European drug regulators gave the green light on Friday (July 24) to the world’s first malaria vaccine, recommending it should be licensed for use in babies in Africa at risk of the mosquito-borne disease.
Developed by British drugmaker GlaxoSmithKline in partnership with the PATH Malaria Vaccine Initiative, the vaccine—called Mosquirix—could help prevent millions of cases of malaria. It won the scientific approval of the European Medicines Agency, which was needed before the World Health Organization would consider supporting its use.
A decision from the WHO is due in November. If it also gives the go-ahead, that would spur African nations to also approve the vaccine, which is not being considered for use in Europe.
The drugmaker spent nearly 30 years developing Mosquirix, which would be the first licensed human vaccine against a parasitic disease (rather than against a bacterium or virus). It spent more than $365 million on the drug, with help coming from grants by the Bill & Melinda Gates Foundation.
The vaccine provides only partial protection. In a Glaxo study involving 16,000 children in seven African nations, the vaccine reduced the number of vaccine cases by 39% in children between five and 17 months old, and by 27% in infants between six and 12 months old. Despite this, the EMA recommended the shot be licensed for use in babies in the age range covered in the trials.
Malaria caused about 584,000 deaths in 2013, and about 453,000 of those were children under the age of five, according to the World Health Organization.