World’s first malaria vaccine approved by EMA

The world’s first malaria vaccine has gotten a thumbs up from the European Medicine Agency for use outside the European Union, paving the way for a WHO policy recommendation by November.

The vaccine, known as Mosquirix or RTS,S, has been developed over the course of 30 years by GlaxoSmithKline (GSK) with funding from the Bill and Melinda Gates Foundation. It aims to stop malaria in the first stages of infection.

“The vaccine is designed to prevent the parasite [Plasmodium falciparum] from infecting the liver where it can mature, multiply, and re-enter the bloodstream, where it infects red blood cells and can lead to disease symptoms,” wrote MVI, a partner in the trials, in a press release.

The European Medicine Agency (EMA), a decentralized agency of the EU, gave its “positive scientific opinion” after seeing the results of 11 clinical trials across seven countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania. There were 15,459 participants in the stage III trials, all children less than two years of age at enrollment.

Acceptable vaccine with moderate results

The EMA found the safety profile of the vaccine to be “acceptable”, and the results were moderate: The vaccine was effective at preventing a first or only clinical malaria episode in 56% of children (5-17 months old at the start) and in 31% of infants (6-12 weeks old at the start). After a year, the efficacy of the vaccine decreased.

“Based on the results of the trial the CHMP concluded that despite its limited efficacy, the benefits of Mosquirix outweigh the risks in both age groups studied. The CHMP considered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very high,” wrote the EMA in a press release.

Even a modestly effective drug can have enormous ramifications, because malaria kills around 584,000 people annually worldwide—82% of that number being children under five years old in Africa. When paired with other protective measures, like bed nets, many more children may be saved from the disease. Further, the vaccine also protects against hepatitis B.

However, before treatment can become available, there must be a policy recommendation by the WHO. Once that is (theoretically) achieved, there are several more steps to take, actions by individual countries regarding licensure, and implementation and locating financing options.

GSK is not looking to make a profit from this medication, announcing, “GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around five percent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.”

According to Reuters, sources say the cost would be about $5 per dose, or $20 for the full-recommended vaccination—roughly the equivalent cost of four insecticide-treated bed nets.

The results of the stage III trial were published in The Lancet.

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