In a new article published by the BMJ, alongside German Newspaper, Die Welt, World Health Organization (WHO) accused a foundation representing BioNTech of frustrating its effort to support African countries to manufacture its own Covid vaccines.
WHO established a technology transfer hub established in South Africa (June 2021). The WHO initiative is supported by the Medicines Patent Pool. They are using available information from the successful Moderna’s vaccine to educate companies on how mRNA technology works and recreate them. They hope to develop in the future, a vaccine that will be commercially produced, and works well.
The WHO are hoping that top pharmas such as Pfizer/BioNTech and Moderna who are producing Covid-19 vaccines will be willing to share the technology used in the vaccine manufacturing. But the foundation, KENUP, sent a document to South African authorities after visitation last year August, demanding that the WHO hub activity should be stopped due to patent issues.
The KENUP Foundation, a public interest foundation company based in Malta, is a consultancy hired by BioNTech. They have claimed that the WHO’s hub, already making Covid-19 mRNA vaccine that can be produced by African pharmaceutical manufacturers, will be less likely to be successful, and will infringe on its patents.
Instead, BioNTech plans to ship mRNA factories housed in sea containers from Europe to Africa with staffs from BioNTech, and licensed by European Medicine Agency (EMA), a move supported by KENUP.
But the move, which wants to bypass licensing by local regulators, is generating debates. Dr. Margareth Sigonda-Ndomondo, an expert leading regulation for Partners for African Vaccine Manufacturing (PAVM) argued that the laboratory in South Africa is well-equipped to handle the testing. It has also been inspected by WHO, and will hopefully regulate the vaccine approval process.
The African Medicines Agency is ratified in 2021, and will serve to regulate and harmonize medicine regulation in Africa, just as EMA.
BioNTech and Moderna announced its plans to establish vaccine manufacturing in Africa in October 2021, five months after the start of WHO hub. According to BioNTech, this will be done in agreement with WHO, African Union, and Africa CDC.
BioNTech pledged to spend up to $500m in the African manufacturing plant, and will make 500 million mRNA vaccines yearly. A memorandum of understanding has already been signed with the governments of Rwanda and Senegal to build mRNA production sites in the countries.