GSK to seek green light for malaria vaccine

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Experts say that they are optimistic about the possibility of the world’s first vaccine after the trial results.

British drug maker GlaxoSmithKline (GSK) said on October 8th it would seek regulatory approval the European Medicines Agency (EMA) for the world’s first malaria vaccine after trial data showed it offered children a partial shield against the disease.

Results for the Phase III stage of the closely-followed RTS,S vaccine were unveiled at a conference in Durban, South Africa, gathering experts on malaria in Africa.

It showed that 18 months after vaccination, children aged five to 17 months had a 46% reduction in the risk of clinical malaria compared to unvaccinated peers. However, in infants aged six to 12 weeks at the time of vaccination, efficacy was lower: a 27% reduction in risk.

A spokeswoman said GSK would file an application to the EMA under a process aimed at facilitating new drugs for poorer countries. Under this process, the European medications watchdog gives a “scientific opinion” on the safety and efficacy of the vaccine. This then opens the way for the vaccine to be considered by the World Health Organisation (WHO), which in turn can fast-track its licensing in individual countries in Africa.

The GSK spokeswoman said the intent was not to make the vaccine available in the EU as it is being developed specifically for children in sub-Saharan Africa who are most at risk of malaria.

UK politician Lynne Featherstone, International Development Minister, said: “Malaria is not just one of the world’s biggest killers of children, it also burdens health systems, hinders children’s development and puts a brake on economic growth. An effective malaria vaccine would have an enormous impact on the developing world.

“We welcome the scientific progress made by this research and look forward to seeing the full results in due course.”

GSK is developing RTS,S with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation. In a press release, GSK said it had invested more than $350m in RTS,S “and expects to invest more than $260m until development is completed”.

Lucas Otieno, one of the principal investigators in the trial who works for the Kenya Medical Research Institute, stressed that the trial “is ongoing”.

“We hope to have more information on the long-term protection some time in 2014. In addition, we will also be evaluating the impact of a booster dose given at 18 months after the primary vaccination series” he said. The initial series comprised three shots.

The malaria trial was Africa’s largest-ever clinical trial, carried out at 11 centres in seven African countries, covering almost 15,500 infants and children. It also included distributing insecticide-treated bednets to help fight the spread of malaria.

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