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Vaccine manufacture in Africa

BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility

How drug industry is undermining WHO plans

| TIMOTHY HUZAR | Since June 2021, the WHO has been coordinating a messenger ribonucleic acid (mRNA) vaccine technology transfer hub in South Africa.

The hub is important because it will increase the availability of mRNA vaccines, including those for COVID-19, in Africa, which currently has access to very few vaccines, compared with areas of the Global North.

In a new investigation, the British Medical Journal (BMJ) has revealed that a consultancy hired by the vaccine manufacturer BioNTech has attempted to undermine the new mRNA hub by lobbying the South African government against the venture.

The WHO’s technology transfer hub aims to use publicly available information about Moderna’s mRNA COVID-19 vaccine to develop a similar vaccine that could be more cheaply and quickly distributed throughout Africa.

The hub is supported by the Africa Centres for Disease Control and Prevention, the Medicines Patent Pool, and the South Africa Medical Research Council. The vaccine would be manufactured by the South African companies Afrigen Biologics and the Biovac Institute.

Medical News Today spoke with Prof. David Walwyn, at the University of Pretoria’s Graduate School of Technology Management, in South Africa, who revealed more about the significance of the WHO’s technology transfer hub.

“The hub will develop generic mRNA vaccines for local manufacture. If the initiative is successful, it will improve vaccine access and lower the cost of critical vaccines in the region.”

“This is very important. Vaccines are essential to public health programs, bringing highly cost effective treatments for infectious diseases into widespread use. At present, these novel vaccines are covered by patents, and there are no generic equivalents. As a result, they are available in limited quantities and at high cost.”

“In other words, (they are) out of the reach of countries in the Global South which do not have manufacturing capability or access to alternative vaccine types,” said Prof. Walwyn.

Dr. Tedros Adhanom Ghebreyesus, WHO director-general, explains that the technology transfer hub “is great news, particularly for Africa, which has the least access to vaccines. COVID-19 has highlighted the importance of local production to address health emergencies, strengthen regional health security, and expand sustainable access to health products.”

Undermining public vaccine development

However, the kENUP Foundation — a consultancy hired by the vaccine manufacturer BioNTech — was not as pleased as others about the WHO’s hub.

BMJ reports that the foundation visited South Africa from August 11–14, 2021, after which it sent the South African government a report.

In it, the kENUP Foundation said: “The WHO Vaccine Technology Transfer Hub’s project of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately.

This is to prevent damage to Afrigen, BioVac, and Moderna.”

“Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable.”

According to Prof. Walwyn, this reflects a broader strategy of BioNTech to protect its profit margin.

“The kENUP Foundation, which has close links to BioNTech — indeed, one could argue that it has been hired by BioNTech to enforce its patents worldwide and prevent other manufacturers from making mRNA vaccines — has been actively campaigning to stop the work of the vaccine hub in Cape Town. This hub has received a mandate from several organisations, including the WHO, to bring COVID-19 vaccine manufacturing to the African continent.”

“As we are all aware, there is as yet no manufacturer of the active substance for a COVID-19 vaccine in Africa. This absence has undoubtedly led to the low vaccine rates within the continent, relative to the global averages.”

“The actions of BioNTech are wrong because they will prolong the social and economic costs of the pandemic,” says Prof. David Walwyn.

The Medicines Patent Pool responded to the kENUP Foundation’s claims in a press release in November 2021.

“Unfounded rumors have been circulating that the mRNA vaccine technology transfer hub being established in South Africa (…) intends to infringe patents. The Medicines Patent Pool (…) wishes to make it clear that this is not the case.”

“The Medicines Patent Pool will ensure that technology used in the hub is either not covered by patents or that licenses and/or commitments-not-to-enforce are in place to enable freedom to operate.”

“The Medicines Patent Pool’s model of public health licensing is dependent on the voluntary participation of intellectual property holders and therefore has no intention of being involved in patent infringement.”

Prof. Walwyn said that much more needed to be done to ensure equitable access to vaccines in Africa, and that the drive for profit from large pharmaceutical companies was an impediment.

“At present, few countries in Africa have any access to COVID-19 vaccine manufacturing technology — I refer here to the manufacture of the active substance. So there is a great deal to be done.”

“There need to be clear commitments from the pharmaceutical companies to technology transfer, investment in manufacturing facilities, and training of staff who can operate these facilities. I do not consider the placement of containerised manufacturing modules operated by expatriate staff (…) to be an example of such commitment,” he continued.

“We should not be naive about pharmaceutical companies and their intentions. The primary objective of BioNTech and others is to make profit, not to save the lives of poor people in Africa. The activities of the kENUP Foundation are perfectly aligned with this perspective,” said Prof. David Walwyn.

“BioNTech will use a number of strategies to ensure that no country invokes the compulsory licensing provisions of Trade-Related Aspects of Intellectual Property Rights or succeeds in the development of generic mRNA technology. Threatening potential producers is just one such strategy. There will be others to come,” he said.

“The present situation for COVD-19 vaccines and access by developing countries to lifesaving prophylactic treatment is exactly analogous to the dispute on antiretroviral drugs for the treatment of HIV which took place in the 2000s. It took a court case to force drug companies to license low-cost producers and drop the cost of treatment from $10,000 per patient per year to about $350 per patient per year.”

“We are heading, at this point, in the same direction. If the vaccine hub is successful in developing a validated Moderna vaccine — and there is still lots to be done before the hub can claim success — BioNTech and others are likely to employ multiple strategies to undermine the initiative.”

“It is exactly on account of this aggressive protection of Big Pharma’s technologies and markets that it has taken Biovac so long to rebuild local vaccine manufacturing capability,” Prof. Walwyn.

Sea containers?

As an alternative to the WHO’s technology transfer hub, BioNTech has proposed that it be given regulatory approval to ship vaccination manufacturing sea containers into Africa.

According to BMJ, the kENUP Foundation suggested that the sea containers could be given regulatory approval by the European Medicines Agency if a new regulatory pathway was opened. The foundation argued that this would speed up the WHO’s validation of the safety and efficacy of any vaccines produced in the sea containers.

However, Dr. Marie-Paule Kieny — chair of the Medicines Patent Pool Governance Board, who has worked on vaccines at the WHO for decades — told BMJ that the foundation’s claim that the European Medicines Agency could approve the sea containers was “pure nonsense,” adding, “Only somebody who doesn’t know how it works can say something like that.”

On Feb.16, the German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said it will set up the vaccination manufacturing sea containers which it termed modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well.  It said South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later.

Speaking at a press briefing on Feb.16, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin said that the first containers would be delivered to Africa in mid-2022.

“We want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers,” he said.

At the event, WHO’s Director General Dr Tedros Adhanom Ghebreyesus  mentioned that “Many colleagues have been discouraged about the success of this project.”

It was interpreted as a soft reference to criticism that had been levelled at the BioNTech container project in the BMJ investigation.

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