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July 25, 2015

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European approval for 1st malaria vaccine

THE world’s first malaria vaccine got a green light yesterday 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 RTS,S or Mosquirix, and 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.

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, part-funded by the Bill & Melinda Gates Foundation, will now be assessed by the World Health Organization, which has promised to give its guidance before the end of this year on when and where it could be used.

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 5.

Andrew Witty, GSK’s chief executive, said the European Medicines Agency’s positive recommendation was an important step toward making the world’s first malaria vaccine available.

“While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions ... such as bed nets and insecticides would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most,” he said.

GSK has promised it will make no profit from Mosquirix, pricing it at the cost of manufacture plus a 5 percent margin, which it will reinvest in research on neglected tropical diseases.

Sources involved in planning for Mosquirix’s potential future use said they’ve been advised to work with a price tag of around US$5 per dose, which would bring the cost of a four-dose immunization to US$20.




 

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