illness Visits ........................................................... 89 
9. STATISTICAL CONSIDERATIONS ................................................................................ 90 
9.1. Statistical Hypotheses ............................................................................................. 90 
9.1.1. Estimands ................................................................................................... 90 
9.1.2. Multiplicity Adjustment ............................................................................. 91 
9.2. Analysis Sets ........................................................................................................... 91 
9.3. Statistical Analyses ................................................................................................. 91 
9.3.1. General Considerations .............................................................................. 91 
9.3.1.1. Analysis for Binary Data .......................................................... 92 
9.3.1.2. Analysis for Continuous Data ................................................... 92 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
 Final Protocol Amendment 5, 13 January 2023 
 
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9.3.2. Primary Endpoint(s)/Estimand(s) Analysis ............................................... 93 
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis ........................................... 93 
9.3.4. Exploratory Endpoint(s)/Estimand(s) Analysis ......................................... 94 
9.4. Interim Analyses ..................................................................................................... 95 
9.4.1. Analysis Timing ......................................................................................... 95 
9.5. Sample Size Determination .................................................................................... 96 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS.......................................................................................................... 97 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations ............... 97 
10.1.1. Regulatory and Ethical Considerations .................................................... 97 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP ........................................................................ 97 
10.1.2. Financial Disclosure ................................................................................. 98 
10.1.3. Informed Consent Process ....................................................................... 98 
10.1.4. Data Protection ......................................................................................... 99 
10.1.5. Committees Structure ............................................................................. 100 
10.1.5.1. Data Monitoring Committee ................................................. 100 
10.1.6. Dissemination of Clinical Study Data .................................................... 100 
10.1.7. Data Quality Assurance .......................................................................... 101 
10.1.8. Source Documents ................................................................................. 103 
10.1.9. Study and Site Start and Closure ............................................................ 103 
10.1.10. Publication Policy ................................................................................ 104 
10.1.11. Sponsor’s Qualified Medical Personnel ............................................... 105 
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting ................................................................... 106 
10.2.1. Definition of AE ..................................................................................... 106 
10.2.2. Definition of an SAE .............................................................................. 107 
10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period ......................................................................... 109 
10.2.4. Reporting of SAEs ................................................................................. 112 
10.3. Appendix 3: Contraceptive and Barrier Guidance .............................................. 114 
10.3.1. Male Participant Reproductive Inclusion Criteria ................................. 114 
10.3.2. Female Participant Reproductive Inclusion Criteria .............................. 114 

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10.3.3. Woman of Childbearing Potential ........................................................... 115 
10.3.4. Contraception Methods ........................................................................... 116 
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments ...... 117 
10.5. Appendix 5: Genetics .......................................................................................... 119 
10.6. Appendix 6: Alternative Measures During Public Emergencies ......................... 120 
10.6.1. Telehealth Visits ...................................................................................... 120 
10.7. Appendix 7: Protocol Amendment History ......................................................... 121 
10.8. Appendix 8: Abbreviations .................................................................................. 129 
11. REFERENCES ................................................................................................................. 133 
 
LIST OF TABLES 
Table 1. 
Blood Sampling Volumes per Assessment, by Age Group ..................... 50 
Table 2. 
RR and HR, by Age, Indicative of Severe Systemic Illness .................... 53 
Table 3. 
Local Reaction Grading Scale for Participants ≥12 Years of Age 
(at Visit 1) ................................................................................................ 58 
Table 4. 
Local Reaction Grading Scale for Participants ≥2 to <12 Years of 
Age (at Visit 1) .......................................................................................... 58 
Table 5. 
Systemic Event Grading Scale for All Study Participants ........................ 59 
Table 6. 
Scale for Fever .......................................................................................... 60 
Table 7. 
Probability of Observing at Least 1 AE by Assumed True Event 
Rates With Different Sample Sizes........................................................... 96 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
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 Final Protocol Amendment 5, 13 January 2023 
 
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Brief Title: Phase 2b, Open-Label Study to Evaluate Safety, Tolerability, and 
Immunogenicity of Vaccine Candidate BNT162b2 in Immunocompromised Participants 
≥2 Years of Age 
Rationale 
Study C4591001 (NCT04368728) is an ongoing Phase 1/2/3 trial in ~44,000 participants 
designed to generate safety, tolerability, immunogenicity, and efficacy data from a novel 
RNA-based vaccine candidate. C4591001 prohibited the enrollment of those with 
significantly suppressed immune function. Given that individuals with compromised immune 
systems (due to primary or acquired conditions, or as a result of the administration of 
immunosuppressant treatment) are at significant risk of morbidity and mortality due to 
SARS-CoV-2 infection, it is imperative that the safety, tolerability, and immune response to 
vaccination among this cohort be investigated. In order to obtain information regarding the 
safety and immunogenicity among immunosuppressed participants, representative medical 
conditions (and their respective treatments) have been selected for this study. Medical 
conditions and associated treatments have been selected on the basis of the substantial 
morbidity/mortality associated with COVID-19, feasible recruitment timelines, regulatory 
requirements, and the ability to generalize safety and immunogenicity results overall. 
Representative conditions for participants ≥18 years of age include NSCLC, CLL, 
maintenance hemodialysis treatment secondary to end-stage renal disease, and 
immunomodulator therapy for an autoimmune disorder. Participants ≥2 to <18 years of age 
with representative conditions include those with autoimmune inflammatory disorders 
receiving immunomodulators, those who have undergone organ transplant and are receiving 
maintenance antirejection medications, and those who have undergone bone marrow or stem 
cell transplant. 
This Phase 2b study (C4591024) will evaluate safety, tolerability, and immunogenicity 
across all age groups based on representative medical conditions. For the participants who 
are ≥12 years of age, a 30-µg dose level will be used. For participants who are ≥5 to 
<12 years of age, a 10-µg dose level will be used. For participants who are <5 years of age, a 
3-µg dose level will be used. These are the same dose levels that have been selected for 
participants <5 years of age and ≥5 to <12 years of age, respectively, in the Phase 2/3 
C4591007 study. 

PF-07302048 (BNT162b2 RNA-Based COVID-19 Vaccine) 
Protocol C4591024 
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Objectives, Endpoints, and Estimands 
 
Objectives 
Endpoints 
Estimands 
Primary: 
Primary: 
Primary: 
To describe the immune response to 
prophylactic BNT162b2 in 
participants ≥18 years of age without 
serological or virological evidence of 
past SARS-CoV-2 infection and 
with: 
• Asymptomatic CLL without 
treatment and undergoing 
observation, or CLL on BTK 
inhibitor or anti-CD20 
monoclonal antibodies 
• Diagnosed with NSCLC and on 
chemotherapy, checkpoint 
inhibitors, or targeted agents for 
oncogene-driven tumors 
• Maintenance hemodialysis 
treatment due to end-stage renal 
disease 
• Immunomodulator therapy for an 
autoimmune inflammatory 
disorder 
In participants complying with the key 
protocol criteria (evaluable participants) 
and no serological or virological 
evidence of past SARS-CoV-2 
infection in each disease subset: 
• GMTs at 1 month after Dose 3 and 
Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To describe the immune response to 
prophylactic BNT162b2 in 
participants ≥2 to <18 years of age 
without serological or virological 
evidence of past SARS-CoV-2 
infection and either: 
• Are on immunomodulator 
therapy for an autoimmune 
inflammatory disorder 
• Are on immunosuppression 
therapy after solid organ 
transplant 
• Underwent bone marrow or stem 
cell transplant at least 6 months 
before enrollment 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each age 
group (≥2 to <5, ≥5 to <12, and ≥12 to 
<18 years) and disease subset: 
• GMTs at 1 month after Dose 3 and 
Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To describe the safety and 
tolerability of prophylactic 
BNT162b2 in participants ≥18 years 
of age with: 
• Asymptomatic CLL without 
treatment and undergoing 
observation, or CLL on BTK 
inhibitor or anti-CD20 
monoclonal antibodies 
• Diagnosed with NSCLC and on 
chemotherapy, checkpoint 
inhibitors, or targeted agents for 
oncogene-driven tumors 
• Maintenance hemodialysis 
treatment due to end-stage renal 
disease 
In participants receiving at least 1 dose 
of study intervention in each disease 
subset, the percentage of participants 
reporting: 
• Local reactions for up to 7 days 
following each dose 
• Systemic events for up to 7 days 
following each dose 
• AEs from Dose 1 through 1 month 
after Dose 2 
• AEs from Dose 3 through 1 month 
after Dose 3 
• AEs from Dose 4 through 1 month 
after Dose 4 
• SAEs from Dose 1 through the 
duration of the study 
• 
Local reactions (pain at the 
injection site, redness, and 
swelling) 
• 
Systemic events (fever, fatigue, 
headache, chills, vomiting, 
diarrhea, new or worsened muscle 
pain, and new or worsened joint 
pain) 
• 
AEs 
• 
SAEs 

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Objectives 
Endpoints 
Estimands 
• Immunomodulator therapy for an 
autoimmune inflammatory 
disorder 
To describe the safety and 
tolerability of prophylactic 
BNT162b2 in participants ≥2 to <18 
years of age and either: 
• Are on immunomodulator 
therapy for an autoimmune 
inflammatory disorder 
• Are on immunosuppression 
therapy after solid organ 
transplant 
• Underwent bone marrow or stem 
cell transplant at least 6 months 
before enrollment 
In participants receiving at least 1 dose 
of study intervention in each age group 
(≥2 to <5, ≥5 to <12, and ≥12 to 
<18 years) and disease subset, the 
percentage of participants reporting: 
• Local reactions for up to 7 days 
following each dose 
• Systemic events for up to 7 days 
following each dose 
• AEs from Dose 1 through 1 month 
after Dose 2 
• AEs from Dose 3 through 1 month 
after Dose 3 
• AEs from Dose 4 through 1 month 
after Dose 4 
• SAEs from Dose 1 through the 
duration of the study 
• 
Local reactions (pain at the 
injection site, redness, and 
swelling) 
• 
Systemic events (fever, fatigue, 
headache, chills, vomiting, 
diarrhea, new or worsened muscle 
pain, and new or worsened joint 
pain) 
• 
AEs 
• 
SAEs 
Exploratory: 
Exploratory: 
Exploratory: 
To further describe the immune 
response to prophylactic BNT162b2 
in participants ≥18 years of age 
without serological or virological 
evidence of past SARS-CoV-2 
infection and with: 
• Asymptomatic CLL without 
treatment and undergoing 
observation, or CLL on BTK 
inhibitor or anti-CD20 
monoclonal antibodies 
• Diagnosed with NSCLC and on 
chemotherapy, checkpoint 
inhibitors, or targeted agents for 
oncogene-driven tumors 
• Maintenance hemodialysis 
treatment due to end-stage renal 
disease 
• Immunomodulator therapy for an 
autoimmune inflammatory 
disorder 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each disease 
subset: 
• GMTs at all immunogenicity blood 
draws 
• GMFRs from baseline to 1 month 
after Dose 2, from baseline to 
1 month after Dose 3, and from 
Dose 4 to 1 month and 6 months 
after Dose 4 
• Percentages of participants with 
seroresponse at 1 month after 
Dose 2, 1 month after Dose 3, and 
1 month and 6 months after Dose 4 
• 
SARS-CoV-2 neutralizing titers 

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Objectives 
Endpoints 
Estimands 
To further describe the immune 
response to prophylactic BNT162b2 
in participants ≥2 to <18 years of age 
without serological or virological 
evidence of past SARS-CoV-2 
infection and either: 
• Are on immunomodulator 
therapy for an autoimmune 
inflammatory disorder 
• Are on immunosuppression 
therapy after solid organ 
transplant 
• Underwent bone marrow or stem 
cell transplant at least 6 months 
before enrollment 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each age 
group (≥2 to <5, ≥5 to <12, and ≥12 to 
<18 years) and disease subset: 
• GMTs at all immunogenicity blood 
draws 
• GMFRs from baseline to 1 month 
after Dose 2, from baseline to 
1 month after Dose 3, and from 
Dose 4 to 1 month and 6 months 
after Dose 4 
• Percentages of participants with 
seroresponse at 1 month after Dose 
2, 1 month after Dose 3, and 1 
month and 6 months after Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To further describe the immune 
response to prophylactic BNT162b2 
in participants with and without 
serological or virological evidence of 
past SARS-CoV-2 infection 
• GMTs at all immunogenicity blood 
draws 
• GMFRs from baseline to 1 month 
after Dose 2, from baseline to 
1 month after Dose 3, and from 
Dose 4 to 1 month and 6 months 
after Dose 4 
• Percentages of participants with 
seroresponse at 1 month after 
Dose 2, 1 month after Dose 3, and 
1 month and 6 months after Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To describe the cell-mediated 
immune response, and additional 
humoral immune response 
parameters in all participants 
≥12 years of age: 
• At baseline, 7 days after Dose 2, 
1 week after Dose 3, Dose 4, and 
6 months after Dose 4 
To describe the incidence of 
confirmed COVID-19 among 
immunocompromised participants 
• Incidence rate of confirmed 
COVID-19 per 1000 person-years 
of follow-up 
• 
COVID-19 incidence per 1000 
person-years of follow-up based 
on central laboratory or locally 
confirmed NAAT 
To characterize SARS-CoV-2 
variants in the study population 
• The number and percentage of each 
SARS-CoV-2 lineage among 
BNT162b2 recipients 
• 
SARS-CoV-2 lineage determined 
by next generation sequencing 
To describe the incidence of MIS-C 
cases 
• Incidence rate of confirmed MIS-C 
cases 
• 
Confirmed cases as per CDC 
symptom criteria 

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Overall Design 
This is a Phase 2b, open-label study with BNT162b2 in immunocompromised participants 
≥18 years of age treated for NSCLC or CLL, receiving hemodialysis treatment secondary to 
end-stage renal disease, or receiving immunomodulator therapy for an autoimmune 
inflammatory disorder, and in immunocompromised participants ≥2 to <18 years of age 
receiving immunomodulator therapy or who have undergone solid organ transplant (within 
the previous 3 months) and are on immunosuppression or who have undergone bone marrow 
or stem cell transplant at least 6 months prior to enrollment. This study will evaluate the 
safety, tolerability, and immunogenicity of BNT162b2: 
• Open-label; 4 doses, with the primary series consisting of 2 doses separated by 21 days 
and a third dose occurring at 28 days after Dose 2. There is a fourth dose (booster) which 
will occur 3-6 months after Dose 3. Note that the timing of the fourth dose should be 
determined by the investigator’s discretion, taking into account factors such as the 
participant’s underlying condition and level of immunosuppression, the evolving clinical 
literature, the COVID-19 incidence in the participant’s geographic area, and the potential 
for increased reactogenicity with Dose 4 occurring earlier. Additionally, although more 
data are needed for COVID-19 vaccines, there is a risk of reduced immunogenicity and 
antibody persistence with a shorter interval between Dose 3 and Dose 4. Investigators are 
encouraged to weigh the risks and benefits for each participant and make an 
individualized decision on the timing of the fourth dose, provided it falls within the 
minimum and maximum time frames detailed above. 
The dose for each of the 4 vaccinations will depend upon the age of the participant at the 
time of vaccination, as follows: 
• For participants who are ≥12 years of age (on the day of vaccination): at a 30-µg dose 
level 
• For participants who are ≥5 to <12 years of age (on the day of vaccination): at a 10-µg 
dose level 
• For participants who are <5 years of age (on the day of vaccination): at a 3-µg dose level 
• In approximately 7 participants who are ≥18 years of age (at Visit 1) in the following 
groups: 
o Approximately 1 participant who is treatment-naïve with planned treatment 
(≥14 days) or who is receiving treatment for NSCLC 
o Approximately 0 participants receiving treatment or under observation for CLL 
o Approximately 1 participant receiving maintenance hemodialysis treatment secondary 
to end-stage renal disease 

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o Approximately 5 participants receiving immunomodulator treatment for an 
autoimmune inflammatory disorder 
• In approximately 117 immunocompromised participants who are <18 years of age 
(at Visit 1), with: 
o Approximately 37 participants: ≥2 to <5 years of age 
o Approximately 65 participants: ≥5 to <12 years of age 
o Approximately 15 participants: ≥12 to <18 years of age 
• In each of the cohorts <18 years of age (at Visit 1), participants with the following 
immunocompromising conditions will be recruited/enrolled: 
o Immunomodulator treatment for an autoimmune inflammatory disorder 
(≥10 participants in each age cohort) 
o Immunomodulator treatment after solid organ transplant (≥10 participants in each age 
cohort) 
o Underwent bone marrow or stem cell transplant ≥6 months (182 days) before 
enrollment (≥10 participants in each age cohort) 
• Follow-up for 6 months after Dose 4. 
• Local reactions (redness, swelling, and pain at the injection site) and systemic events 
(fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain, and 
new or worsened joint pain) will be prompted for and collected by all participants or the 
participants’ parent(s)/legal guardians in an e-diary each day from Day 1 (the day of 
vaccination) through Day 7 after each administration of study intervention. AEs will be 
collected from the time the participant or participant’s parent(s)/legal guardian provides 
informed consent through 1 month after Dose 2, from Dose 3 through 1 month after 
Dose 3, and from Dose 4 through 1 month after Dose 4. SAEs will be collected from the 
time of informed consent through the duration of the study. 
Number of Participants 
Approximately 7 participants ≥18 years of age and 117 participants <18 years of age 
(approximately 124 in total) will be enrolled. 

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Intervention Groups and Duration 
BNT162b2 will be administered to all study participants. The study will evaluate a 4-dose 
schedule (the first 2 doses separated by 21 days), with a third dose occurring 28 days after the 
second dose*. The fourth dose (booster) will occur 3-6 months after Dose 3. 
For participants ≥12 years of age (on the day of vaccination): participants will receive 30 µg 
of BNT162b2, which is the same as that selected for Phase 3 of the pivotal vaccine study 
(C4591001). 
For participants ≥5 to <12 years of age (on the day of vaccination): participants will receive 
10 µg of BNT162b2. 
For participants <5 years of age (on the day of vaccination): participants will receive 3 µg of 
BNT162b2. 
These are the same dose levels that have been selected for participants <5 years of age and 
≥5 to <12 years of age, respectively, in the Phase 2/3 C4591007 study. Participants will 
receive the age-appropriate dose level at each vaccination visit, as detailed above. 
*Note that the timing of the fourth dose should be determined by the investigator’s 
discretion, taking into account factors such as the participant’s underlying condition and level 
of immunosuppression, the evolving clinical literature, the COVID-19 incidence in the 
participant’s geographic area, and the potential for increased reactogenicity with Dose 4 
occurring earlier. Additionally, although more data are needed for COVID-19 vaccines, there 
is a risk of reduced immunogenicity and antibody persistence with a shorter interval between 
Dose 3 and Dose 4. Investigators are encouraged to weigh the risks and benefits for each 
participant and make an individualized decision on the timing of the third dose, provided it 
falls within the minimum and maximum time frames detailed above. Depending on the 
timing of Dose 3 and Dose 4, participants are expected to participate for up to 14 months, 
with a maximum of approximately 15 months. 
Data Monitoring Committee or Other Independent Oversight Committee: Yes 
An external DMC will be utilized for this study and will review cumulative safety data 
throughout the study in accordance with the DMC charter. 
Statistical Methods 
There is no statistical hypothesis in this study. All statistical analyses will be descriptive. All 
safety and immunogenicity data will be summarized separately for each disease subset in 
participants ≥18 years of age and for each disease subset in each of the younger age groups 
(≥2 to <5, ≥5 to <12, and ≥12 to <18 years of age). Analyses for certain cohorts may be 
combined if the number of participants is small. 

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The primary immunogenicity objectives will be evaluated descriptively by GMTs and the 
associated 2-sided 95% CIs for SARS-CoV-2 neutralizing titers at 1 month after Dose 3 and 
1 month after Dose 4 in participants without serological or virological evidence of past 
SARS-CoV-2 infection. 
The primary safety objectives will be evaluated by descriptive summary statistics for local 
reactions, systemic events, AEs, and SAEs. Descriptive summary statistics will include 
counts and percentages of participants with the indicated endpoints and the associated 
Clopper-Pearson 95% CIs. 
1.2. Schema 
Not applicable. 

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1.3. Schedule of Activities 
The SoA table provides an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed infonnation on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the paiiicipant. 
 
Visit Number· 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unplanned 
Visit Identifier· 
Abbreviations used in this table may be 
found in Appendix 8 
Vaxl 
Vax2 
7-Day 
Follow-Up 
(Aftel"Vax 2)
1-Month 
Follow-Up 
(Aftel"Vax 2)
Vax3 
7-Day 
Follow-Up 
(Aftel"Vax 3 
1-Month 
Follow-Up 
(Aftel"Vax 3)
Vax4 
1-Month 
Follow-Up 
(Aftel" 
Vax4) 
6-Month 
Follow-Up 
(After· 
Vax4) 
Potential 
COVID-19,
MIS-C 
Illness 
Visit' 
Visit Window (Days) 
Dayl 
19 to 23
Days 
Aftel" 
Visit 1 
6 to 8 Days 
Aftel"Visit 2 
28 to 35 Days
Aftel"Visit 2b
28 to 35
Days 
After· 
Visit 2 
6 to 8 Days 
After·Visit 5 
28 to 35 Days 
After· Visit 5 
91 to 189 
Days After· 
Visit 5' 
28 to 35 
Days After·
Visit 8 
175 to 189 
Days Aftel"
Visit 8 
Optimally 
Within3 
Days Aftel"
Potential 
COVID-19
MIS-C 
Illness 
Onset 
Type of Visit 
Clinic 
Clinic 
Clinic 01" 
TeleheaJthd 
Clinic 
Clinic 
Clinic 01" 
Telehealthd 
Clinic 
Clinic 
Clinic 
Clinic 
Clinic01· 
Telehealth 
Obtain infonued consent and assent 
(if aooropriate) 
X 
Assign participant number 
X 
Obtain demography and significant 
medical historv data 
X 
Measm·e vital signse 
(includine:oral tempe.rature) 
X 
X 
X 
X 
Pe1fo1m a phvsical examination 
X 
X 
Pe1fo1m m-ine pregnancy test (only for 
female participants biologically capable 
of havine:children) 
X 
X 
X 
X 
Confum use of contraceptives 
(if annrooriate) 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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Visit Number· 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unplanned
Visit Identifiei- 
Abbreviations used in this table may be 
found in Appendix 8 
Vaxl 
Vax2 
7-Day 
Follow-Up 
(Aftei- Vax 2) 
1-Month 
Follow-Up 
(Aftei- Vax 2)
Vax3 
7-Day 
Follow-Up 
(Aftei- Vax 3 
1-Month 
Follow-Up 
(Aftei- Vax 3)
Vax4 
1-Month 
Follow-Up 
(Aftei- 
Vax4) 
6-Month 
Follow-Up 
(After· 
Vax4) 
Potential 
COVID-19,
MIS-C 
Illness 
Visit' 
Visit Window (Days) 
Dayl 
19 to 23
Days 
Aftei- 
Visit 1 
6 to 8 Days 
Aftei- Visit 2 
28 to 35 Days
Aftei- Visit 2b
28 to 35 
Days 
After· 
Visit 2 
6 to 8 Days 
After·Visit 5 
28 to 35 Days 
After· Visit 5 
91 to 189 
Days After· 
Visit 5' 
28 to 35 
Days After·
Visit 8 
175 to 189 
Days Aftei-
Visit 8 
Optimally 
Within3 
Days Aftei-
Potential 
COVID-19,
MIS-C 
Illness 
Onset 
Type of Visit 
Clinic 
Clinic 
Clinic oi- 
TeleheaJthd 
Clinic 
Clinic 
Clinic oi- 
Telehealthd 
Clinic 
Clinic 
Clinic 
Clinic 
Clinic01· 
Telehealth 
Collect nonstudv vaccine infonuation 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collect medication use infonuation 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Review temoorarv delay criteria 
X 
X 
X 
X 
Confirm eligibilitv 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Obtain studv intervention allocation 
X 
X 
X 
X 
Obtain nasal swab for detennination of 
ctm·ent SARS-CoV-2 status 
X 
X 
X 
X 
X 
Collect blood sample for 
immunoizenicitvf 
X 
X 
X 
X 
X 
X 
Collect blood samole for HLA tvoingf 
X 
Administer studv intervention 
X 
X 
X 
X 
Assess acute reactions for at least 
30 minutes after study intervention 
administration 
X 
X 
X 
X 
Explain communication methods 
(including for e-diary completion), 
assist with downloading the app, or 
issue orovisioned device if reouired 
X 
Provide a thermometer and measming 
device 
X 
X 
Record systemic events at baseline in 
the e-diarv 
X 

