LONDON • The world's first malaria vaccine got a green light yesterday from European drugs regulators who recommended it should be licensed for 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 (GSK) 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.
Recommendations for a drug licence made by the European Medicines Agency (EMA) are normally endorsed by the European Commission within a couple of months.
Mosquirix, also part-funded by the Bill and Melinda Gates Foundation, will now be assessed by the World Health Organisation, which has promised to give its guidance on when and where it should be used before the end of this year.
Malaria infects around 200 million people a year and killed an estimated 584,000 in 2013, most of them in sub-Saharan Africa.
More than 80 per cent of malaria deaths are in children under five.
Global health experts have long hoped scientists would be able to develop an effective malaria vaccine, and researchers at GSK have been working on RTS,S for 30 years. The shot also contains an adjuvant, or booster, made by United States biotechnology firm Agenus.
Hopes that Mosquirix would be the final answer to wiping out malaria were dampened when trial data released in 2011 and 2012 showed it reduced episodes of malaria in babies aged six to 12 weeks by only 27 per cent, and by around 46 per cent in children aged five to 17 months.
EMA's recommendation is that the shot should still be licensed for use in children from six weeks to 17 months. Some malaria specialists are concerned that the complexities and potential costs of deploying this first vaccine when it provides only partial protection make it less attractive and more risky.
But GSK scientist Joe Cohen said the vaccine could significantly reduce the toll of sickness and death caused by malaria among African children.