-- In a Phase 3 trial, the vaccine was 100% effective and generally well 
      tolerated in participants aged 12 to 15 years 
 
   -- Data also submitted to European Medicines Agency (EMA) and other global 
      regulators, with additional authorizations expected in coming weeks 
 
 
   NEW YORK and MAINZ, GERMANY, May 11, 2021 -- 
https://www.globenewswire.com/Tracker?data=O1p8RKR00SDmeQSPPLEVRqiNWgUkyypClPt7CP8Kz48AGcIVruqmS7za68dyaiZXea_Q3_0-b6_8D186SEhTpQ== 
Pfizer Inc. (NYSE: PFE) and 
https://www.globenewswire.com/Tracker?data=OTlVmVtXHVMAVLpDKuwFr4qV5bRu8xOIm015cATmEm6AXco9t5jNQD2HDY9cl34e72eiNwAD8DWd91Tzud76AA== 
BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug 
Administration (FDA) has expanded the Emergency Use Authorization (EUA) 
for their COVID-19 vaccine to include individuals 12 to 15 years of age. 
This is the first COVID-19 vaccine authorized in the U.S. for use in 
this age group. 
 
   "Today's expansion of our EUA represents a significant step forward in 
helping the U.S. government broaden its vaccination program and help 
protect adolescents before the start of the next school year," said 
Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We are 
grateful to all of our clinical trial volunteers and their families, 
whose courage helped make this milestone possible. Together, we hope to 
help bring a sense of normalcy back to young people across the country 
and around the world." 
 
   The FDA based its decision on data from a pivotal Phase 3 clinical trial, 
which enrolled 2,260 participants aged 12 to 15 years. Topline results 
from this trial, 
https://www.globenewswire.com/Tracker?data=0mOMbiV5JAsq39OfH2frzA95DtPP6pGf8L__EupGaYdMD3egBKLMmyc6niWNl1ig1Iks8xoVJERzxjDHiDWNngqu4hUgQKjpxb_8_fvDe5hi2ZkwtkehRVlMWfcqUDRQtDJTkcsgQ8prfAlr5OlvmhaOpalmKG6oa8U5epvvUlhbCvHnsEHzGU5LknGI0Evhx0zAWoOggUWyX7qLjDkRInA5Uh_K6SQEgnyy9pkpnRo= 
announced on March 31, 2021, showed a vaccine efficacy of 100% in 
participants with or without prior SARS-CoV-2 infection and robust 
antibody responses. In the trial, the vaccine was also generally well 
tolerated. Participants will continue to be monitored for long-term 
protection and safety for an additional two years after their second 
dose. 
 
   As a next step following today's FDA decision, the U.S. Centers for 
Disease Control and Prevention's (CDC) Advisory Committee on 
Immunization Practices (ACIP) will meet to discuss recommendations for 
use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 
years of age based on the amended EUA. 
 
   "Since securing the EUA in December for individuals 16 years and older, 
we have been working tirelessly to get our COVID-19 vaccine authorized 
around the world so that governments can provide it to as many people as 
possible," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Our 
work is not yet complete, as we continue our research into the use of 
our vaccine in pediatric populations. Our goal is to submit data for 
pre-school and school-age children in September." 
 
   Pfizer and BioNTech have submitted the data in adolescents 12 to 15 
years of age for scientific peer review for potential publication. The 
data also have been submitted to other regulators around the world, 
including the European Medicines Agency (EMA). 
 
   In addition, the pediatric study evaluating the safety and efficacy of 
the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of 
age is ongoing. Pfizer and BioNTech expect to have definitive readouts, 
and subject to the data generated, submit for an EUA or a variation to 
Conditional Marketing Authorizations for two cohorts, including children 
2-5 years of age and 5-11 years of age, in September. The readout and 
submission for the cohort of children 6 months to 2 years of age are 
expected in the fourth quarter. 
 
   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 equivalents 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) caused by severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 
12 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 
https://www.globenewswire.com/Tracker?data=W90Ln88dJSUPhgCZZQwup5wxnDoe3k_ZeM66cSc3o1E4gIE_wCOWqkQkdJ8MXZbon11HYCibSfrLONIoEQ-e5-R4_My2Dja1PYGlg6P11sw= 
www.cvdvaccine-us.com. 
 
   AUTHORIZED USE IN THE U.S.: 
 
   The Pfizer-BioNTech COVID19 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 12 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 (eg, 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/clinical-considerations/managing-anaphylaxis.html 
      https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html) 
 
 
   -- Syncope (fainting) may occur in association with administration of 
      injectable vaccines, in particular in adolescents. Procedures should be 
      in place to avoid injury from fainting 
 
   -- 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%) 
 
   -- In a clinical study, adverse reactions in adolescents 12 through 15 years 
      of age included pain at the injection site (90.5%), fatigue (77.5%), 
      headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), 
      joint pain (20.2%), injection site swelling (9.2%), injection site 
      redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) 
 
   -- Severe allergic reactions, including anaphylaxis, and other 
      hypersensitivity reactions, diarrhea, vomiting, and pain in extremity 
      (arm) have been reported following administration of the Pfizer-BioNTech 
      COVID-19 vaccine 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 online at https://vaers.hhs.gov/reportevent.html. For 
      further assistance with reporting to VAERS call 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 
 
 
   Before administration of Pfizer-BioNTech COVID-19 vaccine, 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

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May 11, 2021 02:30 ET (06:30 GMT)