Pfizer/BioNTech Announce Milestone COVID-19 Vaccine Manufacture Deal in South Africa – But Production Only Beginning Next Year  

In a milestone deal for Africa, Pfizer/BioNTech announced Wednesday that it would partner with the Cape Town-based pharma firm Biovac to produce over 100 million doses annually of it’s cutting edge mRNA vaccine – for distribution within the African Union.  

The deal was quickly hailed as a major breakthrough on a continent that is desperately short of vaccines, and so far has had no capacity to manufacture highly efficacious mRNA vaccines against COVID. 

But the plan to produce 100 million doses, beginning in early 2022, won’t solve the here-and-now problems of vaccine supply shortages in a region where only about 1.5% of the population is fully vaccinated, public health advocates also stressed. That, in comparison to 40-60% vaccine rates in high-income countries, and even 30% coverage in emerging economies such as India.  

“It’s great to see that doses will be made closer to where they’re needed the most.  But they won’t be ready until next year.  Until then, rich countries need to share doses ASAP,” said the Wellcome Trust in a statement summing up the current state-of-play.  

Under the deal, announced by the US-based Pfizer and the German firm BioNTech in a joint statement, Biovac will manufacture at the ”fill-and-finish” stage of the company’s mRNA COVID vaccine, using active ingredients produced from facilities in Europe. 

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately,” the pharma announcement said.

“The 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.”

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

Albert Bourla, Pfizer CEO

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 Vaccine within Africa,” said Biovac CEO Morena Makhoana,  “This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” he added referring to Biovac’s production of a pneumococcal vaccine now used widely around the world to protect infants and young children against bacterial pneumonia. 

“This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic,” Makhoana added. “We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”

South African President Cyril Ramaphosa also welcomed the deal in a special statement. Speaking in his capacity as African Union Champion on COVID-19, Ramaphosa said: “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.”

Pharma heaps praise – vaccine advocates level more criticism on deal 

Meanwhile, the new license agreement doesn’t appear likely to break the ice between medicines access advocates – who support a World Trade Organization waiver on all vaccine-related IP and trade secrets – and pharma voices contending such a move is impractical, and advocate voluntary license deals like the Pfizer/BioNTech-Biovac one as the preferred route.  

 “This is a far cry from full technology transfer to allow independent manufacture of mRNA vaccines and therapeutics,” said Professor Brook Baker, a law and medicines specialist at Northeastern University, of the Pfizer/BioNTech accord with Biovac.

“This agreement is nothing more or less than a contract manufacturing agreement for sterile formulation, fill, and finish.  Biovac will not be an ‘independent producer’- it will instead be a contract ‘subsidiary’ facility, subject to rigid control by Pfizer. In addition to the vaccine having a BioNTech/Pfizer ‘brand’, it will have a price set by them,” he noted in a blog posted on the list-serv IP-Health. 

“The announcement does not indicate the technology transfer/sharing agreement would ever result in the ability of Biovac to produce the mRNA active ingredient,” Baker added. “Thus, the underlying mRNA tech platform continues to be exclusively controlled by BioNTech/Pfizer, and Biovac will not be given the ability to further develop its own internal technical capacity and expertise that might allow it to manufacture other mRNA vaccines and therapeutics in the future.”  

“A somewhat more favorable aspect of the agreement is that the Biovac-produced BioNTech/Pfizer vaccine will be distributed only to 55 countries in Africa,” he conceded. “At least vaccine manufactured in Africa will stay in Africa, unlike the initial J&J agreement with Aspen Pharmacare.”

He was referring to the first Johnson & Johnson deal in South Africa, where most of the initial Aspen fill-and finish doses were contracted for delivery abroad. A subsequent deal with the African Union has secured 400 million J&J doses for use specifically on the continent. But there, too, production will only ramp up fully in the last quarter of 2021. 

IFPMA – more dose-sharing urgently needed as immediate solution to vaccine shortages

Meanwhile, Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, hailed the deal as “great news demonstrating the vaccine innovators’ huge contribution to tackling the pandemic”.  

“It is in line with our industry’s commitment from the first days of the pandemic where we recognised that collaborations would be needed to achieve the massive ramping up production of any COVID-19 vaccine.  Indeed, the first ones were agreed in April 2020; and today there are more 200 collaborations underway, many of which involve technology transfer. Industry is on track to producing 11 billion doses by the end of this year. 

“This would be enough to vaccinate the world’s adult population, if doses are shared equitably. But this will only happen if the world wakes up. Since May, we have been calling for five steps to urgently advance COVID-19 vaccine equity – top of the list is dose sharing, lives depend on it.”  

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