21 July 2021 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) have signed a letter of intent with South African biopharmaceutical company The Biovac Institute Ltd, known as "Biovac," to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union, the companies said.

Biovac will perform manufacturing and distribution activities within Pfizer's and BioNTech's global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities.

To facilitate Biovac's involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately.

Pfizer and BioNTech expect that Biovac's Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022.

At full operational capacity, the annual production will exceed 100 m finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.

Pfizer and BioNTech select contract manufacturers using a rigorous selection process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program.

Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill, finish and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 bn COVID-19 vaccine doses to more than 100 countries or territories in every region of the world.

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 global governments as well as global health partners with the aim to provide 2 bn doses to low and middle income countries in 2021 and 2022 1bn each year.

This includes an agreement to supply 500 m doses to the US government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment countries, as well as a direct supply agreement with the COVAX facility for 40m doses.

The Pfizer-BioNTech COVID-19 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 European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), 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 US Food and Drug Administration, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 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 and C Act unless the declaration is terminated or authorization revoked sooner.