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Visit Number· 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unplanned
Visit Identifiei- 
Abbreviations used in this table may be 
found in Appendix 8 
Vaxl 
Vax2 
7-Day 
Follow-Up 
(Aftei- Vax 2)
1-Month 
Follow-Up 
(Aftei- Vax 2)
Vax3 
7-Day 
Follow-Up 
(Aftei- Vax 3 
1-Month 
Follow-Up 
(Aftei- Vax 3)
Vax4 
1-Month 
Follow-Up 
(Aftei- 
Vax4) 
6-Month 
Follow-Up 
(After· 
Vax4) 
Potential 
COVID-19,
MIS-C 
Illness 
Visit' 
Visit Window (Days) 
Dayl 
19 to 23
Days 
Aftei- 
Visit 1 
6 to 8 Days 
Aftei- Visit 2 
28 to 35 Days
Aftei- Visit 2b
28 to 35
Days 
After· 
Visit 2 
6 to 8 Days 
After·Visit 5 
28 to 35 Days 
After· Visit 5 
91 to 189 
Days After· 
Visit 5' 
28 to 35 
Days After·
Visit 8 
175 to 189 
Days Aftei-
Visit 8 
Optimally 
Within3 
Days Aftei-
Potential 
COVID-19,
MIS-C 
Illness 
Onset 
Type of Visit 
Clinic 
Clinic 
Clinic oi- 
TeleheaJthd 
Clinic 
Clinic 
Clinic oi- 
Telehealthd 
Clinic 
Clinic 
Clinic 
Clinic 
Clinic 01· 
Telehealth 
Ensm·e the pa1ticipant/pa1ticipant's 
parent(s)/legal guardian has a measming 
device and the1mometer 
X 
X 
X 
Ask the pa1ticipant/participant's 
parent(s)/legal guardian to complete 
e-diary and ensm·e that the 
pa1ticipant/pa1ticipant's parent(s)/legal 
guardian remains comfo1table with 
chosen e-diarv olatfo1m 
X 
X 
X 
X 
Review reactogenicity e-dia1y data 
(daily review is optimal dtuing the 
active diarv oeriod) 
+---+ +---+ 
+---+ 
+---+ 
Review ongoing reactogenicity e-diary 
svmotoms and obtain stop dates 
X 
X 
X 
X 
Collect AEsg and SAEsh 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collect e-dia1y or assist the participant 
or participant's parent(s)/legal guardian 
to delete aoo 
X 

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Visit Number· 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unplanned
Visit Identifiei- 
Abbreviations used in this table may be 
found in Appendix 8 
Vaxl 
Vax2 
7-Day 
Follow-Up 
(Aftei- Vax 2)
1-Month 
Follow-Up 
(Aftei- Vax 2)
Vax3 
7-Day 
Follow-Up 
(Aftei- Vax 3 
1-Month 
Follow-Up 
(Aftei- Vax 3)
Vax4 
1-Month 
Follow-Up 
(Aftei- 
Vax4) 
6-Month 
Follow-Up 
(After· 
Vax4) 
Potential 
COVID-19,
MIS-C 
Illness 
Visit' 
Visit Window (Days) 
Dayl 
19 to 23
Days 
Aftei- 
Visit 1 
6 to 8 Days 
Aftei- Visit 2 
28 to 35 Days
Aftei- Visit 2b
28 to 35
Days 
After· 
Visit 2 
6 to 8 Days 
After·Visit 5 
28 to 35 Days 
After· Visit 5 
91 to 189 
Days After· 
Visit 5' 
28 to 35 
Days After·
Visit 8 
175 to 189 
Days Aftei-
Visit 8 
Optimally 
Within3 
Days Aftei-
Potential 
COVID-19,
MIS-C 
Illness 
Onset 
Type of Visit 
Clinic 
Clinic 
Clinic oi- 
TeleheaJthd 
Clinic 
Clinic 
Clinic oi- 
Telehealthd 
Clinic 
Clinic 
Clinic 
Clinic 
Clinic 01· 
Telehealth 
Collection of COVID-19/MIS-C-relatec
clinical and laboratory infonuation 
(includinizlocal diaonosis) 
X 
Abbreviations: app = application; COVID-19 = coronavims disease 2019; CRF = case report form; DMC = data monitoring committee; HLA = human leukocyte 
antigen; MIS-C = multisystem inflammatory syndrome in children; PBMC = peripheral blood mononuclear cell; SARS-CoV-2 = severe acute respiratory 
syndrome coronavims 2. 
a. Potential MIS-C visit: hospitalization for a severe illness with no other alternative etiology. 
b. Visit 4 and Visit 5 are expected to occur on the same day. All visit procedures should be conducted in consecutive order and duplicative procedures listed in 
Visit 4 and Visit 5 not be done. 
c. The timing of Dose 4 should be detennined by the investigator's discretion, taking into account factors such as the participant's underlying condition and 
level of immunosuppression, the evolving clinical literature, the COVID-19 incidence in the pa1ticipant's geographic area, the potential for increased 
reactogenicity, and the risk of reduced immunogenicity and antibody persistence with a shorter interval between Dose 3 and Dose 4. 
d. For pruticipants not in the PBMC collection subset, this visit will be a telehealth visit. 
e. Height and weight will be collected only at Visit 1. 
f.  Immunogenicity blood draws will be taken for all pa1ticipants, with the volume dependent on pa1ticipant age at the visit. Breakdown of blood draw by age is 
referenced in Table 1 (Section 8) (Note: If the participant does not receive Dose 4 ofBNT162b2, this blood draw is not required, and Visits 8, 9, and 10 may 
be conducted via telehealth). 
g. AEs will be collected from info1med consent through 1 month after Dose 2, from Dose 3 through 1 month after Dose 3, and from Dose 4 through 1 month 
after Dose 4. In addition, any AEs occun-ing up to 48 hours after blood draw and nasal swab collection must be recorded (see Section 8.3.1). Note: 
Symptoms that trigger potential COVID-19/MIS-C illness visits (Section 8.11) are expected endpoints and should not be recorded as AEs. These data will be 
captured only on relevant illness pages of the CRF. 
h. Refer to Section 8.3.1 for the time period for collecting SAEs. 

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2. INTRODUCTION 
BNT162b2 is an RNA-based COVID-19 vaccine that is currently being investigated for the 
prevention of COVID-19 in individuals ≥6 months of age. On 02 December 2020, the 
MHRA in the UK granted a temporary authorization. On 11 December 2020, the US FDA 
issued an EUA for use in individuals 16 years of age and older. Other countries have also 
granted EUA (eg, Canada, Mexico, Bahrain), and Pfizer and BioNTech are anticipating 
further regulatory decisions in other countries. 
2.1. Study Rationale 
Study C4591001 (NCT04368728) is an ongoing Phase 1/2/3 trial in ~44,000 participants 
designed to generate safety, tolerability, immunogenicity, and efficacy data from a novel 
RNA-based vaccine candidate. C4591001 prohibited the enrollment of those with 
significantly suppressed immune function. Given that individuals with compromised immune 
systems (due to primary or acquired conditions, or as a result of the administration of 
immunosuppressant treatment) are at significant risk of morbidity and mortality due to 
SARS-CoV-2 infection, it is imperative that the safety, tolerability, and immune response to 
vaccination among this cohort be investigated. In order to obtain information regarding the 
safety and immunogenicity among immunosuppressed participants, representative medical 
conditions (and their respective treatments) were selected for cohort enrollment. The medical 
conditions and associated treatments selected accounted for morbidity/mortality associated 
with COVID-19, feasible recruitment timelines, regulatory requirements, and the ability to 
generalize safety and immunogenicity results overall. Representative conditions for 
participants ≥18 years of age include NSCLC, CLL, hemodialysis treatment secondary to 
end-stage renal disease, or immunomodulator therapy for an autoimmune inflammatory 
disorder. Participants ≥2 to <18 years of age with representative conditions include those 
with autoimmune inflammatory disorders receiving immunomodulators, those who have 
undergone organ transplant and are receiving maintenance antirejection modulators, and 
those who have undergone bone marrow or stem cell transplant. 
This Phase 2b study (C4591024) will evaluate safety, tolerability, and immunogenicity 
across all age groups based on representative medical conditions and utilizing a primary 
vaccination series of 3 doses followed by a fourth booster dose. For the participants who are 
≥12 years of age, a 30-µg dose level will be used. For participants who are ≥5 to <12 years of 
age, a 10-µg dose level will be used. For participants who are <5 years of age, a 
3-µg dose level will be used. These are the same dose levels that have been selected for 
participants <5 years of age and ≥5 to <12 years of age, respectively, in the Phase 2/3 
C4591007 study. 
2.2. Background 
A pneumonia of unknown cause detected in Wuhan, China, was first reported in 
December 2019. In January 2020, the pathogen causing this outbreak was identified as a 
novel coronavirus 2019. The outbreak was declared a Public Health Emergency of 
International Concern on 30 January 2020.1 On 12 February 2020, the virus was officially 
named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO 

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officially named the disease caused by SARS-CoV-2 as coronavirus disease 2019 
(COVID-19).1 On 11 March 2020, the WHO upgraded the status of the COVID-19 outbreak 
from epidemic to pandemic, which continues to spread globally.2 
Study C4591001 is currently being conducted in a heterogeneous study population: relatively 
healthy eligible participants who are ≥12 years of age, including those participants with 
stable chronic medical conditions, including HIV-, HCV-, and HBV-positive participants. 
A younger healthy population (≥6 months through 11 years of age) is being enrolled in a 
separate study (C4591007), and a study is in progress in pregnant women (C4591015). Study 
C4591001 consists of 2 parts: a completed Phase 1 part, which identified the preferred 
vaccine candidate (BNT162b1 or BNT162b2) and dose level (10 µg, 20 µg, 30 µg, or 100 µg 
[for BNT162b1]); and an ongoing Phase 2/3 part: an expanded-cohort portion to review both 
safety and efficacy among recipients of the selected vaccine candidate (BNT162b2). 
BNT162b2 was selected from the Phase 1 part of this study based on its overall safety, 
tolerability, and immunogenicity. In mid-November 2020, an analysis of 36,621 participants 
randomized 1:1 to vaccine or placebo demonstrated 8 infections in the vaccine group and 
162 infections in the placebo group, resulting in a VE of 95% in preventing confirmed 
COVID-19, at least 7 days after receiving 2 doses. Subgroup analyses of the primary efficacy 
endpoint showed similar efficacy point estimates across age groups, sexes, racial and ethnic 
groups, and participants, with medical comorbidities associated with high risk of severe 
COVID-19. Secondary efficacy analyses suggested benefit of the vaccine in preventing 
severe COVID-19, in preventing COVID-19 following the first dose, and in preventing 
COVID-19 in individuals with prior SARS-CoV-2 infection.3 
Safety data from approximately 38,000 participants at least 16 years of age, randomized 1:1 
to vaccine or placebo with a median of 2 months of follow-up after the second dose, suggest 
a favorable safety profile. Available safety data from all participants enrolled through 
14 November 2020 (N=43,252) were consistent with the safety profile demonstrated in the 
initial 38,000 participants.3 
The most common solicited adverse reactions were injection site reactions (84.1%), fatigue 
(62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and 
fever (14.2%); severe adverse reactions occurred in 0% to 4.6% of participants, were more 
frequent after Dose 2 than after Dose 1, and were generally less frequent in participants 
≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%). The frequency of 
SAEs was low (<0.5%), without meaningful imbalances between study arms. Among 
nonserious unsolicited AEs, there was a numerical imbalance of 4 cases of Bell’s palsy in the 
vaccine group compared with no cases in the placebo group, though the 4 cases in the 
vaccine group do not represent a frequency above that expected in the general population. 
Otherwise, there were no notable patterns or numerical imbalances between vaccine groups 
for specific categories of nonserious AEs (including other neurologic, neuroinflammatory, 
and thrombotic events) that would suggest a causal relationship to BNT162b2 vaccine. With 
the exception of more frequent, generally mild to moderate reactogenicity in participants 
<55 years of age, the safety profile of BNT162b2 was generally similar across age groups, 

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sexes, ethnic and racial groups, participants with or without medical comorbidities, and 
participants with or without evidence of prior SARS-CoV-2 infection at enrollment.3 
Regarding systemic events, 17% of the 18- to 55-year age group and 8% of those in the 
65- to 85-year age group reported fever (≥38.0°C to 38.9°C) after the second dose of 30 µg 
of BNT162b2. Severe systemic events (fatigue, headache, chills, muscle pain, and joint pain) 
were reported in small numbers of younger recipients of this vaccine candidate, but no severe 
systemic events were reported in older recipients, and there were no Grade 4 systemic events 
reported.4 
The Phase 2/3 portion of C4591001 was initiated in 18- to 85-year-old adults but was 
amended in September 2020 to include participants ≥16 years of age. It is intended that a 
minimum of 40% of participants will be in the >55-year stratum. 
There are 2 primary efficacy endpoints in the Phase 2/3 part of the C4591001 study. The first 
is to evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID-19 in 
participants without evidence of infection before vaccination and the second is to evaluate 
the efficacy of prophylactic BNT162b2 against confirmed COVID-19 in participants 
regardless of evidence of infection before vaccination. Cases of COVID-19 are defined by 
the presence of specified symptoms plus an NAAT for SARS-CoV-2 at least 7 days 
following the second dose of vaccine. Effectiveness in 12- to 15-year-old participants will be 
inferred by immune noninferiority to 16- to 25-year-old participants based on SARS-CoV-2– 
neutralizing GMTs. 
MIS-C, an emerging condition that appears to be temporally related to recent exposure to 
SARS-CoV-2, has been described and frequently requires ICU admission, and may have a 
fatal outcome.5,6 MIS-C is a febrile hyperinflammatory condition with frequent evidence of 
cardiac damage and dermatologic, mucocutaneous, and GI features.6 The syndrome appears 
to have some overlap with Kawasaki disease shock syndrome.7,8 Compared with Kawasaki 
disease, patients with MIS-C are older, have more cardiac injury, and are more likely to be 
Black, Hispanic, or of South Asian descent.9 As of 29 June 2020, approximately 1000 cases 
had been reported.9 As of 29 July 2020, a total of 570 cases were reported in the US to the 
CDC. Of these, 86.0% involved 4 or more organ systems, 63.9% of patients required ICU 
admission, and severe complications included cardiac dysfunction (40.6%), shock (35.4%), 
myocarditis (22.8%), coronary artery dilation or aneurysm (18.6%), and acute kidney injury 
(18.4%).10 Death rates of 2% to 4% have been reported.9 MIS-C has been reported in many 
countries throughout North America, Europe, Asia, and Latin America,11 including the US,5,6 
Italy,12 and France.13 The US currently has the most reported cases globally, with the number 
of confirmed cases continuing to rise globally. As of 12 March 2021, there are currently no 
licensed vaccines or effective antiviral drugs to prevent SARS-CoV-2 infections or the 
disease it causes, COVID-19.14 

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2.2.1. Clinical Overview 
Prior to this study, clinical data from BNT162b2 trials established a favorable safety profile 
characterized by mild, localized, and transient effects. BNT162 vaccines based on modRNA 
have now been administered to >19,000 people (as of the publication on 
31 December 2020)15 in clinical trials at the 30-μg dose level using a 2-dose schedule since 
the C4591001 Phase 1/2/3 study started in the US and other countries. BNT162b2 was also 
evaluated in the BNT162-01 study conducted in Germany by BioNTech, at dose levels 
between 1 μg and 30 μg.16 
The Phase 1 study population included healthy participants 18 to 55 years and 65 to 85 years 
of age. Enrollment in C4591001 Phase 1 is complete and, although follow-up continues, the 
available safety data from Phase 1 participants in Study C4591001 show that BNT162b2 
reactogenicity, AEs, and laboratory results were consistent with those commonly associated 
with vaccination. The observed reactogenicity was generally mild or moderate (primarily 
pain at the injection site) and short-lived. The local reactions tended to be more frequent after 
Dose 2. There was no redness or swelling reported by participants in the 65- to 85-year age 
group who received BNT162b2.4 
No unexpected AEs or SAEs were reported. Through 1 month after receipt of the second 
vaccination, AEs that were considered by investigators to be related to the study intervention 
were reported in 25% of participants 18 to 55 years of age who received 30 μg of BNT162b2; 
no AEs were reported by the older population who received the same dose.4 The available 
immunogenicity data from Phase 1 participants show that BNT162b2 induced a robust 
IgG-binding response to S1 and SARS-CoV-2 neutralizing response. Immunogenicity also 
substantially increased following Dose 2 of the vaccine. BNT162b2 induces a strong 
antigen-specific Th1-skewed CD4+ response and a strong antigen-specific CD8+ response. 
The Phase 2/3 portion of C4591001 is ongoing in participants ≥12 years of age. The primary 
safety objective includes definition of the safety profile of prophylactic BNT162b2 as 
measured by solicited local reactions and systemic events captured via e-diary within 7 days 
after each vaccination, AEs, and SAEs. 
2.3. Benefit/Risk Assessment 
There is an ongoing global pandemic of COVID-19, which places immunocompromised 
individuals at higher risk for developing severe disease from infection. At the time of 
initiation of this study, accumulating data from ongoing human clinical trials, and use of 
BNT162b2 under the EUA in Europe and the US, demonstrated an acceptable safety and 
tolerability profile. In addition, available nonclinical data and data from nonclinical studies 
and clinical trials with the same or related RNA components, or antigens, supported a 
favorable risk/benefit profile. Anticipated AEs after vaccination were expected to be 
manageable using routine symptom-driven standard of care as determined by the 
investigators and, as a result, the profile of these vaccine candidates supported initiation of 
this PASS clinical study. This interventional study is designated as a PASS, identified as 
Category 3 in the EU RMP, conducted as a Conditional Marketing Approval commitment to 

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EMA and to Swissmedic, and an EUA commitment to the US FDA and to numerous other 
health authorities under respective national emergency use legislation. 
The Phase 2/3 portion of the C4591001 study has reached the final efficacy analysis and 
demonstrates that BNT162b2 is effective, with 95% observed VE, against COVID-19 among 
individuals 16 years of age and older. No specific safety concerns were identified in 
subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 
infection. Although participants 16 through 17 years of age were enrolled in the Phase 3 trial, 
safety data for this age group are limited. However, available data are consistent with the 
safety profile in the adult population, and it is biologically reasonable to extrapolate the 
greater safety experience in adults, in particular younger adults, to the oldest pediatric age 
group of 12 through 17 years. The potential risks are based on the observed safety profile to 
date, which shows mostly mild reactogenicity, low incidence of severe or serious events, and 
no clinically concerning safety observations. Safety evaluation is ongoing; however, ~19,000 
participants as of October 2020 have safety data available for at least 2 months of follow-up 
after Dose 2.15 BNT162b2 had an overall favorable safety profile. BNT162b2 recipients 
reported more reactogenicity events compared to placebo recipients. In general, local 
reactions were mostly mild to moderate in severity and resolved within 1 to 2 days after 
onset. Severe fatigue was reported in 3.8% of BNT162b2 recipients; however, these events 
were transient. Few participants in either group had severe AEs, SAEs, or AEs leading to 
withdrawal from the study.15 
More detailed information about the known and expected benefits and risks, reasonably 
expected AEs of BNT162b2, and the currently available safety and immunogenicity data 
may be found in the IB, which is the SRSD for this study. 

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2.3.1. Risk Assessment 
 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention(s): BNT162b2 RNA-Based COVID-19 Vaccine 
Potential for local reactions 
(injection site redness, injection 
site swelling, and injection site 
pain) and systemic events (fever, 
fatigue, headache, chills, 
vomiting, diarrhea, muscle pain, 
and joint pain) following 
vaccination. 
These are common adverse reactions seen with 
other vaccines, as noted in the FDA CBER 
guidelines on toxicity grading scales for healthy 
adult volunteers enrolled in preventive vaccine 
clinical trials.17 
The study employs the use of a reactogenicity e-diary to monitor 
local reactions and systemic events in real time. Study clinicians 
will closely monitor participants for severe reactions. In addition, 
investigators will contact participants or participants’ 
parent(s)/legal guardians and conduct unscheduled visits for any 
reported severe local reactions or severe systemic events. 
Unknown or unexpected AEs 
with a novel vaccine in an 
immunocompromised population. 
Accumulating safety data from ongoing clinical 
studies have shown an acceptable safety profile. 
Participants will be observed for a minimum of 30 minutes after 
vaccination to assess for immediate AEs. 
A DMC will be used throughout the study to review all safety data. 
The study team will perform ongoing clinical/safety data review of 
AEs and SAEs. 
Potential for COVID-19 
enhancement. 
Disease enhancement has been seen following 
vaccination with RSV, feline coronavirus, and 
Dengue virus vaccines 
Eligibility criteria will exclude any participants who have had a 
previous clinical (signs/symptoms only) or microbiological 
(signs/symptoms and positive SARS-CoV-2 NAAT result) 
diagnosis of COVID-19. 
This will minimize the low risk of potential disease enhancement 
and ensure that the immune response evaluated in the study is not 
impacted by serological changes due to previous COVID-19 
disease. 
Temporary delay criteria defer vaccination of participants with 
symptoms of potential COVID-19. 
All participants are followed for any potential COVID-19 illness, 
including markers of severity, and have blood samples taken for 
potential measurement of SARS-CoV-2 neutralizing titers. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
MIS-C. 
Febrile hyperinflammatory condition with 
multisystem (≥2) organ involvement as defined in 
Section 8.1. 
MIS-C will be prospectively collected as a potential for 
COVID-19/MIS-C illness visits for the duration of study 
participation. 
Potential for worsening disease in 
immunocompromised participants 
following vaccination. 
There are no ongoing COVID-19 vaccine studies 
studying immunocompromised participants; 
therefore, the potential for worsening 
immunocompromised disease following 
vaccination is unknown. 
A DMC will be used throughout the study to review all safety data. 
AEs will be actively solicited to identify and document worsening 
disease. 
Pfizer will continue to monitor surveillance of data for BNT162b2 
for emerging data. 
Very rare cases of anaphylaxis, 
myocarditis, and pericarditis have 
been reported after authorization 
in recipients of BNT162b2. 
Anaphylaxis: The estimated rate is 5.0 per million 
doses administered. 
Myocarditis and pericarditis: Very rare cases of 
myocarditis and pericarditis have been reported 
following vaccination with mRNA COVID-19 
vaccines. Typically, the cases have occurred more 
often in younger men and after the second dose of 
the vaccine and within 14 days after vaccination. 
These are generally 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 in 
vaccine recipients. 
Specific reference to these risks is made within the ICD, with 
instruction to contact a healthcare professional if a case is 
suspected. 
For anaphylaxis, there is an on-site 30-minute observation period 
after vaccination. 
Instructions for handling suspected cases of myocarditis and 
pericarditis are found in Section 8.12. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Procedures 
Participants will be required to 
attend healthcare facilities during 
the global SARS-CoV-2 
pandemic. 
Without appropriate social distancing and PPE, 
there is a potential for increased exposure to 
SARS-CoV-2. 
Pfizer will work with sites to ensure an appropriate COVID-19 
prevention strategy. 
Potential COVID-19 illness visits can be conducted via telehealth, 
without the need for an in-person visit, if required, with the 
participant or participant’s parent(s)/legal guardian obtaining a 
nasal swab from the participant. 
Venipuncture will be performed 
during the study. 
There is the risk of bleeding, bruising, hematoma 
formation, and infection at the venipuncture site. 
Only appropriately qualified personnel will obtain the blood 
sample. 

