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RTS,S Malaria Vaccine Shows Low Protective Effect Among African Infants In Large Phase III Clinical Trial

Published online in the New England Journal of Medicine on Friday, a study on a large Phase III clinical trial conducted in Africa on the malaria vaccine candidate RTS,S/AS01 “reported disappointing results” among “infants who received their first shot between six and 12 weeks of age,” Nature reports. “The low protective effect of the vaccine was around half that reported last year in older children in the same study, and that of an earlier, smaller trial of babies of the same age group,” the journal notes (Butler, 11/9). The “GlaxoSmithKline experimental malaria vaccine touted as a new weapon in the fight to eradicate the disease proved only 30 percent effective when given to babies as part Africa’s largest ever clinical trial,” Reuters writes, adding, “The surprisingly poor result for the world’s first potential vaccine against malaria leaves uncertain whether it can have a useful role in fighting the mosquito-borne disease that kills hundreds of thousands of children a year” (Kelland/Hirschler, 11/9).

“Eleven African research centers in seven African countries are conducting this trial, together with GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI,” a PATH press release notes (11/9). “‘The efficacy came back lower than we had hoped,’ Bill Gates, co-founder of the Bill & Melinda Gates Foundation, which contributed to the trial costs, said in a statement,” adding, “The trial is continuing and we look forward to getting more data to help determine whether and how to deploy this vaccine,” Bloomberg Businessweek reports (Kitamura, 11/9). “Scientists have been working for decades to develop a malaria vaccine, a complicated endeavor since the disease is caused by five different species of parasites,” the Associated Press writes, noting, “There has never been an effective vaccine against a parasite” (Cheng, 11/9). In an accompanying NEJM opinion piece, Johanna Daily of the Albert Einstein College of Medicine writes, “The results of this immunization trial suggest that a malaria vaccine is possible, but a more detailed understanding of effective host responses will be necessary to achieve this goal and avert the illnesses and deaths associated with this devastating infection for millions of children” (11/9).