NEW YORK and MAINZ, GERMANY, May 6, 2021-- 
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Pfizer Inc. (NYSE: PFE) and 
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BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum 
of Understanding (MoU) with the International Olympic Committee (IOC) to 
donate the companies' COVID-19 vaccine to help vaccinate athletes, and 
their delegations, participating in the Olympic and Paralympic Games 
Tokyo 2020, which are scheduled to begin on July 23, 2021. 
 
   Under the MoU, the companies and the IOC will coordinate with National 
Olympic Committees (NOCs) around the world to understand and work to 
help address the local need for vaccine doses for national delegations' 
participation in the Games. Delivery of initial doses to participating 
delegations is expected to begin at the end of May where possible with 
the aim to ensure participating delegations receive second doses ahead 
of arrivals in Tokyo. Under the MoU framework, NOCs and their local 
governments are expected to coordinate the administration of 
vaccinations to eligible Games participants. Doses provided under this 
MoU would be in addition to doses provided under supply agreements with 
governments worldwide. The donation of vaccine doses will not affect the 
supply of the national populations with COVID-19 doses under the supply 
agreements. 
 
   "This donation of the vaccine is another tool in our toolbox of measures 
to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure 
for all participants and to show solidarity with our gracious Japanese 
hosts," said IOC President Thomas Bach. "We are inviting the athletes 
and participating delegations of the upcoming Olympic and Paralympic 
Games to lead by example and accept the vaccine where and when possible. 
By taking the vaccine, they can send a powerful message that vaccination 
is not only about personal health, but also about solidarity and 
consideration of the wellbeing of others in their communities. We would 
like to thank Pfizer and BioNTech for this very generous donation to 
support the vaccination of athletes and Games participants ahead of the 
Olympic and Paralympic Games Tokyo 2020," he added. 
 
   During a conversation between Albert Bourla, Chairman and Chief 
Executive Officer, Pfizer, and Suga Yoshihide, Prime Minister of Japan, 
which is the host country of Tokyo 2020, Mr. Bourla made an offer to 
donate the Pfizer-BioNTech COVID-19 vaccine for athletes and their 
delegations participating in Tokyo 2020. Following this conversation, 
the Japanese government had a meeting with the IOC and now the donation 
plan has been realized. 
 
   "With hundreds of millions of vaccines already administered, and 
hundreds of millions more to go, Pfizer is committed, together with 
BioNTech, to doing all we can to help end this pandemic and help return 
the world to a sense of normalcy," said Albert Bourla, Chairman and 
Chief Executive Officer, Pfizer. "The return of the Olympic and 
Paralympic Games represents a monumental moment of world unity and peace 
after a grueling year of isolation and devastation. We are proud to play 
a role in providing vaccines to athletes and national Olympic 
delegations." 
 
   "Providing vaccines to Games participants is one of the critical ways to 
help ensure the Games are as safe and successful as possible. With more 
than 430 million doses already delivered, our vaccine continues to help 
protect lives around the world and bring us back to our normal lives," 
said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "This year's 
Olympic and Paralympic Games are an historic moment representing the 
global community and how we stand together. We are honored to be able to 
contribute vaccines to support the safety of the Olympic and Paralympic 
Games." 
 
   It is the decision of sovereign States to offer immunization to athletes 
and their delegations in accordance with their local guidance before 
travelling to Japan for the Tokyo Games. The IOC and International 
Paralympic Committee (IPC) have made it clear that vaccination is not 
mandatory in order for athletes to participate in the Olympic and 
Paralympic Games, and that any vaccination program must be conducted in 
full respect of national vaccination priorities. 
 
   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. 
 
   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,

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May 06, 2021 06:30 ET (10:30 GMT)