NEW YORK and MAINZ, GERMANY, April 30, 2021 (GLOBE NEWSWIRE) -- Pfizer 
Inc. 
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(NYSE: PFE) and BioNTech SE 
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(Nasdaq: BNTX) today announced they have submitted a variation to the 
Conditional Marketing Authorization (CMA) in the European Union (EU) to 
the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine 
COMIRNATY(R) (BNT162b2) to request an extension of the indication for 
use in adolescents 12 to 15 years of age. If EMA approves the variation, 
the amended CMA will be valid in all 27 member states of the EU. The 
companies have already submitted a similar request to the U.S. Food and 
Drug Administration (FDA) for the Emergency Use Authorization (EUA) and 
plan to request additional amendments with other regulatory authorities 
worldwide. 
 
   This submission is based on data from a pivotal Phase 3 clinical trial, 
which enrolled 2,260 participants aged 12 to 15 years. Topline results 
from this trial, announced 
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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 also was generally well tolerated. 
Participants will continue to be monitored for long-term protection and 
safety for an additional two years after their second dose. 
 
   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 (jointly with Pfizer), United Kingdom, Canada and other 
countries in advance of a planned application for full marketing 
authorizations in these countries. 
 
   AUTHORIZED USE IN THE EU: 
 
   COMIRNATY(R) (the Pfizer-BioNTech COVID-19 vaccine) has been granted 
conditional marketing authorisation by the by the European Commission to 
prevent coronavirus disease 2019 (COVID-19) in people from 16 years of 
age. The European Medicines Agency's (EMA's) human medicines committee 
(CHMP) has completed its rigorous evaluation of COMIRNATY(R) , 
concluding by consensus that sufficiently robust data on the quality, 
safety and efficacy of the vaccine are now available. 
 
   IMPORTANT SAFETY INFORMATION: 
 
 
   -- Events of anaphylaxis have been reported. Appropriate medical treatment 
      and supervision should always be readily available in case of an 
      anaphylactic reaction following the administration of the vaccine. 
 
   -- The efficacy, safety and immunogenicity of the vaccine has not been 
      assessed in immunocompromised individuals, including those receiving 
      immunosuppressant therapy. The efficacy of COMIRNATY(R) may be lower in 
      immunosuppressed individuals. 
 
   -- As with any vaccine, vaccination with COMIRNATY(R) may not protect all 
      vaccine recipients. Individuals may not be fully protected until 7 days 
      after their second dose of vaccine. 
 
   -- In clinical studies, adverse reactions in participants 16 years of age 
      and older were injection site pain (> 80%), fatigue (> 60%), headache (> 
      50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and 
      injection site swelling (> 10%) and were usually mild or moderate in 
      intensity and resolved within a few days after vaccination. A slightly 
      lower frequency of reactogenicity events was associated with greater age. 
 
   -- There is limited experience with use of COMIRNATY(R) in pregnant women. 
      Administration of COMIRNATY(R) in pregnancy should only be considered 
      when the potential benefits outweigh any potential risks for the mother 
      and fetus. 
 
   -- It is unknown whether COMIRNATY(R) is excreted in human milk. 
 
   -- Interactions with other medicinal products or concomitant administration 
      of COMIRNATY(R) with other vaccines has not been studied. 
 
   -- For complete information on the safety of COMIRNATY(R) always make 
      reference to the approved Summary of Product Characteristics and Package 
      Leaflet available in all the languages of the European Union on the EMA 
      website. 
 
 
   The black equilateral triangle denotes that additional monitoring is 
required to capture any adverse reactions. This will allow quick 
identification of new safety information. Individuals can help by 
reporting any side effects they may get. Side effects can be reported to 
EudraVigilance 
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or directly to BioNTech using email medinfo@biontech.de 
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, telephone +49 6131 9084 0, or via the website www.biontech.de. 
 
   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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www.Pfizer.com and follow us on Twitter at @Pfizer 
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and @Pfizer News 
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, LinkedIn 
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, YouTube 
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and like us on Facebook at Facebook.com/Pfizer 
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. 
 
   Pfizer Disclosure Notice 
 
   The information contained in this release is as of April 30, 2021. 
Pfizer assumes no obligation to update forward-looking statements 
contained in this release as the result of new information or future 
events or developments. 
 
   This release contains forward-looking information about Pfizer's efforts 
to combat COVID-19, the collaboration between BioNTech and Pfizer to 
develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and 
COMIRNATY(R) , the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) 
(including qualitative assessments of available data, potential benefits, 
expectations for clinical trials, the potential of BNT162b2 for 
adolescents 12 to 15 years of age, the anticipated timing of regulatory 
submissions, regulatory approvals or authorizations and anticipated 
manufacturing, distribution and supply) involving substantial risks and 
uncertainties that could cause actual results to differ materially from 
those expressed or implied by such statements. Risks and uncertainties 
include, among other things, the uncertainties inherent in research and 
development, including the ability to meet anticipated clinical 
endpoints, commencement and/or completion dates for clinical trials, 
regulatory submission dates, regulatory approval dates and/or launch 
dates, as well as risks associated with preclinical and clinical data 
(including the topline data outlined in this release), including the 
possibility of unfavorable new preclinical, clinical or safety data and 
further analyses of existing preclinical, clinical or safety data 
(including the topline data outlined in this release); the ability to 
produce comparable clinical or other results, including the rate of 
vaccine effectiveness and safety and tolerability profile observed to 
date, in additional analyses of the Phase 3 trial and additional studies 
or in larger, more diverse populations following commercialization; the 
ability of BNT162b2 to prevent COVID-19 caused by emerging virus 
variants; the risk that more widespread use of the vaccine will lead to 
new information about efficacy, safety, or other developments, including 
the risk of additional adverse reactions, some of which may be serious; 
the risk that preclinical and clinical trial data (including the topline 
data outlined in this release) are subject to differing interpretations 
and assessments, including during the peer review/publication process, 
in the scientific community generally, and by regulatory authorities;

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April 30, 2021 07:00 ET (11:00 GMT)