Some experts question early release of RTS,S malaria vaccine trial data

Nature News reports on last week's announcement of preliminary results from a large clinical trial testing the efficacy of GlaxoSmithKline's (GSK) RTS,S malaria vaccine, writing that while media coverage of the announcement touted it as a "big breakthrough in the long campaign to create a malaria vaccine," "several leading vaccine researchers, who are critical of the unusual decision to publish partial trial data, argue that the results raise questions about whether the RTS,S/AS01 candidate vaccine can actually win approval." According to Nature, low rates of protection suggested by the results and "the frequency of serious adverse events, such as convulsions and meningitis," have added to speculation about the vaccine.

"The [PATH Malaria Vaccine Initiative's (MVI)] director, Christian Loucq, argues that the results were 'robust enough to be published. We decided this before we knew the results; we felt it was our scientific and ethical duty to make the results public when they become available,'" Nature writes. "'If it doesn't reduce deaths, and has only a modest effect on severe malaria, these are going to be big questions for decision-makers at WHO, GSK and the Gates Foundation,' says Stephen Hoffman, a veteran malaria researcher and chief executive of a rival vaccine effort, Sanaria, based in Rockville, Maryland. ... Hoffman, like many researchers contacted by Nature, says that RTS,S still marks a significant achievement," Nature notes (Butler, 10/27).