Pfizer and BioNTech Expand Collaboration to Manufacture and Distribute COVID-19 Vaccines within Africa

Pfizer Inc. and Germany-based BioNTech SE announced today the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 (Comirnaty) vaccine for distribution within the African Union.

The press statement says, '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 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.

“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 vaccine to everyone, everywhere,” commented Albert Bourla, Chairman and CEO, Pfizer, in the July 21, 2021 press release.

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 vaccine within Africa. This is a testament to the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” added Dr. Morena Makhoana, CEO of Biovac.

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 billion 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 billion doses too low and middle-income countries in 2021 and 2022 – 1 billion each year.

This includes an agreement to supply 500 million doses to the U.S. 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 (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses.

The Pfizer-BioNTech COVID-19 vaccine, based on BioNTech’s proprietary mRNA technology, was developed by 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 (Comirnaty) COVID-19 vaccine has not been Approved or licensed by the U.S. Food and Drug Administration (FDA). Still, it has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 caused by the SARS-CoV-2 beta coronavirus 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&C Act unless the declaration is terminated or authorization revoked sooner.

Please see the Full EUA Prescribing Information available at www.cvdvaccine-us.com.

Biovac was established in 2003 to revive local human vaccine production in Southern Africa. Alongside the development of the local vaccine industry, through steep investment in local skills and modern facilities, the company has secured high-profile technology transfers from international pharmaceutical companies, including Pfizer and Sanofi Pasteur, to manufacture pediatric vaccines. The company currently supplies a comprehensive range of vaccines supporting the South African Department of Health’s Expanded Programme for Immunisation.