The US Food and Drug Administration has approved the second vaccine in three months for the prevention of serogroup B meningococcal disease – Novartis’ Bexsero.
The thumbs-up for Bexsero comes after the agency approved Pfizer’s Trumenba at the end of October, making it the first vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B. The FDA noted that before these approvals, meningococcal vaccines in the USA covered only four of the five main serogroups of N. meningitidis bacteria that cause the disease: A, C, Y and W.
About 500 total cases of meningococcal disease were reported in the USA in 2012, of which 160 were caused by serogroup B and Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said the vaccines “represent a major public health accomplishment toward preventing this life-threatening disease”.
The FDA used the accelerated approval pathway to approve Bexsero, which was granted breakthrough therapy status. It is already approved in Europe.
