After decades of trials, GlaxoSmithKline's ($GSK) malaria vaccine, RTS,S or Mosquirix, has won a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). The green light is for use in children aged 6 weeks to 17 months outside the European Union, the agency said in a statement. The decision was based on Phase III data involving more than 16,000 children in 8 African countries.
Now, GSK is waiting for the World Health Organization to come up with a policy recommendation for the use of Mosquirix in national immunization programs once it's approved by national regulatory authorities, the company said in a statement.
"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," said Dr. David Kaslow, vice president of product development of PATH, in a statement. PATH's Malaria Vaccines Initiative (MVI) collaborated with Glaxo on the vaccine.
While it is the first malaria vaccine to be evaluated by a regulatory agency, Mosquirix only confers partial protection, and that protection wanes over time. In Phase III, the vaccine reduced malaria cases by almost half in children aged 5 to 17 months and by 27% in infants aged 6 to 12 weeks. The EMA recommends that existing protective measures continue to be used in addition to the vaccine.
"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," said Andrew Witty, GlaxoSmithKline CEO.
In November 2014, MVI scored $156 million from the Gates Foundation to work on new types of malaria vaccines. And Maryland-based Sanaria recently raised $48.5 million to work on its malaria candidate.
- read the EMA release
- and here's the GSK release
- and another from PATH