European regulators have given their blessing to the world’s first vaccine for malaria after 28 years of development by GlaxoSmithKline and heavy investment from Bill Gates.
GSK, the UK’s biggest drugmaker, announced on Friday that it had received a “positive scientific opinion” from the European Medicines Agency for its Mosquirix vaccine.
The favourable view from the EMA could clear the way for a WHO recommendation and the vaccine’s eventual adoption in sub-Saharan Africa and other affected regions.
However, critics have questioned whether Mosquirix is effective enough to justify the cost of rolling it out and tough debate is expected among global health authorities in coming months over how widely the vaccine should be used.
In clinical trials involving 16,000 young people in eight African countries, malaria cases were reduced by almost half in children aged 5-17 months and by 27 per cent in infants aged 6-12 weeks over 18 months. However, it required three doses to achieve this result and the benefit dwindled over time.
While acknowledging its limitations, advocates for the vaccine say it has the potential to make a significant dent in the roughly 585,000 deaths recorded annually from malaria.
“There are some people who say there is room for improvement, Moncef Slaoui, head of vaccines at GSK, told the Financial Times. “But do we wait until something better comes along or do we do what we can now?”
The World Health Organisation is expected to discuss the vaccine at a meeting in October. If recommended by the global health body, it would then be up to individual governments in malaria-affected regions to decide whether to adopt it.
Ray Chambers, the UN envoy on Malaria, said the vaccine was a “historic achievement” but hinted at its imperfection by expressing hope that it would “open the door for further vaccine development”.
GSK began working on Mosquirix, also known as RTS, S, in 1987 and has since invested $365m with up to $250m more planned as it moves towards launch. A further $200m has come from the Malaria Vaccine Initiative, an offshoot of the Seattle-based Path medical charity, supported by the Bill & Melinda Gates Foundation.
David Kaslow, director of MVI, said Mosquirix proved it was possible for a vaccine to disable the Plasmodium parasite that causes malaria, establishing a foundation for further innovation.
GSK has made it clear it does not see Mosquirix as a money-spinner; the vaccine will be sold at cost plus 5 per cent, with the surplus reinvested in tropical medicine research. It has not revealed what price that would amount to.
Sir Andrew Witty, GSK chief executive, admitted the vaccine was “not the complete answer to malaria”, but said it could make “a very meaningful contribution”.
Dr Slaoui said GSK would be engaging with governments and health authorities to work out where and how the vaccine should be deployed.
Gavi, the international organisation which distributes vaccines to poor countries, said it was ready to supply Mosquirix but Seth Berkley, chief executive, warned that additional funding would be required from the global community to do so.
Great progress has already been made against malaria through increased use of bed nets, insecticide and antimalarial drugs. Incidence decreased by 47 per cent between 2000 and 2013 and by 54 per cent in Africa, where nine in 10 deaths occur.
Yet, the disease still imposes a heavy toll, with more than 400,000 under-5s killed by malaria in 2013 and direct economic costs from treatment and premature deaths estimated at an annual $12bn, according to the US Centers for Disease Control and Prevention.
A vaccine has long been seen as the Holy Grail for malaria prevention, offering the best route to eventual eradication. For all its limitations, David Schellenberg, professor at the London School of Hygiene & Tropical Medicine, said Mosquirix was a “true milestone” towards that goal.