Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at 2020 Tokyo Games

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of 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 possiblewith the aimto 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 Paralympics 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 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 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/).

  • 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 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 www.cvdvaccine-us.com.

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