A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY AND EFFICACY OF A VARIANT-ADAPTED BNT162B2 VACCINE IN HEALTHY PARTICIPANTS 50 THROUGH 64 YEARS OF AGE

This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect against COVID-19 (placebo).

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; SARS-COV-2 Infection
• Intervention / Treatment: Biological: BNT162b2 Vaccine; Biological: Placebo

Detailed Description

The study is designed to evaluate if the COVID-19 vaccine reduces COVID-19 disease as compared to placebo given to healthy adults 50 to 64 years of age. Approximately 25,500 participants will be randomly chosen to get either one dose of COVID-19 vaccine or of a placebo.

• Study Type: Interventional
• Enrollment (Actual): 5240
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center
    • Birmingham, Alabama, United States, 35216
      • Accel Research Sites - Birmingham Clinical Research Unit
    • Birmingham, Alabama, United States, 35211
      • Simon Williamson Clinic / Synexus Clinical Research US, Inc.
    • Cullman, Alabama, United States, 35055
      • Cullman Clinical Trials
    • Daphne, Alabama, United States, 36526
      • AMR Clinical
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center
    • Mobile, Alabama, United States, 36608
      • AMR Clinical
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Clinical Trials
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials
    • Sun City, Arizona, United States, 85351
      • Epic Medical Research-Sun City
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
    • Tucson, Arizona, United States, 85741
      • Synexus Clinical Research US, Inc./Orange Grove Family Practice
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Chula Vista, California, United States, 91911
      • Velocity Clinical Research, Chula Vista
    • Dublin, California, United States, 94568
      • West Coast Research
    • Fullerton, California, United States, 92835
      • Triallogix Medical Corporation
    • Fullerton, California, United States, 92835
      • Upper Echelon Medical
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • La Mesa, California, United States, 91942
      • Eximia Research-CA, LLC
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research, Los Angeles
    • Los Angeles, California, United States, 91316
      • Leading Edge Research
    • Modesto, California, United States, 95350
      • ImmuniMet
    • North Hollywood, California, United States, 91606
      • Carbon Health - North Hollywood - NoHo West
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
    • Sacramento, California, United States, 95821
      • Northern California Research - Sacramento
    • San Bernardino, California, United States, 92408
      • Velocity Clinical Research, San Bernardino
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
    • Toluca Lake, California, United States, 91602
      • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Legacy Clinical Trials
    • Fort Collins, Colorado, United States, 80525
      • Tekton Research, LLC.
    • Longmont, Colorado, United States, 80501
      • Tekton Research, LLC.
    • Wheat Ridge, Colorado, United States, 80033
      • Paradigm Clinical Research Centers, LLC
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20017
      • Washington Health Institute
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • International Clinical Research - FL, LLC
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research
    • Doral, Florida, United States, 33166
      • Universal Axon Clinical Research, LLC
    • Doral, Florida, United States, 33172
      • Suncoast Research Associates
    • Fort Myers, Florida, United States, 33912
      • Robert B. Pritt, DO
    • Fort Myers, Florida, United States, 33912
      • AMR Clinical
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Hialeah, Florida, United States, 33012
      • Las Mercedes Medical Research
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jupiter, Florida, United States, 33458
      • Health Awareness, LLC
    • Lake City, Florida, United States, 32055
      • M3 Wake Research - Lake City
    • Lauderdale Lakes, Florida, United States, 33313
      • SRA Trials North
    • Maitland, Florida, United States, 32751
      • Accel Research Sites - Maitland Clinical Research Unit
    • Medley, Florida, United States, 33166
      • South Florida Research Organization
    • Melbourne, Florida, United States, 32934
      • Optimal Research
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute, LLC
    • Miami, Florida, United States, 33144
      • Nuren Medical and Research Center
    • Miami, Florida, United States, 33176
      • Entrust Clinical Research
    • Miami, Florida, United States, 33135
      • Flourish Research - Miami, LLC
    • Miami, Florida, United States, 33143
      • Florida Pharmaceutical Research & Associates, Inc.
    • Miami, Florida, United States, 33156
      • Advanced Clinical Research - Miami - Southwest 92nd Street
