First malaria vaccine gains regulator approval

The world’s first malaria vaccine got a green light from European drugs regulators who recommended it should be licensed for use in babies in Africa at risk of the mosquito-borne disease.

First malaria vaccine gains regulator approval

The shot, called RTS,S or Mosquirix and developed by 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.

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 & Melinda Gates Foundation, will also 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, the vast majority of them in sub-Saharan Africa. More than 80% of malaria deaths are in children under the age of five.

Andrew Witty, GSK’s chief executive, said EMA’s positive recommendation was a further important step towards 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 in a statement.

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 US biotech company 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 6-12 weeks by only 27%, and by around 46% in children aged 5-17 months.

EMA’s recommendation is that the shot should nevertheless be licensed for use in babies in the full age range covered in the trials - from 6 weeks to 17 months.

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