Meningococcal Vaccine Approved

The US Food and Drug Administration (FDA) approved Bexsero, a Novartis vaccine to prevent meningococcal disease caused by Neisseria meningitides serogroup B.

It is meant for children age 10 and up and young adults through age 25. The vaccine is the second the FDA has approved for that illness in the past 3 months.

The first meningococcal serogroup B vaccine was approved in October 2014. There are also vaccines for 4 of the other serogroups of the bacteria that can cause meningitis, strains A, C, Y, and W.According to the US Centers for Disease Control and Prevention (CDC) the B serogroup in 2012 caused 160 of 500 total cases of meningitis.

Studies evaluating the vaccine’s efficacy were done in 4 nations in 2,600 teenagers and young adults. Side effects were pain and swelling at the injection site, head ache, diarrhea, muscle pain, join pain, fatigue, and chills.

The FDA cleared the drug for trials in April 2014, ruling that it was a “breakthrough” therapy deserving of accelerated review. At that time there was no other FDA-approved vaccine for serogroup B meningococcal disease.

The vaccine is already approved in Europe, Canada and Australia .