GSK sets malaria vaccine roll-out date to 2015
pharmafile | October 8, 2013 | News story | Research and Development, Sales and Marketing | GSK, Vaccine, malaria, rts, s
GlaxoSmithKline says it is just two years away from marketing the world’s first malaria vaccine RTS,S.
This follows results from a large-scale Phase III trial presented in Durban this week which showed RTS,S – the most clinically advanced malaria vaccine candidate – continued to protect young children and infants from clinical malaria up to 18 months after vaccination.
This builds on 2011 data showing that the vaccine could cut the disease risk by half. These latest results demonstrate that after over 18 months of follow-up, RTS,S was also shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination).
Vaccine efficacy was also assessed separately at each of the trial sites, which represent a wide range of malaria transmission settings. Efficacy was found to be statistically significant at all sites in young children and at four sites in infants.
Malaria is a significant public health burden and results in around 660,000 deaths a year and mostly affects children in sub-Saharan Africa, meaning health bodies like the WHO are keen to see these types of treatment available as soon as possible.
GSK says it is planning to submit a regulatory application for its drug to the EMA in 2014, and expects approval the following year. The vaccine which was invented by GSK Biologicals in the 1980s, is being developed in partnership with the PATH Malaria Vaccine Initiative (MVI), which gets the majority of its funding from the Bill & Melinda Gates Foundation.
Current treatments include the antimalarial drug quinine which has been used for decades, but does not vaccinate against the disease, and can have adverse side effects.
GSK has already said that the eventual price of RTS,S will cover the cost of manufacture, plus a 5% return to be reinvested in R&D for second-generation malaria vaccines or vaccines for other tropical diseases.
Sir Andrew Witty, chief executive of GSK, said: “We’re very encouraged by these latest results, which show that RTS,S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa. While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive.
“These data support our decision to submit a regulatory application for the vaccine candidate which, if successful, would bring us a step closer to having an additional tool to fight this deadly disease. We are grateful to the scientists across Africa and GSK and to our partners who have worked tirelessly for almost 30 years to bring us to this point.”
Research into other anti-malaria drugs seems to also be bearing fruit. In 2011 a Phase II trial of the candidate vaccine FMP2.1/AS02A in Mali, found children receiving it were well protected against parasites that had a similar genetic make-up to the malaria strain used in the drug.
The vaccine would kill the malaria parasite as it emerges from the liver into the bloodstream.
Ben Adams
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