EMA Green Lights Malaria Vax

The European Medicines Agency endorses the first-ever malaria vaccine for use in children 6 weeks to 17 months old.

By | July 27, 2015

Malaria sporozoitesFLICKR, NIAIDThe RTS,S vaccine has made headlines since it hit Phase 3 testing in 2009, including both promising results and setbacks. In October 2013, developer GlaxoSmithKline (GSK) announced the most comprehensive analysis yet, which found that the vaccine cut the number of malaria cases by 39 percent in children 5 months to 17 months old, and by about 27 percent in 6- to 12-week-old infants—a resounding good-but-not-great result.

Still, the company said it would submit the vaccine for European regulatory approval, and last week (July 24), the European Medicines Agency (EMA) endorsed the RTS,S vaccine to immunize children in Africa who are 6 weeks to 17 months old.

“We are very much thrilled with the outcome,” Moncef Slaoui, the chair of GSK vaccines, told Science. “Child health in Africa will be transformed.”

However, the vaccine must still be approved by the regulatory agencies in individual countries, many of which have limited resources to devote to health-care costs. “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,” The Globe and Mail reported.

The EMA’s thumbs up for the vaccine’s use in children 6 weeks to 17 months old will be taken into consideration by the World Health Organization (WHO), which is expected to make a global recommendation on the vaccine’s use by the end of the year. While neither the EMA’s nor the WHO’s recommendations are binding, countries in need of funding tend to follow them closely, as donors such as the Vaccine Alliance often won’t pay for vaccine production and delivery without these recommendations.

“With every vaccine of course you hope for 100% protection,” Slaoui told Science. But the current form of the RTS,S vaccine offers “substantial” protection, he said. “If your child has three cases of severe malaria a year instead of six, it will change their lives.”

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