Other substances

BNT162b1

An experimental COVID-19 mRNA-based vaccine.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

BNT162b1 is an experimental COVID-19 mRNA-based vaccine formulated in lipid nanoparticles. It encodes SARS-CoV-2 Spike protein RBD as the immunogen. The RBD is modified with the attachment of a trimerization domain derived from T4 fibritin (Mulligan et al., 2020).

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults RNA Randomized controlled single-blind trial Phase II clinical trial Phase I clinical trial	Patients	42.78	The vaccine of nucleoside-modified RNA encoding receptor-binding domain of the SARS-CoV-2 spike protein delivered via lipid nanoparticles in clinical trial phase I/II displayed immunogenicity. SARS-CoV-2 neutralizing titers and anti-RBD IgG levels increased with dose level and after second dose. Adverse effects were mild to moderate and transient. Second 100 µg dose was not administered. Sample size: 12 (10 µg), 12 (30 µg), 12 (100 µg) + 9 placebo. Dosage: 2 doses of 10 and 30 µg 21 days apart, or a single dose of 100 µg.	Aug/12/2020

AI-suggested references

Link	Publication date
COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses.	Sep/30/2020
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.	Aug/12/2020
Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study.	Dec/15/2020
BNT162b vaccines protect rhesus macaques from SARS-CoV-2.	Apr/23/2020
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates	May/06/2020
Tozinameran (BNT162b2) Vaccine: The Journey from Preclinical Research to Clinical Trials and Authorization	Mar/10/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04368728	Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals	Recruiting	Phase 2\|Phase 3	Apr/29/2020	Feb/08/2024
Alternative id - C4591001\|2020-002641-42 Interventions - Biological: BNT162b1\|Biological: BNT162b2\|Other: Placebo\|Biological: BNT162b2SA Study type - Interventional Study results - No Results Available Locations - North Alabama Research Center, LLC, Athens, Alabama, United States\|Birmingham Clinical Research Unit, Birmingham, Alabama, United States\|Medical Affiliated Research Center, Huntsville, Alabama, United States\|Optimal Research, LLC, Huntsville, Alabama, United States\|Alliance for Multispecialty Research, LLC, Mobile, Alabama, United States\|Chinle Comprehensive Health Care Facility, Chinle, Arizona, United States\|Johns Hopkins Center for American Indian Health, Chinle, Arizona, United States\|The Pain Center of Arizona, Phoenix, Arizona, United States\|HOPE Research Institute, Phoenix, Arizona, United States\|Alliance for Multispecialty Research, LLC, Tempe, Arizona, United States\|Whiteriver Indian Hospital, Whiteriver, Arizona, United States\|Anaheim Clinical Trials, LLC, Anaheim, California, United States\|Collaborative Neuroscience Research, LLC, Long Beach, California, United States\|Long Beach Clinical Trials Services Inc., Long Beach, California, United States\|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States\|National Research Institute, Los Angeles, California, United States\|Providence Clinical Research, North Hollywood, California, United States\|Paradigm Clinical Research Center, Redding, California, United States\|Kaiser Permanente Sacramento, Sacramento, California, United States\|UC Davis Medical Center, Sacramento, California, United States\|California Research Foundation, San Diego, California, United States\|Kaiser Permanente Santa Clara, Santa Clara, California, United States\|Bayview Research Group, Valley Village, California, United States\|Diablo Clinical Research, Inc., Walnut Creek, California, United States\|Lynn Institute of Denver, Aurora, Colorado, United States\|Clinical Research Consulting, LLC, Milford, Connecticut, United States\|Yale Center for Clinical Investigations (CSRU), New Haven, Connecticut, United States\|Alliance for Multispecialty Research, LLC-Miami, Coral Gables, Florida, United States\|Clinical Research of South Florida, Coral Gables, Florida, United States\|DeLand Clinical Research Unit, DeLand, Florida, United States\|Fleming Island Center for Clinical Research, Fleming Island, Florida, United States\|Indago Research & Health Center, Inc, Hialeah, Florida, United States\|Research Centers of America, Hollywood, Florida, United States\|Jacksonville Center for Clinical Research, Jacksonville, Florida, United States\|Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, United States\|Acevedo Clinical Research Associates, Miami, Florida, United States\|Clinical Neuroscience Solutions, Inc. dba CNS Healthcare, Orlando, Florida, United States\|Atlanta Center for Medical Research, Atlanta, Georgia, United States\|IACT Health, Columbus, Georgia, United States\|Meridian Clinical Research, LLC, Savannah, Georgia, United