Millions of children's lives could be saved by a new vaccine shown to halve the risk of malaria in the first large-scale trials across seven African countries.The long-awaited results of the largest-ever malaria vaccine study, involving 15,460 babies and small children, show that it could massively reduce the impact of the much-feared killer disease. Malaria takes nearly 800,000 lives a year - mostly children under five. It damages many more.The vaccine has been in development for two decades - the brainchild of scientists at the UK drug company GlaxoSmithKline, which has promised to sell it at no more than a fraction over cost-price, with the excess being ploughed back into further tropical disease research.
Keywords: immunization, vaccination
"This data brings us to the cusp of having the world's first malaria vaccine, which has the potential to significantly improve the outlook for children living in malaria endemic regions across Africa," said GSK's chief executive, Andrew Witty.
"The addition of a malaria vaccine to existing control interventions, such as bed nets and insecticide spraying, could potentially help prevent millions of cases of this debilitating disease. It could also reduce the burden on hospital services, freeing up much-needed beds to treat other patients who often live in remote villages, with little or no access to healthcare."
Mitchell said a vaccine "offers real hope for the future", adding: "An effective, long-lasting and cost-effective vaccine would make a major contribution to malaria control â€¦ but we must not lose sight of the fact that over 2,000 people die from malaria every day and they need help now. Britain's focus remains on driving down this terrible loss of life by preventing and treating malaria with the tools we have now and tackling resistance."
Small-scale studies, in a few hundred children, have shown promising results in the past, but a trial of this size is needed to prove the vaccine's usefulness across populations. It is being carried out in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.
The early data from five- to 17-month-old children is the first of three important results; the outcome from the vaccination of newborn babies will be published next year. These figures are crucial, because the malaria vaccine needs to be incorporated into the infant immunisation schedule, alongside the usual diphtheria and measles jabs. Earlier small-scale trials suggest the results in six- to 12-week-old babies will also show around 50% protection.
The third important outcome, on how well the protection lasts, will not be known until 2014. The data so far, over 22 months, suggests there may be a drop in the numbers protected from severe malaria.
The WHO has said that if the results are satisfactory, it will recommend its use and the vaccine may begin to be rolled out as early as 2015, but it will need to be used in conjunction with all the other existing tools of malaria prevention, such as bed nets and insecticide spraying on the inside of homes.
Questions remain over the price of the vaccine and whether donors will be willing to pay. Dr Regina Rabinovitch, from the Bill and Melinda Gates Foundation, declined to say if they would fund it, saying they would want to look at the final data on efficacy, duration and safety. "Would I prefer to see a 100% effective vaccine? Certainly," she told a press conference.
Witty says he is exhorting everybody involved in the vaccine's production to pare their costs to the bone. "We are absolutely dedicated to making it as low as possible," he said.
Bill Gates said a vaccine is the simplest, most cost-effective way to save lives. "These results demonstrate the power of working with partners to create a malaria vaccine that has the potential to protect millions of children from this devastating disease," he said.
Severe malaria affects the brain, kidneys and blood and can kill. Most children still suffered malaria, but fewer and less serious bouts. For every 1,000 children who received the vaccine there were 750 cases of malaria over a year, compared with 1,500 per 1,000 children who were given a dummy jab. Side-effects were roughly the same in both the vaccine and placebo groups and relatively high, at around 20%, but investigators say this has to do with other health problems among rural African children.