First Malaria Vaccine Approved by EU Regulators

Disclosures

July 24, 2015

European Union (EU) regulators today approved the world's first malaria vaccine for use outside the EU among children aged 6 weeks to 17 months.

The new vaccine (Mosquirix, GlaxoSmithKline Biologicals), which includes a vaccine for hepatitis B, now awaits a review by the World Health Organization (WHO). The earliest any malaria-endemic country could license the product is 2017, according to WHO.

Mosquirix targets Plasmodium falciparum, one of five malaria-causing plasmodia parasites transmitted by mosquito bites. It limits the parasite's ability to infect, mature, and multiply in the liver. P falciparum is deemed the most serious cause of malaria disease and death. In 2013, malaria killed 627,000 people worldwide, 90% of them in sub-Saharan Africa, where the victims typically are younger than 5 years.

Funded in part by the Bill & Melinda Gates Foundation, the new vaccine, also known as RTS,S/AS01, has proven modestly effective. In a clinical trial in seven African nations, the new vaccine prevented a first or only clinical episode of malaria in 56% of children aged 5 to 17 months, and in 31% of children aged 6 to 12 weeks, according to the European Medicines Agency (EMA). The vaccine's effectiveness decreased after 1 year.

Fever, injection site reactions, and irritability were the most common adverse events associated with Mosquirix, according to an EMA news release.

The EMA's Committee for Medicinal Products for Human Use concluded that "despite its limited efficacy, the benefits of Mosquirix outweigh the risks in both age groups studied."

The European regulatory agency noted that because the new vaccine offers partial, fading protection, its use should be combined with other antimalaria measures such as insecticide-treated bed nets.

The EMA issued its decision on Mosquirix in a special regulatory procedure that involved WHO and countries in sub-Saharan Africa. The EMA said its action will help facilitate access to the vaccine outside of Europe.

WHO spokesperson Gregory Hartl told reporters today that his agency will issue recommendations by November on how to use the new vaccine. WHO will consider issues beyond safety and efficacy that include feasibility of implementation, affordability and cost-effectiveness, as well as the vaccine's public health value compared with other antimalaria measures.

"Any financing for this vaccine must not draw resources away from scaling up bed nets, effective drugs, and rapid diagnostic tests for malaria," Hartl said.

The likely cost of Mosquirix is $5 per dose, or $20 for a recommended round of four doses, Reuters reported.

More information about the EMA action is available on the agency's website.

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