Posted from: Tuesday, November 25, 2014 - 04:59 PM - Present

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. 

 

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Last Updated Monday, December 11, 2017 - 05:37 AM.