Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

COVID-19 Clinical Trial

Official title:

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368728
• Other study ID #: C4591001
• Secondary ID: 2020-002641-42
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 29, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2023
• Source: BioNTech SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.

The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.

The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:

• As a 2-dose (separated by 21 days) schedule;

• At various different dose levels in Phase 1;

• As a booster;

• In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).

The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.

Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.

In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity.

The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.

To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.

To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47079
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or =12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization.

Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment.

Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants =18 years at rerandomization.

Note that participants <18 years of age cannot be enrolled in the EU.

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

• Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.

• Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19.

• Boostability and protection-against-VOCs existing participant subset only:

Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window.

• Capable of giving personal signed informed consent

Exclusion Criteria:

• 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.

• Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).

• Receipt of medications intended to prevent COVID 19.

• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19

• Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors:

• Hypertension

• Diabetes mellitus

• Chronic pulmonary disease

• Asthma

• Current vaping or smoking

• History of chronic smoking within the prior year

• BMI >30 kg/m2

• Anticipating the need for immunosuppressive treatment within the next 6 months

• Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).

• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

• Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.

• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

• Women who are pregnant or breastfeeding.

• Previous vaccination with any coronavirus vaccine.

• Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

• Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids.

• Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.

• Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.

• Previous participation in other studies involving study intervention containing lipid nanoparticles.

• Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.

• Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a = Grade 1 abnormality.

• Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.

• Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention.

• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• BNT162b1
Intramuscular injection
• BNT162b2
Intramuscular injection

