GSK’s malaria vaccine could be in use by 2015

The world’s very first malaria vaccine could finally be available in 2015 and in widespread use after “significant” results were shown during an ongoing clinical trial. This would offer a significant boost alongside current options for malaria treatment and prevention.

British pharmaceutical giant GlaxoSmithKline (GSK) are behind the development of the new vaccine and say they will be submitting an application for a licence from the European Medicines Agency in the new year.

The vaccine, currently being referred to as RTS, S, has been developed by both GSK together with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation. Trial data has so far been promising in the quest to fight a deadly disease which kills an estimated 660,000 people every year.

RTS, S is one of 20 such vaccines in development, but looks on course to be the first to receive European Medicines Agency approval following hugely encouraging results from Africa’s largest ever clinical trial, involving almost 15,500 babies and children across seven African countries.

Testing showed that after 18 of receiving their vaccination, infants aged between five to 17 months were an incredible 46% less at risk of malaria in comparison to those unvaccinated.  However, infants aged six to 12 weeks when vaccinated were only 27% less at risk.

If the vaccine is fully proved to be safe and effective for use, the World Health Organisation has suggested they are willing to support its widespread use from 2015 onwards. GSK have said they will help to provide fund research into tropical diseases by selling the vaccine at cost price plus 5%, and scientists will next investigate whether a ‘booster dose’ can lengthen protection against malaria in the long-term.

Halidou Tinto, one of the study’s principal investigators, is greatly excited by the vaccines possibilities, saying it had “the potential to have a significant public health impact.”

Tinto commented: “Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.”

GSK chief executive Sir Andrew Witty said: “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.”

David Lalloo, professor of tropical medicine at Liverpool School of Tropical Medicine, said: “We’ve known about this vaccine for a number of years now and all the studies have shown that it affects around 50 per cent and in younger age groups who don’t have such a good immune response that is down to around 30 per cent. The other concern is that there have been several studies that show it wanes over time…there are still uncertainties about duration and effects. Having said that, given the huge number of malaria deaths and malaria cases, even a relatively small reduction has the potential to make a big difference.”