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2.3.2. Benefit Assessment 
Benefits to individual participants may include: 
• Receipt of an efficacious COVID-19 vaccine during a global pandemic 
• Access to COVID-19 diagnostic testing 
• Contributing to research to help others in a time of global pandemic 
2.3.3. Overall Benefit/Risk Conclusion 
Taking into account the measures to minimize risk to study participants, the potential risks 
identified in association with BNT162b2 RNA-based COVID-19 vaccine are justified by the 
anticipated benefits that may be afforded to participants. 
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS 
 
Objectives 
Endpoints 
Estimands 
Primary: 
Primary: 
Primary: 
To describe the immune response to 
prophylactic BNT162b2 in participants 
≥18 years of age without serological or 
virological evidence of past 
SARS-CoV-2 infection and with: 
• Asymptomatic CLL without 
treatment and undergoing 
observation, or CLL on BTK 
inhibitor or anti-CD20 monoclonal 
antibodies 
• Diagnosed with NSCLC and on 
chemotherapy, checkpoint 
inhibitors, or targeted agents for 
oncogene-driven tumors 
• Maintenance hemodialysis 
treatment due to end-stage renal 
disease 
• Immunomodulator therapy for an 
autoimmune inflammatory disorder 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each disease 
subset: 
• GMTs at 1 month after Dose 3 and 
Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To describe the immune response to 
prophylactic BNT162b2 in participants 
≥2 to <18 years of age without 
serological or virological evidence of 
past SARS-CoV-2 infection and either: 
• Are on immunomodulator therapy 
for an autoimmune inflammatory 
disorder 
• Are on immunosuppression therapy 
after solid organ transplant 
• Underwent bone marrow or stem 
cell transplant at least 6 months 
before enrollment 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each age 
group (≥2 to <5, ≥5 to <12, and ≥12 to 
<18 years) and disease subset: 
• GMTs at 1 month after Dose 3 and 
Dose 4 
• 
SARS-CoV-2 neutralizing titers 

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Objectives 
Endpoints 
Estimands 
To describe the safety and tolerability 
of prophylactic BNT162b2 in 
participants ≥18 years of age with: 
• Asymptomatic CLL without 
treatment and undergoing 
observation, or CLL on BTK 
inhibitor or anti-CD20 monoclonal 
antibodies 
• Diagnosed with NSCLC and on 
chemotherapy, checkpoint 
inhibitors, or targeted agents for 
oncogene-driven tumors 
• Maintenance hemodialysis 
treatment due to end-stage renal 
disease 
• Immunomodulator therapy for an 
autoimmune inflammatory disorder 
In participants receiving at least 1 dose 
of study intervention in each disease 
subset, the percentage of participants 
reporting: 
• Local reactions for up to 7 days 
following each dose 
• Systemic events for up to 7 days 
following each dose 
• AEs from Dose 1 through 1 month 
after Dose 2 
• AEs from Dose 3 through 1 month 
after Dose 3 
• AEs from Dose 4 through 1 month 
after Dose 4 
• SAEs from Dose 1 through the 
duration of the study 
• 
Local reactions (pain at the 
injection site, redness, and 
swelling) 
• 
Systemic events (fever, fatigue, 
headache, chills, vomiting, 
diarrhea, new or worsened 
muscle pain, and new or 
worsened joint pain) 
• 
AEs 
• 
SAEs 
To describe the safety and tolerability 
of prophylactic BNT162b2 in 
participants ≥2 to <18 years of age and 
either: 
• Are on immunomodulator therapy 
for an autoimmune inflammatory 
disorder 
• Are on immunosuppression therapy 
after solid organ transplant 
• Underwent bone marrow or stem 
cell transplant at least 6 months 
before enrollment 
In participants receiving at least 1 dose 
of study intervention in each age group 
(≥2 to <5, ≥5 to <12, and ≥12 to 
<18 years) and disease subset, the 
percentage of participants reporting: 
• Local reactions for up to 7 days 
following each dose 
• Systemic events for up to 7 days 
following each dose 
• AEs from Dose 1 through 1 month 
after Dose 2 
• AEs from Dose 3 through 1 month 
after Dose 3 
•  AEs from Dose 4 through 1 month 
after Dose 4 
• SAEs from Dose 1 through the 
duration of the study 
• 
Local reactions (pain at the 
injection site, redness, and 
swelling) 
• 
Systemic events (fever, fatigue, 
headache, chills, vomiting, 
diarrhea, new or worsened 
muscle pain, and new or 
worsened joint pain) 
• 
AEs 
• 
SAEs 
Exploratory: 
Exploratory: 
Exploratory: 
To further describe the immune 
response to prophylactic BNT162b2 in 
participants ≥18 years of age without 
serological or virological evidence of 
past SARS-CoV-2 infection and with: 
• Asymptomatic CLL without 
treatment and undergoing 
observation, or CLL on BTK 
inhibitor or anti-CD20 monoclonal 
antibodies 
• Diagnosed with NSCLC and on 
chemotherapy, checkpoint 
inhibitors, or targeted agents for 
oncogene-driven tumor 
• Maintenance hemodialysis 
treatment due to end-stage renal 
disease 
• Immunomodulator therapy for an 
autoimmune inflammatory disorder 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each disease 
subset: 
• GMTs at all immunogenicity blood 
draws 
• GMFRs from baseline to 1 month 
after Dose 2, from baseline 1 month 
after Dose 3, and from Dose 4 to 
1 month and 6 months after Dose 4 
• Percentages of participants with 
seroresponse at 1 month after 
Dose 2, 1 month after Dose 3, and 
1 month and 6 months after Dose 4 
• 
SARS-CoV-2 neutralizing titers 

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Objectives 
Endpoints 
Estimands 
To further describe the immune 
response to prophylactic BNT162b2 in 
participants ≥2 to <18 years of age 
without serological or virological 
evidence of past SARS-CoV-2 
infection and either: 
• Are on immunomodulator therapy 
for an autoimmune inflammatory 
disorder 
• Are on immunosuppression therapy 
after solid organ transplant 
• Underwent bone marrow or stem 
cell transplant at least 6 months 
before enrollment 
In participants complying with the key 
protocol criteria (evaluable 
participants) and no serological or 
virological evidence of past 
SARS-CoV-2 infection in each age 
group (≥2 to <5; ≥5 to <12; ≥12 to <18) 
and disease subset: 
• GMTs at all immunogenicity blood 
draws 
• GMFRs from baseline to 1 month 
after Dose 2, baseline 1 month after 
Dose 3, and from Dose 4 to 
1 month and 6 months after Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To further describe the immune 
response to prophylactic BNT162b2 in 
participants with and without 
serological or virological evidence of 
past SARS-CoV-2 infection 
• GMTs at all immunogenicity blood 
draws 
• GMFRs from baseline to 1 month 
after Dose 2, from baseline to 1 
month after Dose 3, and from Dose 
4 to 1 month and 6 months after 
Dose 4 
• Percentages of participants with 
seroresponse at 1 month after 
Dose 2, 1 month after Dose 3, and 
1 month and 6 months after Dose 4 
• 
SARS-CoV-2 neutralizing titers 
To describe the cell-mediated immune 
response, and additional humoral 
immune response parameters in all 
participants ≥12 years of age: 
• At baseline, 7 days after Dose 2, 
1 week after Dose 3, Dose 4, and 
6 months after Dose 4 
To describe the incidence of confirmed 
COVID-19 among 
immunocompromised participants 
• Incidence rate of confirmed 
COVID-19 per 1000 person-years 
of follow-up 
• 
COVID-19 incidence per 
1000 person-years of follow-up 
based on central laboratory or 
locally confirmed NAAT 
To characterize SARS-CoV-2 variants 
in the study population 
• The number and percentage of each 
SARS-CoV-2 lineage among 
BNT162b2 recipients 
• 
SARS-CoV-2 lineage 
determined by next generation 
sequencing 
To describe the incidence of MIS-C 
cases 
• Incidence rate of confirmed MIS-C 
cases 
• 
Confirmed cases as per CDC 
symptom criteria 
 
4. STUDY DESIGN 
4.1. Overall Design 
This is a Phase 2b, open-label study with BNT162b2 in immunocompromised participants 
≥18 years of age treated for NSCLC or CLL, receiving hemodialysis treatment secondary to 
end-stage renal disease, or receiving immunomodulator therapy for an autoimmune 
inflammatory disorder, and in immunocompromised participants ≥2 to <18 years of age 
receiving immunomodulator therapy or who have undergone solid organ transplant 

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(within the previous 3 months) and are on immunosuppression or who have undergone bone 
marrow or stem cell transplant at least 6 months prior to enrollment. This study will evaluate 
the safety, tolerability, and immunogenicity of BNT162b2: 
• Open-label; 4 doses, with the primary series consisting of 2 doses separated by 21 days 
and a third dose occurring at 28 days after Dose 2. There is a fourth dose (booster) which 
will occur 3-6 months after Dose 3. Note that the timing of the fourth dose should be 
determined by the investigator’s discretion, taking into account factors such as the 
participant’s underlying condition and level of immunosuppression, the evolving clinical 
literature, the COVID-19 incidence in the participant’s geographic area, and the potential 
for increased reactogenicity with Dose 4 occurring earlier. Additionally, although more 
data are needed for COVID-19 vaccines, there is a risk of reduced immunogenicity and 
antibody persistence with a shorter interval between Dose 3 and Dose 4. Investigators are 
encouraged to weigh the risks and benefits for each participant and make an 
individualized decision on the timing of the third dose, provided it falls within the 
minimum and maximum time frames detailed above. Depending on the timing of Dose 4, 
participants are expected to participate for up to 14 months, with a maximum of 
approximately 15 months. 
The dose for each of the 4 vaccinations will depend upon the age of the participant at the 
time of vaccination, as follows: 
• For participants who are ≥12 years of age (on the day of vaccination): at a 30-µg dose 
level 
• For participants who are ≥5 to <12 years of age (on the day of vaccination): at a 10-µg 
dose level 
• For participants who are <5 years of age (on the day of vaccination): at a 3-µg dose level 
Approximately 124 participants in total have been enrolled, with the following breakdown: 
• In approximately 7 participants who are ≥18 years of age (at Visit 1) in the following 
groups: 
o Approximately 1 participant who is treatment-naïve with planned treatment 
(≥14 days) or who is receiving treatment for NSCLC 
o Approximately 0 participants receiving treatment or under observation for CLL 
o Approximately 1 participant receiving maintenance hemodialysis treatment secondary 
to end-stage renal disease 
o Approximately 5 participants receiving immunomodulator treatment for an 
autoimmune inflammatory disorder 

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• In approximately 117 immunocompromised participants who are <18 years of age 
(at Visit 1), with: 
o Approximately 37 participants: ≥2 to <5 years of age 
o Approximately 65 participants: ≥5 to <12 years of age 
o Approximately 15 participants: ≥12 to <18 years of age 
• In each of the cohorts <18 years of age (at Visit 1), participants with the following 
immunocompromising conditions will be recruited/enrolled: 
o Immunomodulator treatment for an autoimmune inflammatory disorder 
(≥10 participants in each age cohort) 
o Immunomodulator treatment after solid organ transplant (≥10 participants in each age 
cohort) 
o Underwent bone marrow or stem cell transplant ≥6 months (182 days) before 
enrollment (≥10 participants in each age cohort) 
• Follow-up for 6 months after Dose 4. 
• Local reactions (redness, swelling, and pain at the injection site) and systemic events 
(fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain, and 
new or worsened joint pain) will be prompted for and collected by all participants or 
participants’ parent(s)/legal guardians in an e-diary each day from Day 1 (the day of 
vaccination) through Day 7 after each administration of study intervention. AEs will be 
collected from the time the participant or participant’s parent(s)/legal guardian provides 
informed consent through 1 month after Dose 2, from Dose 3 through 1 month after 
Dose 3, and from Dose 4 through 1 month after Dose 4. SAEs will be collected from the 
time of informed consent through the duration of the study. 
4.2. Scientific Rationale for Study Design 
Additional surveillance for COVID-19 will be conducted as part of the study, given the 
potential risk of disease enhancement. If a participant experiences symptoms as detailed in 
Section 8.11, a COVID-19/MIS-C illness visit will occur. As part of these visits, nasal swab 
samples will be taken for RT-PCR as well as recording of COVID-19/MIS-C–related clinical 
and laboratory information (including local diagnosis). 

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4.2.1. Diversity of Study Population 
This study will recruit participants with disease states that may disproportionately impact 
certain race and ethnic populations. To the extent possible, proactive recruitment attempts 
will be made to enroll participants so that the overall study demographic profile 
approximates the general population distribution of characteristics shown below: 
 
Race 
US Census Data18 
Target for C4591024 
Black or African American 
13.4% 
Asian 
5.9% 
American Indian or Alaska Native 
1.3% 
Native Hawaiian or other Pacific Islander 
0.2% 
White 
76.3% 
Ethnicity 
US Census Data 
Target for C4591024 
Hispanic or Latino(a) or of Spanish origin 
18.5% 
 
4.3. Justification for Dose 
BNT162b2 will be administered to all study participants. The study will evaluate a 3-dose 
schedule (the first 2 doses separated by 21 days), with a third dose occurring at 28 days after 
the second dose. The fourth dose (booster) will occur 3-6 months after Dose 3*. 
For participants ≥12 years of age (on the day of vaccination): participants will receive 30 µg 
of BNT162b2, which is the same as the dose selected for Phase 3 of the pivotal vaccine study 
(C4591001). 
For participants ≥5 to <12 years of age (on the day of vaccination): participants will receive 
10 µg of BNT162b2. 
For participants <5 years of age (on the day of vaccination): participants will receive 3 µg of 
BNT162b2. 
These are the same dose levels that have been selected for participants <5 years of age and 
≥5 to <12 years of age, respectively, in the Phase 2/3 C4591007 study. Participants will 
receive the age-appropriate dose at each vaccination visit. 
*Note that the timing of the fourth dose should be determined by the investigator’s 
discretion, taking into account factors such as the participant’s underlying condition and level 
of immunosuppression, the evolving clinical literature, the COVID-19 incidence in the 
participant’s geographic area, and the potential for increased reactogenicity with Dose 4 
occurring earlier. Additionally, although more data are needed for COVID-19 vaccines, there 
is a risk of reduced immunogenicity and antibody persistence with a shorter interval between 
Dose 3 and Dose 4. Investigators are encouraged to weigh the risks and benefits for each 
participant and make an individualized decision on the timing of the fourth dose, provided it 
falls within the minimum and maximum time frames detailed above. 

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4.4. End of Study Definition 
A participant is considered to have completed the study if he/she has completed all phases of 
the study, including the last visit. The end of the study is defined as the date of the last visit 
of the last participant in the study. 
5. STUDY POPULATION 
This study can fulfill its objectives only if appropriate participants are enrolled, including 
participants across diverse and representative racial and ethnic backgrounds. Use of a 
prescreener for study recruitment purposes will include collection of information that reflects 
the enrollment of a diverse participant population including, where permitted under local 
regulations, age, sex, race, and ethnicity. The following eligibility criteria are designed to 
select participants for whom participation in the study is considered appropriate. All relevant 
medical and nonmedical conditions should be taken into consideration when deciding 
whether a particular participant is suitable for this protocol. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted. 
Note: “Enrolled” means a participant’s or participant’s parent(s)/legal guardian’s (where 
applicable) agreement for the participant to participate in a clinical study following 
completion of the informed consent process. A participant will be considered enrolled if the 
informed consent is not withdrawn prior to participating in any study activity. 
5.1. Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
Age and Sex: 
1. Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1). 
2. Participants or participants’ parent(s)/legal guardians, as age appropriate, who are willing 
and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle 
considerations, and other study procedures. 
3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment 
(Visit 1). 
4. Participants or participants’ parent(s)/legal guardians, as age appropriate, who are able to 
be contacted by telephone throughout the study period. 
5. Female participant of childbearing potential or male participant able to father children 
who is willing to use a highly effective method of contraception as outlined in this 
protocol for at least 28 days after the last dose of study intervention if at risk of 
pregnancy with her/his partner; or female participant not of childbearing potential or male 
participant not able to father children. 

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Refer to Appendix 3 for reproductive criteria for male (Section 10.3.1) and female 
(Section 10.3.2) participants. 
Type of Participant and Disease Characteristics: 
6. Participants who are immunocompromised by virtue of the following: 
• Having known NSCLC and is ≥18 years of age with at least 1 of the following: 
• Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is 
treatment naïve), and is not expected to receive chemotherapy within at least 
2 weeks (14 days) after dose administration; and/or 
• Receiving checkpoint inhibitor treatment (PD-1/PD-L1 inhibitor, CTLA-4 
inhibitor) and has undergone at least 1 treatment cycle prior to enrollment 
(at Visit 1); or 
• Receiving targeted drug therapy treatment (EGFR, ALK, ROS1, BRAF, RET, 
MET, NTRK inhibitors) and has undergone at least 1 treatment cycle prior to 
enrollment (at Visit 1); or 
• Having known CLL and is ≥18 years of age with at least 1 of the following: 
• Has asymptomatic disease (eg, Rai stage <3, Binet stage A or B) and is 
undergoing observation and does not receive any treatment for CLL; or 
• Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has 
received at least 3 cycles prior to enrollment; and/or 
• Receives a BTK inhibitor, PI3K inhibitor, or BCL-2 inhibitor 
OR 
• Is currently undergoing maintenance hemodialysis treatment secondary to end-stage 
renal disease and is ≥18 years of age 
OR 
• Is on active immunomodulator therapy (eg, TNFα inhibitor, tofacitinib or MTX) for 
an autoimmune inflammatory disorder (eg, inflammatory arthritis, such as rheumatoid 
arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel 
disease, such as ulcerative colitis and Crohn’s disease) at a stable* dose 
*Stable dose is defined as receiving the same dose for at least 3 months (84 days) 
with no changes in the 28 days prior to Visit 1. 

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OR 
• Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment 
(Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to 
enrollment (Visit 1), and is ≥2 to <18 years of age 
OR 
• Has had an autologous or allogenic bone marrow or stem cell transplant at least 
6 months (182 days) prior to enrollment (Visit 1), with adequate immune 
reconstitution for immunization, in the investigator’s opinion, and is ≥2 to <18 years 
of age 
Informed Consent and Assent (as Appropriate): 
7. The participant or participant’s parent(s)/legal guardian is capable of giving signed 
informed consent, and assent (as appropriate), as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in this 
protocol. The investigator, or a person designated by the investigator, will obtain written 
informed consent (and assent, as appropriate) from each study participant or participant’s 
parent(s)/legal guardian (as defined in Appendix 1) before any study-specific activity is 
performed. All parent(s)/legal guardians should be fully informed, and participants 
should be informed to the fullest extent possible, about the study in language and terms 
they are able to understand. The investigator will retain the original copy of each 
participant's signed consent (and assent, as appropriate) document(s). 
5.2. Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
Medical Conditions: 
1. Past clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result 
was not available) or microbiological (based on COVID-19 symptoms/signs and a 
positive SARS-CoV-2 NAAT result) diagnosis of COVID-19, or a past clinical diagnosis 
of MIS-C. 
2. Participants with active GVHD, transplant rejection, or PTLD, or participants who have 
had treatment for these conditions within 3 months (84 days) prior to study enrollment 
(Visit 1). 
3. Participants <18 years of age whose weight is less than the 5th percentile of age-adjusted 
ideal body weight. 

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4. Other medical or psychiatric condition including recent (within the past year) or active 
suicidal ideation/behavior or laboratory abnormality that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate for the 
study. 
5. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s). 
6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular injection. 
7. Participant who is pregnant or breastfeeding. 
8. Participants who may be ineligible because of the number of phlebotomy assessments 
during this study, in the opinion of the investigator. 
9. Participants who do not have adequate deltoid muscle mass to allow intramuscular 
vaccination, in the opinion of the investigator. 
Prior/Concomitant Therapy: 
10. Previous vaccination with any coronavirus vaccine. 
11. Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 
3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to 
Dose 4. 
Prior/Concurrent Clinical Study Experience: 
12. Participation in other studies involving study intervention within 28 days prior to study 
entry and/or during study participation. 
13. Previous participation in other studies involving study intervention containing LNPs. 
Diagnostic Assessments: 
Not applicable. 
Other Exclusions: 
14. Participants who are direct descendants (child or grandchild) of investigational site staff 
members or Pfizer/BioNTech employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family members. 
15. Investigator site staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family members. 

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5.3. Lifestyle Considerations 
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant and his or her partner(s) from the permitted list of contraception methods 
(see Appendix 3, Section 10.3.4) and will confirm that the participant has been instructed in 
its consistent and correct use. 
At time points indicated in the SoA, the investigator or designee will inform the participant 
of the need to use highly effective contraception consistently and correctly and document the 
conversation and the participant’s affirmation in the participant’s chart (participants need to 
affirm their consistent and correct use of at least 1 of the selected methods of contraception) 
considering that their risk for pregnancy may have changed since the last visit. In addition, 
the investigator or designee will instruct the participant to call immediately if the selected 
contraception method is discontinued or if pregnancy is known or suspected in the participant 
or partner. 
5.4. Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the CONSORT 
publishing requirements and to respond to queries from regulatory authorities. Minimal 
information includes demography, screen failure details, eligibility criteria, and any SAEs. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened under a different participant number. 
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of 
Study Intervention 
The following conditions are temporary or self-limiting and a participant may be vaccinated 
once the condition(s) has/have resolved and no other exclusion criteria are met: 
1. Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness 
within 48 hours before study intervention administration. This includes current symptoms 
that, in the judgment of the investigator, could represent a potential COVID-19 illness: 
• New or increased cough; 
• New or increased shortness of breath; 
• Chills; 
• New or increased muscle pain; 

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• New loss of taste/smell; 
• Sore throat; 
• Diarrhea; 
• Vomiting; 
• Inability to eat/poor feeding in participants <5 years of age. 
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol. For the purposes of this protocol, study 
intervention refers to BNT162b2. This study will evaluate a 4-dose schedule of BNT162b2 
(the first 2 doses separated by 21 days), with a third dose occurring a 28 days after Dose 2 for 
active immunization against COVID-19. A fourth dose will occur 3-6 months after Dose 3*. 
Participants will receive the age-appropriate dose level at each vaccination visit. The vaccine 
will be administered to all study participants. 
For participants ≥12 years of age (on the day of vaccination): participants will receive 30 µg 
of BNT162b2, which is the same as the dose selected for Phase 3 of the pivotal vaccine study 
(C4591001). 
For participants ≥5 to <12 years of age (on the day of vaccination): participants will receive 
10 µg of BNT162b2. 
For participants <5 years of age (on the day of vaccination): participants will receive 3 µg of 
BNT162b2. 
These are the same dose levels that have been selected for participants <5 years of age and 
≥5 to <12 years of age, respectively, in the Phase 2/3 C4591007 study. Participants will 
receive the age-appropriate dose level at each vaccination visit. 
*Note that the timing of the fourth dose should be determined by the investigator’s 
discretion, taking into account factors such as the participant’s underlying condition and level 
of immunosuppression, the evolving clinical literature, the COVID-19 incidence in the 
participant’s geographic area, and the potential for increased reactogenicity with Dose 4 
occurring earlier. Additionally, although more data are needed for COVID-19 vaccines, there 
is a risk of reduced immunogenicity and antibody persistence with a shorter interval between 
Dose 3 and Dose 4. Investigators are encouraged to weigh the risks and benefits for each 
participant and make an individualized decision on the timing of the fourth dose, provided it 
falls within the minimum and maximum time frames detailed above. 

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6.1. Study Intervention(s) Administered 
 
Study Intervention 
Intervention Name 
BNT162b2 
(BNT162 RNA-LNP vaccine utilizing modRNA) 
Type 
Vaccine 
Dose Formulation 
modRNA 
Unit Dose Strength(s) 
250 μg/0.5 mL 
Dosage Level(s) 
The dose for each of the 4 vaccinations will depend upon the age of the 
participant at the time of vaccination, as follows: 
For participants ≥12 years of age (on the day of vaccination ): 30 μg 
For participants ≥5 to <12 years of age (on the day of vaccination ): 10 μg 
For participants <5 years of age (on the day of vaccination ): 3 μg 
Route of Administration 
Intramuscular injection 
Use 
Experimental 
IMP or NIMP 
IMP 
Sourcing 
Provided centrally by the sponsor 
Packaging and Labeling 
Study intervention will be provided in a glass vial as open-label supply. 
Each vial will be labeled as required per country requirement. 
 
6.1.1. Administration 
Participants will receive 1 dose of study intervention at each vaccination visit (Visits 1, 2, 5, 
and 8) in accordance with the study’s SoA. Full details are described in the IP manual. 
Study intervention should be administered intramuscularly into the mid-deltoid muscle, 
preferably of the nondominant arm. 
Standard vaccination practices must be observed, and vaccine must not be injected into blood 
vessels. Appropriate medication and other supportive measures for management of an acute 
hypersensitivity reaction should be available in accordance with local guidelines for standard 
immunization practices. 
Administration of study interventions should be performed by an appropriately qualified, 
GCP-trained, and vaccine-experienced member of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacist, or medical assistant) as allowed by 
local, state, and institutional guidance. 
Study intervention administration details will be recorded on the CRF. 
6.2. Preparation, Handling, Storage, and Accountability 
1. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention. 

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2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study interventions 
must be stored in a secure, environmentally controlled, and monitored (manual or 
automated recording) area in accordance with the labeled storage conditions with access 
limited to the investigator and authorized site staff. At a minimum, daily minimum and 
maximum temperatures for all site storage locations must be documented and available 
upon request. Data for nonworking days must indicate the minimum and maximum 
temperatures since previously documented for all site storage locations upon return to 
business. 
3. Any excursions from the study intervention label storage conditions should be reported to 
Pfizer’s designated support team upon discovery along with any actions taken. The site 
should actively pursue options for returning the study intervention to the storage 
conditions described in the labeling, as soon as possible. Once an excursion is identified, 
the study intervention must be quarantined and not used until Pfizer’s designated support 
team provides permission to use the study intervention. Specific details regarding the 
definition of an excursion and information the site should report for each excursion will 
be provided to the site in the IP manual. 
4. Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the label. 
5. Study interventions should be stored in their original containers. 
6. See the IP manual for storage conditions of the study intervention once diluted. 
7. The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records), such as the IPAL or 
sponsor-approved equivalent. All study interventions will be accounted for using a study 
intervention accountability form/record. 
8. Further guidance and information for the final disposition of unused study interventions 
are provided in the IP manual. All destruction must be adequately documented. If 
destruction is authorized to take place at the investigator site, the investigator must ensure 
that the materials are destroyed in compliance with applicable environmental regulations, 
institutional policy, and any special instructions provided by Pfizer. 
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual. 
6.2.1. Preparation and Dispensing 
See the IP manual for instructions on how to prepare the study intervention for 
administration. Study intervention should be prepared and dispensed by a medically qualified 
and experienced member of the study staff (eg, physician, nurse, physician’s assistant, nurse 

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practitioner, pharmacy assistant/technician, or pharmacist) as allowed by local, state, and 
institutional guidance. A second staff member will verify the dispensing. 
6.3. Measures to Minimize Bias: Randomization and Blinding 
6.3.1. Allocation to Study Intervention 
This is an open-label study; however, the specific study intervention dispensed to the 
participant will be assigned using an IRT. The site will contact the IRT prior to the start of 
study intervention administration for each participant. The site will record the study 
intervention assignment on the applicable CRF, if required. 
The investigator’s knowledge of the study intervention should not influence the decision to 
enroll a participant or affect the order in which participants are enrolled. 
Study intervention will be dispensed at the study visits summarized in the SoA. 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system. 
6.4. Study Intervention Compliance 
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF. 
The dose of study intervention and study participant ID will be confirmed at the time of 
dosing by a member of the study site staff other than the person administering the study 
intervention. 
6.5. Dose Modification 
Not applicable to this study. 
6.6. Continued Access to Study Intervention After the End of the Study 
No intervention will be provided to study participants at the end of their study participation. 
6.7. Treatment of Overdose 
For this study, any dose of study intervention greater than 1 dose of study intervention within 
a 24-hour time period will be considered an overdose. 
Pfizer does not recommend specific treatment for an overdose. In the event of an overdose, 
the investigator should: 
1. Contact the medical monitor within 24 hours. 
2. Closely monitor the participant for any AEs/SAEs. 