Other:
• Placebo
Intramuscular injection

Biological:
• BNT162b2SA
Intramuscular injection

Locations

Country	Name	City	State
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Caba
Brazil	Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce	Salvador	Bahia
Brazil	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)	Sao Paulo
Germany	CRS Clinical Research Services Berlin GmbH	Berlin
Germany	Medizentrum Essen Borbeck	Essen
Germany	IKF Pneumologie GmbH & Co KG	Frankfurt am Main
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim
Germany	Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher	Stuhr
South Africa	Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital	Cape Town	Western CAPE
South Africa	Newtown Clinical Research Centre	Johannesburg	Gauteng
South Africa	Jongaie Research	Pretoria	Gauteng
South Africa	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo
Turkey	Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Acibadem Atakent Hastanesi	Istanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi	Istanbul
Turkey	Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi	Istanbul
Turkey	Medipol Mega Universite Hastanesi	Istanbul
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Sakarya Universitesi Egitim ve Arastirma Hastanesi	Sakarya
United States	Lehigh Valley Health Network/Network Office of Research and Innovation	Allentown	Pennsylvania
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)	Annandale	Virginia
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Lynn Institute of Denver	Aurora	Colorado
United States	ARC Clinical Research at Four Points	Austin	Texas
United States	Benchmark Research	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Pharmaron CPC, Inc.	Baltimore	Maryland
United States	University of Maryland Medical Center Investigational Drug Service Pharmacy	Baltimore	Maryland
United States	University of Maryland, Baltimore, Health Sciences Research Facility III	Baltimore	Maryland
United States	University of Maryland, Center for Vaccine Development and Global Health	Baltimore	Maryland
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Meridian Clinical Research, LLC	Binghamton	New York
United States	Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research	Bozeman	Montana
United States	Holston Medical Group	Bristol	Tennessee
United States	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina
United States	PMG Research of Charlotte LLC	Charlotte	North Carolina
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Chinle Comprehensive Health Care Facility	Chinle	Arizona
United States	Johns Hopkins Center for American Indian Health	Chinle	Arizona
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Meridian Clinical Research LLC	Cincinnati	Ohio
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	VA Northeast Ohio Healthcare System	Cleveland	Ohio
United States	Velocity Clinical Research, Inc.	Cleveland	Ohio
United States	Aventiv Research Inc.	Columbus	Ohio
United States	IACT Health	Columbus	Georgia
United States	Alliance for Multispecialty Research	Coral Gables	Florida
United States	North Texas Infectious Diseases Consultants, P.A.	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Dayton Clinical Research	Dayton	Ohio
United States	PriMED Clinical Research	Dayton	Ohio
United States	DeLand Clinical Research Unit	DeLand	Florida
United States	Accessioning Unit and Repository	Durham	North Carolina
United States	Clinical Research Pickett Road	Durham	North Carolina
United States	Duke Investigational Drug Service Pharmacy	Durham	North Carolina
United States	Duke Vaccine and Trials Unit	Durham	North Carolina
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Meridian Clinical Research LLC	Endwell	New York
United States	Lillestol Research Llc	Fargo	North Dakota
United States	Michigan Center for Medical Research	Farmington Hills	Michigan
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Benchmark Research	Fort Worth	Texas
United States	Texas Health Resources	Fort Worth	Texas
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Methodist Physicians Clinic / CCT Research	Fremont	Nebraska
United States	Johns Hopkins Center for American Indian Health	Gallup	New Mexico
United States	University of Texas Medical Branch	Galveston	Texas
United States	PharmQuest	Greensboro	North Carolina
United States	MedPharmics, LLC	Gulfport	Mississippi
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Research Centers of America	Hollywood	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Ventavia Research Group, LLC	Houston	Texas
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Optimal Research, LLC	Huntsville	Alabama
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Iowa Hospitals & Clinics Investigational Drug Servces	Iowa City	Iowa
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Ventavia Research Group, LLC	Keller	Texas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Wake Research-Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Main Street Physician's Care	Little River	South Carolina
United States	Collaborative Neuroscience Research, LLC	Long Beach	California
United States	Long Beach Clinical Trials Services Inc.	Long Beach	California
United States	Main Street Physician's Care	Loris	South Carolina
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	National Research Institute	Los Angeles	California
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	SMS Clinical Research, LLC	Mesquite	Texas
United States	Benchmark Research	Metairie	Louisiana
United States	Acevedo Clinical Research Associates	Miami	Florida
United States	Virginia Research Center LLC	Midlothian	Virginia
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	Alliance for Multispecialty Research, LLC	Mobile	Alabama
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Yale Center for Clinical Investigations (CSRU)	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Langone Health	New York	New York
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Velocity Clinical Research, North Hollywood	North Hollywood	California
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Orlando	Florida
United States	LinQ Research, LLC	Pearland	Texas
United States	Optimal Research	Peoria	Illinois
United States	HOPE Research Institute	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	Kaiser Permanente Northwest-Center for Health Research	Portland	Oregon
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Amici Clinical Research	Raritan	New Jersey
United States	Paradigm Clinical Research Center	Redding	California
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center- Kari Steinmetz	Rochester	New York
United States	Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC)	Sacramento	California
United States	Kaiser Permanente Sacramento	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Benchmark Research.	San Angelo	Texas
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Kaiser Permanente Santa Clara	Santa Clara	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	Johns Hopkins Center for American Indian Health	Shiprock	New Mexico
United States	LSU Health Sciences Center at Shreveport Clinical Trials Office	Shreveport	Louisiana
United States	LSUHSC-Shreveport	Shreveport	Louisiana
United States	Meridian Clinical Research, LLC	Sioux City	Iowa
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	Senders Pediatrics	South Euclid	Ohio
