Trumenba Vaccine Approved to Prevent Meningitis B
October 29, 2014 – The U.S. FDA granted accelerated approval for Pfizer’s Trumenba® (meningococcal group B vaccine), the first vaccine licensed in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 to 25 years of age. Trumenba is administered by intramuscular injection as three doses. The second dose is given two months after the first, and the third dose is given four months after the second. Meningitis vaccines previously available in the U.S. protect against four types of meningitis (A, C, W and Y), but not meningitis B, which is relatively rare in the U.S.
The FDA accelerated the approval process for Trumenba and for a second meningitis B vaccine, Bexsero® (meningococcal group B vaccine [rDNA, component, adsorbed] – Novartis), which currently is undergoing FDA review, also as a breakthrough therapy. In patients with meningitis, bacteria invade the meninges (the membranes surrounding the brain and spinal cord); they also infect the blood, possibly causing sepsis, which can spread infection throughout the body. Meningitis B is hard to diagnose and can progress very quickly. Symptoms are similar to those of various other diseases, but many patients experience stiffness and pain in the neck, a characteristic of meningitis infection. Bacterial meningitis is treated with antibiotics. Untreated meningitis B can have severe results, including seizures, blindness, loss of hearing, brain damage, gangrene that requires amputations, and death. Pfizer has yet to announce a launch date or pricing for Trumenba.
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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information purposes only. The reference to any medication above does not imply that the medication is covered by your plan.