European regulators approved the first-ever malaria vaccine on Thursday even though it doesn’t work very well. And it’s not clear how or even whether it will be deployed in the areas that need it most.
The approval is a sign of how desperate the world is for a vaccine to prevent malaria, which kills nearly 600,000 people a year, most of them young children.
GlaxoSmithKline worked with the PATH Malaria Vaccine Initiative to develop the vaccine, which was called RTS,S when it was experimental and which now has the brand name Mosquirix. The European Medicines Agency has OK'd it for use in children 6 weeks to 17 months old.
“While other vaccines tackle viruses or bacteria, RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa,” Glaxo said in a statement.
“Any financing for this vaccine must not draw resources away from scaling up bed nets, effective drugs and rapid diagnostic tests for malaria."
“In 2013, there were an estimated 584,000 deaths from malaria with around 90 percent of these occurring in sub-Saharan Africa, and 83 percent in children under the age of five in sub-Saharan Africa.”
The vaccine only reduces malaria cases by a third, but experts agree that’s far better than nothing. “In areas of the highest malaria burden more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated,” Glaxo said.
The big question is whether it’s worth the money and effort it would take to distribute it.
“Any financing for this vaccine must not draw resources away from scaling up bed nets, effective drugs and rapid diagnostic tests for malaria. Careful coordination between financing agencies will be needed,” said World Health Organization spokesman Gregory Hartl.
“The EMA assessment is not a recommendation to use this vaccine. WHO will provide our recommendations on use by November 2015,” Hartl added.
“WHO’s policy recommendations take into account several additional factors not addressed by regulators. These include feasibility of implementation, affordability and cost-effectiveness, and the public health value of the vaccine in relation to other available malaria control measures and vaccines.”
“Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children."
Malaria is carried by mosquitoes, and the parasite can persist in the human body for years. It’s harder to make a vaccine against a parasite than a virus or bacteria, because the parasite has a complicated life cycle that takes it from the blood to the liver and back again.
“Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite,” Dr. David Kaslow, MD, vice president of product development for PATH.
“Today’s opinion underscores that it is technically possible to develop malaria vaccines and validates the continued investment in next-generation vaccines.”