GlaxoSmithKline Plc (GSK)’s experimental malaria vaccine cut infections over 18 months in a late-stage study, moving researchers a step closer to making the first protective shot against the disease available as early as 2015.
The RTS,S candidate reduced infections by 46 percent in infants ages 5 months to 17 months, and by 27 percent for 6-to-12-week-old babies in the follow-up period after the first vaccination, the PATH Malaria Vaccine Initiative, which is developing the protection with Glaxo, said in a statement today. The trial involved more than 15,000 children in Africa.
The vaccine would help cut the fatalities from a disease that afflicts 216 million people annually and kills more than 600,000, mostly children under 5 years old in sub-Saharan Africa, according to the World Health Organization. Glaxo plans to submit the vaccine to the European Medicines Agency for approval next year, and the WHO has said it may in 2015 recommend RTS,S for use if safety and efficacy are satisfactory.
“The sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive,” Andrew Witty, chief executive officer of London-based Glaxo, said in the statement. “These data support our decision to submit a regulatory application for the vaccine candidate.”
RTS,S was more effective in the older group of children. Severe malaria cases were cut by 36 percent and hospitalizations by 42 percent among older infants, the study showed. Reductions for babies weren’t statistically significant.
While the vaccine was less effective compared with results after a one-year follow-up, it remained safe for the study participants, the trial showed.
RTS,S was given in three doses a month apart in this phase III trial. Further data from a 32-month follow-up and the impact of a fourth booster dose given 18 months after the first three shots are expected to be ready next year, according to the statement.
Glaxo has spent more than $350 million on the development of the vaccine so far and expects to invest more than $260 million through completion, the statement showed.
The nonprofit PATH Malaria Vaccine Initiative aims to accelerate development of vaccines against the disease and their availability in endemic countries, and has received more than $200 million from the Bill & Melinda Gates Foundation.
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