Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).
The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1
to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety
data through 7 days after the second dose for all Phase 2 participants will be completed.
The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of
BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation.
Maternal participants who originally received placebo will receive BNT162b2 at defined time
points as part of the study.
Biological: BNT162b2
Intramuscular Injection
Other: Placebo
Intramuscular Injection
Inclusion Criteria:
1. Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on
the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at
no known increased risk for complications.
2. Participants who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
3. Healthy participants who are determined by medical history, physical examination, and
clinical judgment to be appropriate for inclusion in the study
4. Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface
antigen test during this pregnancy and prior to randomization
5. Participant is willing to give informed consent for her infant to participate in the
study
6. Capable of giving signed informed consent
Exclusion Criteria:
1. 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.
2. 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.
3. History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention or any related
vaccine.
4. Participants with known or suspected immunodeficiency.
5. Bleeding diathesis or condition associated with prolonged bleeding that would in the
opinion of the investigator contraindicate intramuscular injection.
6. Previous vaccination with any coronavirus vaccine.
7. Receipt of medications intended to prevent COVID 19.
8. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration
of study intervention, or planned receipt through delivery, with 1 exception, anti-D
immunoglobulin (eg, RhoGAM), which can be given at any time.
9. Current alcohol abuse or illicit drug use.
10. Participants who receive treatment with immunosuppressive therapy, including cytotoxic
agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or
planned receipt through the postvaccination blood draw.
11. Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation.
12. Previous participation in other studies involving study intervention containing LNPs.
13. 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.
14. Participants whose unborn baby has been fathered by investigational site staff members
directly involved in the conduct of the study or their family members, site staff
members otherwise supervised by the investigator, or Pfizer employees directly
involved in the conduct of the study.
Children's of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham Women & Infant Center
Birmingham, Alabama, United States
University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama, United States
Velocity Clinical Research, Gulfport
Mobile, Alabama, United States
Arrowhead Hospital
Glendale, Arizona, United States
Abrazo West Campus Hospital
Goodyear, Arizona, United States
St. Joseph Hospital
Phoenix, Arizona, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Matrix Clinical Research.
Huntington Park, California, United States
Matrix Clinical Research
Huntington Park, California, United States
Chemidox Clinical Trials Inc.
Lancaster, California, United States
East LA Doctors Hospital
Los Angeles, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Axcess Medical Research
Loxahatchee Groves, Florida, United States
Idaho Falls Pediatrics
Ammon, Idaho, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
Idaho Falls Pediatrics
Idaho Falls, Idaho, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States
Mountain View Hospital
Idaho Falls, Idaho, United States
Covenant Healthcare
Saginaw, Michigan, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Boeson Research (BUT)
Butte, Montana, United States
SCL St. James Healthcare Hospital
Butte, Montana, United States
Marcus Daly Memorial Hospital
Hamilton, Montana, United States
Providence St. Patrick Hospital
Missoula, Montana, United States
The Birth Center
Missoula, Montana, United States
Boeson Research
Missoula, Montana, United States
Community Medical Center
Missoula, Montana, United States
Community Physicians Group-Maternal Fetal Medicine
Missoula, Montana, United States
St. Luke Community Healthcare Hospital
Ronan, Montana, United States
Meridian Clinical Research, LLC
Hastings, Nebraska, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
OBGYN Associates of Erie
Erie, Pennsylvania, United States
Central Erie Primary Care
Erie, Pennsylvania, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Saint Vincent Hospital
Erie, Pennsylvania, United States
St. David's Medical Center
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Bedford, Texas, United States
Ventavia Research Group LLC
Dallas, Texas, United States
DHR Health Institute for Research and Development
Edinburg, Texas, United States
8th Avenue Obstetrics & Gynecology
Fort Worth, Texas, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Dr. Ruben Aleman & Associates
McAllen, Texas, United States
Ventavia Research Group, LLC
Plano, Texas, United States
Ventavia Research Group, LLC
Weatherford, Texas, United States
Weatherford OBGYN
Weatherford, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
The Group for Women- MAWC
Norfolk, Virginia, United States
Tidewater Physicians for Women- MAWC
Norfolk, Virginia, United States
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital Santa Casa de Misericordia de Sorocaba
Sorocaba, SAO Paulo, Brazil
Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS)
Sorocaba, SAO Paulo, Brazil
Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica
Sorocaba, SP, Brazil
HMU SBC - Hospital Municipal Universitário de São Bernardo
São Bernardo do Campo, SÃO Paulo, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, SÃO Paulo, Brazil
WorthWhile Clinical Trials
Benoni, Gauteng, South Africa
Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre
Johannesburg, Gauteng, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, South Africa
Vaccines and Infectious Diseases Analytics (VIDA)
Soweto, Gauteng, South Africa
Dr Tobias de Villiers
Cape Town, Western CAPE, South Africa
Tiervlei Trial Centre CC
Cape Town, Western CAPE, South Africa
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Hospital de Antequera
Antequera, Malaga, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Clinica Diagonal
Barcelona, Spain
Hospital Madrid Puerta del Sur Mostoles
Mostoles, Spain
Instituto Hispalense de Pediatria- IHP1
Sevilla, Spain
Hospital Materno-Infantil Quirón
Sevilla, Spain
Servicio de Ginecología del Hospital Quirón Salud Sagrado Corazón
Sevilla, Spain
Hampshire Research Hub, Royal South Hants Hospital
Southampton, Hampshire, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
University College London Hospitals
London, City Of, United Kingdom
University College London Hospitals
London, United Kingdom
University College London Hospitals
London, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Pfizer CT.gov Call Center, Study Director
Pfizer