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3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF. 
4. Overdose is reportable to Safety only when associated with an SAE. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 
6.8. Concomitant Therapy 
The following concomitant medications and vaccinations will be recorded in the CRF: 
• Any vaccinations received from 28 days prior to study enrollment until Visit 10. 
• All current medication at baseline, to include name of the medication, start date, dose, 
unit, route, and frequency. 
• All medications (prescription and nonprescription) given during the study, to include the 
name of the medication, start date, stop date, dose, unit, route, and frequency. 
• Nutritional supplements, including vitamins, minerals, and herbal supplements, do not 
need to be recorded. 
6.8.1. Prohibited During the Study 
Receipt of the following vaccines and medications during the time periods listed below may 
exclude a participant from the per-protocol analysis from that point onwards, and may 
require vaccinations to be discontinued in that participant; however, it is anticipated that the 
participant would not be withdrawn from the study (see Section 7). Medications should not 
be withheld if required for a participant’s medical care, including for the treatment of 
COVID-19. 
Based on the CDC guidelines, as of June 2021, there is no prohibition of concomitant 
administration of COVID-19 vaccines and other licensed vaccines. However, it is important 
to note that while the study does not mandate a delay between administration of licensed 
recommended vaccines and BNT162b2, timing of these vaccinations should be based on 
local practice, participant risk of vaccine-preventable disease, and the reactogenicity profiles 
of the vaccines under consideration. 
Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 
3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to 
subsequent doses is prohibited. 
Receipt of any other (nonstudy) coronavirus vaccine at any time prior to or during study 
participation is prohibited. 

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Prophylactic antipyretics and other pain medication to prevent symptoms associated with 
study intervention administration are not permitted. However, if a participant is taking a 
medication for another condition, even if it may have antipyretic or pain-relieving properties, 
it should not be withheld prior to study vaccination. 
6.8.2. Permitted During the Study 
Oral corticosteroids, stable MTX, and NSAIDs are permitted. 
For participants receiving MTX therapy, stable is defined as receiving MTX for at least 
3 months (84 days) prior to Day 1 with no dose changes in the 28 days prior to Day 1, and 
not exceeding a dose of 25 mg/week. 
For participants not receiving MTX therapy, treatment with MTX must have been stopped at 
least 3 months (84 days) prior to Day 1 and not be expected to be initiated prior to Dose 4. 
It is permitted to alter the timing of immunomodulator administration before and after 
vaccination with BNT162b2 according to local guidelines. 
Medication other than that described as prohibited in Section 6.8.1 required for treatment of 
preexisting conditions or acute illness is permitted. 
Inhaled, topical, or localized injections of corticosteroids (eg, intra-articular or intrabursal 
administration) are permitted. 
Hormonal contraceptives that meet the requirements of this study are allowed to be used in 
participants who are WOCBP (see Appendix 3). 
7. Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal 
7.1. Discontinuation of Study Intervention 
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention (definitive discontinuation). Reasons for definitive discontinuation of study 
intervention include the following: AEs warranting discontinuation; safety concern; 
participant’s or participant’s parent(s)/legal guardian’s request; investigator request; 
pregnancy; protocol deviation (including no longer meeting all the inclusion criteria or 
meeting 1 or more exclusion criteria*). In general, unless the investigator considers it unsafe 
to administer Dose 2 (or subsequent doses), or the participant does not wish to receive it, it is 
preferred that Dose 2 (or subsequent doses) be administered and the participant followed for 
safety throughout the study. 
*After Vaccination 1, a positive SARS-CoV-2 NAAT result without symptoms or a 
COVID-19 diagnosis (signs/symptoms only or signs/symptoms and a positive SARS-CoV-2 
NAAT result) should not result in discontinuation of study intervention. If study intervention 
(Dose 2, Dose 3, or Dose 4) has been delayed per Section 5.5, because of febrile or other 
acute illness (Item 1 in the list in Section 5.5), and the investigator later diagnoses the signs 

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and symptoms as COVID-19 (with or without a positive SARS-CoV-2 NAAT result), the 
participant should not be discontinued from any further doses of study intervention. 
Note that discontinuation of study intervention does not represent withdrawal from the study. 
If study intervention is permanently discontinued, the participant will remain in the study to 
be evaluated for safety. See the SoA for data to be collected at the time of discontinuation of 
study intervention and follow-up for any further evaluations that need to be completed. 
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, postvaccination study follow-up, 
and/or future collection of additional information. 
7.2. Participant Discontinuation/Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her or his/her parent(s)/legal 
guardian’s (as applicable) own request. Reasons for discontinuation from the study include 
the following: 
• Refused further study procedures; 
• Lost to follow-up; 
• Death; 
• Study terminated by sponsor; 
• AEs; 
• Participant request; 
• Investigator request; 
• Protocol deviation. 
If a participant does not return for a scheduled visit, every effort should be made to contact 
the participant or participant’s parent(s)/legal guardian. All attempts to contact the participant 
or participant’s parent(s)/legal guardian and information received during contact attempts 
must be documented in the participant’s source document. In any circumstance, every effort 
should be made to document participant outcome, if possible. 
The investigator or his or her designee should capture the reason for withdrawal in the CRF 
for all participants. 

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If a participant withdraws from the study, he/she or the participant’s parent(s)/legal guardian 
may request destruction of any remaining samples taken and not tested, and the investigator 
must document any such requests in the site study records and notify the sponsor 
accordingly. 
If the participant or the participant’s parent(s)/legal guardian withdraws the participant from 
the study and also withdraws consent (see Section 7.2.1) for disclosure of future information, 
no further evaluations should be performed and no additional data should be collected. The 
sponsor may retain and continue to use any data collected before such withdrawal of consent. 
7.2.1. Withdrawal of Consent 
Participants or participants’ parent(s)/legal guardians who request to discontinue receipt of 
study intervention will remain in the study and must continue to be followed for 
protocol-specified follow-up procedures. The only exception to this is when a participant or 
participant’s parent(s)/legal guardian specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information. Participants or participants’ parent(s)/legal guardians should notify the 
investigator in writing of the decision to withdraw consent from future follow-up, whenever 
possible. The withdrawal of consent should be explained in detail in the medical records by 
the investigator, as to whether the withdrawal is only from further receipt of study 
intervention or also from study procedures and/or postvaccination study follow-up and 
entered on the appropriate CRF page. In the event that vital status (whether the participant is 
alive or dead) is being measured, publicly available information should be used to determine 
vital status only as appropriately directed in accordance with local law. 
7.3. Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and he or she, or the participant’s parent(s)/legal guardian, is unable to be 
contacted by the study site. 
The following actions must be taken if a participant fails to attend a required study visit: 
• The site must attempt to contact the participant or a participant’s parent(s)/legal guardian 
and reschedule the missed visit as soon as possible. Counsel the participant or a 
participant’s parent(s)/legal guardian 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 lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant or a participant’s parent(s)/legal 
guardian (where possible, 3 telephone calls and, if necessary, a certified letter to the 
participant’s last known mailing address or local equivalent methods). These contact 
attempts should be documented in the participant’s medical record; 

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• Should the participant or the participant’s parent(s)/legal guardian continue to be 
unreachable, the participant will be considered to have withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES 
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD and assent (where appropriate) before performing any study-specific procedures. 
The full date of birth will be collected to critically evaluate the immune response and safety 
profile by age. 
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed. 
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 
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. 
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner. 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
The total blood sampling volume for participants, dependent on their age (at Visit 1), is 
referenced in Table 1. This consists of blood samples for immunogenicity and additional 
blood collection for isolation of PBMCs. The actual collection times of blood sampling may 
change. 
Additional blood draws for the purpose of PBMC assessment will not be collected for any 
participant. 

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Table 1. 
Blood Sampling Volumes per Assessment, by Age Group 
 
For Immunogenicity 
Assessmentsa 
For PBMC 
Assessmentb/HLA 
Typing 
Approximate Total 
≥2 to <5 Years of age 
~5 mL 
N/A 
~30 mL 
≥5 to <12 Years of age 
~10 mL 
N/A 
~60 mL 
≥12 to <18 Years of age 
~20 mL 
~20 mL/~5 mL 
~225 mL 
≥18 Years of age 
~20 mL 
~100 mL/~5 mL 
~625 mL 
Abbreviations: HLA = human leukocyte antigen; N/A = not applicable; PBMC = peripheral blood 
mononuclear cell; SoA = schedule of activities. 
Note: Blood draw volumes are dependent on the participant’s age at Visit 1, which will be the sampling 
volume for that participant throughout the study. 
a. 
Immunogenicity assessments apply to visits as shown in the SoA. 
b. PBMC assessments will be conducted on a subset of participants ≥12 years of age, with 1 blood draw 
(5 mL) for HLA typing at Visit 1. 
 
 
8.1. Efficacy and/or Immunogenicity Assessments 
Serum samples will be obtained for immunogenicity testing at the visits specified in the SoA. 
The following assays will be performed: 
• SARS-CoV-2 serum neutralization assay 
• Roche Elecsys Anti-SARS-CoV-2, an ECLIA for the presence or absence of 
SARS-CoV-2 N-binding antibodies 
Note that all immunogenicity analyses will be based upon samples analyzed at the central 
laboratory. Additional exploratory assays to measure immune responses may be performed, 
with analyses described in the SAP. 
Surveillance for potential cases of COVID-19 will occur throughout a participant’s 
involvement in the study. If, at any time, a participant develops acute illness or symptoms as 
detailed in Section 8.11, for the purposes of the study he or she will be considered to 
potentially have a COVID-19 illness. In this circumstance, the participant or participant’s 
parent(s)/legal guardian should contact the site, and an in-person or telehealth visit should 
occur. A potential COVID-19/MIS-C illness visit will be initiated if, in the opinion of the 
investigator, an illness visit is warranted. If a COVID-19 illness visit occurs, assessments 
should be conducted as specified in the SoA. The assessments will include collection of a 
nasal swab, which will be tested at a central laboratory using an RT-PCR test (Cepheid; 
FDA-approved under EUA) or other equivalent nucleic acid amplification–based test 
(ie, NAAT), to detect SARS-CoV-2. In addition, clinical information and results from local 
standard-of-care tests (as detailed in Section 8.11) will be assessed. The central laboratory 
NAAT result will be used for the case definition, unless no result is available from the central 
laboratory, in which case a local NAAT result may be used if it was obtained using 1 of the 
following assays: 

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• Cepheid Xpert Xpress SARS-CoV-2 
• Roche cobas SARS-CoV-2 real-time RT-PCR test (EUA200009/A001) 
• Abbott Molecular/RealTime SARS-CoV-2 assay (EUA200023/A001) 
One definition of a SARS-CoV-2–related case, and 2 definitions of SARS-CoV-2–related 
severe cases, will be considered (for all, the onset date of the case will be the date that 
symptoms were first experienced by the participant; if new symptoms are reported within 
4 days after resolution of all previous symptoms, they will be considered as part of a single 
illness). 
8.1.1. SARS-CoV-2–Related Cases 
COVID-19 Definitions: 
Confirmed COVID-19 definition (all participants): presence of at least 1 of the following 
symptoms and SARS-CoV-2 NAAT-positive during, or within 4 days before or after, the 
symptomatic period, either at the central laboratory or at a local testing facility (using an 
acceptable test): 
• Fever; 
• New or increased cough; 
• New or increased shortness of breath; 
• New or increased muscle pain; 
• New loss of taste or smell; 
• Sore throat; 
• Diarrhea; 
• Vomiting; 
• Inability to eat/poor feeding in participants <5 years of age. 
For participants ≥12 years of age: Confirmed severe COVID-19, first definition19: 
confirmed COVID-19 and presence of at least 1 of the following: 
• Admission to an ICU; 
• Death; 

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• Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths/min, HR 
≥125 beats/min, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 <300 mm Hg); 
• Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, 
mechanical ventilation, or ECMO); 
• Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors); 
• Significant acute renal, hepatic, or neurologic dysfunction. 
For participants ≥12 years of age: Confirmed severe COVID-19, second definition20: 
confirmed COVID-19 and presence of at least 1 of the following: 
• Hospitalization; 
• Intubation or mechanical ventilation; 
• Admission to an ICU; 
• Death. 
For participants <12 years of age: SARS-CoV-2–related hospitalization definition: 
confirmed COVID-19 and hospitalization. 
For participants <12 years of age: SARS-CoV-2–related severe case definition: 
confirmed COVID-19 and presence of at least 1 of the following: 
• Clinical signs at rest indicative of severe systemic illness: 
• RR (breaths/min) and HR (beats/min) as shown in Table 221 (below); 
• SpO2 ≤92% on room air or >50% FiO2 to maintain ≥92%, or PaO2/FiO2 
<300 mm Hg22; 
• Respiratory failure (defined as needing high-flow oxygen, including CPaP, BiPaP, 
noninvasive ventilation, mechanical ventilation, or ECMO); 
• Evidence of shock or cardiac failure: 
• SBP (mm Hg): 
• <70 + (age in years × 2) for age up to 10 years, <90 for age ≥10 years; or 
requiring vasoactive drugs to maintain BP in the normal range; 
• Significant acute renal failure: serum creatinine ≥2 times ULN for age or 2-fold increase 
in baseline creatinine; 

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• Significant GI/hepatic failure: TBili ≥4 mg/dL or ALT 2 times ULN for age; 
• Significant neurological dysfunction: Glasgow Coma Scale score ≤11 or acute change in 
mental status with a decrease in Glasgow Coma Scale score ≥3 points from abnormal 
baseline22; 
• Admission to an ICU; 
• Death. 
 
Table 2. 
RR and HR, by Age, Indicative of Severe Systemic Illness 
 
Participant Age 
RR 
HR 
2 to <3 Years 
>38 
>142 
3 to <4 Years 
>33 
>136 
4 to <6 Years 
>29 
>131 
6 to <8 Years 
>27 
>123 
8 to <12 Years 
>25 
>115 
Abbreviations: HR = heat rate; RR = respiratory rate. 
Source: Fleming S, Thompson M, Stevens R, et al. Normal ranges of heart rate and respiratory rate in 
children from birth to 18 years of age: a systematic review of observational studies. 
Lancet 2011;377(9770):1011-8. 
 
8.1.2. Multisystem Inflammatory Syndrome in Children 
Confirmed MIS-C definition23: as per the CDC MIS-C case definition: 
• An individual <21 years of age presenting with fever (≥38.0°C for ≥24 hours or report of 
subjective fever lasting ≥24 hours); AND 
• Laboratory evidence of inflammation (based on local laboratory ranges) including, but 
not limited to, 1 or more of the following: an elevated CRP, ESR, fibrinogen, 
procalcitonin, D-dimer, ferritin, LDH, or IL-6, elevated neutrophils, reduced 
lymphocytes, and low albumin; AND 
• Evidence of clinically severe illness requiring hospitalization (definition as noted above 
for severe disease), with multisystem (≥2) organ involvement: 
o Cardiac (eg, shock, elevated troponin, elevated BNP, abnormal echocardiogram, 
arrhythmia); 
o Renal (eg, acute kidney injury); 
o Respiratory (eg, pneumonia, ARDS, pulmonary embolism); 
o Hematologic (eg, elevated D-dimers, thrombophilia, or thrombocytopenia); 

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o GI/hepatic (eg, elevated bilirubin, elevated liver enzymes, or diarrhea); 
o Dermatologic (eg, rash, mucocutaneous lesions); 
o Neurological (eg, CVA, aseptic meningitis, encephalopathy); AND 
• No alternative plausible diagnoses; AND 
• Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen 
test; OR 
• COVID-19 exposure within the 4 weeks prior to the onset of symptoms. 
Serological definition will be used for participants without clinical presentation of 
COVID-19: 
• Confirmed seroconversion to SARS-CoV-2 without confirmed COVID-19: positive 
N-binding antibody result in a participant with a prior negative N-binding antibody result; 
• Current or recent exposure is established by SARS-CoV-2 infection by RT-PCR, 
serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of 
symptoms; 
• Past serological and virological status is established by SARS-CoV-2 PCR or history of 
reported COVID-19. 
8.1.3. Immunogenicity 
Serum samples will be obtained for immunogenicity testing at the visits specified in the SoA. 
The following assays will be performed: 
• SARS-CoV-2 neutralization assay to establish immune responses to prefusion spike 
glycoprotein 
• N-binding antibody assay to establish prior serological exposure to SARS-CoV-2 
Note that all immunogenicity analyses will be based upon samples analyzed at the central 
laboratory. 
8.1.4. Biological Samples 
Blood and nasal swab samples will be used only for scientific research. Each sample will be 
labeled with a code so that the laboratory personnel testing the samples will not know the 
participant’s identity. Samples that remain after performing assays outlined in the protocol 
may be stored by Pfizer. Unless a time limitation is required by local regulations or ethical 
requirements, the samples will be stored for up to 15 years after the end of the study and then 
destroyed. If allowed by the ICD, stored samples may be used for additional testing to better 

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understand the immune responses to the vaccine(s) under study in this protocol, to inform the 
development of other products, and/or for vaccine-related assay work supporting vaccine 
programs. No testing of the participant’s DNA will be performed, with the exception of those 
participants who have provided specific consent to genetic testing of the blood samples for 
PBMC isolation and HLA typing. 
The participant may request that his or her samples, if still identifiable, be destroyed at any 
time; however, any data already collected from those samples will still be used for this 
research. The biological samples may be shared with other researchers as long as 
confidentiality is maintained, and no testing of the participant’s DNA is performed, with the 
exception of those participants who have provided specific consent to genetic testing of the 
blood samples for PBMC isolation and HLA typing. 
8.2. Safety Assessments 
Planned time points for all safety assessments are provided in the SoA. Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues. 
A clinical assessment, including medical history, will be performed on all participants at their 
first visit to establish a baseline. In addition, a baseline assessment of fatigue, headache, 
vomiting, diarrhea, muscle pain, and joint pain over the previous week will be recorded in the 
e-diary. Significant medical history and observations from any physical examination will be 
documented in the CRF. 
AEs and SAEs are collected, recorded, and reported as defined in Section 8.3. 
Acute reactions within the first 30 minutes after vaccination will be assessed and documented 
in the AE CRF. 
The safety parameters also include reactogenicity e-diary reports of local reactions and 
systemic events (including fever) that occur in the 7 days after administration of the study 
intervention. These prospectively self-collected occurrences of local reactions and systemic 
events are graded as described in Section 8.2.4. 
8.2.1. Physical Examinations 
A physical examination at Visit 1 and Visit 2 will be performed according to the SoA and 
will evaluate any clinically significant abnormalities within the following body systems: 
general appearance; skin; head, eyes, ears, nose, and throat; heart; lungs; abdomen; 
musculoskeletal; extremities; neurological; and lymph nodes. 
Physical examination findings collected during the study will be considered source data and 
will not be required to be reported, unless otherwise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 
definition of an AE or SAE (Appendix 2) must be reported according to the processes in 
Sections 8.3.1 through 8.3.3. 

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8.2.2. Vital Signs 
Height, weight, oral temperature, and pulse rate will be assessed in all participants. BP will 
be assessed in participants ≥5 years of age (at Visit 1). Vital signs will be collected at time 
points specified in the SoA. 
Seated BP and pulse rate measurements will be assessed with a completely automated device. 
Manual techniques will be used if an automated device is not available or is deemed 
necessary by the investigator. 
BP and pulse rate measurements are best conducted when preceded by at least 5 minutes of 
rest for the participant in a quiet setting without distractions (eg, television, cell phones). 
8.2.3. Clinical Safety Laboratory Assessments 
Clinical safety laboratory assessments will not be collected in this study. 
8.2.4. Electronic Diary 
Prior to vaccination on Day 1, a baseline assessment of fatigue, headache, vomiting, 
diarrhea, muscle pain, and joint pain will be recorded in the e-diary. 
For participants <18 years of age, their parent(s)/legal guardian may complete the e-diary on 
their behalf. 
Participants or the participants’ parent(s)/legal guardians will be required to complete a 
reactogenicity e-diary through an app installed on a provisioned device or on the participant’s 
own personal device. All participants or the participants’ parent(s)/legal guardians will be 
asked to monitor and record local reactions, systemic events, and antipyretic medication use 
for 7 days from the day of administration of the study intervention. The reactogenicity 
e-diary allows recording of these assessments only within a fixed time window, thus 
providing the accurate representation of the participant’s experience at that time. Data on 
local reactions and systemic events reported in the reactogenicity e-diary will be transferred 
electronically to a third-party vendor, where they will be available for review by investigators 
and the Pfizer clinicians at all times via an internet-based portal. 
At intervals agreed to by the vendor and Pfizer, these data will be transferred electronically 
into Pfizer's database for analysis and reporting. These data do not need to be reported by the 
investigator in the CRF as AEs. 
Investigators (or designee) will be required to review the reactogenicity e-diary data online at 
frequent intervals as part of the ongoing safety review. 
The investigator or designee must obtain stop dates from the participant for any ongoing 
local reactions or systemic events on the last day that the reactogenicity e-diary was 
completed. The stop dates should be documented in the source documents and the 
information entered in the CRF. 

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8.2.4.1. Grading Scales 
The grading scales used in this study to assess local reactions and systemic events as 
described below are derived from the FDA CBER guidelines on toxicity grading scales for 
healthy adult volunteers enrolled in preventive vaccine clinical trials.17 
8.2.4.2. Local Reactions 
During the reactogenicity e-diary reporting period, participants or participants’ 
parent(s)/legal guardians will be asked to assess redness, swelling, and pain at the injection 
site and to record the symptoms in the reactogenicity e-diary. If a local reaction persists 
beyond the end of the reactogenicity e-diary period following vaccination, the participant or 
his or her parent(s)/legal guardian will be requested to report that information. The 
investigator will enter this additional information in the CRF. 
Redness and swelling will be measured and recorded in measuring device units 
(range: 1 to 21) for the first 7 days following vaccination (Days 1 through 7), and then 
categorized during analysis as absent, mild, moderate, or severe based on the grading scales 
in Table 3 and Table 4. Measuring device units can be converted to centimeters according to 
the following formula: 1 measuring device unit = 0.5 cm. Pain at the injection site will be 
assessed for participants ≥2 to <12 years of age as absent, mild, moderate, or severe 
according to the grading scale in Table 4. Pain at the injection site will be assessed for all 
participants ≥12 years of age according to the grading scale in Table 3. 
If redness or swelling >14 measuring device units is reported in the reactogenicity e-diary, 
regardless of the participant’s age, a telephone contact should occur to ascertain further 
details and determine whether a site visit is clinically indicated. If Grade 3 pain at the 
injection site is reported in the reactogenicity e-diary, a telephone contact should occur to 
ascertain further details and determine whether a site visit is clinically indicated. Only an 
investigator or medically qualified person can classify a participant’s local reaction as 
Grade 4. If a participant experiences a confirmed Grade 4 local reaction, the investigator 
must immediately notify the sponsor and, if it is determined to be related to the 
administration of the study intervention, further vaccinations will be discontinued in that 
participant. 

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Table 3. 
Local Reaction Grading Scale for Participants ≥12 Years of Age 
(at Visit 1) 
 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3)a 
Potentially 
Life-Threatening 
(Grade 4)b 
Pain at the 
injection site 
Does not interfere 
with activity 
Interferes with 
activity 
Prevents daily 
activity 
Emergency room 
visit or 
hospitalization for 
severe pain 
Redness 
>2.0 cm to 5.0 cm 
(5 to 10 measuring 
device units) 
>5.0 cm to 10.0 cm 
(11 to 20 measuring 
device units) 
>10 cm 
(≥21 measuring 
device units) 
Necrosis or 
exfoliative 
dermatitis 
Swelling 
>2.0 cm to 5.0 cm 
(5 to 10 measuring 
device units) 
>5.0 cm to 10.0 cm 
(11 to 20 measuring 
device units) 
>10 cm 
(≥21 measuring 
device units) 
Necrosis 
a. 
For participants experiencing local reactions >14 measuring device units (>7 cm), a telephone contact 
should occur to determine if an unscheduled visit may be required. 
b. Only an investigator or qualified designee can classify a participant’s local reaction as Grade 4, 
after clinical evaluation of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record). Grade 4 local reactions will be collected on the AE case report 
form and assessed by the investigator using the AE intensity grading scale as detailed in Section 10.2.3. 
 
 
Table 4. 
Local Reaction Grading Scale for Participants ≥2 to <12 Years of Age 
(at Visit 1) 
 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3)a 
Potentially 
Life-Threatening 
(Grade 4)b 
Pain at the 
injection site 
Does not interfere 
with activity 
Interferes with 
activity 
Prevents daily 
activity 
Emergency room 
visit or 
hospitalization for 
severe pain at the 
injection site 
Redness 
0.5 to 2.0 cm 
(1 to 4 measuring 
device units) 
>2.0 to 7.0 cm 
(5 to 14 measuring 
device units) 
>7 cm 
(>14 measuring 
device units) 
Necrosis or 
exfoliative 
dermatitis 
Swelling 
0.5 to 2.0 cm 
(1 to 4 measuring 
device units) 
>2.0 to 7.0 cm 
(5 to 14 measuring 
device units) 
>7 cm 
(>14 measuring 
device units) 
Necrosis 
a. 
For participants experiencing local reactions >14 measuring device units (>7 cm), a telephone contact 
should occur to determine if an unscheduled visit may be required. 
b. Only an investigator or qualified designee can classify a participant’s local reaction as Grade 4, 
after clinical evaluation of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record). Grade 4 local reactions will be collected on the AE case report 
form and assessed by the investigator using the AE intensity grading scale as detailed in Section 10.2.3. 

