Ghana has become the first country to approve a new malaria vaccine that has been described as a “world-changer” by the scientists who developed it.
The vaccine, called ‘R21’, appears to be hugely effective, in stark contrast to previous ventures in the same field. Ghana’s drug regulators have assessed the final trial data on the vaccine’s safety and effectiveness, which is not yet public, and have decided to use it.
The World Health Organization is also considering approving the vaccine.
Malaria kills more than a quarter of a million people in Africa a year, most of them young children. It has been a massive, century-long, scientific undertaking to develop a vaccine that protects the body from the malaria parasite.
Trial data from preliminary studies in Burkina Faso showed the ‘R21’ vaccine is up to 80% effective when given as three initial doses, and a booster, a year later. But widespread use of the vaccine hinges on the results of a larger trial involving nearly 5,000 children. These had been expected to take place at the end of last year, but have still not been formally published.
However, they have been shared with some government bodies in Africa, and scientists. Authorities at the FDA say they have not seen the final data, but have been told it shows a similar picture to earlier studies.
The FDA is said to have approved the vaccine’s use in children aged between five months to three years old. Other African countries are also studying the data, as is the World Health Organization. Director of the Jenner Institute at the University of Oxford, where the vaccine was invented, Prof Adrian Hill, says African countries are finally declaring that they will decide for themselves: after being left behind in the rollout of Covid-19 vaccines during the pandemic.
He told the BBC that they expect the ‘R21’ to make a major impact on malaria mortality in children in the coming years, and in the longer term. He said it will contribute to the overall final goal of malaria eradication and elimination.
The Serum Institute of India is preparing to produce between 100-200 million doses of the R21 per year, with a vaccine factory being constructed in Accra. CEO of the Serum Institute, Adar Poonawalla, said: each dose of the R21 is expected to cost a few dollars., adding that “developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult”.
He said Ghana, as the first country to approve the vaccine, represents a “significant milestone in the efforts to combat malaria around the world”.