Loading...
On October 29, 2014, the FDA granted approval for Trumenba, a vaccine to protect against serogroup B meningococcal disease in individuals aged 10 to 25 years and designed to be administered as a three-dose series over 6 months. Vaccines have previously been available for serogroups A, C, Y, and W, but not serotype B, which was implicated in recent meningitis outbreaks on several college campuses.
Due to the severity of invasive meningococcal disease, the FDA granted Trumenba breakthrough therapy status, which expedites development and review of products that address serious or life-threatening conditions. Efficacy was assessed in three randomized, controlled trials. Following vaccination, 82% of participants who completed the three-dose seri…