A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER
Phase: PHASE3
Conditions: Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection
Sponsor: Pfizer

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO DESCRIBE THE 
SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL 
CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE
OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER
Study Intervention Numbers:
PF-06482077
PF-07302048
Study Intervention Names:
20-valent Pneumococcal Conjugate Vaccine 
(20vPnC)
BNT162b2 RNA-Based COVID-19 Vaccine
US IND Numbers:
EudraCT Number:
N/A
Protocol Number:
B7471026
Phase:
3
Brief Title: A Phase 3 Safety and Immunogenicity Study of 20vPnC When 
Coadministered With a Booster Dose of BNT162b2
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.
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Document History
Document
Version Date
Original protocol
08 April 2021

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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
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Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................8
1. PROTOCOL SUMMARY.....................................................................................................9
1.1. Synopsis ....................................................................................................................9
1.2. Schema ....................................................................................................................13
1.3. Schedule of Activities .............................................................................................14
2. INTRODUCTION ...............................................................................................................16
2.1. Pneumococcal Disease ............................................................................................16
2.2. Vaccines to Prevent Pneumococcal Disease ...........................................................16
2.2.1. Pneumococcal Polysaccharide Vaccines....................................................16
2.2.2. Pneumococcal Polysaccharide Conjugate Vaccines...................................17
2.3. Development of 20vPnC .........................................................................................18
2.4. Indication.................................................................................................................19
2.5. Coronavirus Disease 2019 (COVID-19).................................................................19
2.6. Study Rationale .......................................................................................................20
2.7. Background .............................................................................................................20
2.7.1. Clinical Overview.......................................................................................21
2.8. Benefit/Risk Assessment.........................................................................................21
2.8.1. Risk Assessment.........................................................................................23
2.8.2. Benefit Assessment.....................................................................................25
2.8.3. Overall Benefit/Risk Conclusion................................................................25
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................25
4. STUDY DESIGN.................................................................................................................26
4.1. Overall Design.........................................................................................................26
4.2. Scientific Rationale for Study Design.....................................................................28
4.2.1. Diversity of Study Population ....................................................................28
4.2.2. Choice of Contraception/Barrier Requirements .........................................28
4.3. Justification for Dose ..............................................................................................29
4.4. End of Study Definition ..........................................................................................29
5. STUDY POPULATION......................................................................................................29
5.1. Inclusion Criteria.....................................................................................................29

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5.2. Exclusion Criteria....................................................................................................31
5.3. Lifestyle Considerations..........................................................................................32
5.3.1. Contraception..............................................................................................32
5.4. Screen Failures ........................................................................................................33
5.5. Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention...........................33
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................33
6.1. Study Intervention(s) Administered........................................................................33
6.1.1. Administration............................................................................................34
6.1.2. Medical Devices .........................................................................................35
6.2. Preparation, Handling, Storage, and Accountability...............................................35
6.2.1. Preparation and Dispensing........................................................................36
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................37
6.3.1. Allocation to Study Intervention ................................................................37
6.3.2. Blinding of Site Personnel..........................................................................37
6.3.3. Blinding of the Sponsor..............................................................................38
6.3.4. Breaking the Blind......................................................................................38
6.4. Study Intervention Compliance...............................................................................38
6.5. Dose Modification...................................................................................................39
6.6. Continued Access to Study Intervention After the End of the Study......................39
6.7. Treatment of Overdose............................................................................................39
6.8. Concomitant Therapy..............................................................................................39
6.8.1. Prohibited During the Study.......................................................................39
6.8.2. Permitted During the Study ........................................................................40
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................40
7.1. Discontinuation of Study Intervention ....................................................................40
7.2. Participant Discontinuation/Withdrawal From the Study.......................................40
7.2.1. Withdrawal of Consent...............................................................................41
7.3. Lost to Follow-Up ...................................................................................................42
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................42

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8.1. Efficacy and/or Immunogenicity Assessments .......................................................43
8.1.1. Immunogenicity Assessments ....................................................................43
8.1.2. Biological Samples.....................................................................................44
8.2. Safety Assessments .................................................................................................44
8.2.1. Participant Electronic Diary .......................................................................44
8.2.2. Grading Scale for Prompted Events ...........................................................45
8.2.2.1. Local Reactions.........................................................................45
8.2.2.2. Systemic Events – Systemic Symptoms and Fever...................46
8.2.2.3. Use of Antipyretic/Pain Medication..........................................48
8.2.3. Clinical Safety Laboratory Assessments ....................................................48
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................48
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......49
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................49
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................50
8.3.2. Method of Detecting AEs and SAEs ..........................................................50
8.3.3. Follow-Up of AEs and SAEs......................................................................50
8.3.4. Regulatory Reporting Requirements for SAEs...........................................50
8.3.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................51
8.3.5.1. Exposure During Pregnancy......................................................51
8.3.5.2. Exposure During Breastfeeding ................................................53
8.3.5.3. Occupational Exposure .............................................................53
8.3.6. Cardiovascular and Death Events...............................................................53
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................53
8.3.8. Adverse Events of Special Interest.............................................................54
8.3.8.1. Lack of Efficacy........................................................................54
8.3.9. Medical Device Deficiencies......................................................................54
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .........54
8.3.9.2. Follow-Up of Medical Device Deficiencies..............................54
8.3.9.3. Prompt Reporting of Device Deficiencies to the Sponsor ........55

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8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................55
8.3.10. Medication Errors.....................................................................................55
8.4. Pharmacokinetics ....................................................................................................56
8.7. Immunogenicity Assessments.................................................................................57
8.8. Health Economics ...................................................................................................57
8.9. Study Procedures.....................................................................................................57
8.9.1. Visit 1 (Day 1) ............................................................................................57
8.9.2. Visit 2 (21 to 35 Days After Visit 1) ..........................................................60
8.9.3. Visit 3 (6 Months [168 to 196 Days] After Visit 1) ...................................61
8.9.4. Unscheduled Visits.....................................................................................61
9. STATISTICAL CONSIDERATIONS ................................................................................62
9.1. Statistical Hypotheses .............................................................................................62
9.1.1. Estimands....................................................................................................62
9.2. Analysis Sets ...........................................................................................................63
9.3. Statistical Analyses .................................................................................................64
9.3.1. General Considerations...............................................................................64
9.3.1.1. Analysis for Binary Data...........................................................64
9.3.1.2. Analysis for Continuous Data ...................................................64
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis ................................................65
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis............................................65
9.4. Interim Analyses .....................................................................................................66
9.5. Sample Size Determination.....................................................................................67
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................68
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............68
10.1.1. Regulatory and Ethical Considerations ....................................................68
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10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................68
10.1.2. Financial Disclosure .................................................................................69
10.1.3. Informed Consent Process ........................................................................69
10.1.4. Data Protection .........................................................................................70
10.1.6. Dissemination of Clinical Study Data ......................................................70
10.1.7. Data Quality Assurance ............................................................................72
10.1.8. Source Documents....................................................................................73
10.1.9. Study and Site Start and Closure ..............................................................73
10.1.10. Publication Policy...................................................................................74
10.1.11. Sponsor’s Qualified Medical Personnel .................................................75
10.2. Appendix 2: Clinical Laboratory Tests .................................................................76
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................77
10.3.1. Definition of AE .......................................................................................77
10.3.2. Definition of an SAE ................................................................................78
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................80
10.3.4. Reporting of SAEs....................................................................................83
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-Up Assessments .......88
10.6. Appendix 6: AEs, ADEs, SAEs, SADEs, USADEs, and Device 
Deficiencies: Definitions and Procedures for Recording, Evaluating, 
Follow-Up, and Reporting in Medical Device Studies .............................................90
10.6.1. Definition of AE and ADE .......................................................................90
10.6.2. Definition of SAE, SADE, and USADE ..................................................90
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10.6.3. Definition of Device Deficiency...............................................................91
10.6.4. Recording/Reporting and Follow-Up of Medical Device 
Deficiencies......................................................................................................91
10.6.5. Reporting of SAEs....................................................................................93
10.6.6. Reporting of SADEs.................................................................................93
10.7. Appendix 7:  Alternative Measures During Public Emergencies .........................94
10.7.1. Telehealth Visits.......................................................................................94
10.7.2. Home Health Visits...................................................................................94
10.7.3. Adverse Events and Serious Adverse Events...........................................95
10.8. Appendix 8: Abbreviations ...................................................................................96
10.9. Appendix 9: Criteria for Allowing Inclusion of Participants With Chronic 
Stable HIV or HBV Infection or Cured HCV Infection............................................99
11. REFERENCES ................................................................................................................100
LIST OF TABLES
Table 1.
Grading Scales for Local Reactions .........................................................46
Table 2.
Grading Scales for Systemic Events.........................................................47
Table 3.
Ranges for Fever.......................................................................................48
Table 4.
Probability of Detecting at Least 1 AE.....................................................67

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1. PROTOCOL SUMMARY
1.1. Synopsis
Brief Title: A Phase 3 Safety and Immunogenicity Study of 20vPnC When Coadministered 
With a Booster Dose of BNT162b2
Rationale
Pfizer has developed 20vPnC to expand protection against pneumococcal disease beyond that 
covered by current pneumococcal vaccines in children and adults.  20vPnC has the same 
composition as 13vPnC (Prevnar 13®) but contains an additional 7 pneumococcal conjugates 
to protect against serotypes responsible for a substantial burden of remaining pneumococcal 
disease.  20vPnC uses the same platform and contains the same excipients as 13vPnC.  
20vPnC is in late-stage clinical development, and data from Phase 3 studies in adults 
18 years of age and older provide evidence that the safety profile is acceptable and similar to 
13vPnC, and induces immune responses that are expected to support licensure for an adult 
(≥18 years of age) indication. An application to license 20vPnC for an adult indication in the 
US was submitted to the FDA on 08 October 2020, and licensure may occur during the 
conduct of this study. The US ACIP currently has recommendations for 13vPnC, which 
include vaccination of adults with immunocompromising and other conditions that place 
them at high risk of pneumococcal disease and a recommendation for immunization in adults 
65 years of age and older based on decision making shared between the individual and his or 
her health care provider.  Recommendations will be considered for 20vPnC after FDA 
approval.
Pfizer has also developed a vaccine to prevent infection with SARS-CoV-2 and the disease it 
causes, COVID-19. Study C4591001 (NCT04368728) is an ongoing Phase 1/2/3 trial in 
~44,000 participants ≥12 years of age, designed to generate safety, tolerability, 
immunogenicity, and efficacy data from a novel RNA-based vaccine candidate. The 
Phase 2/3 component is assessing the safety and efficacy of two 30-µg doses of BNT162b2 
COVID-19 vaccine (referred to hereafter as BNT162b2) administered 21 days apart, 
compared to placebo. Initial safety data through ~14 weeks after the second dose showed a 
safety profile similar to other viral vaccines; vaccine efficacy was 95% after the second dose 
and 52% after the first dose. Additionally, because of unknowns regarding duration of 
protection, a booster dose of BNT62b2 may be needed; this may be particularly important for 
older adults, who may be more vulnerable.  An evaluation of a booster dose is currently in 
progress. 
When an individual interacts with a healthcare provider to obtain a COVID-19 vaccination, 
this may also be an opportunity to administer another recommended vaccine for which the 
individual may be eligible. However, because of the current lack of safety and 
immunogenicity data on COVID-19 vaccines coadministered with other vaccines, current 
ACIP guidance is that COVID-19 vaccines should be administered alone, with a minimum 
interval of 14 days before or after administration of any other vaccine. Therefore, this study 
describing the safety and immunogenicity of coadministration of a dose of 20vPnC and a 

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PFIZER CONFIDENTIAL
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booster dose of BNT162b2 will help provide timely data to inform potential concomitant use 
of those vaccines.
The purpose of this study is to describe the safety and immunogenicity of 20vPnC and a 
booster dose of BNT162b2 when administered together at the same visit compared to each of 
the vaccines given alone in adults ≥65 years of age, as shown in Section 1.2. To be eligible 
for this study, participants will have participated in Study C4591001 and received 2 doses of 
30 µg BNT162b2, with the second dose at least 6 months prior to the first vaccination in this 
study. 
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
Safety
To describe the safety profile 
of 20vPnC and a booster dose 
of BNT162b2 when 
coadministered or 
administered alone 

Prompted local reactions 
at each injection site 
(redness, swelling, and 
pain at the injection site)

Prompted systemic 
events (fever, headache, 
chills, fatigue, muscle 
pain, and joint pain)

AEs

SAEs
In participants receiving at least 1 dose of 
study intervention and having safety 
follow-up after vaccination, the percentage 
of participants reporting:

Prompted local reactions at each 
injection site for up to 10 days 
following vaccination

Prompted systemic events for up to 
7 days following vaccination

AEs from vaccination at Visit 1 
through approximately 1 month after 
vaccination

SAEs from vaccination at Visit 1 
through 6 months after vaccination
Secondary:
Secondary:
Secondary:
Pneumococcal Immunogenicity
To describe the immune 
response elicited by 20vPnC 
when coadministered with a 
booster dose of BNT162b2 or 
when administered alone

Pneumococcal OPA 
titers
In participants in compliance with the key 
protocol criteria (evaluable participants):

OPA GMTs approximately 1 month 
after vaccination
BNT162b2 Immunogenicity
To describe the immune 
response elicited by a booster 
dose of BNT162b2 when 
coadministered with 20vPnC 
or when administered alone

