GSK To Seek Marketing Approval For Malaria Vaccine From European Medicines Agency
“British drugmaker GlaxoSmithKline [GSK] will seek marketing approval for the world’s first malaria vaccine next year after trial data showed the shot significantly cut cases of the disease in African children,” Reuters reports. “The vaccine known as RTS,S was found, after 18 months of follow-up, to have almost halved the number of malaria cases in young children in the trial, and to have reduced by around a quarter the number of malaria cases in infants,” the news agency writes (Kelland, 10/7). “Although the vaccine doesn’t appear to work as well as originally hoped, both Glaxo and the charitable group helping fund the vaccine trial, the PATH Malaria Vaccine Initiative, said it could still be a useful tool against a disease that kills about 660,000 people a year — mostly children in Africa,” according to the Wall Street Journal (Whalen, 10/7). “Sir Andrew Witty, chief executive of GSK, said the company was very encouraged by the latest results and would now apply for a regulatory license for its use in Africa under a special provision of the European Medicines Agency,” The Guardian notes. “While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive,” Witty said, according to the newspaper (Boseley, 10/7).
“Results for the Phase III stage of the closely-followed RTS,S vaccine were unveiled at a conference in Durban, South Africa, gathering experts on malaria in Africa,” Agence France-Presse writes, adding, “The research was carried out at 11 centers in seven African countries, covering more than 15,000 infants and children” and “78 percent of children and 86 percent of infants in the trial” used bed nets. “GSK said that, if it gets the green light for RTS,S, the vaccine would probably be distributed through agencies such as UNICEF and the GAVI Alliance, a public-private health partnership,” AFP notes (10/8). In a joint statement, the company and the PATH initiative “said that the hope now is that the [WHO] may recommend the use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its license application,” BBC News states (10/8).