October 29, 2014
The FDA announced accelerated approval of Trumenba, a vaccine manufactured by Wyeth Pharmaceuticals, for prevention of Neisseria meningitidis serogroup B among individuals aged 10 to 25 years.
Three randomized studies conducted in the United States and Europe determined efficacy of Trumenba. The studies included approximately 2,800 adolescents. Following receipt of three doses of Trumenba, 82% of patients had antibodies in their blood that combatted four different strains of N. meningitidis serogroup B. Prior to vaccination, only 1% had these antibodies.