Pfizer Covid-19 vaccine to be filled and finished in South Africa for exclusive African use

International pharmaceutical company Pfizer, the manufacturer of one of two Covid-19 vaccines currently in use in South Africa, on Wednesday announced that it had reached an agreement with the Biovac Institute in Cape Town to manufacture their Covid-19 vaccine for distribution in Africa.

The announcement followed one by President Cyril Ramaphosa last week that the Aspen Pharma company’s Gqeberha plant would start producing the Johnson & Johnson vaccine under licence for distribution on the continent.

According to a statement released by Pfizer, the agreement means that Pfizer and BioNTech’s global Covid-19 vaccine supply chain and manufacturing network 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,” the company said. 

It is estimated, according to the company, that Biovac will be fully incorporated into the vaccine supply chain by the end of the year.

“Biovac will obtain drug substances 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,” the statement reads.

“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech Covid-19 vaccine to everyone, everywhere,” said Albert Bourla, chairperson and CEO of Pfizer. 

“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.”

Ugur Sahin, the CEO and co-founder of BioNTech, said: “We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses. 

“We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”

Dr Morena Makhoana, CEO of Biovac, said: “We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech Covid-19 vaccine within Africa. This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine. This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic. 

“We believe this collaboration will create an opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent,” Makhoana said. 

The announcement came as the World Health Organization (WHO) this week reiterated its call to action to have at least 10% of all countries’ populations vaccinated by September 2021. 

“Increased global solidarity is needed to protect vulnerable populations from the emergence and spread of SARS CoV-2 variants. Noting that many countries have now vaccinated their priority populations, it is recommended that doses should be shared with countries that have limited access before expanding national vaccination programmes into lower-risk groups. Vaccination programmes should include vulnerable populations, including seafarers and air crews,” the WHO statement read.

President Cyril Ramaphosa welcomed the latest development and described it as a “breakthrough in the protection of African nations against Covid-19”.

Speaking in his capacity as African Union (AU) Champion on Covid-19, Ramaphosa said the agreement will make a significant contribution to health security and sustainability on the African continent, “which currently has the least access to vaccination in the world”.

Ramaphosa said Biovac, a public-private partnership between the South African government and the pharmaceutical private sector, is the first company on the continent to produce an mRNA-based vaccine.

“Biovac will immediately embark on technological transfer activities that includes on-site development and equipment installation for the production of the Pfizer-BioNTech Covid-19 vaccines,” Ramaphosa said. 

He confirmed that all doses manufactured at Biovac will exclusively be distributed within the 55 AU member states.

He said Biovac’s expansion in production and acquisition of specialised equipment related to mRNA technology entails an investment of R200-million in six months, which will be shared.

“The partnership between Biovac and Pfizer is a breakthrough in our effort to overcome global vaccine inequity. The protection of Africans is a necessary and critical contribution to the protection of humanity as a whole. This partnership demonstrates what we can achieve when the state sector and the private sector craft a shared vision and pool resources for the greater good of society.

“This collaboration recognises the talent and technology that exists on our continent that can be harnessed in our irreversible march of sustainable and inclusive development,” he said.

Vaccine equity activist Fatima Hassan of the Health Justice Initiative said the development was a baby step in the right direction but must not detract from the pursuit to have the intellectual property rights on Covid-19-related technology waived, and technology hubs like the Biovac Institute must get the technology transfer as well.

“They should be giving full licences to multiple manufacturers.” She said while they welcome any initiative that improves vaccine equity for South Africa and the region, a “fill and finish” contract did not fully address issues of supply security.

“We have noted that Pfizer has stated that they were not keen to be a technology partner to the World Health Organization’s technology hubs facilitated to establish local manufacturing. The first such hub for mRNA is in South Africa and this includes Biovac. I hope that the contract that they agreed on does not compromise their role as a key player in the first regional hub,” she added.

“We have heard arguments that there was no capacity. This announcement disproves that argument. This is fill and finish and contract manufacturing, dependent on the importation of drug substances, and presumably decisions are made by Pfizer and Biotech, but we have not seen the terms of the agreement.

“So, this is still creating dependence. To expand global manufacturing capacity means that countries/manufacturers must also have the freedom to produce the drug substance and to make their own production, supply and pricing decisions. We would all like to see the full terms of the agreement and ask Pfizer why it can’t issue a full licence to multiple manufacturers. Why does it choose to play God – in a pandemic?” she asked.

Strive Masiyiwa, AU special envoy on Covid-19 and a member of the African Vaccine Acquisition Task Team, joined Ramaphosa in welcoming the Biovac-Pfizer initiative.

“The only way to guarantee Africa’s access to vaccines now and in the future is through this type of strategic manufacturing partnerships, which we welcome greatly,” he said. DM/MC