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	SUNY Upstate Medical University Global Health Research Unit	Syracuse	New York
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	Martin Diagnostic Clinic	Tomball	Texas
United States	Trinity Clinical Research	Tullahoma	Tennessee
United States	Bayview Research Group	Valley Village	California
United States	Meridian Clinical Research LLC	Vestal	New York
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Wenatchee Valley Hospital	Wenatchee	Washington
United States	Whiteriver Indian Hospital	Whiteriver	Arizona
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
BioNTech SE	Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Germany,  South Africa,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants in Phase 1 reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	Percentage of participants in Phase 1 reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	Percentage of participants in Phase 1 reporting adverse events	As elicited by investigational site staff	From dose 1 through 1 month after the last dose
Primary	Percentage of participants in Phase 1 reporting serious adverse events	As elicited by investigational site staff	From dose 1 through 6 months after the last dose
Primary	Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	1 day after dose 1
Primary	Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	7 days after dose 1
Primary	Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	7 days after dose 2
Primary	Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory	Between baseline and 1 day after dose 1
Primary	Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory	Between baseline and 7 days after dose 1
Primary	Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory	Between before dose 2 and 7 days after dose 2
Primary	In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events	As elicited by investigational site staff	From dose 1 through 1 month after the last dose
Primary	In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events	As elicited by investigational site staff	From dose 1 through 6 months after the last dose
Primary	In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	Percentage of participants in Phase 2/3 reporting adverse events	As elicited by investigational site staff	From dose 1 through 1 month after the last dose
Primary	Percentage of participants in Phase 2/3 reporting serious adverse events	As elicited by investigational site staff	From dose 1 through 6 months after the last dose
Primary	Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Primary	Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Primary	Percentage of participants 12-15 years of age in Phase 3 reporting adverse events	As elicited by investigational site staff	From dose 1 through 1 month after the last dose
Primary	Percentage of participants 12-15 years of age in Phase 3 reporting adverse events	As elicited by investigational site staff	From dose 1 through 6 months after the last dose
Primary	In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after dose 1 and dose 2
Primary	In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events	As elicited by investigational site staff	From dose 1 through 1 month after the last dose
Primary	In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events	As elicited by investigational site staff	From dose 1 through 5 or 6 months after the last dose
Primary	In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days after dose 1 (and dose 2)
Primary	In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after dose 1 (and dose 2)
Primary	In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting adverse events	As elicited by investigational site staff	From the third dose through 1 month after the third dose
Primary	In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting serious adverse events	As elicited by investigational site staff	From the third dose through 6 months after the third dose
Primary	In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days after the third dose
Primary	In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after the third dose
Primary	In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events	As elicited by investigational site staff	From the third dose through 1 month after the third dose
Primary	In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events	As elicited by investigational site staff	From the third dose through 6 months after the third dose
Primary	Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals	As measured at the central laboratory	1 month after the third dose
Primary	Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals	As measured at the central laboratory	1 month after the third dose
Primary	Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2	As measured at the central laboratory	1 month after the second dose
Secondary	In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs	As measured at the central laboratory	Through 2 years after the final dose
Secondary	In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point	As measured at the central laboratory	Through 2 years after the final dose
Secondary	Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels	As measured at the central laboratory	Through 2 years after the final dose
Secondary	In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs	As measured at the central laboratory	Through 2 years after the final dose
Secondary	Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels	As measured at the central laboratory	Through 2 years after the final dose
Secondary	In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point	As measured at the central laboratory	Through 2 years after the final dose
Secondary	In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels	As measured at the central laboratory	Through 2 years after the final dose
Secondary	Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 7 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 2 years
Secondary	GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)	As measured at the central laboratory	1 month after the second dose
Secondary	Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose	Per 1000 person-years of follow-up	Through 1 month after the second dose
Secondary	Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection	Per 1000 person-years of follow-up	Through 6 months after the second dose
Secondary	Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals	As measured at the central laboratory	1 month after the third dose
Secondary	Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals	As measured at the central laboratory	1 month after the first dose of BNT162b2SA
Secondary	Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg	As measured at the central laboratory	1 month after the first dose of BNT162b2SA/third dose of BNT162b2
Secondary	Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals	As measured at the central laboratory	1 month after the second dose of BNT162b2SA
Secondary	Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2	As measured at the central laboratory	1 month after the second dose
Secondary	Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2	As measured at the central laboratory	1 month after the second dose

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