FDA OKs Second Serogroup B Meningococcal Vaccine


January 23, 2015

A vaccine for serogroup B meningococcal disease that received an emergency trial run on two college campuses was approved today by the US Food and Drug Administration (FDA).

Bexsero (Novartis) is the second vaccine for invasive meningococcal disease caused by Neisseria meningitidis serogroup B to gain market clearance in the past three months. The FDA approved Trumenba (Wyeth Pharmaceuticals) in October 2014. Like Trumenba, Bexsero is indicated only for individuals aged 10 through 25 years.

The FDA determined that Bexsero is effective based on studies involving 2600 adolescents and young adults in Canada, Australia, Chile, and the United Kingdom. Laboratory tests showed that 62% to 88% of participants who received two doses of the vaccine afterward had antibodies in their blood that killed three different strains of N. meningitidis serogroup B. These three strains are representative of those causing serogroup B meningococcal disease in the United States, the FDA said in a news release.

Bexsero proved safe in studies involving 5000 participants here and abroad, according to the agency. Pain and swelling at the injection site, headache, diarrhea, fatigue, and chills were among the most commonly reported adverse events. The FDA also monitored the safety of the vaccine when it was administered on an emergency basis at Princeton University in New Jersey and the University of California, Santa Barbara, when those two campuses experienced meningitis outbreaks in 2013.

More information on today's announcement is available on the FDA website.


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