State-backed vaccine distributor Biovac Institute has reached an agreement with Pfizer and BioNTech to help manufacture 100-million doses of its mRNA Covid-19 vaccine a year for African countries.
It will be the first company in Africa to be involved in the production of an mRNA-based vaccine and joins a global network of more than 20 contractors involved in production of the Pfizer/BioNTech shot.
While the development is not immediately expected to boost African nations’ hopes of securing vaccine supplies, which have largely been snapped up by wealthier countries, the government sees it as an important step in bolstering vaccine manufacturing capacity on the continent.
“Today’s agreement will contribute significantly to health security and sustainability on our continent, which currently has the least access to vaccination in the world,” said President Cyril Ramaphosa, who is the AU champion for Covid-19.
Africa manufactures only 1% of the vaccines it uses and is desperately short of coronavirus shots. Only 18-million people in Africa are fully immunised against Covid-19, representing just 1.5% of its population, according to the World Health Organisation (WHO).
Biovac’s agreement with Pfizer/BioNTech is similar to that clinched last year by Aspen Pharmacare with Johnson & Johnson (J&J) to help produce its Covid-19 jab, as neither company has been licensed to make the active pharmaceutical ingredients used in the shots.
Biovac will receive the active pharmaceutical ingredients from Pfizer/BioNTech facilities in Europe, which it will use on site to formulate vaccines, put them into vials, and package them for distribution.
Biovac CEO Morena Makhoana said the institute hoped eventually to manufacture active pharmaceutical ingredients, also known as drug substance, for the vaccine at its Cape Town site. “This is a stepping stone to a bigger vision, not only of making drug substance but also applying this technology to other diseases,” he said.
‘Not far enough’
Biovac has a long-standing relationship with Pfizer and already helps manufacture its childhood vaccine Prevnar 13, which targets respiratory diseases.
Under the agreement, Biovac will produce up to 100-million doses of the Pfizer/BioNTech Covid-19 vaccine a year. The Pfizer shot is one of the two vaccines being administered in SA’s inoculation drive, along with a jab manufactured by J&J.
Makhoana said site expansion and technology transfer for the Pfizer/BioNTech vaccine would take place this year.
Biovac anticipated seeking regulatory approval from the SA Health Products Regulatory Authority by the end of June 2022 and aimed to begin commercial production in the third quarter, he said.
A safe and effective vaccine is widely regarded as the best way of combating the coronavirus pandemic, which has disrupted societies and economies around the world since it emerged in China late in 2019. More than 191-million cases and more than 4.1-million deaths from Covid-19 have been recorded since then, according to Our World in Data.
Public health activist Fatima Hassan, founder of the Health Justice Initiative, said that while any initiative to ensure more vaccines for SA and the region was welcome, the deal did not go far enough.
“Fill and finish approaches do not address the important issue of security of supply, which only comes with diversified and local production,” she said.
“To expand global manufacturing capacity means countries [and] manufacturers must also have the freedom to produce the drug substance and to make their own production, supply and pricing decisions,” she said.
“We would like to see full terms and ask Pfizer why it can’t issue a full licence to multiple manufacturers: why does it play God in a pandemic?” she said.
Pfizer CEO Albert Bourla said the company’s goal was to provide fair and equitable access to the Pfizer/BioNTech vaccine to everyone.
‘Benefit for Africa’
“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,” he said in a statement.
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