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New Malaria Vaccine Nearing Approval in Africa

AFRICA – Nigeria and Ghana are the first countries to support the new R21 vaccine, developed by researchers at the University of Oxford and produced by the Serum Institute of India and Novavax. This approval is surprising as it precedes that of the World Health Organization (WHO). African countries with limited resources for drug regulation previously relied on the UN agency to review new medicines first. Detailed results from the large-scale malaria vaccine trials are not yet public, and how the poorest nations will finance the vaccine remains uncertain.
African countries are preparing to approve a new malaria vaccine, with 20 million doses ready to be purchased this year.
African countries are preparing to approve a new malaria vaccine, with 20 million doses ready to be purchased this year. This image was generated by an artificial intelligence for illustration purposes. © Anas1904 / Midjourney

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Published on April 21, 2023 – 17:06 GMT +02:00

African Regulatory Authorities Reviewing the Vaccine

At least 10 other African regulatory authorities are examining trial data to assess the vaccine, and the WHO expects more of them to give their approval in the coming weeks. Mary Hamel, head of malaria vaccine implementation at the WHO, said at a meeting of experts: “We expect many other countries to follow.” She did not specify which countries might be next, although Tanzania and Kenya, with strong regulators and among the highest rates of the disease, are potential candidates.

Read also: Violent Conflicts in Sudan Despite Ceasefire Attempts

R21 Vaccine Shows 70% to 80% Efficacy

Adrian Hill, an Oxford researcher and one of the main developers of the vaccine, said the vaccine had an efficacy of about 70% to 80% in the final phase trials. A malaria vaccine from GSK Plc, which has been authorized by the WHO but is not yet widely available due to a lack of funding, is considered less effective.

“We are committed to making the R21 vaccine available to those who need it most,” said Poonawalla.

The Serum Institute of India plans to produce 20 million doses of the Oxford vaccine “at risk” over the next two months. This means they do not yet have a buyer among African governments or non-profit organizations that often purchase for the poorest countries. Adar Poonawalla, CEO of the Serum Institute, has pledged to make the R21 vaccine available to those who need it most.

Funding and Distribution Challenges

In the short term, questions arise about financing the purchase and distribution of the new malaria vaccine, which has a shelf life of two years, in the poorest African countries. The two largest buyers of children’s vaccines in the world – Gavi, the Vaccine Alliance, and UNICEF – want WHO approval for the vaccine before funding campaigns.

The WHO said on Thursday that it had received the final data dossier on R21 last week and had begun its assessment, which can take several months. Tedros Adhanom Ghebreyesus, Director-General of the WHO, told reporters in Cape Town on Thursday that the process would be “accelerated.” “We will not lose a single day,” he said.

Health officials in Ghana and Nigeria said there were additional hurdles to overcome before the vaccines become available. For example, Nigeria wants to conduct further clinical trials before a broader rollout. The Serum Institute has previously donated doses for such trials.

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This article was written based on information provided by Reuters news agency here.

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