EMA backs GSK’s malaria vaccine for use in Africa
pharmafile | July 24, 2015 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | CHMP, Committee for Medicinal Products for Human USE, EMA, European Medicines Agency, GSK, WHO, malaria, world health organization
GSK has taken a significant step forward toward being the first company to bring a malaria vaccine to market, after receiving approval from an EMA committee.
RTS,S or Mosquirix, is developed by GSK in partnership with the PATH Malaria Vaccine Initiative, with backing by the Bill and Melinda Gates foundation.
GSK received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). If the drug is signed-off by the European Commission, it will become the first licensed human vaccine against the parasitic disease that has shown partial success in protecting young children.
Andrew Witty, chief executive of GSK says: “Today’s scientific opinion represents a further important step towards making available for young children the world’s first malaria 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. The work doesn’t stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease.”
EMA’s recommendation is for the vaccine, which GSK submitted to regulators in 2014, to be licensed for use on babies from 6 weeks to 17 months following its. The World Health Organization will give its guidance on when and where it should be used before the end of this year.
RTS,S has been designed to prevent malarial infections caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa. In 2013, an estimated 584,000 deaths were caused from malaria.
Clinical trials found that three doses of RTS,S, cases of malaria fell by almost half in children aged 5-17 months and by 27% in infants aged 6-12 weeks. Giving four doses of RTS,S reduced cases by 39% over four years, and by 27% over three years of follow-up in infants.
Dr David Kaslow, vice president of product development at PATH says: “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. PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps.”
GSK, who predicted in 2013 it was two years away from releasing the vaccine, has committed to a not-for-profit price. It says the price of RTS,S would cover the cost of manufacturing the vaccine together with a 5% return to reinvest in R&D for second-generation malaria vaccines, or vaccines against other tropical diseases.
Yasmita Kumar
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