BioNTech advocate accused of undermining WHO's African mRNA production campaign: report

As German mRNA specialist BioNTech works to stand up vaccine production in Africa, some critics are concerned those efforts could obstruct a bigger aim to help the continent achieve manufacturing sovereignty. 

The kENUP Foundation–a public benefit foundation representing Pfizer’s mRNA partner BioNTech–has been accused of undermining a World Health Organization push to help African companies manufacture COVID-19 vaccines, medical journal The BMJ reported in an article co-published with German newspaper Die Welt. 

The consultancy has allegedly branded WHO’s bid to create an mRNA vaccine for production in Africa as doomed to fail and likely to infringe on patents, BMJ said in a release.

Launched in June, the WHO’s South African-based technology transfer hub leverages public information to re-create Moderna’s COVID-19 vaccine. The goal is to teach companies and scientists across the continent how to use mRNA technology, BMJ said. WHO would then develop a comparable vaccine, which would be manufactured at industrial scales, should it pass muster with regulators. 

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The WHO hub’s development approach is legal in South Africa, and the organization had hoped Pfizer-BioNTech or Moderna would share their technology and know-how to hasten the project, BMJ explained. 

But kENUP Foundation says the hub should halt the project, citing concerns about potential patent violations, according to a document sent to South African government officials and referenced by The BMJ. 

Those patent fears are unfounded, says The Medicines Patent Pool, which is in charge of the intellectual property and licensing aspects of WHO’s hub.

Speaking to The BMJ, kENUP said it’s “committed to global collaboration in the fight against infectious diseases,” adding that it “has always coordinated with important intergovernmental organizations, such as WHO and Africa CDC.” 

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BioNTech and Moderna in October telegraphed separate plans to build vaccine production facilities in Africa. BioNTech’s effort centers around shipping mRNA sea container factories from Europe to Africa, BMJ notes. These would be staffed by BioNTech workers to start and licensed by the European Medicines Agency. 

kENUP has backed BioNTech’s plan to ship mRNA factories in sea containers from Europe to Africa, BMJ says. 

BMJ said this regulatory route has been branded “paternalistic and unworkable” by certain experts, such as Margareth Sigonda-Ndomondo, who leads regulation for Partners for African Vaccine Manufacturing (PAVM). 

A BioNTech spokesperson told Fierce Pharma the company “cannot comment on behalf of the WHO nor on kENUP.” 

The spokesperson reiterated BioNTech’s commitment to “the establishment of sustainable mRNA manufacturing solutions in Africa with the aim to promote vaccine access." The company says the project is “a collaborative effort with members of the African Union and respective authorities.”

BMJ’s report comes right as Médecins Sans Frontières put out a call to the South African government to revoke patents on Eli Lilly’s Olumiant (baricitinib) and Moderna’s mRNA vaccine. 

A South African patent on Olumiant “is currently limiting access to affordable generic versions of this medicine,” MSF argued in a release, while at least three patents on Moderna’s COVID-19 shot could lead to patent disputes for companies working with WHO’s mRNA vaccine technology transfer hub.