Novartis nabs FDA nod for group B meningitis vaccine Bexsero
- Bexsero, which was used on an emergency basis in 2013 in response to a meningitis outbreak at two U.S. universities, is now FDA-approved for regular use.
- Students at both Princeton University and the University of California at Santa Barbara were given the then-experimental vaccine during the 2013 outbreak.
- Bexsero is the second FDA-approved vaccine against group B strains of meningitis. The first, Trumenba from Pfizer/Wyeth, was approved in October 2014.
Having two vaccines for prevention of group B strains of meningitis B is a real breakthrough considering the major scare of a potential meningitis B epidemic among young people at universities.
Previous meningitis vaccines only covered the A, C, Y, and W serogroups of Neisseria meningitidis. The clinical database upon which the approval is based includes an efficacy analysis comprised of more than 2,600 teenagers and young adults, and a safety cohort with more than 20,000 people.
In the efficacy study, response rates based on antibody titers ranged from 62% to 88%. Bexsero was given an accelerated approval based on the data.
- Medpage Today FDA OKs Novartis' Bexsero Group B Meningitis Vaccine