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8.2.4.3. Systemic Events 
During the reactogenicity e-diary reporting period, participants or participants’ 
parent(s)/legal guardians will be asked to assess vomiting, diarrhea, headache, fatigue, chills, 
new or worsened muscle pain, and new or worsened joint pain and to record the symptoms in 
the reactogenicity e-diary. The symptoms will be assessed as absent, mild, moderate, or 
severe according to the grading scale in Table 5. 
If a Grade 3 systemic event is reported in the reactogenicity e-diary, a telephone contact 
should occur to ascertain further details and determine whether a site visit is clinically 
indicated. Only an investigator or medically qualified person can classify a participant’s 
systemic event as Grade 4. If a participant experiences a confirmed Grade 4 systemic event, 
the investigator must immediately notify the sponsor and, if it is determined to be related to 
the administration of the study intervention, further vaccinations will be discontinued in that 
participant. 
 
Table 5. 
Systemic Event Grading Scale for All Study Participants 
 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3)a 
Potentially 
Life-Threatening 
(Grade 4)b 
Vomiting 
1-2 times in 
24 hours 
>2 times in 
24 hours 
Requires IV 
hydration 
Emergency room 
visit or 
hospitalization for 
hypotensive shock 
Diarrhea 
2 to 3 loose stools 
in 24 hours 
4 to 5 loose stools 
in 24 hours 
6 or more loose 
stools in 24 hours 
Emergency room 
visit or 
hospitalization for 
severe diarrhea 
Headache 
Does not interfere 
with activity 
Some interference 
with activity 
Prevents daily 
routine activity 
Emergency room 
visit or 
hospitalization for 
severe headache 
Fatigue/tiredness 
Does not interfere 
with activity 
Some interference 
with activity 
Prevents daily 
routine activity 
Emergency room 
visit or 
hospitalization for 
severe fatigue 
Chills 
Does not interfere 
with activity 
Some interference 
with activity 
Prevents daily 
routine activity 
Emergency room 
visit or 
hospitalization for 
severe chills 
New or worsened 
muscle pain 
Does not interfere 
with activity 
Some interference 
with activity 
Prevents daily 
routine activity 
Emergency room 
visit or 
hospitalization for 
severe new or 
worsened muscle 
pain 

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Table 5. 
Systemic Event Grading Scale for All Study Participants 
 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3)a 
Potentially 
Life-Threatening 
(Grade 4)b 
New or worsened 
joint pain 
Does not interfere 
with activity 
Some interference 
with activity 
Prevents daily 
routine activity 
Emergency room 
visit or 
hospitalization for 
severe new or 
worsened joint pain 
Abbreviation: IV = intravenous. 
a. 
For participants experiencing severe systemic events, a telephone contact should occur to determine if an 
unscheduled visit may be required. 
b. Only an investigator or qualified designee can classify a participant’s systemic event as Grade 4, after 
clinical evaluation of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record). Grade 4 local reactions will be collected on the AE case report 
form and assessed by the investigator using the AE intensity grading scale as detailed in Section 10.2.3. 
 
8.2.4.4. Fever 
In order to record information on fever, a thermometer will be given to participants or 
participants’ parent(s)/legal guardians with instructions on how to measure oral temperature 
at home. Temperature will be collected in the reactogenicity e-diary in the evening, daily, 
during the reactogenicity e-diary reporting period. It will also be collected at any time during 
the reactogenicity e-diary data collection period when fever is suspected. Fever is defined as 
an oral temperature ≥38.0°C (100.4°F). The highest temperature for each day will be 
recorded in the reactogenicity e-diary. Temperature will be measured and recorded to 
1 decimal place. Temperatures recorded in degrees Fahrenheit will be programmatically 
converted to degrees Celsius and then categorized according to the scale shown in Table 6 
during analysis. 
If a fever of ≥39.0°C (102.1°F) is reported in the reactogenicity e-diary, a telephone contact 
should occur to ascertain further details and determine whether a site visit is clinically 
indicated. Only an investigator or medically qualified person can confirm a participant’s 
fever as >40.0°C (>104.0°F). If a participant experiences a confirmed fever >40.0°C 
(>104.0°F), the investigator must immediately notify the sponsor and, if it is determined to 
be related to the administration of the study intervention, further vaccinations will be 
discontinued in that participant. 
 
Table 6. 
Scale for Fever 
 
≥38.0-38.4°C (100.4-101.1°F) 
>38.4-38.9°C (101.2-102.0°F) 
>38.9-40.0°C (102.1-104.0°F) 
>40.0°C (>104.0°F) 

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8.2.4.5. Surveillance of Events That Could Represent Enhanced COVID-19 Disease 
As this is a sponsor open-label study, the sponsor will conduct unblinded reviews of the data 
during the study, including for the purpose of safety assessment. 
Participants will be surveilled for potential COVID-19/MIS-C illness from Visit 1 onwards. 
Participants or participants’ parent(s)/legal guardians may utilize a COVID-19/MIS-C illness 
e-diary through an app (see Section 8.2.4) installed on a provisioned device or on the 
participant’s own personal device to prompt him/her to report any symptoms. 
8.2.5. Pregnancy Testing 
Pregnancy tests should be urine tests and must have a sensitivity of at least 25 mIU/mL. 
Pregnancy tests will be performed in WOCBP at the times listed in the SoA, immediately 
before the administration of each vaccine dose. A negative pregnancy test result will be 
required prior to the participant’s receiving the study intervention. Pregnancy tests may also 
be repeated if requested by IRBs/ECs or if required by local regulations. In the case of a 
positive confirmed pregnancy, the participant will be withdrawn from administration of study 
intervention but may remain in the study. 
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting 
The definitions of an AE and an SAE can be found in Appendix 2. 
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, or the participant's parent(s)/legal guardian, 
or they may arise from clinical findings of the investigator or other healthcare providers 
(clinical signs, test results, etc). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study intervention (see Section 7.1). 
During the active collection period as described in Section 8.3.1, each participant/ 
participant’s parent(s)/legal guardian will be questioned about the occurrence of AEs in a 
nonleading manner. 
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion. 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information 
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant/parent(s)/legal guardian 
provides informed consent, which is obtained before the participant’s participation in the 
study (ie, before undergoing any study-related procedure and/or receiving study 

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intervention), through and including 1 month after Dose 2 (Visit 4), from Dose 3 (Visit 5) 
through 1 month after Dose 3 (Visit 7), and from Dose 4 (Visit 8) through 1 month after 
Dose 4 (Visit 9). In addition, AEs occurring up to 48 hours after blood draws or collection of 
nasal swabs that are related to study procedures must be reported in the CRF. 
SAEs will be collected from the time the participant provides informed consent through the 
duration of the study. 
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator. 
For participants who are screen failures, the active collection period ends when screen failure 
status is determined. 
If the participant withdraws from the study and withdraws consent for the collection of future 
information, the active collection period ends when consent is withdrawn. 
If a participant permanently discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the Vaccine SAE Reporting Form. 
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and he/she 
considers the event to be reasonably related to the study intervention, the investigator must 
promptly report the SAE to Pfizer using the Vaccine SAE Reporting Form. 
Note: Symptoms that trigger potential COVID-19/MIS-C illness visits (Section 8.11) are 
expected endpoints and should not be recorded as AEs. These data will be captured only on 
the relevant illness pages of the CRF. 
8.3.1.1. Reporting SAEs to Pfizer Safety 
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Reporting Form immediately 
upon awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 2. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available. 
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF 
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF. 

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The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant. 
8.3.2. Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 2. 
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. 
8.3.3. Follow-Up of AEs and SAEs 
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3). 
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 2. 
8.3.4. 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/ECs, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements. 

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8.3.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure 
Environmental exposure occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include EDP, EDB, and occupational exposure. 
Any such exposure to the study intervention under study are reportable to Pfizer Safety 
within 24 hours of investigator awareness. 
8.3.5.1. Exposure During Pregnancy 
An EDP occurs if: 
• A female participant is found to be pregnant while receiving or after discontinuing study 
intervention. 
• A male participant who is receiving or has discontinued study intervention exposes a 
female partner prior to or around the time of conception. 
• A female is found to be pregnant while being exposed or having been exposed to study 
intervention due to environmental exposure. Below are examples of environmental EDP: 
• A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by inhalation or skin contact. 
• A male family member or healthcare provider who has been exposed to the study 
intervention by inhalation or skin contact then exposes his female partner prior to or 
around the time of conception. 
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 
• If EDP occurs in a participant or a participant’s partner, the investigator must report this 
information to Pfizer Safety on the Vaccine SAE Reporting Form and an EDP 
Supplemental Form, regardless of whether an SAE has occurred. Details of the pregnancy 
will be collected after the start of study intervention and until 28 days after Dose 3 of 
study intervention. 

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• If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the Vaccine SAE Reporting Form and EDP 
Supplemental Form. Since the exposure information does not pertain to the participant 
enrolled in the study, the information is not recorded on a CRF; however, a copy of the 
completed Vaccine SAE Reporting Form is maintained in the investigator site file. 
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly), the investigator should follow the procedures 
for reporting SAEs. Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows: 
• Spontaneous abortion including miscarriage and missed abortion; 
• Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs 
when the investigator assesses the infant death as related or possibly related to exposure 
to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant or participant’s parent(s)/legal guardian with the 
Pregnant Partner Release of Information Form to deliver to the participant’s partner. The 
investigator must document in the source documents that the participant or participant’s 
parent(s)/legal guardian was given the Pregnant Partner Release of Information Form to 
provide to the participant’s partner. 
For a female participant who becomes pregnant, this information will be shared with the 
study participant’s parent(s)/legal guardian if the participant’s age is in accordance with 
local/country regulations. 

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8.3.5.2. Exposure During Breastfeeding 
An EDB occurs if: 
• A female participant is found to be breastfeeding while receiving or after discontinuing 
study intervention. 
• A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure). An example of environmental EDB is a 
female family member or healthcare provider who reports that she is breastfeeding after 
having been exposed to the study intervention by inhalation or skin contact. 
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported 
using the Vaccine SAE Reporting Form. When EDB occurs in the setting of environmental 
exposure, the exposure information does not pertain to the participant enrolled in the study, 
so the information is not recorded on a CRF. However, a copy of the completed Vaccine 
SAE Reporting Form is maintained in the investigator site file. 
An EDB report is not created when a Pfizer drug specifically approved for use in 
breastfeeding women (eg, vitamins) is administered in accord with authorized use. However, 
if the infant experiences an SAE associated with such a drug, the SAE is reported together 
with the EDB. 
8.3.5.3. Occupational Exposure 
The investigator must report any instance of occupational exposure to Pfizer Safety within 
24 hours of the investigator’s awareness using the Vaccine SAE Reporting Form, regardless 
of whether there is an associated SAE. Since the information about the occupational exposure 
does not pertain to a participant enrolled in the study, the information is not recorded on a 
CRF; however, a copy of the completed Vaccine SAE Reporting Form must be maintained in 
the investigator site file. 
8.3.6. Cardiovascular and Death Events 
Not applicable. 
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs 
Symptoms that trigger potential COVID-19/MIS-C illness visits are expected endpoints 
(Section 8.11) and should not be recorded as AEs. These data will be captured only on the 
relevant illness pages of the CRF. 
Potential COVID-19/MIS-C illness events and their sequelae will be reviewed by internal 
blinded case reviewers. Any SAE that is determined by the internal blinded case reviewers 
NOT to meet endpoint criteria is reported back to the investigator site of incidence. The 
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the SAE did not meet endpoint criteria. The investigator’s SAE awareness date is the date on 
which the investigator site of incidence receives the SAE back from the internal case 
reviewers. 
Note: However, if either of the following conditions applies, then the event must be recorded 
and reported as an SAE (instead of a disease-related event): 
The event is, in the investigator’s opinion, of greater intensity, frequency, or duration than 
expected for the individual participant. 
OR 
The investigator considers that there is a reasonable possibility that the event was related to 
study intervention. 
8.3.8. Adverse Events of Special Interest 
The following events are considered AESIs: 
• A confirmed diagnosis of myocarditis or pericarditis. See Section 8.12 for additional 
procedures for monitoring of potential myocarditis or pericarditis. 
• Exacerbation of underlying immunocompromising conditions. Please also refer to 
Section 10.2.1. 
8.3.8.1. Lack of Efficacy 
This section is not applicable, as efficacy is yet to be demonstrated in this study population. 
8.3.9. Medical Device Deficiencies 
Not applicable. 
8.3.10. Medication Errors 
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength. 
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors. 
 
Safety Event 
Recorded on the CRF 
Reported on the Vaccine SAE 
Reporting Form to Pfizer Safety 
Within 24 Hours of Awareness 
Medication errors 
All (regardless of whether 
associated with an AE) 
Only if associated with an SAE 

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Medication errors include: 
• Medication errors involving participant exposure to the study intervention; 
• Potential medication errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant; 
• The administration of expired study intervention; 
• The administration of an incorrect study intervention; 
• The administration of an incorrect dosage; 
• The administration of study intervention that has undergone temperature excursion from 
the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use. 
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page. 
In the event of a medication dosing error, the sponsor should be notified within 24 hours. 
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF. 
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE. 
8.4. Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 
8.5. Genetics 
Some of the blood samples collected for PBMC isolation and HLA typing may be used for 
DNA and/or RNA isolation. The DNA and/or RNA samples from the PBMC isolation may 
be used for sequencing of participants’ antibody and/or BCR heavy- and light-chain genes, 
TCR genes, and/or mRNAs, for understanding the B-cell, T-cell, and antibody repertoires. 
The DNA and/or RNA samples from the blood sample for HLA typing may be used to 
further characterize HLA type. 
See Appendix 5 for information regarding genetic research. Details on processes for 
collection and shipment of these samples will be provided separately. 

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8.6. Biomarkers 
Biomarkers are not evaluated in this study. 
8.6.1. Specified Gene Expression (RNA) Research 
Specified gene expression (RNA) research is not included in this study. 
8.6.2. Specified Protein Research 
Specified protein research is not included in this study. 
8.6.3. Specified Metabolomic Research 
Specified metabolomic research is not included in this study. 
8.7. Immunogenicity Assessments 
Immunogenicity assessments are described in Section 8.1. 
8.8. Health Economics 
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study. 
8.9. Study Procedures 
8.9.1. Visit 1 – Vaccination 1 (Day 1) 
Before enrollment and before any study-related procedures are performed, voluntary, written, 
study-specific informed consent, and assent (where appropriate), will be obtained from the 
participant or participant’s parent(s)/legal guardian. Each signature on the ICD and assent 
(where appropriate) must be personally dated by the signatory. The investigator or his or her 
designee will also sign the ICD and assent (where appropriate). A copy of the signed and 
dated ICD and assent (where appropriate) must be given to the participant or participant’s 
parent(s)/legal guardian. The source data must reflect that the informed consent and assent 
(where appropriate) was obtained before participation in the study. 
It is anticipated that the procedures below will be conducted in a stepwise manner. 
• If a participant is eligible for the study, assign a single participant number using the IRT 
system. 
• Obtain the participant’s demography (including date of birth, sex, race, and ethnicity). 
The full date of birth will be collected to critically evaluate the immune response and 
safety profile by age. 
• Obtain the participant’s significant medical history, including but not limited to 
conditions that put participants at high risk of developing severe outcomes of COVID-19 
infection (see CDC listing at https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical- 
care/underlyingconditions.html). 

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• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Perform physical examination, evaluating any clinically significant abnormalities within 
the following body systems: general appearance; skin; head, eyes, ears, nose, and throat; 
heart; lungs; abdomen; musculoskeletal; extremities; neurological; and lymph nodes. 
• Measure vital signs (weight, height, oral temperature, pulse rate, and seated BP 
(for participants ≥5 years of age). 
• Ensure that it is appropriate to and, if so, collect a blood sample for immunogenicity 
testing, dependent on participant age as referenced in Table 1 (Section 8), and to test for 
prior COVID-19. Please refer to the laboratory manual for further instructions. 
• For participants who are eligible and have consented to PBMC sampling: ensure that it is 
appropriate to and, if so, collect a whole blood sample for PBMC isolation and HLA 
typing, dependent on participant age as referenced in Table 1 (Section 8). Please refer to 
the laboratory manual for further instructions. 
• Obtain a nasal swab (collected by site staff) for determination of current SARS-CoV-2 
status. Please refer to the laboratory manual for further instructions. 
• Perform urine pregnancy test on WOCBP as described in Section 8.2.5. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met. 
• Ensure that the participant meets none of the temporary delay criteria as described in 
Section 5.5. 
• Explain the e-diary technologies available for this study (see Section 8.2.4), and assist the 
participant or participant’s parent(s)/legal guardian in downloading the study app onto the 
participant’s or participant’s parent(s)/legal guardian’s own device or issue a provisioned 
device if required. Provide instructions on e-diary completion and ask the participant or 
participant’s parent(s)/legal guardian to complete the reactogenicity e-diary each day 
from Day 1 through Day 7, with Day 1 being the day of vaccination, and the COVID-19 
illness e-diary (to be completed if the participant is diagnosed with COVID-19 or has 
possible new or increased symptoms, and when he/she receives a reminder, at least 
weekly). 
• Record baseline systemic events in the e-diary. 
• Obtain the participant’s study intervention allocation using the IRT system. 

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• Staff member(s) will dispense/administer 1 dose of study intervention into the deltoid 
muscle of the (preferably) nondominant arm. Please refer to the IP manual for further 
instructions on this process. 
• Staff must observe the participant for at least 30 minutes after study intervention 
administration for any acute reactions. Record any acute reactions (including time of 
onset) in the participant’s source documents and on the AE page of the CRF, and on an 
SAE form as applicable. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if the participant experiences any of the following from Day 1 
through Day 7 after vaccination (where Day 1 is the day of vaccination) to determine if 
an unscheduled reactogenicity visit is required: 
• Fever ≥39.0°C (≥102.1°F). 
• Redness or swelling at the injection site measuring greater than 7 cm (>14 measuring 
device units). 
• Severe pain at the injection site. 
• Any severe systemic event. 
• Issue a measuring device to measure local reactions at the injection site and a 
thermometer for recording daily temperatures and provide instructions on their use. 
• Record AEs/SAEs as described in Section 8.3. AEs that occur prior to dosing should be 
noted on the medical history CRF. 
• Ask the participant to contact the site staff or investigator immediately if any significant 
illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Schedule an appointment for the participant to return for the next study visit. 
• Remind the participant or participant’s parent(s)/legal guardian to bring the 
reactogenicity e-diary to the next visit. 
• Complete the source documents. 

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• The investigator or an authorized designee completes the CRFs. 
• The investigator or appropriately qualified designee reviews the reactogenicity e-diary 
data online following vaccination to evaluate participant compliance and as part of the 
ongoing safety review. Daily review is optimal during the active diary period. 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
8.9.2. Visit 2 – Vaccination 2 (19 to 23 Days After Visit 1) 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Perform physical examination, evaluating any clinically significant abnormalities within 
the following body systems: general appearance; skin; head, eyes, ears, nose, and throat; 
heart; lungs; abdomen; musculoskeletal; extremities; neurological; and lymph nodes. 
• Measure vital signs (oral temperature, pulse rate, and seated BP (for participants ≥5 years 
of age). Height and weight do not need to be re-collected. 
• Perform urine pregnancy test on WOCBP as described in Section 8.2.5. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Obtain a nasal swab (collected by site staff) for determination of current SARS-CoV-2 
status. Please refer to the laboratory manual for further instructions. 
• Review the participant’s reactogenicity e-diary data. Collect stop dates of any 
reactogenicity e-diary events ongoing on the last day that the reactogenicity e-diary was 
completed and record stop dates in the CRF if required. 
• Ensure and document that the participant is still eligible to continue in the study. If not, 
the participant may not receive further study intervention but will remain in the study to 
be evaluated for safety, tolerability, and immunogenicity (see Section 7.1). 
• Ensure that the participant meets none of the temporary delay criteria as described in 
Section 5.5. 
• If potential COVID-19/MIS-C symptoms are present (Section 8.11), conduct a potential 
COVID-19/MIS-C illness visit, including a local laboratory SARS-CoV-2 test. 
• Obtain the participant’s study intervention allocation using the IRT system. 

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• Staff member(s) will dispense/administer 1 dose of study intervention into the deltoid 
muscle of the (preferably) nondominant arm. Please refer to the IP manual for further 
instructions on this process. 
• Staff must observe the participant for at least 30 minutes after study intervention 
administration for any acute reactions. Record any acute reactions (including time of 
onset) in the participant’s source documents and on the AE page of the CRF, and on an 
SAE form as applicable. 
• Ensure that the participant or participant’s parent(s)/legal guardian has a measuring 
device to measure local reactions at the injection site and a thermometer for recording 
daily temperatures, and if not, issue a measuring device and/or a thermometer (as 
required) and provide instructions on their use. 
• Ensure that the participant or participant’s parent(s)/legal guardian remains comfortable 
with the chosen e-diary platform, confirm instructions on e-diary completion, and ask the 
participant to complete the reactogenicity e-diary from Day 1 through Day 7, with Day 1 
being the day of vaccination. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if the participant experiences any of the following from Day 1 
through Day 7 after vaccination (where Day 1 is the day of vaccination) to determine if 
an unscheduled reactogenicity visit is required: 
• Fever ≥39.0°C (≥102.1°F). 
• Redness or swelling at the injection site measuring greater than 7 cm (>14 measuring 
device units). 
• Severe pain at the injection site. 
• Any severe systemic event. 
• Ask the participant to contact the site staff or investigator immediately if any significant 
illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Schedule an appointment for the participant to return for the next study visit. 

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• Remind the participant or participant’s parent(s)/legal guardian to bring the 
reactogenicity e-diary to the next visit. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 
• The investigator or appropriately qualified designee reviews the reactogenicity e-diary 
data online following vaccination to evaluate participant compliance and as part of the 
ongoing safety review. Daily review is optimal during the active diary period. 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
8.9.3. Visit 3 – 1-Week Follow-Up Visit (After Vaccination 2) (6 to 8 Days After Visit 2) 
Note: For participants who are not in the PBMC collection subset, this visit may be a 
telehealth visit. 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Ensure and document that the participant is still eligible to continue in the study. 
• For participants who are eligible and have consented to PBMC sampling: ensure that it is 
appropriate to and, if so, collect a whole blood sample for PBMC isolation, dependent on 
participant age as referenced in Table 1 (Section 8). Please refer to the laboratory manual 
for further instructions. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Ask the participant to contact the site staff or investigator immediately if any significant 
illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 

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• 
Schedule an appointment for the participant for the next study visit. Remind the 
participant or participant’s parent(s)/legal guardian to bring the reactogenicity e-diary to 
the next visit. 
• 
• 
Complete the source documents. 
The investigator or an authorized designee completes the CRFs. 
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8.9.4. Visit 4 – 1-Month Follow-Up Visit (After Vaccination 2) (28 to 35 Days After 
Visit 2) 
Note: Visit 4 and Visit 5 are expected to occur on the same day. All visit procedures should 
be conducted in consecutive order, and duplicative procedures listed in Visit 4 and Visit 5 
need not be done. 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Review the participant’s reactogenicity e-diary data. Collect stop dates of any 
reactogenicity e-diary events ongoing on the last day that the reactogenicity e-diary was 
completed and record stop dates in the CRF if required. 
• Ensure and document that the participant is still eligible to continue in the study. 
• Ensure that it is appropriate to and, if so, collect a blood sample for immunogenicity 
testing, dependent on participant age as referenced in Table 1 (Section 8). Please refer to 
the laboratory manual for further instructions. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Ask the participant to contact the site staff or investigator immediately if any significant 
illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 

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• 
Schedule an appointment for the participant for the next study visit. Remind the 
participant or participant’s parent(s)/legal guardian to bring the reactogenicity e-diary to 
the next visit. 
• 
• 
Complete the source documents. 
The investigator or an authorized designee completes the CRFs. 
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8.9.5. Visit 5 – Vaccination 3 (28 to 35 Days After Visit 2) 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Measure vital signs (oral temperature, pulse rate, and seated BP (for participants ≥5 years 
of age). Height and weight do not need to be re-collected. 
• Perform urine pregnancy test on WOCBP as described in Section 8.2.5. 
• Ensure and document that the participant is still eligible to continue in the study. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Obtain a nasal swab (collected by site staff) for determination of current SARS-CoV-2 
status. Please refer to the laboratory manual for further instructions. 
• Ensure that the participant meets none of the temporary delay criteria as described in 
Section 5.5. 
• If potential COVID-19/MIS-C symptoms are present (Section 8.11), conduct a potential 
COVID-19/MIS-C illness visit, including a local laboratory SARS-CoV-2 test. 
• Obtain the participant’s study intervention allocation using the IRT system. 
• Staff member(s) will dispense/administer 1 dose of study intervention into the deltoid 
muscle of the (preferably) nondominant arm. Please refer to the IP manual for further 
instructions on this process. 
• Staff must observe the participant for at least 30 minutes after study intervention 
administration for any acute reactions. Record any acute reactions (including time of 
onset) in the participant’s source documents and on the AE page of the CRF, and on an 
SAE form as applicable. 