    • Miami, Florida, United States, 33176
      • IMIC Medical Research
    • Miami, Florida, United States, 33176
      • Pioneer Clinical Studies
    • Miami Lakes, Florida, United States, 33014
      • Palm Springs Community Health Center
    • Miami Lakes, Florida, United States, 33016
      • Angels Clinical Research Institute
    • Miami Lakes, Florida, United States, 33014
      • 3Sync Research
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32806
      • Headlands Research Orlando
    • Palm Springs, Florida, United States, 33461
      • 3Sync Research
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Palmetto Bay, Florida, United States, 33176
      • Tropical Clinical Trials
    • Pembroke Pines, Florida, United States, 33029
      • DBC Research USA
    • Pembroke Pines, Florida, United States, 33024
      • Suncoast Research Associates
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • St. Petersburg, Florida, United States, 33705
      • GCP Research, Global Clinical professionals
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • Tampa, Florida, United States, 33615
      • Santos Research Center
    • Tampa, Florida, United States, 33614
      • Angels Clinical Research Institute
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research US, Inc.
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • DelRicht Research
    • Atlanta, Georgia, United States, 30328
      • M3 Wake Research - Atlanta
    • Sandy Springs, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
    • Savannah, Georgia, United States, 31406
      • Javara - Privia Medical Group Georgia - Savannah
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
    • Union City, Georgia, United States, 30291
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute Inc.
    • Melrose Park, Illinois, United States, 60160
      • DM Clinical Research - Chicago
    • Morton, Illinois, United States, 61550
      • Koch Family Medicine
    • Oak Lawn, Illinois, United States, 60453
      • Accellacare - DuPage
  • Indiana
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic /Avacare
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • AMR Clinical
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clinical Trials
    • Newton, Kansas, United States, 67114
      • AMR Clinical
    • Wichita, Kansas, United States, 67218
      • Tekton Research, LLC.
    • Wichita, Kansas, United States, 67226
      • AMR Clinical
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • AMR Clinical
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70119
      • Velocity Clinical Research - New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research, Rockville
  • Massachusetts
    • Brookline, Massachusetts, United States, 02446
      • DM Clinical Research - Boston
    • Malden, Massachusetts, United States, 02148
      • Walgreens Clinical Trials - Malden, MA
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research
  • Michigan
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Henry Ford St. John Hospital
    • Southfield, Michigan, United States, 48075
      • Great Lakes Research Institute
    • Southfield, Michigan, United States, 48076
      • DM Clinical Research - Detroit
    • Southfield, Michigan, United States, 48075
      • Revival Research Institute, LLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research, Gulfport
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Velocity Clinical Research, Grand Island
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies - Lincoln
    • Norfolk, Nebraska, United States, 68701
      • Velocity Clinical Research, Norfolk
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • M3 Wake Research - Las Vegas Wellness Way
  • New Jersey
    • Jersey City, New Jersey, United States, 07306
      • DM Clinical Research - Jersey City
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87106
      • DM Clinical Research - Albuquerque
    • Santa Fe, New Mexico, United States, 87505
      • AXCES Research Group, LLC
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Accellacare - Cary
    • Charlotte, North Carolina, United States, 28210
      • Javara - Tryon Medical Partners
    • Durham, North Carolina, United States, 27703
      • Duke Vaccine and Trials Unit
    • Hickory, North Carolina, United States, 28601
      • Accellacare - Hickory
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • New Bern, North Carolina, United States, 28562
      • Centricity Research New Bern Multispecialty
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
    • Raleigh, North Carolina, United States, 27609
      • Accellacare - Raleigh
    • Raleigh, North Carolina, United States, 27607
      • Eximia Research - NC, LLC
    • Rocky Mount, North Carolina, United States, 27804
      • Accellacare - Rocky Mount
    • Salisbury, North Carolina, United States, 28144
      • Accellacare - Salisbury
    • Statesville, North Carolina, United States, 28625