States\|Clinical Research Atlanta, Stockbridge, Georgia, United States\|East-West Medical Research Institute, Honolulu, Hawaii, United States\|Solaris Clinical Research, Meridian, Idaho, United States\|Optimal Research, LLC, Peoria, Illinois, United States\|University of Iowa Hospitals & Clinics Investigational Drug Servces, Iowa City, Iowa, United States\|University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States\|Meridian Clinical Research, LLC, Sioux City, Iowa, United States\|Alliance for Multispecialty Research, LLC, Newton, Kansas, United States\|Alliance for Multispecialty Research, LLC, Wichita, Kansas, United States\|Kentucky Pediatric/ Adult Research, Bardstown, Kentucky, United States\|Benchmark Research, Metairie, Louisiana, United States\|Ochsner Clinic Foundation, New Orleans, Louisiana, United States\|LSU Health Sciences Center at Shreveport Clinical Trials Office, Shreveport, Louisiana, United States\|LSUHSC-Shreveport, Shreveport, Louisiana, United States\|Pharmaron CPC, Inc., 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\|University of Maryland, Baltimore, Maryland, United States\|Center for Immunization Research Inpatient Unit, Baltimore, Maryland, United States\|Boston Medical Center, Boston, Massachusetts, United States\|UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States\|Michigan Center for Medical Research, Farmington Hills, Michigan, United States\|MedPharmics, Limited Liability Company, Gulfport, Mississippi, United States\|MedPharmics, LLC, Gulfport, Mississippi, United States\|Clinical Research Professionals, Chesterfield, Missouri, United States\|Sundance Clinical Research, LLC, Saint Louis, Missouri, United States\|Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research, Bozeman, Montana, United States\|Bozeman Health Deaconess Hospital, Bozeman, Montana, United States\|Methodist Physicians Clinic / CCT Research, Fremont, Nebraska, United States\|Meridian Clinical Research, LLC, Norfolk, Nebraska, United States\|Quality Clinical Research, Inc., Omaha, Nebraska, United States\|Meridian Clinical Research, LLC, Omaha, Nebraska, United States\|Wake Research-Clinical Research Center of Nevada, LLC, Las Vegas, Nevada, United States\|Amici Clinical Research, Raritan, New Jersey, United States\|South Jersey Infectious Disease, Somers Point, New Jersey, United States\|Johns Hopkins Center for American Indian Health, Gallup, New Mexico, United States\|Johns Hopkins Center for American Indian Health, Shiprock, New Mexico, United States\|Meridian Clinical Research, LLC, Binghamton, New York, United States\|Meridian Clinical Research LLC, Endwell, New York, United States\|NYU Langone Health, New York, New York, United States\|Icahn School of Medicine at Mount Sinai, New York, New York, United States\|Rochester Clinical Research, Inc., Rochester, New York, United States\|Rochester Regional Health/Rochester General Hospital, Rochester, New York, United States\|SUNY Upstate Medical University, Syracuse, New York, United States\|SUNY Upstate Medical University Global Health Research Unit, Syracuse, New York, United States\|Accellacare - Cary, Cary, North Carolina, United States\|PMG Research of Charlotte LLC, Charlotte, North Carolina, United States\|Clinical Research Pickett Road, Durham, North Carolina, United States\|Accessioning Unit and Repository, Durham, North Carolina, United States\|Duke University Medicine Circle- Duke Early Phase Clinical Research Unit, Durham, North Carolina, United States\|PharmQuest, Greensboro, North Carolina, United States\|PMG Research of Hickory, LLC, Hickory, North Carolina, United States\|PMG Research of Raleigh, LLC, Raleigh, North Carolina, United States\|M3 Wake Research, Inc., Raleigh, North Carolina, United States\|PMG Research of Salisbury, LLC, Salisbury, North Carolina, United States\|PMG Research of Wilmington, LLC, Wilmington, North Carolina, United States\|PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina, United States\|Lillestol Research Llc, Fargo, North Dakota, United States\|Sterling Research Group, Ltd., Cincinnati, Ohio, United States\|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States\|Sterling Research Group, Ltd., 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\|Dayton Clinical Research, Dayton, Ohio, United States\|PriMED Clinical Research, Dayton, Ohio, United States\|Senders Pediatrics, South Euclid, Ohio, United States\|Lynn Institute of Norman, Norman, Oklahoma, United States\|Kaiser Permanente Northwest-Center for Health Research, Portland, Oregon, United States\|Lehigh Valley Health Network/Network Office of Research and Innovation, Allentown, Pennsylvania, United States\|Velocity Clinical Research, Providence, East Greenwich, Rhode Island, United States\|Main Street Physician's Care, Little River, South