Second Meningitis B Vaccine Approved by FDA
The U.S. Food and Drug Administration (FDA) provided breakthrough approval to Bexsero (meningococcal group B vaccine [recombinant, adsorbed]). Bexsero received breakthrough approval because the vaccine prevents invasive meningococcal disease caused by serogroup B (meningitis B) for individuals between the ages of 10 years and 25 years. Developed by Novartis co-operation with Diagnostics, Inc., Bexsero it will be sold by GlaxoSmithKline.
Last year there were two outbreaks of bacterial meningitis B in the U.S. Meningitis is an infection of the tissues surrounding the brain and spinal cord which can be caused by many different microorganisms, including several related types of bacteria. Vaccines previously FDA-approved for bacterial meningitis protect against four types of the bacteria that cause it, but not the B strain, which is relatively uncommon in the U.S.
Bexsero is given in two doses at least one month apart to prevent meningitis B. The FDA approved Pfizer’s Trumenba (meningococcal group B vaccine) which is a similar vaccine, in October, 2014.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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