On May 6, 2021, Pfizer 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 were scheduled to begin 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.

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.