Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GlaxoSmithKline (GSK) has received positive scientific opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its malaria candidate vaccine Mosquirix, also known as RTS,S, in children aged six weeks to 17 months.
Subscribe to our email newsletter
Following the positive opinion, the World Health Organization (WHO) will now formulate a policy recommendation on use of the vaccine in national immunization programs once approved by national regulatory authorities.
The company has developed RTS,S in partnership with the PATH Malaria Vaccine Initiative (MVI) and is claimed to be the first candidate vaccine for the prevention of malaria to secure this decision.
RTS,S has been designed for the prevention of malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA).
There were an estimated 584,000 deaths from malaria in 2013, with around 90% of these occurring in SSA, and 83% in children under the age of five in SSA.
The CHMP scientific opinion is a key step in the regulatory process toward making RTS,S available alongside existing tools currently recommended for malaria prevention.
The EMA positive opinion for young children was based on the review of clinical data evaluating the candidate vaccine’s safety, efficacy and quality.
The data submitted for CHMP evaluation were mainly from a Phase III clinical trial program involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries of Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria and Tanzania.
The data showed that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27% in infants aged 6-12 weeks.
The company noted that at study end, four doses of RTS,S reduced malaria cases by 39% over four years of follow-up in children, and by 27% over three years of follow-up in infants.
GlaxoSmithKline CEO Sir Andrew Witty said: "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."
The company has committed to a not-for-profit price for RTS,S so that, if approved, the price of the vaccine would cover its manufacturing cost together with a small return of around 5% that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.