NEW YORK and MAINZ, GERMANY, May 7, 2021 (GLOBE NEWSWIRE) -- 
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Pfizer Inc. (NYSE: PFE) and 
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BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics 
License Application (BLA) with the U.S. Food and Drug Administration 
(FDA) for approval of their mRNA vaccine to prevent COVID-19 in 
individuals 16 years of age and older. Data to support the BLA will be 
submitted by the Companies to the FDA on a rolling basis over the coming 
weeks, with a request for Priority Review. The Prescription Drug User 
Fee Act (PDUFA) goal date for a decision by the FDA will be set once the 
BLA is complete and formally accepted for review by the agency. 
 
   The Pfizer-BioNTech COVID-19 vaccine is currently available in the U.S. 
under an Emergency Use Authorization (EUA) 
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granted by the FDA on December 11, 2020. Since then, the Companies have 
delivered more than 170 million doses of the vaccine across the U.S. 
Submission of a BLA, which requires longer-term follow-up data for 
acceptance and approval, is the next step in the rigorous FDA review 
process. 
 
   "We are proud of the tremendous progress we've made since December in 
delivering vaccines to millions of Americans, in collaboration with the 
U.S. Government," said Albert Bourla, Chairman and Chief Executive 
Officer, Pfizer. "We look forward to working with the FDA to complete 
this rolling submission and support their review, with the goal of 
securing full regulatory approval of the vaccine in the coming months." 
 
   "Following the successful delivery of more than 170 million doses to the 
U.S. population in just a few months, the BLA submission is an important 
cornerstone of achieving long-term herd immunity and containing COVID-19 
in the future," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. 
"We are pleased to work with U.S. regulators to seek approval of our 
COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data." 
 
   Pfizer and BioNTech initiated the BLA by submitting the nonclinical and 
clinical data needed to support licensure of the COVID-19 vaccine for 
use in individuals 16 years of age and older. This includes 
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the most recent analyses from the pivotal Phase 3 clinical trial, where 
the vaccine's efficacy and favorable safety profile were observed up to 
6 months after the second dose. The Companies will submit the required 
manufacturing and facility data for licensure in the coming weeks to 
complete the BLA. 
 
   Pfizer and BioNTech also have submitted an application to expand the 
current EUA for their COVID-19 vaccine to include individuals 12 to 15 
years of age. The Companies intend to submit a supplemental BLA to 
support licensure of the vaccine in this age group once the required 
data 6 months after the second vaccine dose are available. 
 
   The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech 
proprietary mRNA technology, was developed by both BioNTech and Pfizer. 
BioNTech is the Marketing Authorization Holder in the European Union, 
and the holder of emergency use authorizations or equivalent in the 
United States (together with Pfizer), United Kingdom, Canada and other 
countries in advance of a planned application for full marketing 
authorizations in these countries. 
 
   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) and Full EUA Prescribing Information 
available at 
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www.cvdvaccine-us.com. 
 
   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 
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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 
providers, governments and local communities to support and expand 
access to reliable, affordable health care around the world. For more 
than 170 years, we have worked to make a difference for all who rely on 
us. We routinely post information that may be important to investors on 
our website at 
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www.Pfizer.com. In addition, to learn more, please visit us on

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