World’s First Malaria Vaccine Gets Regulatory Go-Ahead, Faces WHO Review

Friday, July 24, 2015

The world’s first malaria vaccine got a green light on Friday from European drugs regulators who recommended it as safe and effective to use in babies in Africa at risk of the mosquito-borne disease.

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

It still faces hurdles before being rolled out in Africa, including winning agreement from governments and other funders that it is worth using, since it offers only partial protection.

Mosquirix, also known as RTS,S and part-funded by the Bill & Melinda Gates Foundation, will now be assessed by the World Health Organization (WHO), which said on Friday it would begin a review in October on when and where it could be used. The WHO aims to make a recommendation by November.

“We will look at the vaccine from the point of view of public health,” said WHO spokesman Gregory Hartl. “We need to think closely about how best to add – and if to add – a malaria vaccine across certain malaria endemic areas.”

Malaria is one of the biggest killers of children in the world, claiming the life of one child every minute. It infects around 200 million people a year and killed an estimated 584,000 people in 2013, the vast majority of them babies in sub-Saharan Africa.

Andrew Witty, GSK’s chief executive, said the European Medicines Agency’s (EMA) positive opinion was an important step towards making the world’s first malaria vaccine available.

Source: Reuters (link opens in a new window)

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