The world’s first malaria vaccine has cleared its last major hurdle on its way to being approved for real-world use. The European Medicines Agency (EMA) — the regulatory group in the European Union which roughly parallels the FDA — gave a positive opinion of the vaccine, saying it is safe and effective to use in babies at risk for the parasitic disease. With this “green light,” the World Health Organization will decide later this year whether or not to recommend the shot for use.
The vaccine RTS,S, also called Mosquirix, is the product of British pharmaceutical company GlaxoSmithKline and is partly funded by the Bill and Melinda Gates Foundation. It’s not the only vaccine developed to fight malaria; an experimental malaria vaccine called PfSPZ was found to be much more effective at preventing malaria infection. Yet Mosquirix is the first to make it this far along in the approval process.
Mosquirix helps to prevent infection from the Plasmodium falciparum, one of the deadlier malaria parasites. The vaccine prompts the body to produce a higher amount of antibodies to stop the parasite from infecting the liver. It’s made specifically to combat infection in children and isn’t intended for use in adults or travelers.
However, the shot comes with its share of controversy. Early results of a clinical trial of Mosquirix showed that three doses of the vaccine could cut the risk of infection in half for children between between five and 17 months old. For younger infants between six weeks and 12 weeks, infection was reduced by only 30 percent. Over time, the effectiveness of Mosquirix waned unless children were given a booster, and children’s chances of getting severe malaria or dying did not change at all.
Some scientists are concerned that the potential costs associated with such a complex and somewhat ineffective vaccine may outweigh the benefits. Still, Africa is in desperate need for a malaria vaccine, even if it’s only partially effective. Malaria infection — spread through the blood by mosquito bites — kills upwards of 500,000 people each year. Half the world’s population lives in areas at risk of infection. “This vaccine could mean children will have only two bouts of malaria a year instead of five,” Dr. Martin De Smet, a malaria expert at Doctors Without Borders, told the Huffington Post. The WHO must decide if that is justification enough to recommend Mosquirix to the public.
