GSK seeks regulatory approval for world's first malaria vaccine

GlaxoSmithKline, a British drug company, recently announced it is seeking regulatory approval for RTS,S, the world's first malaria vaccine, the Montreal-based McGill University said on Monday.

Researchers began developing the RTS,S vaccine more than 20 years ago after it was created in 1987 by scientists working at the GSK laboratories. A Phase III efficacy trial of RTS,S began in May 2009 and is still underway at 11 sites in Africa.

"To date, this trial has indicated that the RTS,S vaccine candidate is safe to administer to young children and provides some protection against malaria disease," David Poland, a senior communications officer with the Malaria Vaccine Initiative, said.

The trial previously showed that the RTS,S vaccine has an acceptable tolerability and safety profile and reduced malaria cases by 56 percent in young children five months to 17 months of age. The vaccine reduced malaria cases by approximately 31 percent in infants between six months and 12 months of age.

Poland said the malaria vaccine candidate could be available as early as 2015, if all regulatory approvals occur on schedule.

"The next steps in RTS,S development come in 2014, when we expect to complete this trial and fully analyze the data," Poland said. "In 2014, the pharmaceutical partner on RTS,S development, GSK, will also be filing for a regulatory opinion with the European Medicines Agency. If the opinion is supportive, the World Health Organization has indicated that a policy recommendation for the RTS,S malaria vaccine candidate would be possible as early as 2015. (This will) pave the way for decisions by African nations regarding large-scale implementation of the vaccine through their national immunization programs."

According to the World Health Organization, malaria causes an estimated 660,000 deaths worldwide each year. There is currently no vaccine available for the mosquito-borne disease.