Malaria vaccine has potential to save millions

After more than 30 years of work, researchers have for the first time succeeded in creating a vaccine against malaria, a deadly disease that kills nearly 800,000 a year, most of them children.

The experimental vaccine, still in the testing phase, only protects about 50% of children who receive it, but even that could "potentially translate into tens of millions of cases of malaria in children averted annually," says Tsiri Agbenyega, the principal investigator for the vaccine trials at Agogo Presbyterian Hospital in Agogo, Ghana.

"This is remarkable when you consider there has never been a successful vaccine against a human parasite nor against malaria."

Malaria is one of the most devastating diseases on the planet. Half the world's population is at risk of malaria. There are about 225 million cases yearly and more than 780,000 deaths, according to the World Health Organization. In Africa, one in five children die from malaria, one every 30 seconds, WHO says.

The vaccine was tested on 15,460 children in two age groups, 6 to 12 weeks old and from 5 to 17 months of age in seven African countries.

It was given in three doses. In children 5 to 17 months, the vaccine was 50% protective against the Plasmodium falciparum malaria parasite, which is carried by mosquitoes. Results in children 6 to 12 weeks old will be released in 2012.

Researchers hope to improve the effectiveness of the vaccine over time, but even at 50% effectiveness it means that for every 1,500 children vaccinated, 750 won't get malaria, says Andrew Witty, the CEO of GlaxoSmithKline, one of the vaccine's developers. "This is a very meaningful start."

Not all vaccines are 100% effective, even in the United States, says William Schaffner, chair of the Department of Preventive Medicine at Vanderbilt University School of Medicine in Nashville.

For example, the meningitis vaccine given to teens "doesn't have the staying power we anticipated it would, so we have to give a booster." But they still prevent disease and will be "great stimulus for further work."

The vaccine may be available in Africa "perhaps as early as 2015," Witty says.

The project is a collaboration between GlaxoSmithKline, the PATH Malaria Vaccine Initiative and the Bill & Melinda Gates Foundation.

It is being funded in part by more than $200 million in grants from the Bill & Melinda Gates Foundation and $300 million from GlaxoSmithKline.

An exact cost for the series of three vaccination is not known, but GlaxoSmithKline will supply the vaccine at the lowest possible cost, Witty says: the cost of producing it plus 5%, which will go to researching other neglected diseases. "We have no intention of making a profit," he says.

The vaccine is being produced in Europe and will go through licensing there for production and use in Africa, says Mary Hamel of the Centers for Disease Control and Prevention. It will then need to undergo market authorization for each African country.

GlaxoSmithKline says its expects the initial production capacity to be about 30 million doses, enough for 10 million children a year. It hopes to scale up manufacturing capability in both Europe and later in Africa and perhaps India, to lower costs.

The vaccine will not be available in the United States because being developed in Europe there is no way for it to undergo the Food and Drug Administration's licensing process.

The vaccine is meant to be used alongside long-proven malaria protections such as insecticide-impregnated bed nets and indoor spraying, both of which have begun to lower malaria rates in Africa in the past decade.

When both are in place "we could expect hundreds of thousands of lives to be saved," CDC's Hamel says.

The way the vaccine was developed is exciting, says Seth Berkley, CEO of the Global Alliance for Vaccines and Immunisation. In the past, such work would be done either by a government or a large company.

In an indication of the weight of expectation around this vaccine, still known only as RTS,S , the results were announced at a malaria forum in Seattle called by Bill and Melinda Gates, with World Health Organisation director general, Margaret Chan, and the UK development secretary, Andrew Mitchell, present. They were published at the same time online by the New England Journal of Medicine.