Mary Wilson
Well-known member
Published 09 February 2022
Cite this as: BMJ 2022;376
304
doi: https://doi.org/10.1136/bmj.o304
The World Health Organization aims to help African companies make covid vaccines. Why did BioNTech’s representative tell governments that the project was doomed? Madlen Davies reports
A foundation representing the vaccine maker BioNTech has been accused of seeking to undermine the World Health Organization’s initiative to bring covid vaccine manufacturing to the African continent, The BMJ can reveal.
The kENUP Foundation, a consultancy hired by BioNTech, has claimed that WHO’s hub, which is creating a covid-19 mRNA vaccine that African companies can make, is unlikely to be successful and will infringe on patents, documents obtained by The BMJ have shown. Instead, they show kENUP promoting BioNTech’s proposal to ship mRNA factories housed in sea containers from Europe to Africa, initially staffed with BioNTech workers, and a proposed new regulatory pathway to approve the vaccines made in these factories. The novel pathway has been described as paternalistic and unworkable by some experts, as it seems to bypass local regulators.
The move threatens the pan-African venture backed by WHO that seeks to scale up African production of lifesaving vaccines from 1% to 60% by 2040.1 The documents, published for the first time, reveal new details of the proposal from kENUP and BioNTech and their criticism of the WHO venture.
... WHO’s technology transfer hub, launched in June 2021 and based in South Africa, uses publicly available information to recreate Moderna’s vaccine, to teach companies and scientists across the continent how to use mRNA technology. It will then develop a comparable vaccine, which, if successful in clinical trials and approved by regulators, it will manufacture industrially.
Two South African companies, Afrigen Biologics and the Biovac Institute, have joined a consortium to develop and manufacture the mRNA vaccine, with guidance from organisations including WHO, the Medicines Patent Pool, the South Africa Medical Research Council, and the Africa Centres for Disease Control (Africa CDC). This is part of the wider Partners for African Vaccine Manufacturing project coordinated by Africa CDC, launched in April 2021.
In a document sent to South African government officials after a visit to the country on 11-14 August last year, the kENUP Foundation said that the hub’s activity should be stopped. kENUP’s Mission Report to South Africa (see supplementary materials in “Related content”) 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.” ...
https://www.bmj.com/content/376/bmj.o304
Cite this as: BMJ 2022;376
304doi: https://doi.org/10.1136/bmj.o304
The World Health Organization aims to help African companies make covid vaccines. Why did BioNTech’s representative tell governments that the project was doomed? Madlen Davies reports
A foundation representing the vaccine maker BioNTech has been accused of seeking to undermine the World Health Organization’s initiative to bring covid vaccine manufacturing to the African continent, The BMJ can reveal.
The kENUP Foundation, a consultancy hired by BioNTech, has claimed that WHO’s hub, which is creating a covid-19 mRNA vaccine that African companies can make, is unlikely to be successful and will infringe on patents, documents obtained by The BMJ have shown. Instead, they show kENUP promoting BioNTech’s proposal to ship mRNA factories housed in sea containers from Europe to Africa, initially staffed with BioNTech workers, and a proposed new regulatory pathway to approve the vaccines made in these factories. The novel pathway has been described as paternalistic and unworkable by some experts, as it seems to bypass local regulators.
The move threatens the pan-African venture backed by WHO that seeks to scale up African production of lifesaving vaccines from 1% to 60% by 2040.1 The documents, published for the first time, reveal new details of the proposal from kENUP and BioNTech and their criticism of the WHO venture.
... WHO’s technology transfer hub, launched in June 2021 and based in South Africa, uses publicly available information to recreate Moderna’s vaccine, to teach companies and scientists across the continent how to use mRNA technology. It will then develop a comparable vaccine, which, if successful in clinical trials and approved by regulators, it will manufacture industrially.
Two South African companies, Afrigen Biologics and the Biovac Institute, have joined a consortium to develop and manufacture the mRNA vaccine, with guidance from organisations including WHO, the Medicines Patent Pool, the South Africa Medical Research Council, and the Africa Centres for Disease Control (Africa CDC). This is part of the wider Partners for African Vaccine Manufacturing project coordinated by Africa CDC, launched in April 2021.
In a document sent to South African government officials after a visit to the country on 11-14 August last year, the kENUP Foundation said that the hub’s activity should be stopped. kENUP’s Mission Report to South Africa (see supplementary materials in “Related content”) 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.” ...
https://www.bmj.com/content/376/bmj.o304
