EU regulators green light world’s first malaria vaccine

Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU

At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU).

Mosquirix, part-funded by the Bill & Melinda Gates Foundation, was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU.

In addition, ten medicines were recommended for marketing authorisation in the EU. The recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

Mosquirix, developed by British drugmaker GlaxoSmithKline in partnership with the PATH Malaria Vaccine Initiative, would be the first licensed human vaccine against a parasitic disease and could help prevent millions of cases of malaria in countries that use it.

Malaria infects around 200 million people a year and killed an estimated 584,000 in 2013, the vast majority of them in sub-Saharan Africa. More than 80 percent of malaria deaths are in children under the age of five.

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