FROM THE FDA

A second serogroup B meningococcal vaccine has been approved by the Food and Drug Administration, based on an international study of over 2,500 adolescents and young adults, the agency announced on Jan. 23.

The vaccine is approved to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in people aged 10-25 years. The vaccine will be marketed as Bexsero, by Novartis Vaccines and Diagnostics, according to the FDA statement . The first serogroup B meningococcal vaccine was approved in October 2014; that vaccine is Trumenba , manufactured by Wyeth Pharmaceuticals. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

Before the two vaccines were approved, commercially available FDA-approved meningococcal vaccines covered four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease (A, C, Y, and W). In 2012, about 160 of the approximately 500 cases of meningococcal disease reported in the United States were caused by serogroup B, according to Centers for Disease Control and Prevention data cited in the FDA statement.

Approval of Bexsero was based on three studies of about 2,600 adolescents and young adults in Canada, Australia, Chile, and the United Kingdom. After two doses of the vaccine, 62%-88% of recipients “had antibodies in their blood that killed three different N. meningitidis serogroup B strains in tests carried out in a laboratory,” compared with 0-23% before they were vaccinated, according to the FDA statement. The most common adverse effects associated with the vaccine include pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills. Safety information is from an evaluation of 5,000 people who received the vaccine in the United States and other countries, and in over 15,000 people who received the vaccine during two outbreaks of meningococcal disease at universities in the United States.

Almost 30,000 doses of the vaccine were provided to students and staff members during outbreaks of meningitis B at Princeton (New Jersey) University and the University of California, Santa Barbara, according to Novartis.

Because this was an accelerated approval, Novartis will conduct studies to determine if the vaccine is effective against other strains of N. meningitidis serogroup B. Bexsero was approved in people aged 2 months and older in Europe in January 2013.

More information on serogroup B meningococcal vaccine and the outbreaks is available on the CDC website at http://www.cdc.gov/meningococcal/outbreaks/vaccine-serogroupB.html

emechcatie@frontlinemedcom.com

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