New York and Mainz, Germany, January 20, 2021 -- Today, 
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Pfizer Inc. (NYSE: PFE) and 
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BioNTech SE (Nasdaq: BNTX) announced results from an in vitro study that 
provides additional data on the capability of sera from individuals 
immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to 
neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or 
VOC 202012/01. The results were published on the preprint server 
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bioRxiv and submitted to a peer-reviewed journal. 
 
   The B.1.1.7 lineage is a rapidly spreading variant of SARS-CoV-2 
initially detected in the United Kingdom that carries a larger than 
usual number of genetic changes with 10 mutations located in the spike 
protein. BioNTech and Pfizer have previously published 
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data from an in vitro study that evaluated one of the key mutations 
(N501Y) in the U.K. strain, which is also shared by the South African 
strain. That study showed efficient neutralization of the N501Y mutated 
spike bearing virus by sera of individuals who had received the 
Pfizer-BioNTech COVID-19 vaccine. 
 
   The current in-vitro study investigated the full set of UK strain spike 
mutations. To this aim, a pseudovirus featuring the UK strain spike 
protein was generated. 
 
   The pseudovirus recapitulates SARS-CoV-2 virus binding and cell entry. 
Sera of participants from the 
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previously reported German Phase 1/2 trial inhibited pseudovirus bearing 
the U.K. strain SARS-CoV-2 spike in a neutralization range that is 
regarded as biologically equivalent to the unmutated Wuhan SARS-CoV-2 
spike. 
 
   While the pseudovirus system used is a surrogate for authentic 
SARS-CoV-2, previous studies have shown excellent concordance between 
pseudotype neutralization and SARS-CoV-2 neutralization assays.(i) The 
preserved neutralization of the pseudovirus bearing the U.K. strain 
spike by BNT162b2-immune sera makes it likely that COVID-19 caused by 
the UK virus variant will also be prevented by immunization with 
BNT162b2. 
 
   Pfizer and BioNTech are encouraged by these early in vitro study 
findings. Further data are needed to monitor the Pfizer-BioNTech 
COVID-19 vaccine's effectiveness in preventing COVID-19 caused by new 
virus variants. So far, for COVID-19 vaccines it has not been 
established what reduction in neutralization might indicate the need for 
a vaccine strain change. Should a vaccine strain change be required to 
address virus variants in the future, the Companies believe that the 
flexibility of BioNTech's proprietary mRNA vaccine platform is well 
suited to enable such adjustment. 
 
 
 
   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 
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www.cvdvaccine.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 
      https://www.cvdvaccine-us.com/dosing-and-administration#description 
      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 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 150 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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www.Pfizer.com and follow us on Twitter at 
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@Pfizer and 
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@Pfizer News,

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January 20, 2021 07:50 ET (12:50 GMT)