EMA approves use of Mosquirix for malaria prevention among sub-Saharan African children

The Committee for Medicinal Products for Human Use of the European Medicines Agency recently adopted a positive scientific opinion for the malaria candidate vaccine, Mosquirix, among children aged 6 weeks to 17 months, according to a company press release.

In light of this decision, WHO is expected to formulate a policy recommendation on use of the vaccine in national immunization programs once approved by national regulatory authorities.

Developed in partnership with the PATH malaria vaccine initiative, Mosquirix (RTS,S, GlaxoSmithKline) is the first candidate vaccine to achieve EMA approval to prevent malaria caused by the Plasmodium falciparum parasite, most widespread in sub-Saharan Africa.

“Today’s scientific opinion represents a further important step toward making available for young children the world’s first malaria vaccine,” Sir Andrew Witty, CEO of GlaxoSmithKline, said in a press release. “While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available, 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.”

The EMA based its opinion for young children on data from a phase 3 vaccine trial program conducted at 13 African research centers in eight African countries, including more than 16,000 children. Data demonstrated that during the first 18 months, after three doses of RTS,S, malaria cases were reduced by nearly half among children aged 5 to 17 months at the time of first vaccination and by 27% among infants aged 6 to 12 weeks. The company release highlighted that at study end, four doses of RTS,S reduced malaria cases by 39% over 4 years of follow-up in children, and by 27% across 3 years of follow-up in infants.

“[This] scientific and regulatory landmark is a credit to GlaxoSmithKline’s 30-year commitment to malaria vaccine development and the innovative partnership forged with PATH, working in close collaboration with African research centers, to develop a first-generation vaccine to protect young children in sub-Saharan Africa against malaria,” David C. Kaslow, MD, vice president of product development for PATH, said in a press release. “This opinion is an important step in the process that could result in RTS,S being available alongside existing tools currently recommended for malaria prevention. [This] opinion underscores that it is technically possible to develop malaria vaccines and validates the continued investment in next-generation vaccines.”