Carolina, United States\|Main Street Physician's Care, Loris, South Carolina, United States\|Holston Medical Group, Bristol, Tennessee, 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\|Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, United States\|Clinical Research Associates, Inc., Nashville, Tennessee, United States\|Trinity Clinical Research, Tullahoma, Tennessee, United States\|Benchmark Research, Austin, Texas, United States\|ARC Clinical Research at Wilson Parke, Austin, Texas, United States\|Tekton Research, Inc., Austin, Texas, United States\|North Texas Infectious Diseases Consultants, P.A., Dallas, Texas, United States\|Ventavia Research Group, LLC, Fort Worth, Texas, United States\|Benchmark Research, Fort Worth, Texas, United States\|Texas Health Resources, Fort Worth, Texas, United States\|University of Texas Medical Branch, Galveston, Texas, United States\|Ventavia Research Group, LLC, Houston, Texas, United States\|Texas Center for Drug Development, Inc., Houston, Texas, United States\|Ventavia Research Group, LLC, Keller, Texas, United States\|SMS Clinical Research, LLC, Mesquite, Texas, United States\|LinQ Research, LLC, Pearland, Texas, 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\|Martin Diagnostic Clinic, Tomball, Texas, 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\|Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID), Annandale, Virginia, United States\|Virginia Research Center LLC, Midlothian, Virginia, United States\|Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States\|Wenatchee Valley Hospital, Wenatchee, Washington, United States\|Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Caba, Argentina\|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, Brazil\|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, Germany\|Newtown Clinical Research Centre, Johannesburg, Gauteng, South Africa\|Jongaie Research, Pretoria, Gauteng, South Africa\|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa\|Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital, Cape Town, Western CAPE, South Africa\|Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi, Ankara, Turkey\|Hacettepe Universitesi Tip Fakultesi, Ankara, Turkey\|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey\|Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul, Turkey\|Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi, Istanbul, Turkey\|Medipol Mega Universite Hastanesi, Istanbul, Turkey\|Acibadem Atakent Hastanesi, Istanbul, Turkey\|Kocaeli Universitesi Tip Fakultesi, Kocaeli, Turkey\|Sakarya Universitesi Egitim ve Arastirma Hastanesi, Sakarya, Turkey Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Triple (Participant, Care Provider, Investigator)\|Primary Purpose: Prevention Enrollment - 43998 Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures - Percentage of participants in Phase 1 reporting local reactions\|Percentage of participants in Phase 1 reporting systemic events\|Percentage of participants in Phase 1 reporting adverse events\|Percentage of participants in Phase 1 reporting serious adverse events\|Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values\|Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments\|In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions\|In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events\|In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events\|In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events\|In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions\|In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events\|Percentage of participants in Phase 2/3 reporting adverse events\|Percentage of participants in Phase 2/3 reporting serious adverse events\|Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination\|Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination\|Percentage of participants 12-15 years of age in Phase 3 reporting adverse events\|In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions\|In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events\|In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events\|In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events\|In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions\|In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events\|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\|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\|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\|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\|In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events\|In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events\|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\|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\|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