World's first malaria vaccine approved by European regulators

The vaccine is expected to be put into use by the World Health Organization by 2017.
By Stephen Feller  |  July 24, 2015 at 9:30 AM
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LONDON, July 24 (UPI) -- The world's first vaccine against malaria was approved by the European Medicines Agency, clearing the first regulatory hurdle before using it to battle the parasite that claims half a million lives per year.

The vaccine, called RTS.S, or Mosquirix, is not universally effective and its ability to protect from malaria infection begins to fade after a year, but when combined with current efforts such as treated bed nets, researchers think it will be effective at reducing malaria cases and deaths.

Malaria is spread through bites from mosquitoes carrying parasites called plasmodia.

"While RTS.S on its own is not the complete answer to malaria," said Andrew Witty, chief executive of GlaxoSmithKline, which developed the vaccine, in a press release, "its use alongside those interventions currently available such as bed nets and insecticides would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most," he said in a statement.

The vaccine against malaria was particularly difficult to develop, researchers said, because it is the first vaccine to be aimed at a parasite, rather than a bacteria or virus. The drug works in the body to prevent plasmodia from reproducing in the liver, which prevents the infection from taking hold.

Researchers conducted a clinical test of Mosquirix with more than 16,000 young children in 8 African countires, according to a press release from the EMA. Over the first 18 months, after three doses of the vaccine, malaria cases were slashed almost in half in children between the ages of 5 and 17, and cut by 27 percent in infants between 6 and 12 weeks old.

Based on the results of the test, researchers said people should continue to use insecticide-treated bed nets, anti-mosquito sprays and other tactics against getting bitten, in addition to taking the vaccine.

The vaccine will not be marketed in the European Union, however approval from the European drug regulators was necessary for the World Health Organization to begin considering it for use. The WHO is expected to issue its recommendations on the drug by November.

"The timing, duration, and outcomes of some of the critical steps to possible vaccine implementation in African countries are not yet known," said Dr. David Kaslow, vice president of product development for the Malaria Vaccine Initiative, in a press release. "Positive outcomes throughout the policy and regulatory process, as well as the availability of the necessary financing, are a prerequisite for the introduction of RTS.S through African national immunization programs."

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