British drugmaker GlaxoSmithKline will seek marketing approval for the world's first malaria vaccine next year after trial data shows the shot significantly cut cases of the disease in African children.
BAGAMOYO, TANZANIA (GSK HANDOUT) - British drugmaker GlaxoSmithKline (GSK) will seek marketing approval for the world's first malaria vaccine next year after trial data showed the shot significantly cut cases of the disease in African children.
The vaccine known as RTS,S was found, after 18 months of follow-up, to have almost halved the number of malaria cases in young children in the trial, and to have reduced by around a quarter the number of malaria cases in infants.
"What we've seen today is 18 months follow-up data for the vaccine trials. And essentially, the date we've seen is that the vaccines reduces by about half the risk of malaria for children between five and 17 months, and by about a quarter for children six to 12 weeks. It's a huge population of children we've been following up, 15 000 across 11 sites in seven countries in Africa," Dr. Allan Pamba from GSK said in London on Tuesday (October 8).
Malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people a year, mainly babies in the poorest parts of sub-Saharan Africa, and scientists say an effective vaccine is key to attempts to eradicate it.
"This vaccine - when we developed it, we had, who we had in mind was the person who suffers most from malaria: that's the African child. So out of the 660 000 people who die every year, 90 per cent of those are going to be children below the age of five in Africa. So the vaccine was developed specifically for that population," Dr. Pamba said.
Tuesday's latest readout from the malaria trial, which is Africa's largest ever clinical trial involving almost 15,500 children in seven countries, were presented at a medical meeting in Durban, South Africa.
GSK is developing RTS,S with the non-profit PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI.
GSK has promised that if RTS,S is given the market go-ahead, it will be priced at cost of manufacture plus a 5 percent margin, and the margin would be reinvested in malaria research.
"In the countries we are talking about, so in Africa, the developing countries in Africa, vaccine coverage is under what is called 'the expanded programme on immunisation' and is free for users at point of delivery. Now we very much see this vaccine fitting within that context. And this is all made possible by a number of international partners who come together to ensure this happens. So as GSK, our commitment is to make sure that no child who needs this vaccine doesn't get it," Dr. Pamba said.
Yet hopes that RTS,S would be the final answer were dampened last year when results from a final-stage trial with 6,537 babies aged six to 12 weeks showed the shot provided only modest protection, reducing episodes of the disease by 30 percent compared to immunisation with a control vaccine.
And further data released earlier this year found RTS,S's effectiveness wanes over time, with the shot protecting only 16.8 percent of children over four years.
Pharma analyst Mark Hollins warned that vaccine uptake and government support in poor African countries might be poor.
"There is often challenges around vaccine uptake in poor regions of the world - issues around patient compliance, especially, where you have several doses of a vaccine. There is also issues around funding as well, you know, who is providing funding for that. And also, do kind of governments perceive benefit as well."
Despite these drawbacks, David Kaslow, vice president of product development at PATH, said RTS,S would serve as a useful additional tool alongside other malaria control measures such as mosquito nets, insecticides and anti-malaria drugs.
The World Health Organization (WHO) said RTS,S would be evaluated "as an addition to, not a replacement for" existing methods for malaria prevention, diagnosis and drug treatment.