\|In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs\|In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point\|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\|In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs\|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\|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\|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\|Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination\|Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination\|Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination\|Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination\|GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)\|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\|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\|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\|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\|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\|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\|Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2\|Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2
NCT04380701	A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults	Active, not recruiting	Phase 1\|Phase 2	Apr/23/2020	Apr/01/2023
Alternative id - BNT162-01\|2020-001038-36\|U1111-1249-4220 Interventions - Biological: BNT162a1\|Biological: BNT162b1\|Biological: BNT162b2\|Biological: BNT162c2 Study type - Interventional Study results - No Results Available Locations - Contract Research Organization, Berlin, Germany\|Universitäts Klinikum, Frankfurt am Main, Germany\|Universitäts Klinikum, Heidelberg, Germany\|Contract Research Organization, Kiel, Germany\|Contract Research Organization, Mannheim, Germany Study designs - Allocation: Non-Randomized\|Intervention Model: Sequential Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 512 Age - 18 Years to 85 Years (Adult, Older Adult) Outcome measures - Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization.\|Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization.\|The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):\|For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):\|For BNT162c2 (SD):\|For BNT162b2 (P/B):
NCT04523571	Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects	Completed	Phase 1	Jul/28/2020	Aug/10/2021
Alternative id - BNT162-03 Interventions - Biological: BNT162b1\|Other: Placebo Study type - Interventional Study results - No Results Available Locations - Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu, China Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Triple (Participant, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 144 Age - 18 Years to 85 Years (Adult, Older Adult) Outcome measures - Occurrence of solicited local reactions in the subjects (e.g., vaccination sites: pain/tenderness, erythema/redness, induration/swelling) during the 14-days after each dose of BNT162b1 or placebo.\|Occurrence of solicited systematic reactions (e.g., nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) during 14-day after each dose of BNT162b1 or placebo.\|Occurrence of adverse event (AE) associated with vaccination in subjects during the 21-day period after prime vaccination of BNT162b1 or placebo.\|Occurrence of AE associated with vaccination in subjects during the 28-day period after boost dose of BNT162b1 or placebo.\|The proportion of subjects experiencing serious adverse events (SAEs), occurring up to Day 21 after prime vaccination and Day 28 after boost vaccination, up to Month 3, 6 and 12.\|The proportion of subjects experiencing AE associated with BNT162b1, occurring up to Month 3, 6 and 12.\|The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis, occurring at Hour 24 and Day 7 after prime vaccination and Day 7 period after boost dose of BNT162b1 or placebo.\|Geometric mean titer (GMT) of anti-S1 IgG antibody at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.\|GMT of anti-receptor binding domain (RBD) immunoglobulin G (IgG) antibody at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.\|GMT of SARS-CoV-2 neutralizing antibody (including true virus-based SARS-CoV-2 neutralizing test) at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.\|Fold increase in antibody anti-S1 IgG antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.\|Fold increase in antibody anti-RBD IgG antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.\|Fold increase in SARS-CoV-2 neutralizing antibody titers (virus neutralizing test), as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.\|Seroconversion rates (SCR) defined as a minimum of 4-fold increase of antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, and at Day 7, Day 21 after boost vaccination.

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