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• Ensure that the participant or participant’s parent(s)/legal guardian has a measuring 
device to measure local reactions at the injection site and a thermometer for recording 
daily temperatures, and if not, issue a measuring device and/or a thermometer 
(as required) and provide instructions on their use. 
• Ensure that the participant or participant’s parent(s)/legal guardian remains comfortable 
with the chosen e-diary platform, confirm instructions on e-diary completion, and ask the 
participant or participant’s parent(s)/legal guardian to complete the reactogenicity e-diary 
from Day 1 through Day 7, with Day 1 being the day of vaccination. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if the participant experiences any of the following from Day 1 
through Day 7 after vaccination (where Day 1 is the day of vaccination) to determine if 
an unscheduled reactogenicity visit is required: 
• Fever ≥39.0°C (≥102.1°F). 
• Redness or swelling at the injection site measuring greater than 7 cm (>14 measuring 
device units). 
• Severe pain at the injection site. 
• Any severe systemic event. 
• Ask the participant to contact the site staff or investigator immediately if any significant 
illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
• Schedule an appointment for the participant for the next study visit. 
• Remind the participant or participant’s parent(s)/legal guardian to bring the 
reactogenicity diary for collection at the next visit. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 

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• The investigator or appropriately qualified designee reviews the reactogenicity e-diary 
data online following vaccination to evaluate participant compliance and as part of the 
ongoing safety review. Daily review is optimal during the active diary period. 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
8.9.6. Visit 6 – 1-Week Follow-Up Visit (After Vaccination 3) (6 to 8 Days After Visit 5) 
Note: For participants not in the PBMC collection subset, this visit may be a telehealth visit. 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Ensure and document that the participant is still eligible to continue in the study. 
• For participants who are eligible and have consented to PBMC sampling: ensure that it is 
appropriate to and, if so, collect a whole blood sample for PBMC isolation, dependent on 
participant age as referenced in Table 1 (Section 8). Please refer to the laboratory manual 
for further instructions. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if any significant illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
• Schedule an appointment for the participant for the next study visit. Remind the 
participant or participant’s parent(s)/legal guardian to bring the reactogenicity e-diary to 
the next visit. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 

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8.9.7. Visit 7 – 1-Month Follow-Up Visit (After Vaccination 3) (28 to 35 Days After 
Visit 5) 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Review the participant’s reactogenicity e-diary data. Collect stop dates of any 
reactogenicity e-diary events ongoing on the last day that the reactogenicity e-diary was 
completed and record stop dates in the CRF if required. 
• Ensure and document that the participant is still eligible to continue in the study. 
• Ensure that it is appropriate to and, if so, collect a blood sample for immunogenicity 
testing, dependent on participant age as referenced in Table 1 (Section 8). Please refer to 
the laboratory manual for further instructions. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if any significant illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
• Schedule an appointment for the participant for the next study visit. Remind the 
participant or participant’s parent(s)/legal guardian to bring the reactogenicity e-diary to 
the next visit. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 
8.9.8. Visit 8 – Vaccination 4 (91 to 189 Days After Visit 5) 
Note: The timing of Dose 4 should be determined by the investigator’s discretion, taking into 
account factors such as the participant’s underlying condition and level of 
immunosuppression, the evolving clinical literature, the COVID-19 incidence in the 
participant’s geographic area, the potential for increased reactogenicity, and the risk of 

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reduced immunogenicity and antibody persistence with a shorter interval between Dose 3 and 
Dose 4. 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Ensure and document that the participant is still eligible to continue in the study. 
• Measure vital signs (oral temperature, pulse rate, and seated BP) for participants ≥5 years 
of age. Height and weight do not need to be recollected. 
• Perform urine pregnancy test on WOCBP as described in Section 8.2.5. 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Obtain a nasal swab (collected by site staff) for determination of current SARS-CoV-2 
status. Please refer to the laboratory manual for further instructions. 
• Ensure that the participant meets none of the temporary delay criteria as described in 
Section 5.5. 
• If potential COVID-19/MIS-C symptoms are present (Section 8.11), conduct a potential 
COVID-19/MIS-C illness visit, including a local laboratory SARS-CoV-2 test. 
• Ensure that it is appropriate to and, if so, collect a blood sample for immunogenicity 
testing, dependent on participant age as referenced in Table 1 (Section 8). Please refer to 
the laboratory manual for further instructions. (Note: If the participant does not receive 
Dose 4 of BNT162b2, this blood draw is not required, and this visit may be conducted via 
telehealth). 
• For participants who are eligible and have consented to PBMC sampling: ensure that it is 
appropriate to and, if so, collect a whole blood sample for PBMC isolation dependent on 
participant age as referenced in Table 1 (Section 8). Please refer to the laboratory manual 
for further instructions. 
• Obtain the participant’s study intervention allocation using the IRT system. 
• Staff member(s) will dispense/administer 1 dose of study intervention into the deltoid 
muscle of the (preferably) nondominant arm. Please refer to the IP manual for further 
instructions on this process. 

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• Staff must observe the participant for at least 30 minutes after study intervention 
administration for any acute reactions. Record any acute reactions (including time of 
onset) in the participant’s source documents and on the AE page of the CRF, and on an 
SAE form, as applicable. 
• Ensure that the participant or participant’s parent(s)/legal guardian has a measuring 
device to measure local reactions at the injection site and a thermometer for recording 
daily temperatures, and if not, issue a measuring device and/or a thermometer 
(as required) and provide instructions on their use. 
• Ensure that the participant or participant’s parent(s)/legal guardian remains comfortable 
with the chosen e-diary platform, confirm instructions on e-diary completion, and ask the 
participant or participant’s parent(s)/legal guardian to complete the reactogenicity e-diary 
from Day 1 through Day 7, with Day 1 being the day of vaccination. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if the participant experiences any of the following from Day 1 
through Day 7 after vaccination (where Day 1 is the day of vaccination) to determine if 
an unscheduled reactogenicity visit is required: 
• Fever ≥39.0°C (≥102.1°F). 
• Redness or swelling at the injection site measuring greater than 7 cm (>14 measuring 
device units). 
• Severe pain at the injection site. 
• Any severe systemic event. 
• Ask the participant to contact the site staff or investigator immediately if any significant 
illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
• Schedule an appointment for the participant for the next study visit. 
• Remind the participant or participant’s parent(s)/legal guardian to bring the 
reactogenicity diary for collection at the next visit. 

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• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs 
8.9.9. Visit 9 – 1-Month Follow-Up Visit (After Vaccination 4) (28 to 35 Days After 
Visit 8) 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Review the participant’s reactogenicity e-diary data. Collect stop dates of any 
reactogenicity e-diary events ongoing on the last day that the reactogenicity e-diary was 
completed and record stop dates in the CRF if required. 
• Ensure and document that the participant is still eligible to continue in the study. 
• Ensure that it is appropriate to and, if so, collect a blood sample for immunogenicity 
testing, dependent on participant age as referenced in Table 1 (Section 8). Please refer to 
the laboratory manual for further instructions. (Note: If the participant does not receive 
Dose 4 of BNT162b2, this blood draw is not required, and this visit may be conducted via 
telehealth). 
• If appropriate, discuss contraceptive use as described in Section 10.3. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator immediately if any significant illness or hospitalization occurs. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant develops any symptoms as detailed in Section 8.11. 
• Ask the participant or participant’s parent(s)/legal guardian to contact the site staff or 
investigator if the participant experiences acute chest pain, shortness of breath, or 
palpitations (see Section 8.12). 
• The investigator or appropriately qualified designee reviews COVID-19/MIS-C illness 
e-diary data at frequent intervals. 
• Schedule an appointment for the participant for the next study visit. Remind the 
participant or participant’s parent(s)/legal guardian to bring the reactogenicity e-diary to 
the next visit. 

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• Complete the source documents. The investigator or an authorized designee completes 
the CRFs. 
8.9.10. Visit 10 – 6-Month Follow-Up Visit (After Vaccination 4) (175 to 189 Days After 
Visit 8) 
• Record AEs/SAEs as described in Section 8.3. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• Ensure and document that the participant is still eligible to continue in the study 
• Ensure that it is appropriate to and, if so, collect a blood sample for immunogenicity 
testing, dependent on participant age as referenced in Table 1 (Section 8). Please refer to 
the laboratory manual for further instructions 
• For participants who are eligible and have consented to PBMC sampling: ensure that it is 
appropriate to and, if so, collect a whole blood sample for PBMC isolation dependent on 
participant age as referenced in Table 1 (Section 8). Please refer to the laboratory manual 
for further instructions. (Note: If the participant does not receive Dose 4 of BNT162b2, 
this blood draw is not required, and this visit may be conducted via telehealth). 
• Collect the participant’s e-diary or assist the participant or participant’s parent(s)/legal 
guardian to remove the study app from his or her own personal device. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 
• Inform the participant or participant’s parent(s)/legal guardian that the participant’s study 
participation has ended. 
8.10. Unscheduled Visit for Fever or a Grade 3 or Suspected Grade 4 Reaction 
If redness or swelling >14 units, Grade 3 pain (Section 8.2.4.2), a Grade 3 systemic event 
(Section 8.2.4.3), or fever (≥39.0°C [≥102.1°F]) (Section 8.2.4.4) is reported by the 
participant or participant’s parent(s)/legal guardian in the reactogenicity e-diary, a telephone 
contact should occur to ascertain further details and determine whether a site visit is 
clinically indicated. 
If a suspected Grade 4 local reaction (Section 8.2.4.2), Grade 4 systemic event 
(Section 8.2.4.3), or fever (>40.0°C [>104.0°F]) (Section 8.2.4.4) is reported by the 
participant or participant’s parent(s)/legal guardian in the reactogenicity e-diary, a telephone 
contact or site visit should occur to confirm the fever and determine whether the event meets 
the criteria for Grade 4. 

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A site visit must be scheduled as soon as possible to assess the participant unless any of the 
following is true: 
• The participant is unable to attend the unscheduled visit. 
• The local reaction/systemic event is no longer present at the time of the telephone 
contact. 
• The participant or participant’s parent(s)/legal guardian recorded an incorrect value in the 
reactogenicity e-diary (confirmation of a reactogenicity e-diary data entry error). 
• The PI or authorized designee determined it was not needed. 
• This telephone contact will be recorded in the participant’s source documentation and the 
CRF. 
If the participant is unable to attend the unscheduled visit, or the PI or authorized designee 
determined it was not needed, any ongoing local reactions/systemic events must be assessed 
at the next study visit. 
During the unscheduled visit, the reactions/events should be assessed by the investigator or a 
medically qualified member of the study staff such as a study physician or a study nurse, as 
applicable to the investigator’s local practice, who will: 
• Measure body temperature (°F/°C). 
• Measure minimum and maximum diameters of redness (if present). 
• Measure minimum and maximum diameters of swelling (if present). 
• Assess injection site pain (if present) in accordance with the grades provided in 
Section 8.2.4.2. 
• Assess systemic events (if present) in accordance with the grades provided in 
Section 8.2.4.3. 
• Assess for other findings associated with the reaction/event and record on the AE page of 
the CRF, if appropriate. 
• The investigator or an authorized designee will complete the unscheduled visit 
assessment page of the CRF. 

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8.11. COVID-19 Surveillance (All Participants) and MIS-C Surveillance (Participants 
<21 Years of Age) 
COVID-19 Surveillance: If a participant experiences any 1 of the following within a 
24-hour period, from Visit 1 onwards (irrespective of perceived etiology or clinical 
significance), the participant or his/her parent(s)/legal guardian is instructed to contact the 
site immediately and, if in the opinion of the investigator a COVID-19/MIS-C illness visit is 
indicated, a potential COVID-19/MIS-C illness visit should be conducted. The test and visit 
would be optimal within 3 days after symptom onset (and at the latest 4 days after symptom 
resolution). During the 7 days following each vaccination, potential COVID-19 symptoms 
that overlap with specific systemic events (ie, fever, chills, new or increased muscle pain, 
diarrhea, vomiting) should not trigger a potential COVID-19 illness visit unless, in the 
investigator’s opinion, the clinical picture is more indicative of a possible COVID-19 illness 
than vaccine reactogenicity. 
Note that: 
• If new symptoms are reported within 4 days after resolution of all previous symptoms, 
they will be considered as part of a single illness and a second illness visit is not required; 
• Surveillance of potential COVID-19 symptoms should continue even if a participant has 
a positive SARS-CoV-2 test earlier in the study. 
If, in the investigator’s opinion, the symptoms are considered more likely to be vaccine 
reactogenicity, but a participant is required to demonstrate that he or she is SARS-CoV-2– 
negative, a local SARS-CoV-2 test may be performed. If the result is positive, the symptoms 
should be recorded as a potential COVID-19 illness; if not, the symptoms should be recorded 
as AEs (unless already captured in the reactogenicity e-diary). 
MIS-C Surveillance: If a participant experiences a hospitalization for a severe illness with 
no other alternative etiology, the participant’s parent(s)/legal guardian is instructed to contact 
the site immediately and participate in an in-person or telehealth visit as soon as possible, 
optimally within 3 days after symptom onset (and at the latest 4 days after symptom 
resolution). Note that if new symptoms are reported within 4 days after resolution of all 
previous symptoms, they will be considered as part of a single illness, and a second illness 
visit is not required. 
COVID-19/MIS-C Surveillance 
The participant or participant’s parent(s)/legal guardian may utilize a COVID-19/MIS-C 
illness e-diary through an app (see Section 8.2.4) installed on a provisioned device or on a 
personal device to report any symptoms listed below. Note that this does not substitute for a 
participant’s routine medical care. Therefore, participants should be encouraged to seek care, 
if appropriate, from their usual provider. 

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• A diagnosis of COVID-19; 
• Fever; 
• New or increased cough; 
• New or increased shortness of breath; 
• Chills; 
• New or increased muscle pain; 
• New loss of taste/smell; 
• Sore throat; 
• Diarrhea; 
• Vomiting. 
In addition, the following symptoms are for participants who are ≤12 years of age: 
• Hospitalization for a severe illness with no other alternative etiology; 
• Hospitalization due to confirmed COVID-19 infection; 
• Inability to eat/poor feeding in participants <5 years of age; 
• Abdominal pain. 
Note that: 
• If new symptoms are reported within 4 days after resolution of all previous symptoms, 
they will be considered as part of a single illness, and a second illness visit is not 
required. 
• Surveillance of potential COVID-19 symptoms should continue even if a participant has 
a positive SARS-CoV-2 test earlier in the study. 
8.11.1. Potential COVID-19/MIS-C Illness Visit (Optimally Within 3 Days After 
Potential COVID-19 Illness Onset) 
This visit may be conducted as an in-person or telehealth visit; a telehealth visit involves the 
sharing of healthcare information and services via telecommunication technologies 
(eg, audio, video, videoconferencing software) remotely, thus allowing the participant or 
participant’s parent(s)/legal guardian and investigator to communicate on aspects of clinical 
care. 

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As a participant’s COVID-19/MIS-C illness may evolve over time, several contacts may be 
required to obtain the following information: 
• Record AEs/SAEs as described in Section 8.3. Symptoms that trigger potential 
COVID-19/MIS-C illness visits (Section 8.11) are expected endpoints and should not be 
recorded as AEs. These data will be captured only on the relevant illness pages of the 
CRF. 
• Record details of medications currently taken and nonstudy vaccinations as described in 
Section 6.8. 
• If the visit is conducted in person, obtain a nasal swab (collected by site staff). 
Alternatively, if conducted by telehealth, instruct the participant to self-collect a nasal 
swab or request the participant’s parent(s)/legal guardian to collect a nasal swab from the 
participant and ship for assessment as instructed. Note: Participants in Mexico will not 
self-collect nasal swabs. 
• Collect COVID-19/MIS-C–related standard-of-care clinical and laboratory information. 
This includes symptoms and signs including, but not limited to: 
• Clinical signs at rest indicative of severe systemic illness: 
• RR (breaths/min) and HR (beats/min) as shown in Table 221 (Section 8.1.1); 
• SpO2 ≤92% on room air or >50% FiO2 to maintain ≥92%, or PaO2/FiO2 
<300 mm Hg)22; 
• Respiratory failure (defined as needing high-flow oxygen, including CPaP/BiPaP, 
noninvasive ventilation, mechanical ventilation, or ECMO); 
• Evidence of shock or cardiac failure: 
• SBP (mm Hg) <70 + (age in years × 2) for age up to 10 years, <90 for age 
≥10 years; or 
• requiring vasoactive drugs to maintain BP in the normal range; 
• Significant acute renal failure (serum creatinine ≥2 times ULN for age or 2-fold 
increase in baseline creatinine); 
• Significant GI/hepatic failure (TBili ≥4 mg/dL or ALT 2 times ULN for age); or 
• Significant neurological dysfunction: Glasgow Coma Scale score ≤11 or acute change 
in mental status with a decrease in Glasgow Coma Scale score ≥3 points from 
abnormal baseline22; 

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• Admission to an ICU; 
• Collect MIS-C data: 
• Additional clinical signs and symptoms related to hematologic, dermatologic, 
and/or other; 
• Any potential cardiac, respiratory, neurological, or GI/hepatic complications; 
• COVID-19 exposure within the 4 weeks prior to the onset of symptoms; 
• Imaging (chest, abdominal, etc), CSF studies, and/or echocardiogram; 
• Clinical diagnosis; 
• Local laboratory SARS-CoV-2 test result(s), including RT-PCR, serology, or antigen 
test. Note that, if it is routine practice to perform a repeat local SARS-CoV-2 test for 
any reason, then a repeat nasal swab should also be obtained and shipped for 
assessment at the central laboratory; 
• Full blood count, blood chemistry, specifically creatinine, urea, LFTs, and CRP, ESR, 
fibrinogen, procalcitonin, D-dimer, ferritin, LDH, or IL-6 if available; 
• Number and type of any healthcare contact; duration of hospitalization and ICU stay; 
• Death. 
• Complete the source documents. 
• The investigator or an authorized designee completes the CRFs. 
8.12. Additional Procedures for Monitoring of Potential Myocarditis or Pericarditis 
Any study participant who reports acute chest pain, shortness of breath, palpitations, or any 
other symptom(s) that might be indicative of myocarditis or pericarditis within 4 weeks after 
a study vaccination should be specifically evaluated, preferably by a cardiologist, for possible 
myocarditis or pericarditis. 
In addition to a clinical evaluation, the following should be performed: 
• ECG and 
• Measurement of the troponin level 

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If myocarditis or pericarditis is suspected based upon the initial evaluation, the following 
should also be performed: 
• Cardiac echocardiogram and/or 
• Cardiac magnetic resonance study 
Details of the symptoms reported, and results of the investigations performed, will be 
recorded in the CRF. 
8.13. Communication and the Use of Technology 
In a study of this nature that requires illness events to be reported outside of scheduled study 
visits, it is vital that communication between the study site and the participant is maintained 
to ensure that endpoint events are not missed. This study will employ various methods, 
tailored to the individual participant, to ensure that communication is maintained and study 
information can be transmitted securely. Using appropriate technology, such as a study app, a 
communication pathway between the participant or participant’s parent(s)/legal guardian and 
the study site staff will be established. The participant or participant’s parent(s)/legal 
guardian may be able to utilize his/her own devices to access this technology, or use a device 
provided by the sponsor. Traditional methods of telephone communication will also be 
available. The technology solution may facilitate the following: 
• Contact with the investigator, including the ability of the participant to report whether or 
not the participant has experienced symptoms that could represent a potential 
COVID-19/MIS-C illness (see in Section 8.11). 
• A platform for recording local reactions and systemic events (reactogenicity e-diary) 
(see Section 8.2.4). 
If a participant or participant’s parent(s)/legal guardian is not actively completing either the 
reactogenicity or COVID-19/MIS-C illness e-diary, the investigator or designee is required to 
contact the participant or participant’s parent(s)/legal guardian to ascertain why and also to 
obtain details of any missed events. 
8.14. SARS-CoV-2 NAAT Results From Visit 1 and Subsequent Vaccination Visits and 
Potential COVID-19 Illness Visits 
Nasal swabs for SARS-CoV-2 NAAT are obtained at: 
• Visit 1 and subsequent vaccination visits: to determine whether a participant has 
serological or virological evidence of past SARS-CoV-2 infection. 
• Potential COVID-19/MIS-C illness visits: to determine whether symptoms experienced 
by the participant fulfill the COVID-19/MIS-C case definition. 

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Research laboratory–generated positive results from the swabs taken at or after Visit 1, and 
all results from the potential COVID-19 illness visit swabs, will be provided to the site once 
available, but this will not be in real time and cannot be relied upon to direct clinical care. 
Therefore, the participant or participant’s parent(s)/legal guardian should be directed to seek 
additional testing through the participant’s primary healthcare providers at a licensed clinical 
laboratory when exhibiting potential COVID-19 symptoms or otherwise receiving a positive 
result and counseled on whether to take any precautionary measures pending confirmatory 
testing. 
Participants who have a positive SARS-CoV-2 NAAT result after Visit 1 should be handled 
as follows: 
• Positive SARS-CoV-2 test with no symptoms, either at or after Visit 1 or any time 
between Visit 1 and subsequent vaccination visits: Subsequent vaccinations should 
proceed as normal. 
• Confirmed COVID-19 (ie, symptoms and positive SARS-CoV-2 test): Subsequent 
vaccination may be given if all other eligibility criteria are met and no temporary delay 
criteria are met, and the participant should remain in the study. 
9. STATISTICAL CONSIDERATIONS 
Methodology for summary and statistical analyses of the data collected in this study is 
described here and further detailed in a SAP, which will be maintained by the sponsor. The 
SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment. 
9.1. Statistical Hypotheses 
There is no statistical hypothesis specified in this study. All statistical analyses will be 
descriptive. 
9.1.1. Estimands 
The estimands corresponding to each primary and exploratory objective are described in the 
table in Section 3. 
The estimands to evaluate the immunogenicity objectives are based on the evaluable 
immunogenicity population (Section 9.2). These estimands estimate the vaccine effect in the 
hypothetical setting where participants follow the study schedules and protocol requirements 
as directed. Missing antibody results will not be imputed. Immunogenicity results that are 
below the LLOQ will be set to 0.5 × LLOQ in the analysis; this may be adjusted once 
additional data on the assay characteristics become available. 
In the primary safety objective evaluations, missing reactogenicity e-diary data will not be 
imputed. Missing AE start dates will be imputed according to Pfizer safety rules. No other 
missing information will be imputed in the safety analysis. 

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9.1.2. Multiplicity Adjustment 
No multiplicity adjustment is needed for the study, as there is no statistical hypothesis. 
9.2. Analysis Sets 
For purposes of analysis, the following analysis sets are defined: 
 
Participant Analysis Set 
Description 
Enrolled 
All participants who have a signed ICD and assent (where 
appropriate). 
Assigned to study 
intervention 
All participants who are assigned an enrollment number in 
the IRT system. 
Dose 3 evaluable 
immunogenicity 
All eligible participants who receive 3 doses of the vaccine 
with Dose 2 and Dose 3 received within the predefined 
window, have at least 1 valid and determinate 
immunogenicity result from the blood sample collected 
within an appropriate window after Dose 3, and have no 
other important protocol deviations as determined by the 
clinician. 
Dose 4 evaluable 
immunogenicity 
All eligible participants who receive 3 doses of the vaccine 
with Dose 2, Dose 3, and Dose 4 received within the 
predefined window, have at least 1 valid and determinate 
immunogenicity result from the blood sample collected 
within an appropriate window after Dose 4, and have no 
other important protocol deviations as determined by the 
clinician. 
All-available 
immunogenicity 
All participants who receive at least 1 dose of the study 
intervention with at least 1 valid and determinate 
immunogenicity result after vaccination. 
Safety 
All participants who receive at least 1 dose of the study 
intervention. 
 
9.3. Statistical Analyses 
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and exploratory 
endpoints. 
9.3.1. General Considerations 
All safety and immunogenicity data will be summarized separately for each disease subset in 
participants ≥18 years of age and for each disease subset in each of the younger age groups 

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(≥2 to <5, ≥5 to <12, and ≥12 to <18 years of age). Analyses for certain cohorts may be 
combined if the number of participants is small. 
CIs for all endpoints in the statistical analysis will be presented as 2-sided at the 95% level 
unless specified otherwise. 
For all the immunogenicity endpoints, the analysis will be based on the evaluable 
immunogenicity population. An additional analysis will be performed based on the 
all-available immunogenicity population if there is a large enough difference in sample size 
between the all-available immunogenicity population and the evaluable immunogenicity 
population. 
The safety analyses will be based on the safety population. 
9.3.1.1. Analysis for Binary Data 
Descriptive statistics for categorical variables (eg, proportions) are the percentage (%), the 
numerator (n) and the denominator (N) used in the percentage calculation, and the 95% CIs 
where applicable. 
The exact 95% CIs for binary endpoints for each group will be computed using the 
F distribution (Clopper-Pearson). 
9.3.1.2. Analysis for Continuous Data 
Unless otherwise stated, descriptive statistics for continuous variables are n, mean, median, 
standard deviation, minimum, and maximum. 
9.3.1.2.1. Geometric Means 
The geometric means will be calculated as the mean of the assay results after making the 
logarithm transformation and then exponentiating the mean to express results on the original 
scale. Two-sided 95% CIs will be obtained by taking log transforms of assay results, 
calculating the 95% CI with reference to Student’s t distribution, and then exponentiating the 
confidence limits. 
9.3.1.2.2. Geometric Mean Fold Rises 
GMFRs are defined as ratios of the results after vaccination to the results before vaccination. 
GMFRs are limited to participants with nonmissing values at both time points. 
GMFRs will be calculated as the mean of the difference of logarithmically transformed assay 
results (later time point minus earlier time point) and exponentiating the mean. The 
associated 2-sided 95% CIs will be obtained by constructing CIs using Student’s 
t distribution for the mean difference on the logarithm scale and exponentiating the 
confidence limits. 