      • Accellacare - Piedmont
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates - Wilmington - Floral Parkway
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45206
      • Cincinnati Children's Hospital Medical Center Vaccine Research Center
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
  • Oklahoma
    • Chickasha, Oklahoma, United States, 73018
      • Epic Medical Research - Chickasha
    • Edmond, Oklahoma, United States, 73013
      • Tekton Research, LLC.
    • Moore, Oklahoma, United States, 73160
      • Tekton Research, LLC.
    • Norman, Oklahoma, United States, 73069
      • AMR Clinical
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research, LLC.
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Central Erie Primary Care
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • TMA Headlands LLC (d/b/a Trial Management Associates)
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • M3 Wake Research - Chattanooga
    • Knoxville, Tennessee, United States, 37912
      • Accellacare US Inc., d/b/a Accellacare of Knoxville
    • Knoxville, Tennessee, United States, 37909
      • AMR Clinical
  • Texas
    • Austin, Texas, United States, 78759
      • Orion Clinical Research
    • Austin, Texas, United States, 78704
      • Elligo Clinical Research Center
    • Austin, Texas, United States, 78759
      • Velocity Clinical Research, Austin
    • Brownsville, Texas, United States, 78526
      • Headlands Horizons, LLC dba Headlands Research-Brownsville
    • Carrollton, Texas, United States, 75006
      • Epic Medical Research - Carrollton
    • Dallas, Texas, United States, 75243
      • Lonestar Clinical Research - Dallas
    • El Paso, Texas, United States, 79902
      • Headlands Research-El Paso
    • Euless, Texas, United States, 76040
      • Cedar Health Research - Euless
    • Houston, Texas, United States, 77081
      • DM Clinical Research - Bellaire
    • Houston, Texas, United States, 77065
      • DM Clinical Research- Cyfair
    • Houston, Texas, United States, 77087
      • Mercury Clinical Research - Santa Clara Family Clinic
    • Houston, Texas, United States, 77054
      • Mercury Clinical Research (Administrative Office - Archival Purposes)
    • Irving, Texas, United States, 75061
      • DM Clinical Research - Dallas
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • Mesquite, Texas, United States, 75150
      • Epic Medical Research - Mesquite
    • Pearland, Texas, United States, 77584
      • LinQ Research
    • Plano, Texas, United States, 75024
      • ACRC Trials
    • Plano, Texas, United States, 75093
      • ACRC Trials
    • San Angelo, Texas, United States, 76903
      • Avacare
    • San Antonio, Texas, United States, 78229
      • Ima Clinical Research San Antonio
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials
    • Sugar Land, Texas, United States, 77479
      • Sugar Lakes Family Practice, PA
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research - Sugar Land
    • Tomball, Texas, United States, 77375
      • Dynamed Clinical Research, LP d/b/a DM Clinical Research
  • Utah
    • Bountiful, Utah, United States, 84010
      • Cope Family Medicine / Avacare
    • Draper, Utah, United States, 84020
      • J. Lewis Research, Inc. / Foothill Family Clinic Draper
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Norfolk, Virginia, United States, 23502
      • AMR Clinical
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research, LLC
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria

• People who are between 50 and 64 years old at their first appointment.
• People who are healthy and, based on their medical history and a doctor's judgment, are considered suitable to join the study.

Key Exclusion Criteria

• People who had COVID-19 in the past 3 months (90 days) before their first visit.
• People who got a COVID-19 vaccine, either as part of a research study or an approved vaccine, in the last 3 months-or plans to get one during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Single dose
Experimental: BNT162b2 Vaccine	Biological: BNT162b2 Vaccine; Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants reporting local reactions or systemic events	From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events	From Day 1 through 4 weeks after vaccination
Percentage of participants reporting serious adverse events	From Day 1 through 6 months after vaccination
First episode of confirmed COVID-19 cases	From 0 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
First episode of confirmed COVID-19 cases	From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination
Geometric Mean Ratio (GMR)	From before vaccination to 1 month after vaccination

Collaborators and Investigators

• Sponsor: BioNTech SE
• Collaborators: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; COVID-19 Vaccines; Antigens; BNT162 Vaccine
• Other Study ID Numbers: C4591081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No