GSK's malaria vaccine hits roadblock as WHO recommends pilot projects

The World Health Organization is throwing a roadblock in GlaxoSmithKline's ($GSK) plans to roll out its malaria vaccine by calling for the vaccine to be used in pilot projects before the company can launch a widespread campaign. Such pilot projects can take up to 5 years to complete.

In the leadup to an EMA green light for the use of the vaccine in young children, sources said it would likely be approved thanks to "the weight of history" pushing for the world's first malaria vaccine. But the vaccine, dubbed RTS,S or Mosquirix, is far from perfect, with a four-dose regimen conferring only 40% efficacy, which wanes over time.

Pilot projects will test the vaccine's efficacy in a real-world setting versus a carefully controlled clinical trial setting. However, it's unclear who would be bankrolling these pilot projects, with two likely funders--GAVI and the Global Fund to Fight AIDS, Tuberculosis and Malaria--saying in a joint statement on Friday that they were still undecided on whether they would support the vaccine in conjunction with other interventions.

And Médecins Sans Frontières opted out, with Medical Director Dr. Micaela Serafini commending the WHO decision as "rational," but that the successful deployment of RTS,S would be "extremely challenging," and that the resources required would be better used elsewhere. Such resources would be "better placed on scaling up existing malaria treatment and prevention activities," she said

And a new study published in The New England Journal of Medicine didn't have good news for RTS,S either, showing that the vaccine is less effective when the parasite that causes malaria mutates.

Meanwhile, in India, researchers at the Tata Institute of Fundamental Research reported "early success" of their malaria vaccine in mice. The team identified proteins on the parasite and used that information in conjunction with genetic and nanoparticle research to produce antibodies against malaria in mice.

- read more from The New York Times
- here's Médecins Sans Frontières' statement
- and here's GAVI and the Global Fund to Fight AIDS, Tuberculosis and Malaria's statement

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