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9.3.1.2.3. Reverse Cumulative Distribution Curve 
Empirical RCDCs will plot proportions of participants with values equal to or exceeding a 
specified assay value versus the indicated assay value, for all observed assay values. Data 
points will be joined by a step function with data points on the left side of the step. 
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis 
 
Endpoint 
Statistical Analysis Methods 
Immunogenicity 
GMT of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 
and 1 month after Dose 4 in participants without serological or 
virological evidence of past SARS-CoV-2 infection 
The GMT of SARS-CoV-2 neutralizing titers at 1 month after Dose 3 
and 1 month after Dose 4, and the associated 2-sided 95% CI, will be 
provided for participants without serological or virological evidence of 
past SARS-CoV-2 infection. 
Statistical methods are described in Section 9.3.1.2.1. 
Safety 
Descriptive statistics will be provided for each reactogenicity endpoint 
for each dose. Local reactions and systemic events from Day 1 
through Day 7 after each vaccination (where Day 1 is the day of 
vaccination) will be presented by severity and cumulatively across 
severity levels. Descriptive summary statistics will include counts and 
percentages of participants with the indicated endpoint and the 
associated Clopper-Pearson 95% CIs (see Section 9.3.1.1). 
AEs and SAEs will be categorized according to MedDRA terms. 
Counts, percentages, and the associated Clopper-Pearson 95% CIs of 
AEs from Dose 1 through 1 month after Dose 2, from Dose 3 through 
1 month after Dose 3, and from Dose 4 through 1 month after Dose 4, 
and SAEs from Dose 1 through the duration of the study will be 
provided. 
 
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis 
Not applicable. 

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9.3.4. Exploratory Endpoint(s)/Estimand(s) Analysis 
 
Endpoint 
Statistical Analysis Methods 
Immunogenicity 
GMTs of SARS-CoV-2 neutralizing titers in participants without 
serological or virological evidence of past SARS-CoV-2 infection 
GMTs and the associated 2-sided 95% CIs will be provided for 
participants with no serological or virological evidence of past 
SARS-CoV-2 infection using the same statistical analysis method 
described above for the primary endpoints at the following time 
points: baseline (before Dose 1), 1 month after Dose 2, 1 month after 
Dose 3, at Dose 4, 1 month and 6 months after Dose 4. Participants’ 
data will be excluded from the time point that the participant has a 
positive or missing NAAT or N-binding result. 
GMFRs of SARS-CoV-2 neutralizing titers in participants without 
serological or virological evidence of past SARS-CoV-2 infection 
GMFRs from before vaccination to 1 month after Dose 2, from before 
vaccination to 1 month after Dose 3, and from Dose 4 to 1 month and 
6 months after Dose 4, and the associated 2-sided 95% CIs, will be 
provided for participants with no serological or virological evidence of 
past SARS-CoV-2 infection. Participants’ data will be excluded from 
the time point that the participant has a positive or missing NAAT or 
N-binding result. 
GMFRs will be limited to participants with nonmissing values prior to 
the vaccination and at the postvaccination time point. The statistical 
methods are described in Section 9.3.1.2.2. 
Percentages of participants with seroresponse in participants 
without serological or virological evidence of past SARS-CoV-2 
infection 
The percentages of participants with seroresponse and the associated 
2-sided 95% Clopper-Pearson CIs will be provided at 1 month after 
Dose 2, 1 month after Dose 3, and 1 month and 6 months after Dose 4. 
Seroresponse is defined as achieving ≥4-fold rise from baseline 
(before Dose 1). If the baseline measurement is below LLOQ, the 
postvaccination measure of ≥4 × LLOQ is considered seroresponse. 
In addition, GMTs, GMFRs, and percentages of participants with 
seroresponse at each time point, along with the associated 95% CI, 

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Endpoint 
Statistical Analysis Methods 
will be provided for participants with and without evidence of past 
SARS-CoV-2 infection using same methods described above. 
Subgroup analyses of immunogenicity endpoints based on various 
time points for Dose 3 administration may be performed. 
Incidence and 
genotypic lineage 
of confirmed 
COVID-19 
Counts, incidence of confirmed COVID-19 cases per 1000 
person-years of follow-up, and the associated 2-sided 95% CIs will be 
provided. 
Summary of genotypic lineage of SARS-CoV-2 will be provided for 
confirmed COVID-19 cases. 
MIS-C incidence 
Counts, incidence of confirmed MIS-C cases per 1000 person-years of 
follow-up, and the associated 2-sided 95% CIs will be provided. 
 
9.4. Interim Analyses 
No formal interim analysis will be conducted for this study. As this is an open-label study, 
the sponsor may conduct reviews of all available data during the course of the study for the 
purpose of safety assessment and/or supporting clinical development. 
9.4.1. Analysis Timing 
Statistical analyses may be carried out when the final data for specified objectives for a 
particular cohort (out of the 7 cohorts; participants ≥18 years of age receiving treatment for 
CLL, NSCLC, end-stage renal disease, and an autoimmune inflammatory disorder; 
participants ≥2 to <5, ≥5 to <12, and ≥12 to <18 years of age) are available: 
• Safety and immunogenicity data through 1 month after Dose 4 from all participants 
within a particular cohort 
• Complete safety and immunogenicity analysis after complete data are available at the end 
of the study 
Analyses may be combined as one if the data become available around the same time. 

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9.5. Sample Size Determination 
The study size is not based on any formal hypothesis test. All statistical analyses will be 
descriptive. 
Table 7 shows the probability of observing at least 1 AE for a given true event rate of a 
particular AE, for various sample sizes based on anticipated enrollment in each subgroup. 
For example, if the true AE rate is 1%, with 60 participants in a group, there is 45% 
probability of observing at least 1 AE. 
 
Table 7. 
Probability of Observing at Least 1 AE by Assumed True Event Rates 
With Different Sample Sizes 
 
Sample Size (N) 
Assumed True Event Rate of an AE 
0.5% 
1% 
2% 
3% 
5% 
7% 
10% 
10 
0.05 
0.09 
0.18 
0.26 
0.40 
0.52 
0.65 
60 
0.26 
0.45 
0.70 
0.84 
0.95 
0.99 
>0.99 
Note: A total of 60 participants are to be vaccinated within each disease subset of participants ≥18 years of 
age; at least 10 participants are to be vaccinated within each disease subset in each younger age group. 

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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
10.1.1. 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 CIOMS International Ethical Guidelines; 
• Applicable ICH GCP guidelines; 
• Applicable laws and regulations, including applicable privacy laws. 
The protocol, protocol amendments, ICD(s), assent(s), SRSD(s), and other relevant 
documents (eg, advertisements) must be reviewed and approved by the sponsor, submitted to 
an IRB/EC by the investigator, and reviewed and approved by the IRB/EC before the study is 
initiated. 
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation 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/EC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/EC; 
• Notifying the IRB/EC of SAEs or other significant safety findings as required by IRB/EC 
procedures; 
• Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 536/2014 for clinical 
studies (if applicable), European Medical Device Regulation 2017/745 for clinical device 
research (if applicable), and all other applicable local regulations. 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP 
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 

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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of. 
10.1.2. Financial Disclosure 
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the study and for 
1 year after completion of the study. 
10.1.3. Informed Consent Process 
The investigator or his/her representative will explain the nature of the study to the 
participant and where appropriate his/her parent(s)/legal guardian and answer all questions 
regarding the study. The participant and where appropriate his/her parent(s)/legal 
guardian should be given sufficient time and opportunity to ask questions and to 
decide whether or not to participate in the trial. 
When consent is obtained from a participant’s parent(s)/legal guardian, the participant’s 
assent (affirmative agreement) must be subsequently obtained when the participant has the 
capacity to provide assent, as determined by the IRB/EC. If the investigator determines that a 
participant’s decisional capacity is so limited he/she cannot reasonably be consulted, then, as 
permitted by the IRB/EC and consistent with local regulatory and legal requirements, the 
participant’s assent may be waived with source documentation of the reason assent was not 
obtained. If the study participant does not provide his or her own assent, the source 
documents must record why the participant did not provide assent (for example, minor child), 
how the investigator determined that the person signing the consent was the 
participant’s parent(s)/legal guardian, the consent signer’s relationship to the study 
participant, and that the participant’s assent was obtained or waived. If assent is obtained 
verbally, it must be documented in the source documents. 
If study participants are minors who reach the age of majority during the study, as recognized 
under local law, they must be reconsented as adults to remain in the study. If the enrollment 
of emancipated minors is permitted by the IRB/EC and local law, they must provide 
documentation of legal status to give consent without the permission of the participant’s 
parent(s)/legal guardian. 
Participants and where appropriate their parent(s)/legal guardian must be informed that their 
participation is voluntary. Participants or where appropriate their parent(s)/legal 
guardians will be required to sign a statement of informed consent that meets the 
requirements of 21 CFR 50, local regulations, ICH guidelines, HIPAA requirements, where 
applicable, and the IRB/EC or study center. 

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The investigator must ensure that each study participant, and where appropriate the 
participant’s parent(s)/legal guardian, is fully informed about the nature and objectives of the 
study, the sharing of data related to the study, and possible risks associated with 
participation, including the risks associated with the processing of the participant’s personal 
data. 
Participants and where appropriate the participants’ parent(s)/legal guardians must be 
informed that the participant’s 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 participants and where appropriate their parent(s)/legal guardians. 
The participants and where appropriate participants’ parent(s)/legal guardians must be 
informed that the participant’s medical records may be examined by Clinical Quality 
Assurance auditors or other authorized personnel appointed by the sponsor, by appropriate 
IRB/EC members, and by inspectors from regulatory authorities. 
The investigator further must ensure that each study participant, and where appropriate the 
participant’s parent(s)/legal guardian, is fully informed about the participant’s right to access 
and correct the participant’s personal data and to withdraw consent for the processing of the 
participant’s personal data, keeping in mind the privacy rights that may restrict access of 
older adolescents’ medical records by their parent(s)/legal guardians in certain regions. 
The source documentation must include a statement that written informed consent, and as 
applicable, assent, was obtained before the participant was enrolled in the study and the date 
the written consent/assent was obtained. The authorized person obtaining the informed 
consent must also sign the ICD. 
Participants, and where appropriate parent(s)/legal guardians, must be reconsented to the 
most current version of the ICD(s)/assent during the participant’s participation in the study. 
A copy of the ICD(s) and assent, if written, must be provided to the parent(s)/legal 
guardian and the participant. 
If participants are rescreened, the participants or where appropriate the participants’ 
parent(s)/legal guardians are required to sign a new ICD/assent (as applicable). 
10.1.4. Data Protection 
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data. 
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password-protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 

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determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law. 
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to his or her actual identity and medical record ID. In case of 
data transfer, the sponsor will protect the confidentiality of participants’ personal data 
consistent with the clinical study agreement and applicable privacy laws. 
10.1.5. Committees Structure 
10.1.5.1. Data Monitoring Committee 
This study will use a DMC. The DMC is independent of the study team and includes a mix of 
internal and external members. The DMC charter describes the role of the DMC in more 
detail. 
The DMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter. The recommendations made by the DMC will be forwarded to 
the appropriate authorized Pfizer personnel for review and final decision. Pfizer will 
communicate such decisions, which may include summaries of aggregate analyses of 
endpoint events and of safety data that are not endpoints, to regulatory authorities, 
investigators, as appropriate. 
10.1.6. Dissemination of Clinical Study Data 
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or 
www.pfizer.com, and other public registries in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted. 
www.clinicaltrials.gov 
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law. 

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EudraCT 
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements. 
www.pfizer.com 
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov. 
Documents within marketing authorization packages/submissions 
Pfizer complies with the EU Policy 0070, the proactive publication of clinical data to the 
EMA website. Clinical data, under Phase 1 of this policy, includes clinical overviews, 
clinical summaries, CSRs, and appendices containing the protocol and protocol amendments, 
sample CRFs, and statistical methods. Clinical data, under Phase 2 of this policy, includes the 
publishing of individual participant data. Policy 0070 applies to new marketing authorization 
applications submitted via the centralized procedure since 01 January 2015 and applications 
for line extensions and for new indications submitted via the centralized procedure since 
01 July 2015. 
Data sharing 
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class. Pfizer will make data from these trials available 
24 months after study completion. Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations. CSRs will have personally identifiable information 
redacted. 
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes. 
10.1.7. Data Quality Assurance 
All participant data relating to the study will be recorded on printed or electronic CRF 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 CRF. 
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document. 

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The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties. 
QTLs are predefined parameters that are monitored during the study. Important deviations 
from the QTLs and any remedial actions taken will be summarized in the CSR. 
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) and 
their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process. 
Monitoring details describing strategy, including definition of study critical data items and 
processes (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, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee. 
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
Records and documents, including signed ICDs and assents (where appropriate), pertaining 
to the conduct of this study must be retained by the investigator for 15 years after study 
completion unless local regulations or institutional policies require a longer retention period. 
No records may be destroyed during the retention period without the written approval of the 
sponsor. No records may be transferred to another location or party without written 
notification to the sponsor. The investigator must ensure that the records continue to be 
stored securely for as long as they are maintained. 
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems. 
The investigator(s) will notify the sponsor or its agents immediately of any regulatory retain 
notification in relation to the study. Furthermore, the investigator will cooperate with the 
sponsor or its agents to prepare the investigator site for the inspection and will allow the 
sponsor or its agent, whenever feasible, to be present during the inspection. The investigator 
site and investigator will promptly resolve any discrepancies that are identified between the 
study data and the participant's medical records. The investigator will promptly provide 
copies of the inspection findings to the sponsor or its agent. Before response submission to 
the regulatory authorities, the investigator will provide the sponsor or its agents with an 
opportunity to review and comment on responses to any such findings. 

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10.1.8. Source Documents 
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 site. 
Data reported on the CRF or entered in the eCRF that are 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. 
Definition of what constitutes source data and its origin can be found in the Study 
Monitoring Plan, which is maintained by the sponsor. 
Description of the use of the computerized system is documented in the Data Management 
Plan, which is maintained by the sponsor. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF 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 guidelines, and all applicable regulatory requirements. 
10.1.9. Study and Site Start and Closure 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date. 
The sponsor 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. 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. 
The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee if requested to do so by the responsible IRB/EC or if such termination is required 
to protect the health of study participants. 

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Reasons for the early closure of a study site by the sponsor may include but are not limited 
to: 
• Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or the ICH GCP 
guidelines; 
• Inadequate recruitment of participants by the investigator; 
• Discontinuation of further study intervention development. 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/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. 
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights. 
10.1.10. Publication Policy 
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after the end of the study 
(or study termination), whichever comes first. 
The investigator agrees to refer to the primary publication in any subsequent publications, 
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 
30 days before submission. This allows the sponsor to protect proprietary information and to 
provide comments, and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study- or Pfizer 
intervention-related information necessary for the appropriate scientific presentation or 
understanding of the study results. 
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors. 
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites. In accordance with standard editorial and ethical practice, the 
sponsor will 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 of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements. 

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If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply. 
10.1.11. Sponsor’s Qualified Medical Personnel 
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study documentation. 
To facilitate access to appropriately qualified medical personnel for study-related medical 
questions or problems, participants are provided with an ECC at the time of informed 
consent. The ECC contains, at a minimum, (a) protocol and study intervention identifiers, (b) 
participant’s study ID number, (c) site emergency phone number active 24 hours/day, 7 days 
per week, and (d) Pfizer Call Center number. 
The ECC is intended to augment, not replace, the established communication pathways 
between the investigator, site staff, and study team. The ECC is to be used by healthcare 
professionals not involved in the research study only, as a means of reaching the investigator 
or site staff related to the care of a participant. The Pfizer Call Center number should only be 
used when the investigator and site staff cannot be reached. The Pfizer Call Center number is 
not intended for use by the participant directly; if a participant calls that number directly, he 
or she will be directed back to the investigator site. 

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10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting 
10.2.1. Definition of AE 
 
AE Definition 
• 
 An AE is any untoward medical occunence in a patient or clinical study 
paiiicipant, temporally associated with the use of study intervention, whether or not 
considered related to the study intervention. 
• 
Note: An AE can therefore be any unfavorable and unintended sign (including an 
abno1mal laborato1y finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention. 
 
 
Events Meeting the AE Definition 
• 
 Any abno1mal laborato1y test results (hematology, clinical chemistiy, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnonnal laborato1y test 
results that meet any of the conditions below must be recorded as an AE: 
• 
Is associated with accompanying symptoms. 
• 
Requires additional diagnostic testing or medicaVsurgical intervention. 
• 
 Leads to a change in study dosing (outside of any protocol-specified dose 
adjustinents) or discontinuation from the study, significant additional 
conc01nitant drng ti·eatinent, or other therapy. 
• 
Exacerbation of a chronic or inte1mittent preexisting condition, including either an 
increase in frequency and/or intensity of the condition. 
• 
New condition detected or diagnosed after study intervention administi·ation, even 
though it may have been present before the staii of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drng-drng interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE or SAE unless it is an intentional overdose taken with possible 

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suicidal/self-hanning intent. Such overdoses should be reported regardless of 
sequelae. 
 
 
Events 
Meeting the AE Definition 
• 
Any clinically significant abno1mal laborato1y findings or other abno1mal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the paiiicipant's condition. 
• 
The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
paiiicipant's condition. 
• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• 
 Situations in which an untowai·d medical occunence did not occur (social and/or 
convenience admission to a hospital). 
• 
 Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the staii of the study that do not worsen. 
 
10.2.2. Definition of an SAE 
 
An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below: 
a. Results in death 
b. Is life-threatening 
The tenn "life-threatening" in the definition of "serious" refers to an event in which the 
paiiicipant was at risk of death at the time of the event. It does not refer to an event that 
hypothetically inight have caused death if it were more severe. 
C.  Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency wai·d for observation 
and/or treatment that would not have been appropriate in the physician's office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 

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serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious. 
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person’s 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), that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
e.  Is a congenital anomaly/birth defect 
f. Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic 
or non-pathogenic, is considered serious. 
The event may be suspected from clinical symptoms or laboratory findings indicating 
an infection in a participant exposed to a Pfizer product. The terms “suspected 
transmission” and “transmission” are considered synonymous. These cases are 
considered unexpected and handled as serious expedited cases by pharmacovigilance 
personnel. Such cases are also considered for reporting as product defects, if 
appropriate. 
g. Other situations: 
• Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations, such as significant 
medical events that may jeopardize the participant or may 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 events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse. 

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10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active 
Collection Period 
 
AE and SAE Recording/Reporting 
The table below summarizes the requirements for recording AEs on the CRF and for 
repo1iing SAEs on the Vaccine SAE Repo1iing F01m to Pfizer Safety throughout the active 
collection period. These requirements are delineated for 3 types of events: (1) SAEs; 
(2) nonserious AEs; and (3) exposure to the study intervention under study during 
pregnancy or breastfeeding, and occupational exposure. 
It should be noted that the Vaccine SAE Repo1iing Fonn for repo1iing of SAE info1mation 
is not the same as the AE page of the CRF. When the same data are collected, the fo1ms 
must be completed in a consistent manner. AEs should be recorded using concise medical 
te1minology and the same AE te1m should be used on both the CRF and the Vaccine SAE 
Repo1iing Fonn for repo1iing of SAE info1mation. 
Safety Event 
Recorded on the CRF 
Reported on the Vaccine 
SAE Reporting Form to 
Pfizer Safety Within 
24 Hours of Awareness 
SAE 
All 
All 
Nonserious AE 
All 
None 
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding. 
All AEs or SAEs associated 
with exposure during 
pregnancy or breastfeeding. 
All instances of EDP are 
repo1ied (whether or not 
there is an associated 
SAE).* 
Note: Instances of EDP or 
EDB not associated with an AE 
or SAE are not captured in the 
CRF. 
All instances of EDB are 
reported (whether or not 
there is an associated 
SAE).** 
Environmental or 
occupational exposure to 
the product under study 
to a non-pa1iicipant (not 
involving EDP or EDB). 
None. Exposure to a study non­ 
participant is not collected on 
the CRF. 
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
repo1ied.*** 
* 
 EDP (with or without an associated AE or SAE): any pregnancy information is repo1ted to Pfizer 
Safety using the Vaccine SAE Repo1ting Fonn and EDP Supplemental Fo1m; if the EDP is associated 
with an SAE, then the SAE is repo1ted to Pfizer Safety using the Vaccine SAE Repo1ting Fonn. 
** EDB is repo1ted to Pfizer Safety using the Vaccine SAE Reporting Form, which would also include 
details of any SAE that might be associated with the EDB. 
*** Environmental or occupational exposure: AEs or SAEs associated with occupational exposure are 
repo1ted to Pfizer Safety using the Vaccine SAE Reporting Form. 

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• When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laborato1y repo1is, and diagnostic 
repo1is) related to the event. 
• The investigator will then record all relevant AE or SAE info1mation in the CRF . 
• It is not acceptable for the investigator to send photocopies of the paiiicipant's 
medical records to Pfizer Safety in lieu of completion of the Vaccine SAE 
Repo1iing Fonn/AE or SAE CRF page. 
• There may be instances when copies of medical records for ce1iain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the paiiicipant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety. 
•  The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical info1mation. Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE or SAE. 
Assessment of Intensity 
The investigator will make an assessment of intensity for each AE and SAE repo1ied 
during the study and assign it to 1 of the following categories: 
GRADE 
If required on the AE page of the CRF, the investigator will use the 
adjectives MILD, MODERATE, SEVERE, or LIFE-THREATENING to 
describe the maximum intensity of the AE. For pmposes of consistency, 
these intensity grades are defined as follows: 
1 
MILD 
Does not interfere with paiiicipant's usual 
function. 
2 
MODERATE 
Interferes to some extent with paiiicipant's usual 
function. 
3 
SEVERE 
Interferes significantly with paiiicipant's usual 
function. 
4 
LIFE-THREATENING 
Life-threatening consequences; urgent 
intervention indicated. 

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Assessment of Causality 
• 
The investigator is obligated to assess the relationship between study intervention 
and each occmTence of each AE or SAE. The investigator will use clinical 
judgment to detennine the relationship. 
• 
A "reasonable possibility" of a relationship conveys that there are facts, evidence, 
and/or argmnents to suggest a causal relationship, rather than a relationship cannot 
be rnled out. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administrntion, will be considered and investigated. 
• 
The investigator will also consult the IB and/or product infonnation, for marketed 
products, in his/her assessment. 
• 
For each AE or SAE, the investigator !!!!!.U docUillent in the medical notes that 
he/she has reviewed the AE or SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occmTed, and the investigator has 
minimal info1mation to include in the initial repo1i to the sponsor. However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to the sponsor. 
• 
The investigator may change his/her opinion of causality in light of follow-up 
info1mation and send an SAE follow-up report with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when dete1mining regulato1y 
repo1iing requirements. 
• 
 If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as "related to study intervention" for repo1iing 
pmposes, as defined by the sponsor. In addition, if the investigator dete1mines that 
an SAE is associated with study procedmes, the investigator must record this 
causal relationship in the somce docUillents and CRF, and report such an 
assessment in the dedicated section of the Vaccine SAE Repo1iing Fonn and in 
accordance with the SAE repo1iing requirements. 

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Follow-Up of AEs and SAEs 
• 
 The investigator is obligated to perfonn or aiTange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor, to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laborato1y tests or investigations, 
histopathological exaininations, or consultation with other healthcare providers. 
• 
If a paiiicipant dies during paiiicipation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmo1iem findings, including histopathology. 
• 
New or updated infonnation will be recorded in the originally submitted 
documents. 
• 
The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the infonnation. 
 
 
10.2.4. Reporting of SAEs 
 
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool 
• 
The primaiy mechanism for reporting a SAE to Pfizer Safety will be the electronic 
data collection tool. 
• 
 If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) to repo1i the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as the data 
become available. 
• 
After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entiy of new data or changes to existing data. 
• 
 If a site receives a report of a new SAE from a study paiiicipant or receives updates 
data on a previously repo1ied SAE after the electi·onic data collection tool has been 
taken offline, then the site can repo1i this infonnation on paper SAE fo1m (see next 
section (or to Pfizer Safety by telephone). 

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SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form 
• 
Facsimile transmission of the Vaccine SAE Repo1iing Fonn is the prefe1Ted 
method to transmit this info1mation to Pfizer Safety. 
• 
In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Repo1iing Fo1m sent by overnight mail 
or con . r serv.ce. 
ne 
i 
• 
 Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Repo1iing Fonn pages within the designated 
repo1iing time frames. 

