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Biological Chemistry

Malaria Vaccine Nears Finish Line

Global Health: GSK could ask for a regulatory review by 2014

by Lisa M. Jarvis
October 14, 2013 | APPEARED IN VOLUME 91, ISSUE 41

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Credit: Joseph Okanga/REUTERS/Newscom
A child in Kilifi, Kenya, receives an injection as part of a malaria vaccine trial.
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Credit: Joseph Okanga/REUTERS/Newscom
A child in Kilifi, Kenya, receives an injection as part of a malaria vaccine trial.

After decades of painstaking work, the first vaccine against malaria could be ready in the next few years. Last week, GlaxoSmithKline unveiled positive results from a Phase III study of its malaria vaccine candidate RTS,S, one of the final steps before asking regulators to recommend it for use in developing countries.

Malaria, a mosquito-transmitted infection caused by the Plasmodium falciparum parasite, kills approximately 660,000 people every year, many of them children in sub-Saharan Africa. In the study, which involved more than 15,000 children across seven African countries, RTS,S was shown to be 46% effective in preventing malaria in infants aged five to 17 months and 27% effective in babies aged six to 12 weeks. Although efficacy is low compared with other childhood vaccines, which typically offer at least 80% immunity, malaria is particularly challenging, says Johanna Daily, who studies malaria pathogenesis at Albert Einstein College of Medicine. Even given the limited efficacy, “this may be for some countries the piece that will help them decrease transmission,” she says.

“While we want to be careful about not getting ahead of the data, this trial continues to show that a malaria vaccine could potentially bring an important additional benefit beyond that provided by the tools already in use,” says David C. Kaslow, vice president of product development at the PATH Malaria Vaccine Initiative (MVI), GSK’s partner in RTS,S development.

The next big milestone for RTS,S will be the release next year of final data from the study, which could reveal more about long-term efficacy. In 2014, GSK will ask European regulators to weigh in on the vaccine’s efficacy, paving the way for the World Health Organization to make a policy recommendation. A rollout of RTS,S is unlikely before 2016, an MVI official says.

GSK and the Gates Foundation have together sunk $550 million into the project to date.

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Comments
Prof. Gilbert B Bukenya (October 16, 2013 7:18 PM)
This finding is a great advancement in the control and prevention of this serious problem in sub-saharan Africa. For us who have worked in Africa and see children die away in numbers because of malaria will sigh a sign of relief. Thank you very much and I urge developed countries to inject in more money towards research and in more field trials. A twenty % efficacy is very positive given the seriousnes of malaria globally.

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