Full-length S-binding 
IgG levels 
In evaluable participants:

GMCs of full-length S-binding 
IgG levels approximately 1 month 
after vaccination

GMFR in full-length S-binding 
IgG levels from before to 
approximately 1 month after 
vaccination

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Overall Design
This Phase 3, multicenter, randomized, double-blind study will be conducted at investigator 
sites in the US. The purpose of this study is to describe the safety and immunogenicity of 
20vPnC and a booster dose of BNT162b2 when administered together at the same visit 
compared to each of the vaccines given alone in adults ≥65 years of age, as shown in 
Section 1.2.  There are no formal comparisons and the study is not designed or powered for 
hypothesis testing.
Approximately 600 participants from the US, 65 years of age and older who received 2 doses 
of 30 µg BNT162b2 in Study C4591001, will be stratified by prior pneumococcal vaccine 
status (no previous pneumococcal vaccine [naïve] or receipt of at least 1 dose of a 
pneumococcal vaccine [experienced]) and randomized at a 1:1:1 ratio to 1 of 3 vaccine
groups. 
At Visit 1 (Day 1), the Coadministration group (20vPnC+BNT162b2) will receive 20vPnC 
and a booster dose of BNT162b2, the 20vPnC-only group (20vPnC+saline) will receive 
20vPnC and saline, and the BNT162b2-only group (BNT162b2+saline) will receive a 
booster dose of BNT162b2 and saline.  Since the vaccines and saline have different 
appearances, they will be administered by an unblinded administrator at each site.
Participants from all groups will have blood drawn at Visit 1 prior to vaccination, and at 
Visit 2, approximately 1 month after vaccination, for immunogenicity assessments and 
serological testing for prior COVID-19 infection. 
All participants will be contacted by telephone at Month 6 for collection of SAEs.
Local reactions at each injection site and systemic events occurring within 10 days and 
7 days after vaccination, respectively, will be collected in an e-diary. AEs (nonserious AEs 
and SAEs) will be collected for each participant from the time informed consent is obtained 
through approximately 1 month after vaccination (Visit 2). SAEs will be collected through 
approximately 6 months after vaccination.
Number of Participants
Approximately 600 participants (200 per group) will be randomly assigned to study 
intervention.
Intervention Groups and Duration
Participants will be randomized at a 1:1:1 ratio to 1 of 3 vaccine groups. At Visit 1 (Day 1), 
the Coadministration group will receive 20vPnC and a booster dose of BNT162b2, the 
20vPnC-only group will receive 20vPnC and saline, and the BNT162b2-only group will 
receive a booster dose of BNT162b2 and saline. Study intervention will be administered by 

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an unblinded administrator via intramuscular injection to the upper deltoid muscle of each 
arm.
The duration of the study for each participant is approximately 6 months.
Statistical Methods
There is no formal hypothesis test for any safety or immunogenicity results. All statistical 
analyses will be descriptive.
Safety will be evaluated by descriptive summary statistics (including counts and percentages 
of participants and the associated 2-sided 95% CIs) for local reactions at each injection site, 
systemic events, AEs, and SAEs for each vaccine group. With 200 vaccinated participants 
per group, the study will provide a greater than 86% chance of observing at least 1 AE in 
each group if the true rate is at least 1%.
Pneumococcal immunogenicity will be evaluated descriptively by OPA GMTs 
approximately 1 month after 20vPnC. 
 
 
 
 
BNT162b2 immunogenicity will be evaluated descriptively using GMCs of full-length 
S-binding IgG levels approximately 1 month after BNT162b2, and GMFR from before to 
approximately 1 month after BNT162b2, each with corresponding 2-sided 95% CIs in 
evaluable participants from the Coadministration and BNT162b2-only groups.
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1.2. Schema

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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 information 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 participant.
Visit Identifier
Abbreviations used in this table may be found in Appendix 8.
Visit 1
Visit 2
Visit 3
Visit Description
Vaccination
Follow-up After Vaccination
6-Month Safety Telephone Contacta
Visit Window
Day 1
21 to 35 Days After Visit 1
168 to 196 Days After Visit 1
Obtain informed consent
X
Assign participant number
X
Obtain and record the participant number assigned to the 
participant in Study C4591001
X
Collect demography data
X
Perform clinical assessment, including medical history and 
smoking historyb
X
Measure height and weight
X
Obtain prevaccination oral temperature
X
Collect pneumococcal vaccine history
X
Record dates of prior BNT162b2 vaccinations received in 
Study C4591001
X
Collect nonstudy vaccine information
X
Confirm use of contraceptives (if appropriate)
X
X
Review inclusion and exclusion criteria
X
Review continued eligibility
X
Assign randomization number and study intervention 
allocation
X
Obtain blood sample for immunogenicity assessment & for 
serological testing for prior COVID-19 infectionc
~30 mL
~30 mL
Administer study intervention
X

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Visit Identifier
Abbreviations used in this table may be found in Appendix 8.
Visit 1
Visit 2
Visit 3
Visit Description
Vaccination
Follow-up After Vaccination
6-Month Safety Telephone Contacta
Visit Window
Day 1
21 to 35 Days After Visit 1
168 to 196 Days After Visit 1
Observe and record acute reactions for 30 minutes after 
administration of study intervention
X
Collect concomitant medication use for treatment of SAEs
X
X
X
Provide participant with an e-diary (device or application), 
thermometer, and measuring device and instruct to collect 
prompted local reactions, systemic events, and use of 
pain/antipyretic medications
X
Provide a participant contact card
X
Review reactogenicity e-diary data (daily review is optimal 
during the active diary period) 
X
Review ongoing reactogenicity e-diary symptoms with 
participant and obtain stop dates
X
Collect e-diary or assist the participant to delete the 
application
X
Record and report AEs
X------------------------------X
Record and report SAEs
X---------------------------------------------------------------------------X
a.
Safety telephone contact should be attempted for all participants who received at least 1 dose of study intervention, unless they have withdrawn consent.
b.
Including, if indicated as necessary by clinical assessment, a physical examination. Refer to Section 8.9.1 for information about medical history.
c.
Administration of study intervention is not dependent on test results.

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2. INTRODUCTION
2.1. Pneumococcal Disease
Streptococcus pneumoniae are gram-positive encapsulated cocci that have been a leading 
cause of bacteremia, bacterial meningitis, pneumonia, and AOM and continue to be a major 
global public health concern.1,2,3  Serious pneumococcal disease may occur at any age; 
however, children <5 and adults ≥65 years of age are at particularly increased risk.4  
Individuals with certain comorbidities and immunocompromising conditions are also at 
increased risk, including persons with chronic heart, lung, liver, and renal disease, and those 
with functional asplenia.
Surveillance studies conducted in 2010 to 2012 by the CDC found that S pneumoniae were 
among the most common bacterial pathogens identified in CAP requiring hospitalization in 
both children and adults in the US.5,6  Bacteremic pneumococcal pneumonia (accounting for 
the majority of IPD in adults) is less common than nonbacteremic pneumococcal pneumonia 
(an estimated 3 to 10 or more cases of nonbacteremic pneumococcal pneumonia occur for 
every 1 case of bacteremic pneumonia); both bacteremic and nonbacteremic pneumococcal 
pneumonia are associated with significant morbidity and mortality in all age groups.1,7  
Pneumococcal disease in older adults represents a high healthcare burden.  Pneumococcal 
pneumonia accounted for 20.6% of hospitalizations with an incidence of 274/100,000 
population.8  A CDC analysis of Active Bacterial Core surveillance data from 1998-2018 
showed that since the introduction of 13vPnC the incidence of IPD among adults ≥65 years 
of age decreased by 60%, with 13vPnC-type IPD decreasing by 86%; however, non-VT IPD 
increased in this age group by 22%, with serotypes 22F, 33F, and 11A among the 10 most 
common causes of IPD in this population.9 In a study of the global burden of LRIs using 
data from 195 countries, it was estimated that LRIs were among the leading causes of death 
in people of all ages and pneumococcal LRIs accounted for approximately 50% of LRI 
deaths (1.2 million deaths) across all ages in 2016.10  As these numbers suggest, 
S pneumoniae remains an important cause of serious disease in the US and worldwide.
Pneumococcal pneumonia is associated with coinfection with other viral respiratory 
infections, such as influenza. Although there is currently no substantial evidence of 
coinfections of COVID-19 and S pneumoniae,11,12 there are reports of decreased risk of 
COVID-19 infection among persons who previously received 13vPnC.13,14
2.2. Vaccines to Prevent Pneumococcal Disease
2.2.1. Pneumococcal Polysaccharide Vaccines
The polysaccharide capsule has been identified as an important virulence factor for this 
pathogen.  While more than 95 pneumococcal serotypes, differentiated by their capsular 
polysaccharide composition, have been identified, serious disease is generally caused by a 
smaller subset of serotypes.15,16  Anticapsular antibodies, directed against the specific 
serotype, bind to the capsule and promote complement-mediated opsonophagocytic killing 
and clearance of the organism.17  Pneumococcal disease can be prevented with 

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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polysaccharide-based vaccines that induce antibody responses with functional 
(opsonophagocytic) activity and target the capsular serotypes responsible for disease.18
Vaccines containing free polysaccharides have been licensed since the 1970s.  One such 
vaccine, PPSV23, has been licensed in the US since 1983.19  PPSV23 elicits a 
T-cell–independent immune response.  Unconjugated polysaccharide vaccines do not induce 
robust responses in certain populations (eg, immunocompromised persons), nor do they 
generate immunologic memory, and their protective effect wanes over 2 to 5 years.4,20,21,22
Moreover, their ability to prevent nonbacteremic pneumonia is limited or lacking.18,22,23,24  
Another limitation is that in several studies, individuals vaccinated with pneumococcal 
polysaccharide vaccine had lower functional antibody responses following subsequent 
vaccination with either another dose of pneumococcal polysaccharide vaccine or a dose of 
pneumococcal conjugate vaccine, compared to the first dose of polysaccharide vaccine.25,26,27  
Such “hyporesponsiveness” has been observed with other polysaccharide vaccines as well 
and raises concern regarding the quality of response after revaccination or natural exposure 
to an invading VT pneumococcus.28  Despite waning immunity, these concerns of 
hyporesponsiveness, as well as other factors, have led most recommending bodies to restrict 
PPSV23 to a single lifetime dose in adults ≥65 years of age and 1 to 2 doses in most other 
high-risk populations.28,29,30
2.2.2. Pneumococcal Polysaccharide Conjugate Vaccines
Pneumococcal conjugate vaccines contain polysaccharides that are covalently linked 
(conjugated) to an immunogenic protein.  This modification results in T-cell–dependent 
immune responses, which have been shown to be protective in young children, older adults, 
and populations with high-risk conditions.21,31  Prevnar® (7vPnC) was the first pneumococcal 
conjugate vaccine to be licensed (2000) and was indicated for prevention of pneumococcal 
disease in infants and young children on the basis of efficacy studies.  7vPnC contained 
capsular polysaccharide conjugates for 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 
and 23F), each covalently linked to CRM197, a nontoxic variant of diphtheria toxin.  
Following the introduction of 7vPnC, a reduction of nasopharyngeal carriage and 
transmission has resulted in indirect herd effects, with a 92% reduction of 7vPnC VT IPD in 
older adults ≥65 years of age.32
Prevnar 13® (13vPnC) was developed to expand serotype coverage and was licensed in the 
US in 2010.  13vPnC includes the same S pneumoniae serotypes as 7vPnC and an additional 
6 polysaccharide conjugates for serotypes 1, 3, 5, 6A, 7F, and 19A.31,33,34 The vaccine was 
licensed for use in infants and young children based on comparisons of serotype-specific IgG 
to 7vPnC, with supportive data to demonstrate the functional activity of the immune 
responses.  13vPnC was subsequently licensed in adults based on an accelerated approval 
pathway demonstrating comparable serotype-specific OPA responses to PPSV23, followed 
by traditional approval based on demonstration of efficacy against VT CAP in 
Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), a randomized 
controlled study of adults ≥65 years of age.35  Prevention of nonbacteremic VT CAP in this 
older adult population was also demonstrated and protection was observed through 4 years of 

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follow-up.  This is notable given the lack of definitive data showing that PPSV23 prevents 
nonbacteremic disease in older adults, and the evidence that protection against IPD wanes 
significantly over time.20
Prevnar 13 was licensed for adults ≥50 years of age in 2011 and recommended by the ACIP 
for use in adults with immunocompromising conditions in 2012.30,36,37,38  In July 2016, it was 
also licensed for use in adults 18 to 49 years of age.  The potential burden of VT CAP in 
adults in the US was demonstrated by a study conducted well after the introduction of 
Prevnar 13 into the routine infant immunization schedule, suggesting potential value in direct 
immunization of adults rather than reliance solely on the herd effect.39  13vPnC is currently 
recommended for adults ≥65 years of age, based on shared decision-making between the 
individual and his or her healthcare practitioner.  The prevalence of IPD due to most of the 
serotypes contained only in PPSV23 has remained stable or slightly increased in the US and 
other countries, despite continued recommendation and use of PPSV23 in adults ≥65 years of 
age and high-risk adults.9,40,41,42  These serotypes account for a significant amount of 
pneumococcal disease and their continued presence highlights the need for a better vaccine 
than PPSV23 to expand protection.
2.3. Development of 20vPnC
The 20vPnC candidate is modeled after 7vPnC and 13vPnC.  20vPnC contains the 
polysaccharides of capsular serotypes present in 13vPnC and 7 new capsular polysaccharides 
(for serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) individually conjugated to CRM197.  
The 7 additional serotypes were selected based on their relative prevalence as a cause of IPD, 
their generalized geographic distribution, and other factors that would support inclusion, such 
as the presence of antibiotic resistance (11A, 15B), association with outbreaks (8, 12F), and 
greater disease severity (eg, meningitis, mortality) (10A, 11A, and 
22F).43,44,45,46,47,48,49,50,51,52,53,54,55,56  These 7 serotypes have a long-standing association with 
serious pneumococcal disease and are responsible for a substantial burden of remaining 
pneumococcal disease.9,42
The 20vPnC clinical development program in adults has included several trials, including 
2 Phase 1 trials in healthy adults; 1 Phase 2 trial in adults 60 through 64 years of age; and 
4 Phase 3 trials in adults ≥18 years of age.  Studies in pediatric populations are also ongoing.
In Phase 1 and Phase 2 trials, 20vPnC induced immune responses to the pneumococcal 
serotypes in the vaccine.  The Phase 3 pivotal trial (B7471007) met its primary 
immunogenicity objectives of noninferiority for all serotypes matched to the licensed 
Prevnar 13 and 6 of the 7 additional serotypes when compared to PPSV23. The primary 
endpoint for 1 of the new 7 serotypes (serotype 8) missed the noninferiority criteria by a 
small margin, but further characterization data showed that 20vPnC elicited a robust immune 
response to that serotype. Secondary immunogenicity objectives showed that 20vPnC 
elicited immune responses in adults 18 to 59 years of age that met or exceeded responses to 
all 20 serotypes in adults 60 to 64 years of age. Together these findings suggest that 
protective antibodies against all 20 serotypes were elicited by 20vPnC, and that protection 

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Protocol B7471026
Final Protocol, 08 April 2021
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against pneumococcal disease will be expected to be similar to 13vPnC. The safety 
objectives were met in adults ≥18 years of age, demonstrating that the safety and tolerability 
of 20vPnC were comparable to licensed pneumococcal vaccines.
Additionally, the Phase 3 program has demonstrated equivalence of immunogenicity among 
3 different lots of 20vPnC in a clinical lot-consistency trial, and 20vPnC has acceptable 
safety and elicits immune responses to the 20 vaccine serotypes in adults previously 
vaccinated with pneumococcal vaccines.  An application to license 20vPnC for an adult 
indication in the US was submitted to the FDA on 08 October 2020, and licensure may occur 
during the course of this study.
Additional description of the clinical trial results, epidemiology of the 7 serotypes, and 
clinical (and nonclinical) program are described in the 20vPnC IB.
2.4. Indication
20vPnC has been developed in adults for the prevention of pneumococcal disease (including 
pneumonia and invasive disease) caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 
9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults ≥18 years of age.
2.5. Coronavirus Disease 2019 (COVID-19)
In December 2019, a pneumonia outbreak of unknown cause occurred in Wuhan, China.  
In January 2020, it became clear that a novel coronavirus (2019-nCoV) was the underlying 
cause.  Later in January, the genetic sequence of the 2019-nCoV became available to the 
WHO and the public (MN908947.3), and the virus was categorized in the Betacoronavirus
subfamily.  By sequence analysis, the phylogenetic tree revealed a closer relationship to 
SARS virus isolates than to another coronavirus infecting humans, the MERS virus.57,58
The outbreak was declared a Public Health Emergency of International Concern on 
30 January 2020.59  On 12 February 2020, the virus was officially named as severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO officially named the 
disease caused by SARS-CoV-2 as coronavirus disease 2019 (COVID-19).59 SARS-CoV-2 
infections and the resulting disease, COVID-19, have spread globally and on 11 March 2020,
the WHO characterized the COVID-19 outbreak as a pandemic.60 On 03 April 2021, The 
Center for Systems Science and Engineering at Johns Hopkins University reported more than 
130 million cases globally, with over 2.8 million deaths from 192 countries.  The US has 
reported more than 30.6 million cases and over 554,000 deaths.61
Pfizer has developed a vaccine to prevent infection with SARS-CoV-2 and the disease it 
causes, COVID-19. A prophylactic, RNA-based SARS-CoV-2 vaccine provides one of the 
most flexible and fastest approaches available to immunize against the emerging virus.62,63 In 
an attempt to prevent the spread of disease and to control the pandemic, numerous 
COVID-19 vaccine candidates are in development.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Study C4591001 is an ongoing Phase 1/2/3 trial in ~44,000 participants ≥12 years of age.
The study consists of 2 parts: Phase 1: to identify the preferred vaccine candidate 
(BNT162b1 or BNT162b2) and dose level; Phase 2/3: an expanded-cohort and efficacy part 
for the selected vaccine candidate (BNT162b2).
Based on the C4591001 Phase 1/2/3 study safety, immunogenicity, and efficacy data, a 
2-dose series of BNT162b2 has been either authorized for emergency use or licensed in 
multiple countries.  The primary 2-dose series of 30 µg BNT162b2 (Pfizer-BioNTech
COVID-19 vaccine) received emergency use authorization in the US on 11 December 2020,
and an application for licensure will be submitted to the FDA in the near future.  As of 
20 December 2020 in the US, the ACIP recommends a stepwise approach to COVID-19 
vaccination that includes all adults ≥65 years of age when supply is sufficient.64
The potential duration of protection afforded after SARS-CoV-2 infection or after
vaccination remains unknown.65,66,67,68 Because of the unknowns regarding duration of 
protection, a booster dose of BNT162b2 may be needed. This may be particularly important 
for older adults, who may be more vulnerable. Study C4591001 now includes a subset of 
Phase 1 participants who will receive a third dose of BNT162b2 approximately 6 to 
12 months after their second dose of BNT162. The data from that will provide an early 
assessment of the safety of a third dose of BNT162, as well as its immunogenicity; no new 
safety signals have been identified as of March 2021 (study is ongoing).
2.6. Study Rationale
When an individual interacts with a healthcare provider to obtain a COVID-19 vaccination, 
this may also be an opportunity to administer another recommended vaccine for which the 
individual may be eligible. However, because of the current lack of safety and 
immunogenicity data on COVID-19 vaccines coadministered with other vaccines, current 
ACIP guidance is that COVID-19 vaccines should be administered alone, with a minimum 
interval of 14 days before or after administration of any other vaccine.68 Therefore, assessing 
the safety and immunogenicity of coadministration of a dose of 20vPnC and a dose of 
BNT162b2 will help provide timely data to inform potential concomitant use of those 
vaccines.
The purpose of this study is to describe the safety and immunogenicity of 20vPnC and a 
booster dose of BNT162b2 when administered together at the same visit compared to each of
the vaccines given alone in adults ≥65 years of age, as shown in Section 1.2. To be eligible 
for this study, participants will have participated in Study C4591001 and received 2 doses of 
30 µg BNT162b2, with the second dose at least 6 months prior to the first vaccination in this 
study.
2.7. Background
20vPnC has been developed to further expand protection beyond 13vPnC against the global 
burden of vaccine-preventable pneumococcal disease in children and adults.  The clinical 
development program in adults has been generally modeled on the 13vPnC program.  The 

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
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clinical program is currently in late-stage development.  To date, 2 Phase 1, 1 Phase 2, and 
4 Phase 3 studies in adults have been conducted to support licensure for an adult indication.  
These are all safety and immunogenicity studies.
BNT162b2 is a SARS-CoV-2–RNA-LNP vaccine based on a platform of modRNA with 
blunted innate immune sensor–activating capacity and augmented expression encoding P2 S.
The development of an RNA-based vaccine encoding a viral antigen, which is then expressed 
by the vaccine recipient as a protein capable of eliciting protective immune responses, 
provides significant advantages over more traditional vaccine approaches.  Unlike live 
attenuated vaccines, RNA vaccines do not carry the risks associated with infection and may 
be given to people who should not receive live virus vaccine (eg, pregnant women and 
immunocompromised persons). RNA-based vaccines are manufactured via a cell-free 
in vitro transcription process, which allows an easy and rapid production and the prospect of 
producing high numbers of vaccination doses within a shorter time period than achieved with 
traditional vaccine approaches.  This capability is pivotal to enable the most effective 
response in outbreak scenarios.
2.7.1. Clinical Overview
For 20vPnC, safety data from 3 Phase 3 adult studies (B7471006, B7471007, and B7471008) 
have shown safety profiles consistent with other pneumococcal conjugate vaccines.  
Immunogenicity data from the pivotal Phase 3 study demonstrated that 20vPnC induces OPA 
GMTs that are noninferior to 13vPnC for the 13 matched serotypes and noninferior to 
PPSV23 for 6 of the 7 additional serotypes.  The remaining serotype demonstrated strong 
immune responses.  See the 20vPnC IB for additional details.
Study C4591001 (NCT04368728) is an ongoing Phase 1/2/3 trial in ~44,000 participants 
12 years of age and older, designed to generate safety, tolerability, immunogenicity, and 
efficacy data from a novel RNA-based vaccine candidate.69  The Phase 2/3 component is 
assessing the safety and efficacy of two 30-µg doses of BNT162b2 administered 21 days 
apart, compared to placebo. Initial safety data through ~14 weeks after the second dose 
showed a safety profile similar to other viral vaccines; VE was 95% after the second dose 
and 52% after the first dose.69 See the BNT162 IB for additional details.
2.8. Benefit/Risk Assessment
The safety profile of 20vPnC is expected to be similar to 13vPnC, but AEs may be different 
with the investigational 20vPnC.  The safety profiles are expected to be similar because 
20vPnC contains the same components and excipients as 13vPnC, along with the 
polysaccharide conjugates for 7 additional pneumococcal serotypes, and to date, 20vPnC has 
demonstrated a safety profile similar to 13vPnC in clinical trials.  The most common AEs 
noted in adults after vaccination are primarily related to local reactions (injection site pain, 
redness, and swelling) and systemic events (fever, headache, fatigue, joint pain, and muscle 
pain).  Safety review of data from the 3 completed Phase 3 adult trials has not revealed any 
unexpected safety concerns.  See the 20vPnC IB for additional details.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
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As of March 2021, there are limited approved or licensed preventive or therapeutic options
available for the ongoing global pandemic of COVID-19.
In the C4591001 study, the observed safety profile to date shows mostly mild reactogenicity, 
low incidence of severe or serious events, and no clinically concerning safety observations.
BNT162b2 has been shown to elicit increased local and systemic adverse reactions as 
compared to those in the placebo arm, usually lasting a few days. Adverse reactions 
characterized as reactogenicity were generally mild to moderate. The number of participants 
reporting hypersensitivity-related AEs was numerically higher in the active vaccine group 
compared with the placebo group (137 [0.63%] vs 111 [0.51%]). Severe adverse reactions 
occurred in 0.0% to 4.6% of participants, and were generally less frequent in older adults 
(>55 years of age) (<2.8%) compared to younger participants (≤4.6%). Among reported 
unsolicited AEs, lymphadenopathy occurred much more frequently in the active vaccine 
group than the placebo group and is plausibly related to vaccination.70 See the BNT162 IB 
for additional details.
As with any vaccine, an allergic reaction can occur.  The allergic reaction can vary from skin 
rash to swelling of the face or lips, wheezing, and/or shortness of breath.  A severe allergic 
reaction (anaphylactic shock, collapse, or shock-like state [hypotonic-hyporesponsive 
episode]) may also occur.  There may also be additional risks related to the vaccines 
administered in the study that are not known at this time.
Additional potential risks of clinical significance are presented in the table in Section 2.8.1.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of 20vPnC and BNT162b2 may be found in the respective IBs, which are the 
SRSDs for this study.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
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Final Protocol, 08 April 2021
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2.8.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention: Vaccination With 20vPnC
The relevant key risks associated with 20vPnC 
include: local reactions (injection site pain, 
redness, and swelling); and systemic events (fever, 
headache, fatigue, joint pain, and muscle pain).  
Uncommon events can include allergic reactions, 
which may be associated with skin rash, face or lip 
swelling, wheezing, shortness of breath, or rarely 
severe allergic reaction (eg, anaphylactic shock).
The risks are derived from the 
experience with the related 7vPnC and 
13vPnC clinical trials and 
postmarketing data and the 20vPnC 
clinical data described in the 20vPnC 
IB.

Eligibility criteria have been selected to ensure that only 
appropriate participants are included in the study (see 
Section 5).

All study participants will be observed for 30 minutes 
after vaccination.

E-diary and AE data will be monitored by the 
investigator (or designee) and sponsor.
Study Intervention: Vaccination With BNT162b2
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. Risks associated with 
BNT162b2 include the following:

Common or very common events: injection 
site pain, swelling, or redness, fatigue, fever, 
chills, headache, joint aches, muscle aches, 
nausea.

Uncommon events: enlarged lymph glands, 
allergic reactions (including rash, itching, 
hives, and swelling of the face or lips), pain in 
the arm, and feeling weak or unwell.

Frequency cannot be estimated from available
data: severe allergic reaction (anaphylaxis).
These are adverse reactions based on 
clinical study results and information 
gathered during general use.
Eligibility criteria have been selected to ensure that only 
appropriate participants are included in the study (see 
Section 5).
All study participants will be observed for 30 minutes after 
vaccination.
E-diary and AE data will be monitored by the investigator 
(or designee) and sponsor.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Safety profile of a novel vaccine not yet fully 
characterized.
Data available from Study C4591001 
showed low incidence of severe or 
serious events, and no clinically 
concerning safety observations. The 
vaccine appears to be safe and well
tolerated across the safety population 
and within demographic subgroups 
based on age, sex, race/ethnicity,
country, and baseline SARS-CoV-2 
status.

Eligibility criteria have been selected to ensure that only 
appropriate participants are included in the study (see 
Section 5).

AE and SAE reports will be collected from signing of the 
ICD through approximately 1 month after vaccination.

All participants will be observed for 30 minutes after 
vaccination.
Potential for COVID-19 enhancement.
Disease enhancement has been seen 
following vaccination with RSV, feline 
coronavirus, and Dengue virus 
vaccines. No evidence of disease 
enhancement has been seen in a 
large-scale clinical study of BNT162b2 
in humans.69

Eligibility criteria will exclude any participants who have 
had a previous positive SARS-CoV-2 NAAT result in 
Study C4591001.  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.
Study Procedures: Venipuncture
There is the risk of fainting, and pain, swelling, 
bruising, and infection at the venipuncture site.
Venipuncture is required to collect 
immunogenicity data from participants.
Only qualified nurses, physicians, nurse practitioners, 
physician assistants, phlebotomists, or medical assistants 
certified or otherwise authorized to draw blood per the 
standards and procedures of the investigative site, as allowed 
by institutional, local, and country guidance, will be allowed 
to draw blood, to minimize local complications.
Other
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.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Protocol B7471026
Final Protocol, 08 April 2021
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2.8.2. Benefit Assessment
Pneumococcal conjugate vaccines have been shown to elicit T-cell–dependent immune 
responses, which have been shown to be protective in older adults. A safe and immunogenic 
pneumococcal conjugate vaccine with expanded pneumococcal serotype coverage would 
fulfill an unmet need for expanded protection against pneumococcal disease.
If 20vPnC is approved, it is anticipated to provide a benefit to a participant in the prevention 
of pneumonia and invasive disease caused by vaccine serotypes.
Individual participants may also benefit from the receipt of a booster dose of an efficacious 
COVID-19 vaccine during a global pandemic, access to COVID-19 diagnostic testing, and 
contributing to research to help others in a time of global pandemic.
2.8.3. Overall Benefit/Risk Conclusion
Taking into account the measures to minimize risk to study participants, the potential risks 
identified in association with 20vPnC and BNT162b2 are justified by the anticipated benefits 
that may be afforded to participants.
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
Safety
To describe the safety profile 
of 20vPnC and a booster dose 
of BNT162b2 when 
coadministered or 
administered alone

Prompted local reactions 
at each injection site
(redness, swelling, and 
pain at the injection site)

Prompted systemic 
events (fever, headache, 
chills, fatigue, muscle 
pain, and joint pain)

AEs

SAEs
In participants receiving at least 1 dose of 
study intervention and having safety 
follow-up after vaccination, the percentage 
of participants reporting:

Prompted local reactions at each 
injection site for up to 10 days 
following vaccination

Prompted systemic events for up to 
7 days following vaccination

AEs from vaccination at Visit 1 
through approximately 1 month after 
vaccination

SAEs from vaccination at Visit 1 
through 6 months after vaccination
Secondary:
Secondary:
Secondary:
Pneumococcal Immunogenicity
To describe the immune 
response elicited by 20vPnC 
when coadministered with a 
booster dose of BNT162b2 or 
when administered alone

Pneumococcal OPA 
titers
In participants in compliance with the key 
protocol criteria (evaluable participants):

OPA GMTs approximately 1 month
after vaccination

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
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Objectives
Endpoints
Estimands
BNT162b2 Immunogenicity
To describe the immune 
response elicited by a booster
dose of BNT162b2  when 
coadministered with 20vPnC 
or when administered alone
•
Full-length S-binding 
IgG levels 
In evaluable participants:
•
GMCs of full-length S-binding 
IgG levels approximately 1 month
after vaccination
•
GMFR in full-length S-binding 
IgG levels from before to
approximately 1 month after 
vaccination
4. STUDY DESIGN
4.1. Overall Design
This Phase 3, multicenter, randomized, double-blind study will be conducted at investigator 
sites in the US. The purpose of this study is to describe the safety and immunogenicity of 
20vPnC and a booster dose of BNT162b2 when administered together at the same visit 
compared to each of the vaccines given alone in adults ≥65 years of age, as shown in 
Section 1.2. There are no formal comparisons and the study is not designed or powered for 
hypothesis testing.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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Approximately 600 participants ≥65 years of age who received 2 doses of 30 µg BNT162b2
at least 6 months previously in Study C4591001 will be randomized at a 1:1:1 ratio to 1 of
3 groups with center-based randomization: Coadministration group, 20vPnC-only group, and 
BNT162b2-only group, stratified by prior pneumococcal vaccine status (no previous 
pneumococcal vaccine [naïve] or receipt of at least 1 dose of a pneumococcal vaccine 
[experienced]). 
At Visit 1 (Day 1), participants will be assessed for eligibility, including medical history and 
pneumococcal vaccine history. If eligible, participants will have blood drawn for 
immunogenicity assessments and serological testing for prior COVID-19 infection and 
participants will be randomized to 1 of 3 vaccine groups. The Coadministration group 
(20vPnC+BNT162b2) will receive 20vPnC and a booster dose of BNT162b2, and the 
separate administration groups (20vPnC-only group [20vPnC+saline]) and BNT162b2-only 
group [BNT162b2+saline]) will receive either 20vPnC and saline or a booster dose of 
BNT162b2 and saline. All study interventions will be prepared and administered by an 
unblinded investigator site staff member. Participants will be observed for 30 minutes after 
vaccination by blinded investigator site staff, and any reactions occurring during that time 
will be recorded as AEs.
At Visit 1, participants will receive an e-diary (device or mobile-device application), 
thermometer, and measuring device (caliper) and will be instructed to record prompted local 
reactions (redness, swelling, and pain at the injection site) occurring at each injection site 
within 10 days after vaccination (Days 1 through 10, where Day 1 is the day of vaccination) 
and prompted systemic events (fever, headache, chills, fatigue, muscle pain, and joint pain) 
occurring within 7 days after vaccination (Days 1 through 7, where Day 1 is the day of 
vaccination) daily in the e-diary. Separate e-diary entries will be captured for local reactions 
occurring at the left and right arm injection sites. Participants will also be instructed to 
record any use of antipyretic/pain medications in the e-diary daily for 7 days after 
vaccination.  Participants will be instructed to contact the study staff if they experience 
redness or swelling at either injection site measuring >20 measuring device units (>10 cm) or 
severe injection site pain (prevents daily activity) in the 10 days after vaccination, a severe 
systemic event in the 7 days after vaccination, or have an emergency room visit or 
hospitalization.
At Visit 2 (21 to 35 days after Visit 1), participants will return to the investigator site and be 
assessed for continued eligibility. Participants will be asked to provide information on any 
AEs (including nonserious AEs and SAEs), and on any needed e-diary follow-up. 
Participants will also be asked for information on concomitant medications used to treat any 
SAEs and on any nonstudy vaccines they received since Visit 1. Blood will be drawn for 
immunogenicity assessments and serological testing for prior COVID-19 infection.
At Visit 3 (6 months [168 to 196 days] after Visit 1), the site will contact the participant via 
telephone to inquire about SAEs and concomitant medications used to treat SAEs since the 
last visit. 

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 28
Since participation in Study C4591001 for safety follow-up may be ongoing for participants 
in this study, safety events relevant to both protocols will be reported as applicable.
The duration of this study for each participant is approximately 6 months.
If either 20vPnC or a booster dose of BNT162b2 becomes licensed or authorized for 
emergency use during the conduct of this study, and the participant meets local/national 
recommendations for receipt of the applicable vaccine/dose, unblinding to vaccine 
assignment may be allowed after Visit 2 so that participants may be vaccinated, outside of 
this study, with the vaccine not received at Visit 1.
4.2. Scientific Rationale for Study Design
The purpose of this study is to describe the safety and immunogenicity of 20vPnC and a 
booster dose of BNT162b2 when administered together at the same visit compared to each of 
the vaccines given alone in adults ≥65 years of age. Coadministration of 20vPnC with a 
booster dose of BNT162b2 was selected based on the expected uptake of COVID-19 vaccine 
among persons ≥65 years of age in the US. The safety and immunogenicity results from this 
study will help inform potential considerations for coadministration of 20vPnC and
BNT162b2. This study includes assessments similar to those in the 20vPnC and BNT162b2 
studies.71,72
Participants in this study will be randomized to 1 of 3 groups. The Coadministration group
receives both vaccines, while the 2 other groups serve as controls for each vaccine given 
separately.
4.2.1. Diversity of Study Population
Reasonable attempts will be made to enroll participants to ensure the study population is 
representative of the US population ≥65 years of age.  However, since the study population is 
coming from Study C4591001, in order to ensure booster dosing with the appropriate interval 
from the last dose of primary vaccination, diversity is limited to that within the study 
population of adults 65 years of age and older.
4.2.2. Choice of Contraception/Barrier Requirements
Human reproductive safety data are not available for 20vPnC and BNT162b2, but there is no 
suspicion of human teratogenicity based on the intended pharmacology of the compound.
The use of an acceptable method of contraception is required 
.
CCI
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 29
4.3. Justification for Dose
The 20vPnC candidate is modeled after 7vPnC and 13vPnC, and contains capsular 
polysaccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 
14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F individually conjugated to CRM197.  The vaccine 
formulation contains 2.2 μg of each saccharide, except for 4.4 μg of 6B, per 0.5-mL dose.  In 
adults, administration of 1 dose of pneumococcal conjugate vaccine induces immune 
responses.
Based on data from the Phase 1 component of Study C4591001 and available nonclinical 
data, the modRNA BNT162b2 vaccine candidate was selected at a dose of 30 μg for 
Phase 2/3 evaluation of safety, immunogenicity, and efficacy. This is the dose that has 
shown to be efficacious and has been authorized for conditional or emergency use and is 
anticipated to be licensed in the future.
For these products the term “dose” refers to an injection of a vaccine or placebo.
4.4. End of Study Definition
The end of the study is defined as the date of the last visit of the last participant in the study.
A participant is considered to have completed the study if he/she has completed all periods of 
the study, including the final safety telephone contact.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled. 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.
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 ≥65 years of age at the time of consent.
•
Refer to 
for reproductive criteria for male 
 and female 
 participants.
CCI
CCI
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 30
Type of Participant and Disease Characteristics:
2. Participating or participated in Study C4591001, received 2 doses of 30 μg BNT162b2
with the second dose given ≥6 months prior to the first vaccination in this study, and have 
not received a third dose of BNT162b2.
3. Participants who are willing and able to comply with all scheduled visits, treatment plan, 
laboratory tests, lifestyle considerations, and other study procedures.
4. Participants who are determined by medical history, physical examination (if required), 
and clinical judgment of the investigator to be eligible for inclusion in the study.
Note: Participants with preexisting stable disease, defined as disease not requiring 
significant change in therapy or hospitalization for worsening disease during the 6 weeks 
before enrollment, can be included. Specific criteria for participants with known stable 
infection with HIV or HBV or cured HCV infection can be found in Section 10.9.
5. Expected to be available for the duration of the study and can be contacted by telephone 
during study participation.
6. Male participant who is able to father children and willing to use an acceptable method of 
contraception as outlined in this protocol for at least 28 days after the last dose of study 
intervention; or female participant not of childbearing potential; or male participant not 
able to father children.
 
7. Adults who have no history of ever receiving a pneumococcal vaccine (ie, pneumococcal 
vaccine–naïve), or received a licensed pneumococcal vaccination ≥12 months prior to the 
first vaccination in this study.
Note: For participants with a history of receiving a licensed pneumococcal vaccination, 
documentation of date(s) and type(s) of prior pneumococcal vaccination(s) will be 
obtained.
Informed Consent:
8. Capable of giving signed informed consent as described in Appendix 1, which includes 
compliance with the requirements and restrictions listed in the ICD and in this protocol.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 31
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s) or any other 
diphtheria toxoid–containing vaccine.
2. Serious chronic disorder, including metastatic malignancy, severe COPD requiring 
supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the 
liver, clinically unstable cardiac disease, or any other disorder that in the investigator’s 
opinion would make the participant inappropriate for entry into the study.
3. History of microbiologically proven invasive disease caused by S pneumoniae.
4. Previous clinical or microbiological diagnosis of COVID-19. 
5. Known or suspected immunodeficiency (aside from stable HIV meeting inclusion 
criterion 4) or other conditions associated with immunosuppression, including, but not 
limited to, immunoglobulin class/subclass deficiencies, generalized malignancy, 
leukemia, lymphoma, or organ or bone marrow transplant.
6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular injection.
7. Congenital, functional, or surgical asplenia.
8. Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness 
within 48 hours before study intervention administration.
9. 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.
Prior/Concomitant Therapy:
10. Previous vaccination with any investigational pneumococcal vaccine, or planned receipt 
of any licensed or investigational pneumococcal vaccine through study participation.
11. Previous vaccination with any coronavirus vaccine, other than those received in 
Study C4591001.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 32
12. Currently receives treatment with immunosuppressive therapy, including cytotoxic agents 
or systemic corticosteroids, receipt of short-term (<14 days) systemic corticosteroids for 
treatment of an acute illness in the 28 days before administration of study intervention, or 
planned receipt through the last blood draw (Visit 2).  Inhaled/nebulized, intra-articular, 
intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies from 
60 days before administration of study intervention, or receipt of any passive antibody 
therapy specific to COVID-19 from 90 days before administration of study intervention,
or planned receipt through Visit 2.
14. Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live 
vaccine within 28 days before administration of study intervention.
Prior/Concurrent Clinical Study Experience:
15. Participation in other studies involving investigational drugs, investigational vaccines, or 
investigational devices within 28 days prior to study entry and/or during study 
participation other than Study C4591001. Participation in purely observational studies is 
acceptable.
16. Previous participation in studies other than C4591001 involving study intervention 
containing LNPs.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
17. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of 
the study, site staff otherwise supervised by the investigator, and their respective family 
members.
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 from the permitted list of contraception methods 
 
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 acceptable 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. 
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 33
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 randomly assigned to study intervention/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 SAE.
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened. 
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of 
Study Intervention
Not applicable.
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 20vPnC, BNT162b2, and saline 
control.
6.1. Study Intervention(s) Administered
Study Interventions(s)
Intervention 
Name
20vPnC
BNT162b2 
(BNT162 RNA-LNP 
vaccine utilizing modRNA
and encoding the P2 S)
Saline control
Type
Vaccine
Vaccine
Placebo
Dose 
Formulation
Sterile liquid suspension 
formulation containing 
saccharides from 
pneumococcal serotypes 1, 
3, 4, 5, 6A, 6B, 7F, 8, 9V, 
10A, 11A, 12F, 14, 15B, 
18C, 19A, 19F, 22F, 23F, 
and 33F individually 
conjugated to CRM197
modRNA; frozen-liquid 
Sterile normal saline 
solution for injection (0.9% 
sodium chloride injection)

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 34
Study Interventions(s)
 
 
Route of 
Administration
Intramuscular injection
Intramuscular injection
Intramuscular injection
Sourcing
Provided centrally by the 
sponsor
Provided centrally by the 
sponsor
Provided centrally by the 
sponsor
Packaging and 
Labeling
Study intervention will be 
provided in single-use 
PFSs. Each PFS will be 
labeled as required per local 
and legal requirement.
Cartons will include a 
blinded label and a 
tamper-evident seal. 
Study intervention will be 
provided in glass vials.
Each vial will be labeled as 
required per local and legal
requirement. Cartons will 
include a blinded label and 
a tamper-evident seal.
Study intervention will be 
provided in single-use PFSs
or glass vials. Each PFS or 
vial will be labeled as 
required per local and legal
requirement. Cartons will 
include a blinded label and 
a tamper-evident seal.
6.1.1. Administration
Participants will receive study intervention at Visit 1 in accordance with the study’s SoA.
At Visit 1, participants will receive a single 0.5-mL dose of either 20vPnC or saline injected 
intramuscularly into the right deltoid, and a single 0.3-mL dose of either BNT162b2 or saline
injected intramuscularly into the left deltoid.
All vaccines will be prepared and administered by third-party unblinded site staff member(s) 
and will be administered to blinded participants. All other study personnel including the PI
will be blinded. The unblinded site staff members will not participate in participant
assessments.
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.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 35
6.1.2. Medical Devices
In this study, medical devices being deployed are the PFSs containing 20vPnC or saline.
Instructions for medical device use are provided in the IP manual.
All medical device deficiencies (including malfunction, use error, and inadequate labeling) 
shall be documented and reported by the unblinded site staff throughout the clinical 
investigation (see Section 8.3.9) and appropriately managed by the sponsor.
6.2. Preparation, Handling, Storage, and Accountability
The investigator or an approved representative, eg, pharmacist, will ensure that all study 
interventions are stored in a secured area with controlled access under required storage 
conditions and in accordance with applicable regulatory requirements.
Study interventions should be stored in their original containers and in accordance with the 
labels.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 36
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 an appropriately 
qualified and experienced unblinded member of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as 
allowed by local, state, and institutional guidance. A second unblinded staff member will 
verify the preparation and dispensing.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 37
6.3. Measures to Minimize Bias: Randomization and Blinding
As the appearances, storage conditions, preparation methods, and dose volumes of 20vPnC, 
BNT162b2, and saline are different, the study interventions will be prepared and 
administered by a designated third-party–unblinded site staff member.  All other study 
personnel, including the PI, and the participant will be blinded.  The unblinded site staff 
member(s) will not participate in participant assessments. See Section 6.3.2 and Section 6.3.3
for more details on blinding of site personnel members and sponsor.
6.3.1. Allocation to Study Intervention
Allocation (randomization) of participants to vaccine groups will proceed through the use of 
an IRT system (IWR). The site personnel (study coordinator or specified designee) will be 
required to enter or select information including but not limited to the user’s ID and 
password, the protocol number, and the participant number. The site personnel will then be 
provided with a study intervention assignment, randomization number, and DU or container 
number when study intervention is being supplied via the IRT system. The IRT system will 
provide a confirmation report containing the participant number, randomization number, and 
DU or container number assigned. The confirmation report must be stored in the site’s files. 
Study intervention will be administered 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.
An otherwise uninvolved third party will be responsible for administration of the vaccines. 
This includes ensuring that there are no differences in time or effort taken to administer the 
study intervention and no blinded site staff are able to view the administration.
6.3.2. Blinding of Site Personnel
The study staff receiving, storing, dispensing, preparing, and administering the study 
interventions will be unblinded.  All other study and site personnel, including the 
investigator, investigator staff, and participants, will be blinded to study intervention 
assignments. In particular, the individuals who evaluate participant safety will be blinded. 
Additionally, because there are differences in physical appearance, preparation timing, and 
dose volumes of 20vPnC, BNT162b2, and saline placebo, the study intervention will be 
prepared and administered in a manner that prevents the study participants from identifying 
the vaccine group based on the study intervention’s appearance. This includes approximate 
alignment of dose preparation timing for 20vPnC and saline placebo with that of BNT162b2, 
which requires 30 minutes to thaw.  Refer to the IP Manual for additional instructions.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 38
6.3.3. Blinding of the Sponsor
The sponsor staff will be blinded to study intervention allocation
 
except for those described below.  All laboratory testing 
personnel performing serology assays will remain blinded to study intervention 
assigned/received throughout the study.  
 
 
 
 
 
 
 
6.3.4. Breaking the Blind
The IRT will be programmed with blind-breaking instructions. In case of an emergency, the 
investigator has the sole responsibility for determining if unblinding of a participant’s 
vaccine assignment is warranted. Participant safety must always be the first consideration in 
making such a determination. If the investigator decides that unblinding is warranted, the 
investigator should make every effort to contact the sponsor prior to unblinding a 
participant’s vaccine assignment unless this could delay further management of the 
participant. If a participant’s vaccine assignment is unblinded, the sponsor must be notified 
within 24 hours after breaking the blind. The date and reason that the blind was broken must 
be recorded in the source documentation and CRF.
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
Unblinding to vaccine assignment may be allowed after Visit 2 to facilitate administration of
20vPnC and BNT162b2 after licensure and recommendation as described in Section 4.1.
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 identification will be confirmed at the 
time of dosing by a member of the study site staff other than the person administering the 
study intervention.
CCI
CCI
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 39
6.5. Dose Modification
Not applicable.
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 each study intervention 
within a 24-hour time period will be considered an overdose.
There is no 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.
3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF.
4. Overdose is reportable to Pfizer 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 name and date of administration of any prior pneumococcal vaccines will be collected 
and recorded in the CRF. The name(s) and date(s) of administration are to be obtained from 
sources, such as medical records or vaccination cards.
The date of administration of the 2 doses of BNT162b2 given in Study C4591001 will be 
collected and recorded in the CRF.
The name and date of administration for all nonstudy vaccinations received from the time of 
signing of the ICD to Visit 2 will be collected and recorded in the CRF.
Medications taken to treat SAEs from the time of signing of the ICD through Visit 3 will be
recorded in the CRF.
6.8.1. Prohibited During the Study

Receipt of any investigational vaccines, drugs, or medical devices is prohibited during 
study participation.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 40

Receipt of nonstudy pneumococcal or coronavirus vaccine is prohibited during study 
participation.

Receipt of any other licensed nonstudy vaccine is prohibited until after Visit 2.

Receipt of blood/plasma products or immunoglobulins is prohibited through Visit 2.

Receipt of chronic systemic treatment with known immunosuppressant medications or 
radiotherapy is prohibited through Visit 2.

Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for 
≥14 days is prohibited through Visit 2.

Receipt of prophylactic medications intended to prevent symptoms associated with study 
intervention is not permitted.  However, if a participant is taking a medication for another 
condition, even if it may have such properties, it should not be withheld prior to study 
vaccination.
6.8.2. Permitted During the Study

Prescription and nonprescription medications, vitamins, minerals, and herbal remedies 
are permitted during participation in the study.

Antipyretic and other pain medication to treat symptoms following administration of 
study intervention are permitted during participation in the study.

Inhaled/nebulized, topical (eg, skin, eyes, or ears), or localized injections of 
corticosteroids (eg, intraarticular or intrabursal administration) are permitted during study 
participation.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single-dose study, this section is not applicable.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at his/her own request. Reasons for 
discontinuation from the study include the following:

Refused further study procedures;

Lost to follow-up;

Death;

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 41

Study terminated by sponsor;

AE;

Physician decision;

Pregnancy;

Protocol deviation;

Screen failure;

Participant request;

Medication error without associated AE;

No longer meets eligibility criteria;

Other.
If a participant withdraws from the study, he/she 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 withdraws 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 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 specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information. Participants 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.

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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 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 and reschedule the missed visit as soon as 
possible. Counsel the participant on the importance of maintaining the assigned visit 
schedule, and ascertain whether the participant wishes to and/or should continue in the 
study;

Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant (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;

Should the participant continue to be unreachable, he/she 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 before performing any study-specific procedures.
The 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 Section 8.9 of 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 Section 4 and 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.

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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 individual participants in this study is approximately 
60 mL.
8.1. Efficacy and/or Immunogenicity Assessments
8.1.1. Immunogenicity Assessments
Blood samples (approximately 30 mL) will be collected from all participants at Visits 1 and 2
as specified in the SoA. Sample collection, processing, storage, and shipping information 
can be found in the ISF or equivalent manual.
Pneumococcal Responses
OPA titers for the 20vPnC serotypes will be measured in sera collected at Visits 1 and 2 from 
the Coadministration and 20vPnC-only groups. Participants from these 2 groups will be 
identified by an independent unblinded statistician;
 
 
BNT162b2 Responses
IgG levels will be measured in the SARS-CoV-2 full-length S-binding assay in sera collected 
at Visits 1 and 2 from the Coadministration and BNT162b2-only groups. Participants from 
these 2 groups will be identified by an independent unblinded statistician; additional 
participants from the 20vPnC-only group may be included in order to maintain the blinding 
of randomization assignment.
 
Blood samples taken at Visits 1 and 2 will also be measured for the N-binding antibody and 
analyzed at a central laboratory.
CCI
CCI

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8.1.2. Biological Samples
Blood 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.
 
 
No testing of the participant’s DNA will be performed. 
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.
8.2. Safety Assessments
A clinical assessment, including medical history and measurement of oral temperature, will 
be performed on all participants prior to any vaccination at Visit 1 to determine participant 
eligibility and to establish a clinical baseline. Significant medical history and significant 
findings from any physical examination (if performed) will be recorded as medical history in 
the CRF. Temperature measurement prior to vaccination at Visit 1 will be documented and 
recorded in the CRF.
The participant will be observed for 30 minutes after vaccination and any reactions occurring 
during that time will be recorded as AEs.
Prompted e-diary events, including local reactions (redness, swelling, and pain) at each of the 
sites of injection and systemic events (fever, headache, chills, fatigue, muscle pain, and joint 
pain) that occur 10 and 7 days, respectively, after vaccination at Visit 1 (where Day 1 is the 
day of vaccination) are graded as described in Section 8.2.2.1 and Section 8.2.2.2.
Information about use of antipyretic/pain medication within 7 days after vaccination at 
Visit 1 will be collected as described in Section 8.2.2.3. Furthermore, AEs and SAEs will be 
collected as defined in Section 8.3.
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.
8.2.1. Participant Electronic Diary
Participants will be asked to monitor and record local reactions and systemic events using an 
e-diary (in a provisioned device or an application on a personal device). Use of 
antipyretic/pain medication will also be collected. This allows recording of these 
assessments only within a fixed time window, thus providing the accurate representation of 
C
C
I

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the participant’s experience. Data reported in the e-diary will be transferred electronically to 
the e-diary vendor, where they will be available for review by investigators, their 
appropriately qualified designees, and sponsor staff at all times via an internet-based portal. 
At intervals agreed to by the vendor and Pfizer, these data will be transferred electronically to 
Pfizer for analysis and reporting.
The daily e-diary data will not be captured in the CRF. However, if a participant is 
withdrawn because of prompted events reported in the e-diary, the event(s) should be 
recorded on the AE page of the CRF, regardless of whether the investigator considers the 
event(s) to be clinically significant.
The investigator or designee must obtain stop dates for any local reactions and specific 
systemic events that were ongoing on the last day that the e-diary was completed. The stop 
dates should be entered in the CRF. Because chronic use of antipyretic/pain medication is 
very common in this population and is not being used as a surrogate for an adverse 
sign/symptom, a stop date will not be sought if antipyretic/pain medication use is present on 
the last day that the e-diary was completed.
Investigators (or an appropriately qualified designee) are required to review the e-diary data 
online at frequent intervals (daily is optimal) to evaluate participant compliance and reported 
events as part of the ongoing safety review.
8.2.2. Grading Scale for Prompted Events
The grading scales used in this study to assess prompted events as described below are based 
on concepts outlined in the FDA CBER guidelines on toxicity grading scales for healthy 
adult volunteers enrolled in preventive vaccine clinical trials.73
8.2.2.1. Local Reactions
For the first 10 days following vaccination at Visit 1 (Days 1 through 10, where Day 1 is the 
day of vaccination), the participants will be asked to assess redness, swelling, and pain at 
each injection site and to record the symptoms in the e-diary in the evening.  Separate e-diary 
entries will be captured for local reactions occurring at the left and right arm injection sites.
Redness and swelling will be measured and recorded in measuring device (caliper) units 
(range: 1 to 21+) and then categorized during analysis as mild, moderate, or severe based on 
the grading scale in Table 1. Measuring device units can be converted to centimeters 
according to the following scale: 1 measuring device unit = 0.5 cm.  Pain at the vaccine 
injection site will be assessed by the participant as mild, moderate, or severe according to the 
grading scale in Table 1. The participant will be prompted to contact the investigator if 
he/she experiences a severe (Grade 3 or above) local reaction to assess the reaction and 
perform an unscheduled assessment or visit as appropriate.
Only an investigator is able to classify a participant’s local reaction as Grade 4, after physical 
examination of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record). If a participant experiences a Grade 4 local 

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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reaction, the investigator must immediately notify the sponsor. Site staff will educate the 
participants regarding signs and symptoms that would prompt site contact. Grade 4 reactions 
will be collected as an AE on the CRF. The event will be graded using the AE severity 
grading scale (Section 10.3.3).
The procedure for notification of the sponsor is provided in the ISF or equivalent.
Table 1.
Grading Scales for Local Reactions
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Redness
5 to 10 measuring 
device units
=
>2.0 to 5.0 cm
11 to 20 measuring
device units
=
>5.0 to 10.0 cm
>20 measuring 
device units
=
>10.0 cm
Necrosis or 
exfoliative 
dermatitis
Swelling
5 to 10 measuring 
device units
=
>2.0 to 5.0 cm
11 to 20 measuring 
device units
=
>5.0 to 10.0 cm
>20 measuring 
device units
=
>10.0 cm
Necrosis
Pain at 
injection site
Does not interfere 
with activity
Interferes with 
activity
Prevents daily 
activityc
Emergency room 
visit or 
hospitalization for 
severe injection site 
pain
Abbreviations: CRF = case report form; e-diary = electronic diary.
Note: If the size of the redness and/or swelling falls between 2 measuring device units, the higher measuring 
device unit number will be recorded in the e-diary.
a.
Participants experiencing Grade 3 local reactions are required to contact the investigator site. In the 
event that the participant does not call, the investigator will call the participant.
b.
Grade 4 assessment should be made by the investigator; Grade 4 local reactions will not be collected in 
the e-diary but will be collected as AEs on the CRF.  The severity of the local reaction should be graded 
using the AE severity grading scale in Section 10.3.3.
c.
Prevents daily activity, eg, results in missed days of work or is otherwise incapacitating.
8.2.2.2. Systemic Events – Systemic Symptoms and Fever
From Day 1 through Day 7 following vaccination at Visit 1, where Day 1 is the day of 
vaccination, participants will be asked to assess headache, fatigue, chills, muscle pain, and 
joint pain and to record the symptoms in the e-diary in the evening. The symptoms will be 
assessed by the participant as mild, moderate, or severe according to the grading scale in 
Table 2 below. Participants will also be instructed to contact site staff or the investigator if 
they experience any severe (Grade 3 or above) prompted systemic event within 7 days after 
vaccination. Study staff may also contact the participant to obtain additional information on 
Grade 3 events entered into the e-diary.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Protocol B7471026
Final Protocol, 08 April 2021
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Only an investigator is able to classify a participant’s systemic event as Grade 4, after 
physical examination of the participant or documentation from another medically qualified 
source (eg, emergency room or hospital record) or telephone contact with the participant. If 
a participant experiences a Grade 4 systemic event, the investigator must immediately notify 
the sponsor. Grade 4 events will be collected as an AE on the CRF. The event will be graded 
using the AE severity grading scale (See Section 10.3.3).
The procedure for notification of the sponsor is provided in the ISF or equivalent.
Table 2.
Grading Scales for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Fatigue (tiredness)
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe fatigue
Headache
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe headache
Chills
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe chills
Muscle pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe muscle pain
Joint pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe joint pain
Abbreviations: CRF = case report form; e-diary = electronic diary.
a.
Prevents daily routine activity, eg, results in missed days of work or is otherwise incapacitating; includes 
use of narcotics for analgesia.
b.
Grade 4 assessment should be made by the investigator; Grade 4 systemic events will not be collected in 
the e-diary but will be collected as AEs on the CRF.  The severity of the systemic event should be 
graded using the AE severity grading scale in Section 10.3.3.
8.2.2.2.1. Fever
In order to record information on fever, a digital thermometer will be given to the participant 
with instructions on how to measure oral temperature at home. Temperature will be 
collected in the evening daily for 7 days following vaccination at Visit 1 (Days 1 through 7, 
where Day 1 is the day of vaccination) and at any time during the 7 days that fever is 

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Final Protocol, 08 April 2021
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suspected. Fever is defined as an oral temperature of ≥100.4°F (≥38.0°C). The highest 
temperature for each day will be recorded in the e-diary. In the event of a fever on Day 7, 
temperature will be collected daily until the fever has resolved (1 day of temperature 
<100.4°F [<38.0°C]) in order to collect a stop date in the CRF. Participants reporting a fever 
>102.0°F (>38.9°C) will be prompted to contact the study site. Study staff may also contact 
the participant to obtain additional information if a temperature of >102.0°F (>38.9°C) is 
entered into an e-diary. Temperature will be measured and recorded to 1 decimal place.
Temperatures reported in degrees Fahrenheit will be programmatically converted to degrees 
Celsius for reporting. Fever will be grouped into ranges for the analysis according to 
Table 3.
Table 3.
Ranges for Fever
38.0°C to 38.4°C
>38.4°C to 38.9°C
>38.9°C to 40.0°Ca
>40.0°Ca
Note: Fever is defined as a temperature of ≥38.0°C.
a.
Participants reporting a fever >38.9°C will be prompted to contact the study site.
8.2.2.3. Use of Antipyretic/Pain Medication
The participant will be asked to record the use of antipyretic/pain medication (yes/no) in the 
e-diary in the evening, daily, for 7 days following vaccination at Visit 1 (Days 1 through 7, 
where Day 1 is the day of vaccination). Antipyretic/pain medication includes chronic use of 
NSAIDs; however, use of low-dose aspirin (<325 mg) should not be recorded in the e-diary.
8.2.3. Clinical Safety Laboratory Assessments
Clinical safety laboratory assessments will not be collected in this 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 3.
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Appendix 6.  Device deficiencies are covered in Section 8.3.9.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant’s legally 
authorized representative), 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 

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Final Protocol, 08 April 2021
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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 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 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 intervention), through and including 
Visit 2. At Month 6 (Visit 3), all participants will be contacted by telephone to inquire about
SAEs, including hospitalizations, and medications to treat SAEs since the last visit. Since 
participation in Study C4591001 for safety follow-up may be ongoing for participants in this 
study, safety events relevant to both protocols will be reported as applicable.
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 also 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 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.
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 

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Appendix 3. 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.
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 3.
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 3.
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.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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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.
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 exposure during pregnancy, exposure during 
breastfeeding, 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 injection, inhalation, or skin 
contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by injection, 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).

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
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 the final 
telephone contact.

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 
preprocedure 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 with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Final Protocol, 08 April 2021
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8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding 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 exposure 
during breastfeeding is a female family member or healthcare provider who reports that 
she is breastfeeding after having been exposed to the study intervention by injection, 
inhalation, or skin contact.
The investigator must report exposure during breastfeeding 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 exposure 
during breastfeeding 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 exposure during breastfeeding 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 exposure during breastfeeding.
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 ISF.
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
Not applicable.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
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8.3.8. Adverse Events of Special Interest
Not applicable. However, although there are no AESIs for the B7471026 protocol, an 
unplanned potential COVID-19 illness visit and unplanned potential COVID-19 convalescent 
visit are required in the C4591001 protocol (see the C4591001 protocol for details).
8.3.8.1. Lack of Efficacy
The investigator must report signs, symptoms, and/or clinical sequelae resulting from lack of 
efficacy. Lack of efficacy or failure of expected pharmacological action is reportable to 
Pfizer Safety only if associated with an SAE.
8.3.9. Medical Device Deficiencies
Medical devices being provided for use in this study as the study intervention are supplied in 
PFSs. In order to fulfill regulatory reporting obligations worldwide, the unblinded site staff is 
responsible for the detection and documentation of events meeting the definitions of device 
deficiency that occur during the study with such devices.
The definition of a medical device deficiency can be found in Appendix 6.
Note: AEs and/or SAEs that are associated with a medical device deficiency will follow the 
same processes as other AEs or SAEs, as outlined in Sections 8.3.1 through 8.3.4 and 
Appendix 3 of the protocol.
8.3.9.1. Time Period for Detecting Medical Device Deficiencies
Medical device deficiencies that result in an incident will be detected, documented, and 
reported during all periods of the study in which the medical device is used.
Importantly, reportable device deficiencies are not limited to problems with the device itself 
but also include incorrect or improper use of the device and even intentional misuse, etc. 
If the unblinded site staff learns of any device deficiency at any time after a participant has 
been discharged from the study, and such deficiency is considered reasonably related to a 
medical device provided for the study, the unblinded site staff will promptly notify the 
sponsor.
The method of documenting medical device deficiencies is provided in Appendix 6.
8.3.9.2. Follow-Up of Medical Device Deficiencies
Follow-up applies to all participants, including those who discontinue study intervention.
The unblinded site staff is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency.

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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 55
New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the unblinded site staff.
8.3.9.3. Prompt Reporting of Device Deficiencies to the Sponsor
When a device deficiency occurs: 
1. The unblinded site staff notifies the sponsor by telephone within 1 business day of 
determining that the incident meets the protocol definition of a medical device 
deficiency.
2. The device deficiency must be recorded on the Medical Device Complaint form.
3. If an AE (either serious or non-serious) associated with the device deficiency occurs, then 
the AE must be entered into the AE section of the CRF.
4. If an SAE associated with the device deficiency is brought to the attention of the
unblinded site staff, the unblinded site staff must immediately notify Pfizer Safety of the 
SAE (see Section 8.3.1.1). All relevant details related to the role of the device in the 
event must be included in the Vaccine SAE Reporting Form as outlined in 
Sections 8.3.1.1 and 8.3.1.2.
The sponsor will be the contact for the receipt of device deficiency information.
8.3.9.4. Regulatory Reporting Requirements for Device Deficiencies
The unblinded site staff will promptly report all device deficiencies occurring with any 
medical device provided for use in the study in order for the sponsor to fulfill the legal 
responsibility to notify appropriate regulatory authorities and other entities about certain 
safety information relating to medical devices being used in clinical studies.
The unblinded site staff, or responsible person according to local requirements (eg, the head 
of the medical institution), will comply with the applicable local regulatory requirements 
relating to the reporting of device deficiencies to the IRB/EC.
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.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
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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
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.
Other examples include, but are not limited to:
•
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. 
CCI

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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 57
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
The study procedures are summarized in the SoA. The day of vaccination is considered to be 
Day 1. The timing of visit procedures (ie, prior to vaccination and after vaccination) must be 
maintained; however, there is flexibility in the order in which the procedures can be 
conducted at each visit. The only exception is that at Visit 1, the ICD must be signed prior to 
the start of any study procedure.
8.9.1. Visit 1 (Day 1)
Prior to randomization:
•
Obtain a personally signed and dated ICD indicating that the participant has been 
informed of all pertinent aspects of the study before performing any study-specific 
procedures.
•
Assign a participant number via the IRT.
•
Obtain and record the participant number assigned to the participant in Study C4591001.
•
Obtain and record the participant’s demographic information (including date of birth, sex, 
race, and ethnicity).  The complete date of birth (ie, DD-MMM-YYYY) will be collected 
to critically evaluate the immune response and safety profile by age.
•
Obtain and record significant interim medical history, defined as significant medical 
history occurring since enrollment in Study C4591001, including COVID-19 infection, 
the presence of chronic conditions (eg, diabetes, asthma, cardiac disease, COPD), and/or 
medical history of significance, such as relevant surgical procedures. Please note that 
although significant medical history previously recorded in C4591001 will not need to be 
recorded again in this study, significant medical history will be reviewed to verify and 
confirm eligibility in this study.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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
Perform a clinical assessment.  If the clinical assessment indicates that a physical 
examination is necessary to comprehensively evaluate the participant, perform a physical 
examination and record any findings in the source documents and, if significant, record 
such findings on the medical history CRF.

Assess and record smoking history.

Measure and record the participant’s height and weight.

Measure and record the participant’s oral temperature (°F/°C).

Record pneumococcal vaccine history, including name(s) of the vaccine(s) received and 
date(s) given (dates may be approximate but minimally sufficient to confirm eligibility 
and appropriate stratification).

Record the dates of the BNT162b2 vaccinations received in Study C4591001 and ensure 
at least 6 months have passed since the second vaccination.

If applicable, instruct the participant to use appropriate contraceptives until 28 days after 
administration of the last dose of study intervention, and document the conversation and 
the participant’s affirmation in the participant’s source document (see Section 5.3.1).

Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met. This includes a review of the participant’s medical history as recorded in Study 
C4591001.

Assign a randomization number and a study intervention container number via the IRT.  
This must be the last step before proceeding.  An unblinded site staff member will 
prepare the study intervention according to the IP manual.
After randomization:

Collect a blood sample of approximately 30 mL prior to vaccination for immunogenicity 
assessments and to test for prior COVID-19. Please refer to the ISF for further 
instructions.

A designated third-party–unblinded site staff member will prepare the study interventions 
for administration in a manner that prevents the study participants from identifying the 
study intervention group based on preparation time prior to administration. This includes 
approximate alignment of dose preparation timing for 20vPnC and saline placebo with 
that of BNT162b2, which requires 30 minutes to thaw.  Refer to the IP manual for further
instructions.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 59

An unblinded site staff member will administer a single 0.5-mL injection of 20vPnC or 
saline into the deltoid muscle of the right arm. Please refer to the IP manual for further 
instructions.

An unblinded site staff member will administer a single 0.3-mL injection of BNT162b2
or saline into the deltoid muscle of the left arm. Please refer to the IP manual for further 
instructions.

Blinded site staff will observe the participant for 30 minutes after administration of study 
intervention for any 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 the Vaccine
SAE Reporting Form as applicable. Record concomitant medications used to treat SAEs.

Record AEs and SAEs as described in Section 8.3.

Issue the participant a measuring device to measure injection site reactions and a digital 
thermometer and provide instructions on their use. Separate e-diary entries will be 
captured for local reactions occurring at the left and right arm injection sites.

Explain the e-diary technologies available for this study (Section 8.2.1), and assist the 
participant in downloading the study application onto the participant’s own device or 
issue a provisioned device, if required. Provide instructions on the e-diary’s use and 
completion and ask the participant to complete the e-diary from Day 1 through Day 10, 
with Day 1 being the day of vaccination.

Ask the participant to contact the investigator site staff or investigator as soon as possible 
during the 10-day postvaccination period if the participant has redness and/or swelling at 
the left or right arm injection site measuring >20 measuring device units (>10 cm), or 
severe right or left arm injection site pain (prevents daily activity) to determine if an 
unscheduled reactogenicity visit is required (refer to Section 8.9.4).

Ask the participant to contact the investigator site staff or investigator as soon as possible
if he or she experiences fever ≥39.0°C (≥102.1°F) or any severe systemic event from 
Day 1 to Day 7 after vaccination (where Day 1 is the day of vaccination) to determine if 
an unscheduled reactogenicity visit is required (see Section 8.9.4).

Ask the participant to contact the site staff or investigator immediately if any significant 
illness or medical event (eg, emergency room visit or hospitalization) occurs.

Provide the participant with the participant contact card containing the study and 
investigator information (see Section 10.1.11).

Inform the participant that he or she may be contacted by site staff to obtain additional 
information on reports of fever >102.0°F (>38.9°C) or Grade 3 events entered into the 
e-diary.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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•
Remind the participant to use appropriate contraceptives until 28 days after the last study 
vaccination, if applicable.
•
Schedule an appointment for the participant to return for the next study visit.
•
Remind the participant to bring the reactogenicity e-diary to the next visit.
•
The investigator or an authorized designee completes the CRF and the source documents 
and updates the study intervention accountability records.
•
The investigator or appropriately qualified designee reviews the e-diary data online at 
frequent intervals (daily is optimal) for the 10 days (Day 1 is the day of vaccination) 
following vaccination to evaluate participant compliance and as part of the ongoing 
safety review.
8.9.2. Visit 2 (21 to 35 Days After Visit 1)
•
Ensure and document that the participant continues to be eligible for the study 
(see Section 7 for participant discontinuation/withdrawal).
•
Record nonstudy vaccinations as described in Section 6.8.
•
Discuss contraceptive use
 if applicable.
•
Review the participant’s e-diary data. Collect stop dates of any e-diary events (local 
reactions or systemic events) ongoing on the last day that the e-diary was completed and 
record stop dates in the CRF.
•
Collect the participant’s reactogenicity e-diary or assist the participant to remove the 
study application from his or her own personal device.
•
Determine if any AEs (includes nonserious AEs and SAEs) have occurred since the 
previous visit, follow up on any previously reported events to determine the outcome 
(ie, record stop dates or confirm if they are still continuing), record as described in 
Section 8.3, and record concomitant medications used to treat SAEs.
•
Collect a blood sample of approximately 30 mL for immunogenicity assessments.
•
Ask the participant to contact the site staff or investigator immediately if any significant 
illness or medical event (eg, emergency room visit or hospitalization) occurs.
•
Schedule an appointment for the participant to be contacted by telephone for the next 
study visit.
•
The investigator or an authorized designee completes the CRF and the source documents.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
Page 61
8.9.3. Visit 3 (6 Months [168 to 196 Days] After Visit 1)

Contact the participant by telephone approximately 6 months after study vaccination; this 
contact should be attempted for all participants who have received study vaccination, 
unless the participant has withdrawn consent for this.

Determine whether any SAEs have occurred since the previous visit, follow up on any 
previously reported events to determine the outcome (ie, record stop dates or confirm if 
they are still continuing), record as described in Section 8.3, and record concomitant 
medications used to treat SAEs.

The investigator or an authorized designee completed the CRF and the source documents.
8.9.4. Unscheduled Visits
If the participant reports redness or swelling at the injection site measuring >20 measuring 
device units (>10.0 cm) or severe injection site pain (Section 8.2.2.1) during the 10 days 
following vaccination at Visit 1, or a severe systemic event (Section 8.2.2.2) during the 
7 days following vaccination at Visit 1, a telephone contact must occur as soon as possible 
between the investigator or medically qualified designee and the participant to assess if an 
unscheduled investigator site visit is required. A site visit should be scheduled as soon as 
possible to assess the extent of the injection site reaction unless any of the following is true:

The participant is unable to attend the unscheduled visit.

The reaction is no longer present at the time of the telephone contact.

The participant recorded an incorrect value in the e-diary (confirmation of an 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 reactions must be assessed at the next study visit.
During the unscheduled visit, the reactions 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 oral temperature (°F/°C).

Measure minimum and maximum diameters of redness (if present).

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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
Measure minimum and maximum diameters of swelling (if present).

Assess injection site pain (if present) in accordance with the grades provided in
Section 8.2.2.1.

Assess systemic events (if present) in accordance with the grades provided in 
Section 8.2.2.2.

Assess for other findings associated with the reaction 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.
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
9.1.1. Estimands
The estimand corresponding to each primary (for safety) or secondary (for immunogenicity)
objective is described in the table in Section 3. In the primary safety objective evaluations, 
missing e-diary data will not be imputed. A partial AE start date (missing day, missing both 
month and day) will be imputed by assigning the earliest possible start date using all 
available information, such as the stop date of the AE and the vaccination date(s) from the 
same participant, following the Pfizer standard of handling incomplete AE start date. An AE 
with a completely missing start date is not allowed in the data collection. No other missing 
information will be imputed in the safety analysis.
The estimand to evaluate each immunogenicity objective will be based on the evaluable 
immunogenicity population (Section 9.2). The estimand estimates the vaccine effect in the
hypothetical setting where participants follow the study schedules and protocol requirements 
as directed. Missing serology results will not be imputed. Immunogenicity results that are 
below the LLOQ will be set to 0.5 × LLOQ in the analysis.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Final Protocol, 08 April 2021
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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.
Randomized
All participants who are assigned a randomization 
number in the IWR system.
Evaluable immunogenicity
All eligible randomized participants who receive 
the study intervention(s) as assigned at Visit 1, 
have at least 1 valid immunogenicity result from 
the blood sample collected within an appropriate 
window approximately 1 month after vaccination 
(Visit 2), and have no other major protocol 
deviations as determined by the clinician.
In the analysis for BNT162b2 immunogenicity 
endpoints based on the evaluable immunogenicity 
population, data from participants with clinically 
documented SARS-CoV-2 infection occurring 
between vaccination and 1 month after vaccination 
may be excluded.
Participants will be grouped according to the 
vaccine as randomized in the analysis based on the 
evaluable immunogenicity population.
 
 
 
 
 
Safety
All participants who receive at least 1 dose of the 
study intervention and have safety follow up after 
vaccination.
Participants will be analyzed according to the 
vaccine as administered in the analysis based on 
the safety population.
CCI

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9.3. Statistical Analyses
The SAP will be developed and finalized before any unblinded 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 
secondary endpoints.
9.3.1. General Considerations
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 2-sided 
95% CIs where applicable.
The exact 95% CI for binary endpoints for each group will be computed using the 
F distribution (Clopper-Pearson).
For the between-group difference, the 2-sided 95% CI will be calculated using the Miettinen 
and Nurminen method.74
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 Mean
The geometric mean for each vaccine group will be calculated as the mean of the 
logarithmically transformed assay results and then exponentiating the mean. The 2-sided 
95% CI will be obtained by exponentiating the limits of the CI for the mean of the 
logarithmically transformed assay results based on Student’s t-distribution.
9.3.1.2.2. Geometric Mean Fold Rise
The GMFR for each vaccine group is defined as the geometric mean of the fold rises in the 
assay results from before to approximately 1 month after vaccination. Only data from 
participants with nonmissing assay results at both time points will be included in the GMFR 
calculation.
GMFR will be calculated as the mean difference of logarithmically transformed assay results 
(1 month after vaccination – before vaccination) and exponentiating the mean difference. 
The 2-sided 95% CI will be obtained by exponentiating the limits of the CI for the mean 
difference of the logarithmically transformed assay results based on Student’s t-distribution.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
Protocol B7471026
Final Protocol, 08 April 2021
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9.3.2. Primary Endpoint(s)/Estimand(s) Analysis
Objectives
Endpoint and Estimand
Statistics & Hypothesis Test
Safety
•
Proportions of participants with local 
reactions (redness, swelling, and pain at the 
injection site) within 10 days after 
vaccination at each injection site in each 
vaccine group
•
Proportions of participants with systemic 
events (fever, headache, chills, fatigue, 
muscle pain, and joint pain) within 7 days
after vaccination in each vaccine group
•
Descriptive summary statistics
for participants with each local 
reaction/systemic event within 
10/7 days after vaccination by 
maximum severity 
cumulatively across severity 
levels
•
AEs and SAEs from vaccination through
approximately 1 month after vaccination
•
Descriptive summary statistics 
•
SAEs from vaccination to 6 months after 
vaccination
•
Descriptive summary statistics
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis
Objectives
Endpoint and Estimand
Statistics & Hypothesis Test
Immunogenicity
•
OPA GMTs for the 20vPnC serotypes at 
approximately 1 month after vaccination in 
each vaccine group
•
GMT and 2-sided 95% CI
•
GMCs of full-length S-binding IgG levels at 
approximately 1 month after vaccination in 
each vaccine group
•
GMC and 2-sided 95% CI
•
GMFR of full-length S-binding IgG levels 
from before to approximately 1 month after 
vaccination in each vaccine group
•
GMFR and 2-sided 95% CI
CCI

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9.4. Interim Analyses
No formal interim analysis will be conducted for this study.
CCI
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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Final Protocol, 08 April 2021
PFIZER CONFIDENTIAL
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9.5. Sample Size Determination
The sample size of the study is determined primarily based on considerations of 
accumulating an informative overall safety and immunogenicity data for coadministration 
considerations. With 200 participants in each vaccine group, there is a greater than 86% 
chance of observing at least 1 AE in each group if the true rate is at least 1% (Table 4).
Table 4.
Probability of Detecting at Least 1 AE
Sample Size
True Rate of AEs
Probability of Observing at Least 1 AE
200
0.5%
63.3%
1.0%
86.6%
1.5%
95.1%

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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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, 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 course of 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, including the 
risks and benefits, to the participant and answer all questions regarding the study. The 
participant should be given sufficient time and opportunity to ask questions and to decide 
whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each study participant 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. 
The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.
The investigator further must ensure that each study participant is fully informed about his or 
her right to access and correct his or her personal data and to withdraw consent for the 
processing of his or her personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.

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Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study.
A copy of the ICD(s) must be provided to the participant.
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 
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.
10.1.6. 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 
CCI
CCI

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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.
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 European Union 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.

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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.
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 clinical study 
report.
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, 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.

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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.
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 ISF, 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.

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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/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
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.

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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. 
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/study portal or other electronic system.
To facilitate access to appropriately qualified medical personnel for study-related medical 
questions or problems, participants are provided with an Emergency Contact Card (ECC) at 
the time of informed consent. The ECC contains, at a minimum, (a) protocol and study 
intervention identifiers, (b) participant’s study identification 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: Clinical Laboratory Tests
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues. Investigators must document their review of each 
laboratory safety report.

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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting
10.3.1. Definition of AE
AE Definition

An AE is any untoward medical occurrence in a patient or clinical study 
participant, 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 
abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, 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 abnormal laboratory 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 medical/surgical intervention.

Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.

Exacerbation of a chronic or intermittent preexisting condition, including either an 
increase in frequency and/or intensity of the condition.

New condition detected or diagnosed after study intervention administration, even 
though it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug 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-harming intent. Such overdoses should be reported regardless of 
sequelae.
Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’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 
participant’s condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.

Situations in which an untoward medical occurrence 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 start of the study that do not worsen.
10.3.2. 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 term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might 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 ward 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 

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complication prolongs hospitalization or fulfills any other serious criteria, the event is 
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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10.3.3. 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 
reporting SAEs on the Vaccine SAE Reporting Form 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 Reporting Form for reporting of SAE information 
is not the same as the AE page of the CRF. When the same data are collected, the forms 
must be completed in a consistent manner. AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the Vaccine SAE 
Reporting Form for reporting of SAE information.
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
Note:  Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF.
All instances of EDP are 
reported (whether or not 
there is an associated 
SAE)*
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-participant (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 
reported.***
*
EDP (with or without an associated AE or SAE): any pregnancy information is reported to Pfizer 
Safety using Vaccine SAE Reporting Form and EDP Supplemental Form; if the EDP is associated 
with an SAE, then the SAE is reported to Pfizer Safety using the Vaccine SAE Reporting Form. 
** EDB is reported 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 
reported 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, laboratory reports, and diagnostic 
reports) related to the event.

The investigator will then record all relevant AE or SAE information in the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the Vaccine SAE 
Reporting Form/AE or SAE CRF page.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant 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 information. 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 reported 
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, or SEVERE to describe the maximum 
intensity of the AE. For purposes of consistency, these intensity grades are 
defined as follows:
1
MILD
Does not interfere with participant's usual 
function.
2
MODERATE
Interferes to some extent with participant's usual 
function.
3
SEVERE
Interferes significantly with participant's usual 
function.

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Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE or SAE. The investigator will use clinical 
judgment to determine the relationship.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled 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 
administration, will be considered and investigated.

The investigator will also consult the IB and/or product information, for marketed 
products, in his/her assessment.

For each AE or SAE, the investigator must document 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 occurred and the investigator has 
minimal information to include in the initial report 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 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting 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 reporting 
purposes, as defined by the sponsor. In addition, if the investigator determines that 
an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and report such an 
assessment in the dedicated section of the Vaccine SAE Reporting Form and in 
accordance with the SAE reporting requirements.

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Follow-Up of AEs and SAEs

The investigator is obligated to perform or arrange 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 laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings, including histopathology.

New or updated information 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 information.
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an 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 report 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 entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (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 Reporting Form is the preferred 
method to transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Form sent by overnight mail 
or courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Reporting Form pages within the designated 
reporting time frames.

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CCI

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CCI

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CCI

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10.5. Appendix 5: 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 
below.
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:

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).

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
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 coformulated 
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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10.6. Appendix 6: AEs, ADEs, SAEs, SADEs, USADEs, and Device Deficiencies:
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting in 
Medical Device Studies
Definitions of a Medical Device Deficiency
The definitions and procedures detailed in this appendix are in accordance with ISO 14155
and the European MDR 2017/745 for clinical device research (if applicable). 
Both the investigator and the sponsor will comply with all local reporting requirements for 
medical devices.
The detection and documentation procedures described in this protocol apply to all sponsor 
medical devices provided for use in the study (see Section 6.1.2 for the list of sponsor 
medical devices).
10.6.1. Definition of AE and ADE
AE and ADE Definition

An AE is defined in Appendix 3 (Section 10.3.1).

An ADE is defined as an AE related to the use of an investigational medical device. 
This definition includes any AEs resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device as well as any event resulting 
from use error or from intentional misuse of the investigational medical device.
10.6.2. Definition of SAE, SADE, and USADE
SAE Definition

An SAE is defined in Appendix 3 (Section 10.3.2).
SADE Definition

An SADE is defined as an adverse device effect that has resulted in any of the 
consequences characteristic of an SAE.

Any device deficiency that might have led to an SAE if appropriate action had not 
been taken, intervention had not occurred, or circumstances had been less fortunate.

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USADE Definition

A USADE is a serious adverse device effect that by its nature, incidence, severity, 
or outcome has not been identified in the current version of the risk analysis 
management file.
10.6.3. Definition of Device Deficiency
Device Deficiency Definition

A device deficiency is an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or performance. Device deficiencies 
include malfunctions, use errors, and inadequate information supplied by the 
manufacturer.
10.6.4. Recording/Reporting and Follow-Up of Medical Device Deficiencies
Device Deficiency Recording

When a device deficiency occurs, it is the responsibility of the unblinded site staff
to review all documentation (eg, hospital progress notes, laboratory reports, and 
diagnostic reports) related to the event.

The unblinded site staff will then record all relevant device deficiency information 
in the participant’s medical records, in accordance with the investigator’s normal 
clinical practice and will also capture the required information on the Medical 
Device Complaint form.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of following the reporting process described 
in the Medical Device Complaint form.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.

If the unblinded site staff determines that the medical device deficiency may have 
injured the participant (ie, the medical device deficiency is associated with an AE 
or SAE), then the unblinded site staff will attempt to establish a diagnosis of the 
event based on signs, symptoms, and/or other clinical information. Whenever 
possible, the diagnosis will be documented in the participant’s medical record and 
recorded as the AE or SAE rather than the individual signs/symptoms. 

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Requirements for recording and reporting an AE or SAE are provided in 
Appendix 3 (Section 10.3.3).

For device deficiencies, it is very important that the unblinded site staff describes 
any corrective or remedial actions taken to prevent recurrence of the incident.

A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency. This includes any amendment to the device design to prevent 
recurrence.
Assessment of Causality Occurring in Conjunction With a Medical Device Deficiency

If an AE or SAE has occurred in conjunction with a medical device deficiency, the 
investigator must assess the relationship between each occurrence of the AE or 
SAE and the medical device deficiency. The investigator will use clinical judgment 
to determine the relationship.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled 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 
administration will be considered and investigated.

The investigator will also consult the IB in his/her assessment.

For each device deficiency, the investigator must document in the medical notes 
that he/she has reviewed the device deficiency and has provided an assessment of 
causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report 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 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

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Follow-Up of Medical Device Deficiency

The investigator is obligated to perform or arrange 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 device deficiency as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

New or updated information regarding the nature of the device deficiency will be 
recorded in the originally completed Medical Device Complaint form.

New or updated information regarding any SAE that was potentially associated 
with the medical device deficiency will be submitted to Pfizer Safety on the 
Vaccine SAE Reporting Form within 24 hours of receipt of the information, 
according to the requirements provided in Appendix 3.
10.6.5. Reporting of SAEs
Reporting of an SAE to Pfizer Safety must be performed according to the processes 
described in Appendix 3 (Section 10.3.4).
10.6.6. Reporting of SADEs
SADE Reporting to Pfizer Safety
Note: There are additional reporting obligations for medical device deficiencies that are 
potentially related to SAEs (ie, a SADE) that must fulfill the legal responsibility to notify 
appropriate regulatory authorities and other entities about certain safety information 
relating to medical devices being used in clinical studies.

Any device deficiency that is associated with an SAE must be reported to the 
sponsor within 24 hours after the investigator determines that the event meets the 
definition of a device deficiency.

The sponsor shall review all device deficiencies and determine and document in 
writing whether they could have led to an SAE. These shall be reported to the 
regulatory authorities and IRBs/ECs as required by national regulations.

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10.7. Appendix 7:  Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic in the US and will become effective for other public emergencies 
only upon written notification from Pfizer.
Use of these alternative study measures are expected to cease upon the return of business as 
usual (including the lifting of any quarantines and travel bans/advisories).
10.7.1. 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, video-conferencing software) remotely, 
allowing the participant and the investigator to communicate on aspects of clinical care, 
including medical advice, reminders, education, and safety monitoring. 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.

Confirm that the participant is adhering to the contraception method(s) required in the 
protocol.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.
10.7.2. Home Health Visits
A home health care service may be utilized to facilitate scheduled visits per the SoA. Home 
health visits include a healthcare provider conducting an in-person study visit at the 
participant’s location, rather than an in-person study visit at the site. Conduct of home health 
visits is subject to approval of the sponsor. The following may be performed during a home 
health visit:

Collection of a blood sample for immunogenicity assessments and to test for prior 
COVID-19. Please refer to the ISF for further instructions.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine (20vPnC);
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10.7.3. Adverse Events and Serious Adverse Events
If a participant has COVID-19 during the study, this should be reported as an AE or SAE and 
appropriate medical intervention provided. Study vaccination should continue unless the 
investigator/treating physician is concerned about the safety of the participant, in which case 
temporary or permanent discontinuation may be required. 
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the study medical monitor.

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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
13vPnC
13-valent pneumococcal conjugate vaccine
2019-nCoV
novel coronavirus 2019
20vPnC
20-valent pneumococcal conjugate vaccine
7vPnC
7-valent pneumococcal conjugate vaccine
ACIP
Advisory Committee on Immunization Practices
ADE
adverse device effect
AE
adverse event
AESI
adverse event of special interest
ALT
alanine aminotransferase
AOM
acute otitis media
AST
aspartate aminotransferase
CAP
community-acquired pneumonia
CBER
Center for Biologics Evaluation and Research
CDC
Centers for Disease Control and Prevention
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CONSORT
Consolidated Standards of Reporting Trials
COPD
chronic obstructive pulmonary disease
COVID-19
coronavirus disease 2019
CRF
case report form
CRM197
cross-reactive material 197
CRO
contract research organization
CSR
clinical study report
DILI
drug-induced liver injury
DNA
deoxyribonucleic acid
DU
dispensable unit
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram
eCRF
electronic case report form
EDB
exposure during breastfeeding
e-diary
electronic diary
EDP
exposure during pregnancy
EMA
European Medicines Agency
EU
European Union
CCI

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Abbreviation
Term
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMC
geometric mean concentration
GMFR
geometric mean fold rise
GMT
geometric mean titer
HBe
hepatitis B e
HBeAg
hepatitis B e antigen
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HIV
human immunodeficiency virus
HRT
hormone replacement therapy
IB
investigator’s brochure
ICD
informed consent document
ICH
International Council for Harmonisation
ID
identification
IgG
immunoglobulin G
IND
investigational new drug
INR
international normalized ratio
IP manual
investigational product manual
IPAL
Investigational Product Accountability Log
IPD
invasive pneumococcal disease
IRB
institutional review board
IRT
interactive response technology
ISF
investigator site file
ISO
International Organization for Standardization
IWR
interactive Web-based response
LFT
liver function test
LLOQ
lower limit of quantitation
LNP
lipid nanoparticle
LRI
lower respiratory tract infection
MDR
medical device regulation
MERS
Middle East respiratory syndrome
modRNA
nucleoside-modified messenger ribonucleic acid
N/A
not applicable
NAAT
nucleic acid amplification test
N-binding
SARS-CoV-2 nucleoprotein–binding
NSAID
nonsteroidal anti-inflammatory drug

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Abbreviation
Term
OPA
opsonophagocytic activity
P2 S
SARS-CoV-2 full-length, P2 mutant, prefusion spike glycoprotein
PFS
prefilled syringe
PI
principal investigator
PPE
personal protective equipment
PPSV23
23-valent pneumococcal polysaccharide vaccine
PT
prothrombin time
QTL
quality tolerance limit
RNA
ribonucleic acid
RSV
respiratory syncytial virus
S
spike protein
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
SARS
severe acute respiratory syndrome
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SoA
schedule of activities
SOP
standard operating procedure
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
ULN
upper limit of normal
US
United States
USADE
unanticipated serious adverse device effect
VT
vaccine-type
WHO
World Health Organization
CCI
CCI

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10.9. Appendix 9: Criteria for Allowing Inclusion of Participants With Chronic Stable 
HIV or HBV Infection or Cured HCV Infection
Potential participants with chronic stable HIV or HBV infection or cured HCV infection may 
be considered for inclusion if they fulfill the following respective criteria. 
Known HIV infection
Confirmed stable HIV disease, defined as documented viral load 200 cells/mm3 within 
6 months before enrollment, and on stable antiretroviral therapy for at least 6 months.
Known HBV infection
Confirmed inactive chronic HBV infection, defined as HBsAg present for ≥6 months and the 
following:

HBeAg negative, anti-HBe positive 

Serum HBV DNA <2000 IU/mL

Persistently normal ALT and/or AST levels
In those who have had a liver biopsy performed, findings that confirm the absence of 
significant necroinflammation.
Known cured HCV infection

History of chronic HCV with evidence of sustained virological response (defined as 
undetectable HCV RNA) for ≥12 weeks following HCV treatment or without evidence of 
HCV RNA viremia (undetectable HCV viral load). 

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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccine)
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