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10.3. Appendix 3: Contraceptive and Barrier Guidance 
10.3.1. Male Participant Reproductive Inclusion Criteria 
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 28 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s): 
• Refrain from donating sperm. 
PLUS either: 
• Be abstinent from heterosexual intercourse with a female of childbearing potential as 
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and 
agree to remain abstinent. 
OR 
• Must agree to use contraception/barrier as detailed below: 
• Agree to use a male condom and should also be advised of the benefit for a female 
partner to use a highly effective method of contraception, as a condom may break or 
leak when having sexual intercourse with a woman of childbearing potential who is 
not currently pregnant. 
• In addition to male condom use, a highly effective method of contraception may be 
considered in WOCBP partners of male participants (refer to the list of highly 
effective methods below in Section 10.3.4). 
10.3.2. Female Participant Reproductive Inclusion Criteria 
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies: 
• Is not a WOCBP (see definitions below in Section 10.3.3). 
• OR 
• Is a WOCBP and using an acceptable contraceptive method as described below during 
the intervention period (for a minimum of 28 days after the last dose of study 
intervention). The investigator should evaluate the effectiveness of the contraceptive 
method in relationship to the first dose of study intervention. 
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 

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10.3.3. Woman of Childbearing Potential 
A female participant is 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 the first dose of study intervention, additional evaluation should be 
considered. 
Female participants in the following categories are not considered WOCBP: 
1. Premenarchal. 
2. Premenopausal female with 1 of the following: 
• Documented hysterectomy; 
• Documented bilateral salpingectomy; 
• Documented bilateral oophorectomy. 
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry. 
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study. 
3. Postmenopausal female: 
• A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition: 
• A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 
• A female on HRT and whose menopausal status is in doubt will be required to use 
one of the non-estrogen 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. 

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10.3.4. Contraception Methods 
Contraceptive use by male or female participants should be consistent with local 
availability/regulations regarding the use of contraceptive methods for those participating in 
clinical trials. 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation. 
2. Intrauterine device. 
3. Intrauterine hormone-releasing system. 
4. Bilateral tubal occlusion (eg, bilateral tubal ligation). 
5. Vasectomized partner: 
• A vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the woman of childbearing potential and the 
absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used. The spermatogenesis cycle is approximately 90 days. 
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation: 
• Oral; 
• Intravaginal; 
• Transdermal. 
7. Progestogen-only hormone contraception associated with inhibition of ovulation: 
• Oral; 
• Injectable. 
8. Sexual abstinence: 
• Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant. 
9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action. 

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10. Male or female condom with or without spermicide. 
11. Cervical cap, diaphragm, or sponge with spermicide. 
12. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods). 
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments 
Potential Cases of Drug-Induced Liver Injury 
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.” 
LFTs are not required as a routine safety monitoring procedure in this study. However, 
should an investigator deem it necessary to assess LFTs because a participant presents with 
clinical signs/symptoms, such LFT results should be managed and followed as described. 
In the majority of DILI cases, elevations in AST and/or ALT precede TBili elevations 
(>2 × ULN) by several days or weeks. The increase in TBili typically occurs while AST/ALT 
is/are still elevated above 3 × ULN (ie, AST/ALT and TBili values will be elevated within 
the same laboratory sample). In rare instances, by the time TBili elevations are detected, 
AST/ALT values might have decreased. This occurrence is still regarded as a potential DILI. 
Therefore, abnormal elevations in either AST OR ALT in addition to TBili that meet the 
criteria outlined below are considered potential DILI (assessed per Hy’s law criteria) cases 
and should always be considered important medical events, even before all other possible 
causes of liver injury have been excluded. 
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values: 
• Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value >2 × ULN 
with no evidence of hemolysis and an alkaline phosphatase value <2 × ULN or not 
available. 
• For participants with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline: 

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• Preexisting AST or ALT baseline values above the normal range: AST or ALT values 
>2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is smaller). 
• Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches >3 × ULN 
(whichever is smaller). 
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and TBili for suspected Hy’s law 
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a co-formulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of serum 
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities. 
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology. 

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10.5. Appendix 5: Genetics 
Use/Analysis of DNA and/or RNA 
• Genetic variation may impact a participant’s response to study intervention, as well as 
susceptibility to, and severity and progression of disease. Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA and/or RNA 
analysis. 
• The results of genetic analyses may be reported in a CSR or in a separate study summary, 
or may be used for internal decision making without being included in a study report. 
• The sponsor will store the DNA and/or RNA samples in a secure storage space with 
adequate measures to protect confidentiality. 
• The samples will be retained as indicated: 
o Samples for specified genetic analysis (see Section 8.5) will be stored for up to 
15 years or other period as per local requirements. 
• Samples for genetic research will be labeled with a code. The key between the code and 
the participant’s personally identifying information (eg, name, address) will be held 
securely at the study site. 

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10.6. Appendix 6: Alternative Measures During Public Emergencies 
10.6.1. Telehealth Visits 
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the SoA or unscheduled 
visits. Telehealth visits may be used to continue to assess participant safety and collect data 
points. Telehealth includes the exchange of healthcare information and services via 
telecommunication technologies (eg, audio, video, videoconferencing software) remotely, 
allowing the participant and the investigator to communicate on aspects of clinical care, 
including medical advice, reminders, education, and safety monitoring. Every effort should 
be made to bring the study participant to their scheduled visit. If the participant or 
participant’s parent(s)/legal guardian is unable to, as a minimum, the following 
assessments must be performed during a telehealth visit: 
• Review and record study intervention(s), including compliance and missed doses. 
• Review and record any AEs and SAEs since the last contact. Refer to Section 8.3. 
• Review and record any new concomitant medications or changes in concomitant 
medications since the last contact. 
• Review and record contraceptive method and results of pregnancy testing. Confirm that 
the participant is adhering to the contraception method(s) required in the protocol. Refer 
to Appendix 3 regarding pregnancy tests. 
Study participants or their parent(s)/legal guardians must be reminded to promptly notify site 
staff about any change in the participant’s health status. 

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10.7. Appendix 7: Protocol Amendment History 
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the table of contents. The protocol amendment summary of changes tables for 
past amendment(s) can be found below: 
Amendment 4 (21 January 2022) 
Overall Rationale for the Amendment: Updating procedures to allow a fourth dose 
(booster), reducing the window for provision of Dose 3, and allowing vaccination with the 
age-appropriate dose 
 
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1 – Synopsis, 
Section 1.3 – Schedule of 
Activities, 
Section 4.1 – Overall 
Design, 
Section 4.3 – Justification 
for Dose, and 
Section 6: Study 
Intervention(s) and 
Concomitant Therapy 
Section 8.9 – Study 
Procedures 
• Added a fourth dose 
(booster), and 1 and 6 
months post-Dose 3 
visits, with associated 
objectives 
• Reduced the Visit 5 
window for provision of 
Dose 3 
• Clarified that if Visit 4 
and Visit 5 occur on the 
same day, duplicate 
procedures need not be 
conducted 
• Updated procedures to 
allow vaccination with 
the age-appropriate dose 
• In line with regulatory 
recommendations for 
providing third/fourth 
doses of BNT162b2 to 
immunocompromised 
individuals 
Section 1.3 – Schedule of 
Activities 
• Removed 
immunogenicity blood 
collection at Visit 5 and 
Visit 6 
• Removed PBMC 
collection at Visit 5 and 
Visit 7 
• Updated Visit 6 to allow 
conducting via telephone 
for participants not in 
the PBMC subset 
• To streamline the 
schedule of visits and 
blood draws, taking into 
account the fixed timing 
of Dose 3 and the 
addition of a fourth dose 
(booster) 
Section 9.2 – Analysis Sets 
Section 9.3 – Statistical 
Analyses 
• Clarified the definition 
of Dose 3 and Dose 4 
evaluable 
immunogenicity analysis 
sets 
• In line with regulatory 
recommendations for 
providing third/fourth 
doses of BNT162b2 to 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.4 – Interim 
Analyses 
• Updated wording to 
align with the modified 
objectives and endpoints 
• Removed the analysis 
timing at 1 month after 
Dose 2 and added the 1 
month after Dose 4 
analysis 
immunocompromised 
individuals 
Section 10.2.4 – Reporting 
of SAEs 
• Added a mechanism for 
reporting SAEs 
electronically 
• To allow multiple routes 
to report SAEs 
 
Amendment 3 (15 September 2021) 
Overall Rationale for the Amendment: To remain in alignment with changing regulatory 
guidance on administering Dose 3 
 
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1 – Synopsis, 
Section 1.3 – Schedule of 
Activities, 
Section 4.1 – Overall 
Design, 
Section 4.3 – Justification 
for Dose, and 
Section 8.9 – Study 
Procedures 
• Updated the Visit 5 
window to allow its 
occurrence as early as 
28 days after Visit 2 
• Clarified that if Visit 4 
and Visit 5 occur on the 
same day, duplicate 
procedures need not be 
conducted; Visit 5 
immunogenicity blood 
draws are not required in 
this circumstance 
• In line with regulatory 
recommendations for 
providing a third dose of 
BNT162b2 to 
immunocompromised 
individuals 
Section 9.3.4 – Exploratory 
Endpoint(s)/Estimand(s) 
Analysis 
• Updated wording to 
allow subgroup analysis 
of immunogenicity 
endpoints based on 
various time points for 
Dose 3 administration 
• This analysis may be 
performed in line with 
regulatory 
recommendations for 
providing a third dose of 
BNT162b2 to 
immunocompromised 
individuals, as the 
vaccination window may 
vary 

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Amendment 2 (05 August 2021) 
Overall Rationale for the Amendment: As individuals with compromised immune systems 
are at significant risk of morbidity and mortality due to SARS-CoV-2 infection, it is 
imperative that the safety, tolerability, and immune response to vaccination among these 
individuals be investigated. Therefore, the conditions for study participants ≥18 years of age 
include NSCLC, CLL, hemodialysis treatment secondary to end-stage renal disease, and 
participants ≥2 to <18 years of age with representative conditions, including those with 
inflammatory and autoimmune inflammatory disorders receiving immunomodulators, those 
who have undergone organ transplant and are receiving maintenance antirejection 
modulators, and those who have undergone bone marrow or stem cell transplant. 
The changes in this amendment include the removal of the upper age limit for the cohort of 
participants on active immunomodulator therapy (eg, TNFα inhibitors, tofacitinib, or MTX) 
for an autoimmune inflammatory disorder (eg, inflammatory arthritis, such as rheumatoid 
arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, 
such as ulcerative colitis and Crohn’s disease) and the addition of risks associated with 
myocarditis and pericarditis as well as their subsequent unplanned visits, as committed to 
CBER. 
 
Section # and Name 
Description of Change 
Brief Rationale 
Section 2.3.1 – Risk 
Assessment 
• Updated the risk 
assessment for 
participants in this study 
• Risk assessment has 
been further informed, 
including the very rare 
cases of myocarditis, 
pericarditis, and 
anaphylaxis reported 
after authorization in 
recipients of BNT162b2 
Section 3 – Objectives, 
Endpoints, and Estimands 
• Added primary and 
exploratory safety, 
tolerability, and immune 
response objectives for 
the expanded cohort of 
participants on active 
immunomodulator 
therapy 
• This update has been 
implemented to allow 
the expanded cohort to 
follow the same primary 
and exploratory 
objectives as the other 
cohorts in the study 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 4.1 – Overall Design • Clarified wording on 
participants in the cohort 
who are taking active 
immunomodulator 
therapy 
• This update clearly 
documents the intended 
therapies for participants 
who are part of this 
cohort 
Section 5 – Study 
Population 
• Clarified wording on 
diversity of recruitment 
• This addition will enable 
collection of race and 
ethnicity data in 
prescreeners 
Section 5.1 – Inclusion 
Criteria 
• Clarified wording on 
inclusion criterion 4 to 
specify that the 
participant or 
participant’s 
parent(s)/legal 
guardians, as age 
appropriate, need to be 
able to be contacted by 
telephone throughout the 
study 
• This update clearly 
documents the intended 
criterion for participants 
to meet in order to be 
enrolled into this study 
Section 6.8.1 – Prohibited 
During the Study 
• Included explanatory 
text on the removal of 
prohibition on 
concomitant 
vaccinations within 
28 days before and after 
vaccination with 
BNT162b2 
• This update has been 
implemented in line with 
CDC guidelines as of 
June 2021 
Section 6.8.2 – Permitted 
During the Study 
• Inserted text to allow 
flexibility of 
immunomodulator 
administration before 
and after vaccination 
with BNT162b2 
• This update has been 
implemented to clarify 
that the alteration of 
immunomodulator 
administration is 
permitted according to 
local guidelines 
Section 8 – Study 
Assessments and Procedures 
• Expanded the subset of 
participants participating 
in PBMC collection 
• This update has been 
implemented to allow 
the expanded cohort to 
follow similar 
procedures to other 
participants who have 
consented to PBMC 
collection 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 8.3.8 – Adverse 
Events of Special Interest 
• Added myocarditis and 
pericarditis 
• This update has been 
implemented in response 
to commitments made to 
CBER 
Section 8.9 – Study 
Procedures 
• Added a visit procedure 
to any visit that occurs 
sooner than 1 month 
after any vaccination 
requesting that 
participants or 
participant’s 
parent(s)/legal guardian 
to contact site staff or 
the investigator if the 
participant experiences 
acute chest pain, 
shortness of breath, or 
palpitations 
• This update has been 
implemented in response 
to commitments made to 
CBER 
Section 8.12 – Additional 
Procedures for Monitoring 
of Potential Myocarditis or 
Pericarditis 
• Added an unplanned 
visit to capture data 
pertaining to myocarditis 
and pericarditis 
• This visit has been 
implemented in response 
to commitments made to 
CBER 
Section 9.4.1 – Analysis 
Timing 
• Updated wording to 
reflect the addition of 
the new cohort of 
participants ≥18 years of 
age receiving treatment 
for an autoimmune 
inflammatory disorder 
• This update clearly 
reflects the new number 
of cohorts in the study 
Section 10.7 – Appendix 7: 
Protocol Amendment 
History 
• Added Appendix 7 to 
include the protocol 
amendment history and 
moved the Protocol 
Amendment Summary 
of Changes Table for 
Protocol Amendment 1 
from the beginning of 
the document to this new 
section 
• This update ensures only 
the latest Protocol 
Amendment Summary 
of Changes Table for the 
current amendment is 
located directly before 
the table of contents 

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Amendment 1 (24 June 2021) 
Overall Rationale for the Amendment: Addition of dose levels for participants ≥5 to <12 
and <5 years of age 
 
Section # and Name 
Description of Change 
Brief Rationale 
Section 2.3 – Benefit/Risk 
Assessment 
• Added safety text 
indicating that no 
specific safety concerns 
were identified by 
subgroup analysis by 
age, race, ethnicity, 
medical comorbidities, 
or prior SARS-CoV-2 
infection 
• Benefit/risk assessment 
has been further 
informed by the 
C4591001 study data 
Section 3 – Objectives, 
Endpoints, and Estimands 
• Removed the 
exploratory objective to 
describe viral shedding 
in line with the removal 
of the convalescent visit 
• As the convalescent visit 
will no longer be 
conducted, the swabs 
intended for this 
exploratory analysis will 
no longer be collected 
Section 5.2 – Exclusion 
Criteria 
• Added the exclusion 
criterion for participants 
with insufficient deltoid 
muscle mass 
• This exclusion criterion 
was added to ensure 
participant safety, so that 
those with insufficient 
muscle mass are not 
vaccinated 
Section 5.5 – Criteria for 
Temporarily Delaying 
Enrollment/Randomization/ 
Administration of Study 
Intervention 
• Clarified that symptoms 
indicative of COVID-19 
illness, in the opinion of 
the investigator, meet 
the criteria for 
temporarily delaying 
vaccine administration 
• This clarification was 
added in line with other 
C459 program studies 
Section 6 – Study 
Intervention(s) and 
Concomitant Therapy 
• Clarified that study age 
groups are assigned by 
age at Visit 1; 
participants will receive 
the same dose level at all 
3 vaccination visits 
• This clarification was 
added in response to 
Investigator questions 
Section 6.1 – Study 
Intervention(s) 
Administered 
• Added the 10-µg dose 
level for participants ≥5 
to <12 years of age 
• This dose level was 
determined by data from 
the C4591007 study 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 6.1 – Study 
Intervention(s) 
Administered 
• Added the 3-µg dose 
level for participants 
<5 years of age 
• This dose level was 
determined by data from 
the C4591007 study 
Section 8.9 – Study 
Procedures 
• Clarified visit 
procedures for 
participants in the 
PBMC subset 
• Clarification was added 
that the PBMC blood 
draw (and inclusion in 
the PBMC subset) is 
only for those 
participants who are 
eligible and have 
consented to this 
procedure 
Section 8.9.3 – Visit 3 – 
1-Week Follow-up Visit 
(After Vaccination 2) (6 to 
8 Days After Visit 2) 
• Added wording to allow 
Visit 3 to be conducted 
via telehealth for 
participants not in the 
PBMC subset 
• As in-person procedures 
are not required for these 
participants at Visit 3, 
this visit may be 
conducted via telehealth 
Section 8.11.1 – Potential 
COVID-19/MIS-C 
Convalescent Visit (28 to 
35 Days After Potential 
COVID-19 Illness Visit) 
• Removed the 
requirement to conduct a 
potential 
COVID-19/MIS-C 
convalescent visit 
following each 
COVID-19/MIS-C 
illness visit 
• Sufficient data were 
collected in Study 
C4591001 
Section 9.2 – Analysis Sets 
• Clarified that 
participants are not 
randomized 
• As this is an open-label 
study and study 
intervention will be 
assigned to participants, 
no randomization will 
occur 
Section 9.4 – Interim 
Analyses 
• Clarified that, as this is 
an open-label study, the 
sponsor may conduct 
reviews of all available 
safety and 
immunogenicity data 
during the course of the 
study 
• This update clearly 
documents the intended 
data reviews during the 
study 
Section 9.4 – Interim 
Analyses 
• Clarified that no formal 
interim analysis will be 
conducted for this study, 
but analyses may be 
• This update clearly 
documents the intended 

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Section # and Name 
Description of Change 
Brief Rationale 
carried out when the 
final data for specified 
objectives for a 
particular cohort (out of 
the 6 cohorts; 
participants ≥18 years of 
age receiving treatment 
for CLL, NSCLC, and 
end-stage renal disease; 
participants ≥2 to <5, ≥5 
to <12, and ≥12 to 
<18 years of age) are 
available 
data analyses during the 
study 
Section 9.4.1 – Analysis 
Timing 
• Removed the analysis at 
7 days after Dose 3 
• Analysis is being 
conducted 1 month after 
Dose 3, which is a more 
appropriate timepoint to 
look at responses 
following vaccination in 
an immunosuppressed 
population 

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10.8. Appendix 8: Abbreviations 
The following is a list of abbreviations that may be used in the protocol. 
 
Abbreviation 
Term 
AE 
adverse event 
AESI 
adverse event of special interest 
ALK 
anaplastic lymphoma kinase 
ALT 
alanine aminotransferase 
app 
application 
ARDS 
adult respiratory distress syndrome 
AST 
aspartate aminotransferase 
BCL-2 
B-cell lymphoma-2 
BCR 
B-cell receptor 
BiPaP 
bilevel positive airway pressure 
BNP 
brain natriuretic peptide 
BP 
blood pressure 
BRAF 
v-raf murine sarcoma viral oncogene homolog B1 
BTK 
Bruton tyrosine kinase 
CBER 
Center for Biologics Evaluation and Research 
CD20 
B-lymphocyte antigen CD20 
CDC 
Centers for Disease Control and Prevention (United States) 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CK 
creatine kinase 
CLL 
chronic lymphocytic leukemia 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
coronavirus disease 2019 
CPaP 
continuous positive airway pressure 
CRF 
case report form 
CRO 
contract research organization 
CRP 
C-reactive protein 
CSF 
cerebrospinal fluid 
CSR 
clinical study report 
CTLA-4 
cytotoxic T-lymphocyte–associated protein 4 
CVA 
cerebrovascular accident 
DBP 
diastolic blood pressure 
DILI 
drug-induced liver injury 
DMC 
data monitoring committee 
DNA 
deoxyribonucleic acid 
EC 
ethics committee 

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Abbreviation 
Term 
ECC 
emergency contact card 
ECG 
electrocardiogram 
ECLIA 
electrochemiluminescence immunoassay 
ECMO 
extracorporeal membrane oxygenation 
eCRF 
electronic case report form 
EDB 
exposure during breastfeeding 
e-diary 
electronic diary 
EDP 
exposure during pregnancy 
EGFR 
epidermal growth factor receptor 
EMA 
European Medicines Agency 
ESR 
erythrocyte sedimentation rate 
EU 
European Union 
EUA 
emergency use authorization 
EudraCT 
European Clinical Trials Database 
FDA 
Food and Drug Administration 
FiO2 
fraction of inspired oxygen 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase 
GI 
gastrointestinal 
GMFR 
geometric mean fold rise 
GMT 
geometric mean titer 
GVHD 
graft-vs-host disease 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HLA 
human leukocyte antigen 
HR 
heart rate 
HRT 
hormone replacement therapy 
IB 
investigator’s brochure 
ICD 
informed consent document 
ICH 
International Council for Harmonisation 
ICU 
intensive care unit 
ID 
identification 
IgG 
immunoglobulin G 
IL-6 
interleukin 6 
IMP 
investigational medicinal product 
IND 
investigational new drug 
INR 
international normalized ratio 
IP manual 
investigational product manual 

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Abbreviation 
Term 
IPAL 
Investigational Product Accountability Log 
IRB 
institutional review board 
IRT 
interactive response technology 
IV 
intravenous(ly) 
LDH 
lactate dehydrogenase 
LFT 
liver function test 
LLOQ 
lower limit of quantitation 
LNP 
lipid nanoparticle 
MedDRA 
Medical Dictionary for Regulatory Activities 
MET 
hepatocyte growth factor receptor 
MHRA 
Medicines and Healthcare Products Regulatory Agency 
MIS-C 
multisystem inflammatory syndrome in children 
modRNA 
nucleoside-modified messenger ribonucleic acid 
mRNA 
messenger ribonucleic acid 
MTX 
methotrexate 
N 
SARS-CoV-2 nucleoprotein 
N/A 
not applicable 
NAAT 
nucleic acid amplification test 
NIMP 
noninvestigational medicinal product 
NSAID 
nonsteroidal anti-inflammatory drug 
NSCLC 
non–small cell lung cancer 
NTRK 
neurotrophic tyrosine kinase (gene) 
PACL 
protocol administrative change letter 
PaO2 
partial pressure of oxygen, arterial 
PASS 
postauthorization safety study 
PBMC 
peripheral blood mononuclear cell 
PCR 
polymerase chain reaction 
PD-1 
programmed cell death protein 1 
PD-L1 
programmed death-ligand 1 
PI 
principal investigator 
PI3K 
phosphoinositide 3-kinase 
PPE 
personal protective equipment 
PT 
prothrombin time 
PTLD 
posttransplant lymphoproliferative disorder 
QTL 
quality tolerance limit 
RCDC 
reverse cumulative distribution curve 
RET 
rearranged during transfection 
RMP 
risk management plan 
RNA 
ribonucleic acid 
ROS1 
[gene encoding] proto-oncogene tyrosine-protein kinase 
RR 
respiratory rate 

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Abbreviation 
Term 
RSV 
respiratory syncytial virus 
RT-PCR 
reverse transcription–polymerase chain reaction 
S1 
spike protein S1 subunit 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SBP 
systolic blood pressure 
SoA 
schedule of activities 
SOP 
standard operating procedure 
SpO2 
oxygen saturation as measured by pulse oximetry 
SRSD 
single reference safety document 
SUSAR 
suspected unexpected serious adverse reaction 
TBili 
total bilirubin 
TCR 
T-cell receptor 
Th1 
T-helper type 1 
TNFα 
tumor necrosis factor alpha 
UK 
United Kingdom 
ULN 
upper limit of normal 
US 
United States 
Vax 
vaccination 
VE 
vaccine efficacy 
WHO 
World Health Organization 
WOCBP 
woman/women of childbearing potential 

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11. REFERENCES 
 
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Pfizer and BioNTech. Vaccines and Related Biological Products Advisory Committee 
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Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and immunogenicity of two 
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Feldstein LR, Rose EB, Horwitz SM, et al; Overcoming COVID-19 Investigators and 
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Dufort EM, Koumans EH, Chow EJ, et al. Multisystem inflammatory syndrome in 
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Ma L, Zhang YY, Yu HG. Clinical manifestations of Kawasaki disease shock syndrome. 
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Li Y, Zheng Q, Zou L, et al. Kawasaki disease shock syndrome: clinical characteristics 
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Godfred-Cato S, Bryant B, Leung J, et al. COVID-19–associated multisystem 
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Verdoni L, Mazza A, Gervasoni A, et al. An outbreak of severe Kawasaki-like disease at 
the Italian epicentre of the SARS-CoV-2 epidemic: an observational cohort study. 
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Toubiana J, Poirault C, Corsia A, et al. Kawasaki-like multisystem inflammatory 
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Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): 
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Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA 
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Fleming S, Thompson M, Stevens R, et al. Normal ranges of heart rate and respiratory 
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https://www.cdc.gov/mis-c/hcp/. Accessed: 09 Dec 2020. 

 
 
Document Approval Record 
 
 
C4591024 Protocol Amendment 5 Clean Copy, 13 Jan 2023 
 
A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, T 
OLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE 
BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ೦2 YEARS 
OF AGE 
 
Signed By: 
Date(GMT) 
Signing Capacity 
PPD 
 
13-Jan-2023 15:18:58 
Final Approval 
PPD 
 
13-Jan-2023 16:56:02 
Final Approval 
PPD 
 
16-Jan-2023 14:16:24 
EUQPPV Approval 
 
Document Name: 
Document Title: