Pfizer, BioNTech team with South African manufacturer, but only on fill-finish

 The manufacturing expansion into Africa continued Wednesday with Pfizer and BioNTech’s announcement that the two companies signed on with the Biovac Institute to manufacture its Covid-19 vaccine to distribute throughout Africa. But while the continent is in dire need of doses, vaccines from the expansion won’t be available until the start of next year.

Biovac will only handle distribution and fill-finish duties. Drug substance for these batches will come from European facilities. When fully operational, the facility will pump out 100 million doses a year, set to be evenly distributed among the 55 member states of the African Union.

The announcement marks the fourth continent that the vaccine will be manufactured in, at over 20 facilities. Technical transfer, on-site development and equipment installations are all already underway, Pfizer said.

As the continent has been left behind in the race between countries to inoculate its residents, drugmakers have made moves to play catch-up, particularly after being spooked by President Joe Biden’s declaration that his administration supported vaccine intellectual property waivers. Moderna’s only involvement in Africa has come in the form of a distribution agreement with Dubai-based Magenta Investments, a company which has dealings in both the Middle East and Africa. In March, J&J made 220 million doses of the shot available to the African Vaccine Acquisition Trust, but no announcements surrounding manufacturing have been made.

The WHO and CDC have both thrown support at a South African consortium to establish a Covid-19 mRNA vaccine technology transfer hub that will, in theory, allow for the sharing of IP to train manufacturers and learn the process.

But the demand for doses is urgent; nearly all vaccines used in Africa are imported and only about 1% of people on the continent have been fully vaccinated. The Covid-19 pandemic isn’t the first time Africa has been neglected by the pharmaceutical industry, but it’s the latest example.

“As we and many others have long said, sharing Covid-19 tech and manufacturing is only way to move toward equity. huge un-tapped African capacity and expertise,” Georgetown global health professor Matthew Kavanagh tweeted Wednesday. “Past time to use state power to compel sharing. Today, companies show they will not do right without it.”

The contract was awarded to the Biovac Institute after a selection process that factors in compliance, quality and safety track record, among other things. Pfizer has worked with Biovac since 2015, when the two joined forces for fill-finish duties and distribution of Prevenar 13, an intramuscularly injected jab to prevent infections such as pneumonia and meningitis.

“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 Vaccine to everyone, everywhere,” Pfizer CEO Albert Bourla said in a statement. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

Pfizer-BioNTech’s jab is still awaiting full approval from the FDA. It’s currently available under the Emergency Use Authorization.

In May, the EU backed an effort to expand manufacturing in Africa. Three locations were being considered, including the Institut Pasteur in Senegal, and in Rwanda and South Africa.

https://endpts.com/pfizer-and-biontech-team-up-with-south-african-manufacturer-but-it-will-only-handle-fill-finish/