-- The evaluation is part of the Phase 1/2/3 trial and will study a third 
      dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, at 30 ug that 
      will be given to Phase 1 participants to evaluate the safety and 
      tolerability of a booster vaccine 
 
   -- Discussions with regulatory authorities are ongoing regarding an 
      additional registration-enabling study using an mRNA vaccine with a 
      variant sequence; this would provide a flexible solution for rapidly 
      adapting the vaccine for use against the B.1.351 lineage or other new 
      strains that may emerge as possible immune escape virus variants 
 
   -- Based on in-vitro studies conducted to date and observations from real 
      world evidence, the Companies have not observed changes to neutralizing 
      antibody levels that would predict a significant reduction in protection 
      provided by two doses of BNT162b2 
 
   New York and Mainz, Germany, February 25, 2021 -- 
https://www.globenewswire.com/Tracker?data=z8ZLpLd657dAmsIwT-ePQmCuBE9FYjO4ok4I9cYOsYlZ3nfZ9YckEHPQGf5Pna_9rSCS9mJz_ri8wufR13mfQg== 
Pfizer Inc. (NYSE: PFE) and 
https://www.globenewswire.com/Tracker?data=tJGQ4No_0uSYONPTbvNSpNbelDH2-VNnqwCN3h-XDegXi4-jMTRhHC3bJ84LlHIxbxHPMN5_F8sXTBk3y54vKw== 
BioNTech SE (Nasdaq: BNTX) announced today they have begun an evaluation 
of the safety and immunogenicity of a third dose of the Pfizer-BioNTech 
COVID-19 vaccine (BNT162b2) to understand the effect of a booster on 
immunity against COVID-19 caused by the circulating and potential newly 
emerging SARS-CoV-2 variants. The study will draw upon participants from 
the 
https://www.globenewswire.com/Tracker?data=Dx0k_RwRIaZvdyDVnjZ52oXS-evPV6NYRPkCe2L8Q2MDN3XMhCBQa4xXk7iL5-vnzXxZ07IMV1TWMyWY8VlH1vo2GjTXfVANGyq56DrXma8RltfufppKoAmsaRe8FrwxrF6IAX_CNI-de8kyPXp0p-jpgRhIC_gynMLfpctZg9VPjrW_zOSXQ-v1K41qe9dCQHvGZWS3XU_Kk0gayTZRzA== 
Phase 1 study in the United States who will be offered the opportunity 
to receive a 30 ug booster of the current vaccine 6 to 12 months after 
receiving their initial two-dose regimen. The study is part of the 
Companies' clinical development strategy to determine the effectiveness 
of a third dose against evolving variants. 
 
   Separately, in order to be prepared for any potential future strain 
changes, Pfizer and BioNTech are in ongoing discussions with regulatory 
authorities, including the U.S. Food and Drug Administration (FDA) and 
the European Medicines Agency, regarding a registration-enabling 
clinical study to evaluate a variant-specific vaccine having a modified 
mRNA sequence. This study would use a new construct of the 
Pfizer-BioNTech vaccine based on the B.1.351 lineage, first identified 
in South Africa. This could position the Companies to update the current 
vaccine quickly if the need arises to protect against COVID-19 from 
circulating strains. In alignment with the updated guidance issued by 
the FDA regarding emergency use of vaccines to prevent COVID-19 which 
provides recommendations for evaluating a modified vaccine to address 
variants, the Companies are hoping to pursue the validation of future 
modified mRNA vaccines with a regulatory pathway similar to what is 
currently in place for flu vaccines. 
 
   "While we have not seen any evidence that the circulating variants 
result in a loss of protection provided by our vaccine, we are taking 
multiple steps to act decisively and be ready in case a strain becomes 
resistant to the protection afforded by the vaccine. This booster study 
is critical to understanding the safety of a third dose and immunity 
against circulating strains," said Albert Bourla, Chairman and Chief 
Executive Officer, Pfizer. "At the same time, we are making the right 
investments and engaging in the appropriate conversations with 
regulators to help position us to potentially develop and seek 
authorization for an updated mRNA vaccine or booster if needed." 
 
   "Our proactive clinical development strategy aims to create the 
foundation today, that will enable us to address the challenges of 
tomorrow. We want to be prepared for different scenarios," said Ugur 
Sahin, CEO and Co-founder of BioNTech. "Therefore, we will be evaluating 
a second booster in the current regimen as well as preparing for a 
potential rapid adaption of the vaccine to address new variants which 
might escape the current version of our mRNA-based vaccine. The 
flexibility of our proprietary mRNA vaccine platform allows us to 
technically develop booster vaccines within weeks, if needed. This 
regulatory pathway is already established for other infectious diseases 
like influenza. We take these steps in order to ensure a long-term 
immunity against the virus and its variants." 
 
   Administering a third dose will provide an early assessment of the 
safety of a third dose of BNT162b2, as well as its immunogenicity. The 
study will evaluate up to 144 Phase 1 participants in two age cohorts, 
18-55 and 65-85 years of age. This study will include trial participants 
who received the two doses in the Phase 1 study 6 to 12 months ago in 
order to assess the boostability of BNT162b2. Thus, the study will 
evaluate the safety and tolerability of a third vaccination irrespective 
of the level of antibody titers of the trial participant. Participants 
will be assessed at the time they receive the third dose, then one week 
and one month after, and Pfizer and BioNTech plan to study the ability 
of the sera from those participants to neutralize SARS-CoV-2 strains of 
interest. The participants will continue being followed in the study for 
up to 2 years as originally planned. 
 
   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=8vfqJLm5RQ1mJsIF-rMTpiFsKgyW1VIqVTT6l6oX4I8rvmMLt-bYLr_aAWbD8JLpwxB2pq-lFKbEivwPxngQUcxJJR3NFjI0EgCqO_mgKa0= 
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

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February 25, 2021 06:45 ET (11:45 GMT)