-- European Union orders 100 million additional doses of COMIRNATY(R) 
      bringing total doses to 300 million for 27 EU member states 
 
   -- All 300 million doses expected to be delivered in 2020 and 2021 
 
 
   NEW YORK and MAINZ, GERMANY, December 29, 2020 (GLOBE NEWSWIRE) -- 
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Pfizer Inc. (NYSE: PFE) and 
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BioNTech SE (Nasdaq: BNTX) today announced they will supply an 
additional 100 million doses of COMIRNATY(R) , the companies' COVID-19 
Vaccine, to the 27 European Union (EU) member states in 2021. This 
announcement is a result of the European Commission's (EC) decision to 
exercise its option to purchase an additional 100 million doses under 
its Advanced Purchase Agreement signed on 
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November 11, 2020. This agreement brings the total number of doses to be 
delivered to the EU to 300 million. 
 
   "We remain committed to moving as quickly and safely as possible to 
bring this vaccine to more people in Europe, as the deadly virus 
continues to spread at an alarming rate." said Albert Bourla, Chairman 
and Chief Executive Officer, Pfizer. "In partnership with the European 
Commission, member states and healthcare providers, we will be able to 
reach a total of 150 million Europeans across the continent." 
 
   "The additional 100 million doses will be delivered in 2021 supporting 
the vaccination campaigns which started two days ago in all 27 member 
states. Our goal remains to bring a safe and effective COVID-19 vaccine 
to as many people as we can all around the world," said Ugur Sahin, 
M.D., CEO and Co-founder of BioNTech. 
 
   COMIRNATY, will be produced in BioNTech's and Pfizer's manufacturing 
sites in Europe. The distribution of COMIRNATY by the EU member states 
will continue to be determined according to the populations identified 
in EU and national guidance. Pfizer and BioNTech announced on November 
11, 2020, that they reached an agreement with the European Commission to 
supply 200 million, with an option for the European Commission to 
request an additional 100 million doses. The companies previously stated 
their potential to supply up to 1.3 billion doses worldwide by the end 
of 2021 (subject to manufacturing capacity). 
 
   AUTHORIZED USE IN THE EU: 
 
   COMIRNATY(R) (the Pfizer-BioNTech COVID-19 Vaccine) has been granted 
conditional marketing authorisation by the European Medicines Agency 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 included pain at the injection site (84.1%), fatigue (62.9%), 
      headache (55.1%), muscle pain (38.4%), 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%) 
 
   -- 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. 
 
 
   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 
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EudraVigilance or directly to BioNTech using email 
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medinfo@biontech.de, telephone +49 6131 9084 0, or via the website 
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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 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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   Pfizer Disclosure Notice 
 
   The information contained in this release is as of December 29, 2020. 
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,  an agreement with the European 
Commission and the timing of delivery of doses thereunder, the 
anticipated timing of regulatory submissions, regulatory approval or 
authorization 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 clinical data (including the Phase 3 data), including 
the possibility of unfavorable new preclinical or clinical trial data 
and further analyses of existing preclinical or clinical trial data; 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 upon 
commercialization; 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 clinical trial data are subject to differing 
interpretations and assessments, including during the peer 
review/publication process, in the scientific community generally, and

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December 29, 2020 13:10 ET (18:10 GMT)