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GSK hoping to file malaria vaccine next year

New phase III data backs submission plans

GSK GlaxoSmithKline house 

The first vaccine against malaria could be on the market by 2015, with its developer GlaxoSmithKline (GSK) now planning to file for approval of its RTS,S candidate in Europe as early as next year.

GSK has decided to press ahead with a regulatory submission for the vaccine on the strength of new phase III data which found that children aged 5 to 17 months immunised with RTS,S experienced 46 per cent fewer malaria episodes 18 months later than those who received a control vaccine.

Infants aged 6-12 weeks at first vaccination with RTS,S had 27 per cent fewer cases of clinical malaria than controls, according to the data which were released at a conference in Durban, South Africa, yesterday.

Reductions in severe malaria cases and malaria hospitalisations by 15 and 17 per cent, respectively, were not statistically significant, and the efficacy of the vaccine seems to decline over time.

For example, 12-month results indicated the protective efficacy was 56 per cent against clinical malaria and 47 per cent against severe malaria for the 5-17 month-old age group, and 31 and 37 per cent respectively for children aged 6-12 weeks.

While the protective efficacy of RTS,S is relatively modest, the scale of human suffering caused by malaria means that even a partially effective vaccine could have significant health benefits across a population.

While preventable with measures such as mosquito nets and treatable with antimalarial drugs, access to medicines is problematic in many areas of the world and complicated by increasing resistance which may be related in part to medicines counterfeiting.

"The World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by EMA," said GSK yesterday.

One of the principal investigators for the RTS,S trial, Halidou Tinto of the Burkina Faso trial site, said that the data support approval of the vaccine to save lives, reduce the number of sick children occupying hospital beds and the financial and time pressures on families who are carrying for them.

"In Africa we experience nearly 600,000 deaths annually from malaria, mainly children under five years of age [while] many millions of malaria cases fill the wards of our hospitals," he said.

"Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease."

RTS,S is not the only malaria candidate in development but is the furthest ahead in development and the most likely to be used first in immunisation programmes.

In the summer, researcher at the US National Institutes of Health (NIH) reported encouraging early clinical of another candidate called PfSPZ - in development at small US biotech Sanaria - which provided complete protection against malaria at the highest dose tested. It is estimated that this vaccine is still at least three to five years away from the market.

RTS,S is being developed by GSK and the PATH Malaria Vaccine Initiative (MVI), alongside African research centres, with funding support from the Bill & Melinda Gates Foundation.

Article by
Phil Taylor

8th October 2013

From: Research



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