-- Phase 2/3 trial will enroll approximately 4,000 healthy pregnant women in 
      the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, 
      U.K., and Spain 
 
   -- First participants dosed in the U.S. 
 
   -- Women enrolled in the trial will be unblinded shortly after giving birth 
      to allow those women who originally received placebo to be vaccinated 
      while staying in the study 
 
   New York, USA and Mainz, Germany, February 18, 2021 -- 
https://www.globenewswire.com/Tracker?data=bCWPLVhdTyF8pybz1nFBGk3ZkYJDy9udz9OmBXPtF_iZc5vQ8-cKTJ3imf5YFl_1DimN4PoAtV3DARRL6hDjhw== 
Pfizer Inc. (NYSE: PFE) and 
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BioNTech SE (Nasdaq: BNTX) announced today that the first participants 
have been dosed in a global Phase 2/3 study to further evaluate the 
safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 
vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women 18 
years of age and older. 
 
 
 
   "We are proud to start this study in pregnant women and continue to 
gather the evidence on safety and efficacy to potentially support the 
use of the vaccine by important subpopulations," said William Gruber 
M.D., Senior Vice President of Vaccine Clinical Research and Development, 
Pfizer. "Pregnant women have an increased risk of complications and 
developing severe COVID-19, which is why it is critical that we develop 
a vaccine that is safe and effective for this population. We are deeply 
thankful to the volunteers who are enrolling in the trial, and site 
investigators who are leading this work." 
 
   "Enabling broad access to our highly effective COVID-19 vaccine is an 
important goal for us. Now that we are seeing successful initial 
implementation of vaccine campaigns with BNT162b2 across the globe, it 
is time to take the next step and extend our clinical program to other 
vulnerable populations, such as pregnant women, to potentially protect 
both them and future generations," said Özlem Türeci, M.D., 
Chief Medical Officer of BioNTech. 
 
   The Phase 2/3 trial is designed as a randomized, placebo-controlled, 
observer-blind study in approximately 4,000 healthy pregnant women 18 
years of age or older vaccinated during 24 to 34 weeks of gestation. The 
study will evaluate the safety, tolerability, and immunogenicity of two 
doses of BNT162b2 or placebo administered 21 days apart. Each woman will 
participate in the study for approximately 7 to 10 months, depending on 
whether she was randomized to receive the vaccine or placebo. The study 
will assess safety in infants of vaccinated pregnant women and the 
transfer of potentially protective antibody to their infants. Infants 
will be monitored through approximately six months of age. As 
established in the study protocol, after a participant's infant is born, 
maternal trial participants will be unblinded and those who were in the 
placebo group will receive the vaccine. Additional information about the 
study can be found at www.clinicaltrials.gov under the identifier 
NCT04754594. 
 
   Prior to conducting their COVID-19 vaccine clinical trial in pregnant 
women, Pfizer and BioNTech completed a developmental and reproductive 
toxicity (DART) study with BNT162b2 which was required by the regulatory 
authorities before starting the study in pregnant women. Those studies 
showed no evidence of fertility or reproductive toxicity in animals. 
 
   Pfizer is leveraging its expertise in conducting clinical trials in 
pregnant women, informed by the experience with its ongoing trials for 
vaccine candidates against Respiratory Syncytial Virus (Phase 3), and 
Invasive Group B Streptococcus Infection (Phase 2). 
 
   Pfizer and BioNTech expect to start additional studies in children 
between the ages of 5 and 11 over the next couple of months, and in 
children younger than 5 later in 2021. Safety and efficacy in subjects 
12 to 15 years of age are already being evaluated in the global Phase 3 
study (C4591001) and the relevant data are planned to be submitted to 
the regulatory authorities in the second quarter of 2021. The Companies 
are also planning studies to further evaluate the vaccine in people with 
compromised immune systems. 
 
