LETTER: Why kENUP’s proposals would weaken Africa’s vaccine manufacturing industry

I was disappointed to read Madlen Davies’ investigative piece in the reputable British Medical Journal on how a Malta-based consultancy firm kENUP Foundation is undermining efforts to bring vaccine manufacturing to Africa. 

Davies’ paper explores why the kENUP Foundation, a representative of BioNTech, one of the largest Covid-19 vaccine manufacturers, is advising governments that the World Health Organization project to help African biotech companies manufacture mRNA vaccines is doomed to fail, and as such should be terminated.

When I recently publicly expressed my disappointment, kENUP  chair and CEO Holm Keller reached out and invited me to read his foundation’s “white book,” hinting that it would set the record straight by showing that rather than trying to undermine vaccine manufacturing in Africa, as suggested by the BMJ article, kENUP is in fact doing the opposite. So I read the white book on kENUP’s recommended shortest path for Africa to acquire vaccine manufacturing capacity.

What immediately jumped out at me was that the authors lack a basic understanding of how medicines are regulated and how the existing norms and standards that guide medicines regulation work the world over. The central thesis of kENUP’s white book is the “transfer of mobile factories with embedded product-specific production processes”, with “the associated regulatory approvals from the EU to Africa”.

In essence, what kENUP is suggesting is to create a mobile copy of a European medicines factory that makes a vaccine that is approved for use in Europe, bring it to African soil, start producing the vaccine locally, and distribute it under the oversight of the European Medicines Agency, with no further scrutiny or regulatory approvals required by regulators in the respective African countries.

kENUP’s recommendations are based on flawed premises that could never work in practice. Its recommendations assume that a vaccine that is approved by a regulatory agency in Europe can be translocated, with or without WHO emergency use listing, to an African country, for that vaccine to be produced there. Not only does this contradict the national medicines acts of respective African nations, it also contravenes international norms and standard of medicines regulation.

kENUP’s recommendations present a real risk of serious harm to the African people who would take those medications. They also weaken the local manufacturing industry by advocating against BioNTech fully conceding oversight over its African manufacturing operations to the respective African regulators or to the African Medicines Agency.

Lenias Hwenda

Founder and CEO, Medicines for Africa

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