Playing the blame game I Medicines for Africa

Criticism that the World Health Organization responded too slowly in its evaluations of vaccines already approved by the US and Europe and that this is why Africans are dependent on donations are simply unjustified. Bavarian Nordic has clearly stated that it will not sell its vaccines directly to African nations and that any vaccines to African countries will only be made available though donors. There is no ambiguity whatsoever in the company's position. So far its actions are quite consistent with that decision. Bavarian Nordic’s Vice President of Investor Relations Rolf Sass S?rensen, said this. “Bavarian Nordic has no plans to sell or manufacture its vaccines directly to African countries.”According to, him, “It’s very unlikely that any African country will ever be responsible for buying vaccines.” According to him, “Vaccines to Africa will come from donations from organizations and countries."

The Africa CDC announced two weeks ago that it was negotiating 200’000 doses of vaccines with Bavarian Nordic. The company has not made those vaccines available yet. Instead, Bavarian has pledged a donation that is yet to me made. A more pertinent question that Africans are asking is this. Does the Africa CDC or the African Union have a plan for getting vaccines to Africans in a timely manner and why did the Africa CDC not prenegotiate access to vaccines over the many months when this outbreak has been growing? It is not clear that they actually do because of the contradicting messages coming from the Africa CDC. For instance, the Africa CDC C has said that it is negotiating a technology transfer agreement with Bavarian Nordic to have mpox vaccines manufactured on the African continent. Bavarian Nordic soon after said that production of its vaccine in Africa region is also out of the question.

Furthermore, the Africa CDC has also announced a string of donations cumulatively amounting to a million doses from disparate donations including 5’000 pledged donation by GAVI. So far all the doses pledged for donation, only 10’000 doses of vaccines have been received by Nigeria and they will vaccine 5’000 people in a country of 219 million on a continent of 1.3 billion people. This number is simply grotesque.the 3 million doses that the Africa CDC said would be available by the end of the year have still not materialized. Africa needs vaccine now. This outbreak is growing everyday and 4 months is really far away. It does not reassure Africans that Africa CDC appears to be floundering without a clear plan to ensure that affected African communities will receive essential vaccinations in a timely manner. Africa needs vaccines. It needs then now. The Africa CDC had months to prepare for this moment.

According to the WHO, Mpox vaccines provide a level of protection against infection and severe disease. At the present time, there are currently two mpox vaccines that can be used to prevent the spread of mpox. One vaccine is a live Modified Vaccinia Virus Ankara (MVA-BN) produced by Bavarian Nordic, a Danish biotech company. The other vaccine, LC16KMB, is a freeze-dried vaccine produced by the Japanese pharmaceutical company KM Biologics Co. Ltdrecently approved domestically in Japan. The Japanese vaccine is the only one licensed for use in children, but so far it has not been available to the African outbreak which is disproportionately affecting children with two thirds of those affected being children according to Africa CDC. There are however reports that Japan may now be willing to donate some doses.

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Vaccine efficacy studies indicate that vaccines provide a good level of protection against mpox following vaccination. However, the majority of clinical trials were done in the context of the 2022 mpox outbreak in Europe. That outbreak was caused by a variant different from the one causing the current outbreak in Africa. The vaccine was studied in populations different from those affected by the currently outbreak - men who have sex with men and not in women and children, with children being the biggest affected group in the current outbreak. Pregnant women are also particularly vulnerable. High rates of miscarriages have been reported for many months. The mode of transmission of the current viral variant has also changed. Clinical studies in the currently affected populations are needed urgently. Bavarian Nordic’s vaccine is not licensed in children. It has however recently submitted a request for approval ?of the vaccine’s use in children between 12 and 17 years old by the European Medicines Agency based on data done in 300 trial participants in the US. Whether 300 children in the US are representative enough of children in Africa is for regulators to determine. What Africans would want to know is whether the US regulator, the FDA would find a clinical study of 300 kids in Africa enough to support vaccine use in American children. ?African people will be reassured when African regulators also have the opportunity to review available data supporting vaccine use in children.

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In any case, African regulators should be performing their own regulatory evaluations in emergency situations like this one. The African Medicines Agency was supposed to have its Director General in place by June 2024. We are in August and the African Union just released a call for applications to fill the position of the Director General of the African Medicines Agency. The nomination of the AMA board of directors was done a few months ago though no formal announcement was ever made of the fact. This left Africans wondering ?why those particular individuals were found to be the best equipped to guide the African Medicines Agency at such a pivotal moment in its development. A moment that requires proven leadership and individuals with a proven track record developing medicines regulatory agencies that perform to a high standard. The majority of the board members were selected from countries at low regulatory maturity or that are still trying to create a regulatory agency in the first place. So far, the signs are not promising, but sooner or later, Africans will be able to judge for themselves.

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