   The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed 
by the U.S. Food and Drug Administration (FDA), but has been authorized 
for emergency use by FDA under an Emergency Use Authorization (EUA) to 
prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 
years of age and older. The emergency use of this product is only 
authorized for the duration of the declaration that circumstances exist 
justifying the authorization of emergency use of the medical product 
under Section 564 (b) (1) of the FD&C Act unless the declaration is 
terminated or authorization revoked sooner. Please see Emergency Use 
Authorization (EUA) Fact Sheet for Healthcare Providers Administering 
Vaccine (Vaccination Providers) including Full EUA Prescribing 
Information available at 
https://www.globenewswire.com/Tracker?data=I_mUaTPBHrpldCVansihOH26ibeo6xW1QwFZbYGGJwOezz0dBmtgTJaFcxUk2jClFNhE9NNXPEF_JvqwQq4Ycg3QFFgutD6-vAwZW7M6tAs= 
www.cvdvaccine.com. 
 
   The vaccine, which is based on BioNTech proprietary mRNA technology, was 
developed by both BioNTech and Pfizer. BioNTech is the Marketing 
Authorizations Holder in the European Union, and the holder of emergency 
use authorizations or equivalent in the United States, United Kingdom, 
Canada and other countries in advance of a planned application for full 
marketing authorizations in these countries. 
 
   AUTHORIZED USE IN THE U.S.: 
 
   The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an 
Emergency Use Authorization (EUA) for active immunization to prevent 
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and 
older. 
 
   IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION 
PRESCRIBING INFORMATION: 
 
 
   -- Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with 
      known history of a severe allergic reaction (e.g., anaphylaxis) to any 
      component of the Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Appropriate medical treatment used to manage immediate allergic reactions 
      must be immediately available in the event an acute anaphylactic reaction 
      occurs following administration of Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of 
      immediate adverse reactions according to the Centers for Disease Control 
      and Prevention guidelines ( https://www.cdc.gov/vaccines/covid-19/ 
      https://www.cdc.gov/vaccines/covid-19/) 
 
   -- Immunocompromised persons, including individuals receiving 
      immunosuppressant therapy, may have a diminished immune response to the 
      Pfizer-BioNTech COVID-19 Vaccine 
 
   -- The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine 
      recipients 
 
   -- In clinical studies, adverse reactions in participants 16 years of age 
      and older included pain at the injection site (84.1%), fatigue (62.9%), 
      headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), 
      fever (14.2%), injection site swelling (10.5%), injection site redness 
      (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) 
 
   -- Severe allergic reactions, including anaphylaxis, have been reported 
      following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination 
      outside of clinical trials. Additional adverse reactions, some of which 
      may be serious, may become apparent with more widespread use of the 
      Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Available data on Pfizer-BioNTech COVID-19 Vaccine administered to 
      pregnant women are insufficient to inform vaccine-associated risks in 
      pregnancy 
 
   -- Data are not available to assess the effects of Pfizer-BioNTech COVID-19 
      Vaccine on the breastfed infant or on milk production/excretion 
 
   -- There are no data available on the interchangeability of the 
      Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete 
      the vaccination series. Individuals who have received one dose of 
      Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of 
      Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series 
 
   -- Vaccination providers must report Adverse Events in accordance with the 
      Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html 
      https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The 
      reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" 
      in the description section of the report 
 
   -- Vaccination providers should review the Fact Sheet for Information to 
      Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for 
      Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use 
      Authorization 
 
   -- Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare 
      Providers Administering Vaccine (Vaccination Providers) including Full 
      EUA Prescribing Information available at www.cvdvaccine-us.com 
 
   About Pfizer: Breakthroughs That Change Patients' Lives 
 
   At Pfizer, we apply science and our global resources to bring therapies 
to people that extend and significantly improve their lives. We strive 
to set the standard for quality, safety and value in the discovery, 
development and manufacture of health care products, including 
innovative medicines and vaccines. Every day, Pfizer colleagues work 
across developed and emerging markets to advance wellness, prevention, 
treatments and cures that challenge the most feared diseases of our 
time. Consistent with our responsibility as one of the world's premier 
innovative biopharmaceutical companies, we collaborate with health care

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February 18, 2021 13:30 ET (18:30 GMT)