22 September 2021 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) plan to expand their agreement with the US government by providing an additional 500m doses of the companies' COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them, the companies said.

This expanded agreement brings the total number of doses to be supplied to the US government for donation to these countries to one bn.

Consistent with the initial agreement, the US government will allocate doses of the Pfizer-BioNTech COVID-19 Vaccine to 92 low- and lower-middle-income countries as defined by Gavi's COVAX Advanced Market Commitment and the 55 member states of the African Union.

Deliveries of the initial 500 m doses began in August 2021, and the total one bn doses under the expanded agreement are expected to be delivered by the end of September 2022.

The current plan is to produce these doses in Pfizer's US facilities located in Kalamazoo, MI, Andover, MA, Chesterfield, MO, and McPherson, KS.

Overall, Pfizer and BioNTech have shipped more than 1.5 bn COVID-19 vaccine doses worldwide.

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with governments and health partners worldwide, and have pledged to provide two bn doses to low- and middle-income countries in 2021 and 2022 at least one bn each year.

In addition to the supply agreement with the US government, this includes direct supply agreements with individual country governments and a direct supply agreement with COVAX for 40m doses in 2021.

The vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

An individual may be offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and 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 and C Act unless the declaration is terminated or authorization revoked sooner.