Pfizer Launches Trumenba Vaccine For Meningitis B In U.S.

Pfizer announced the launch of Trumenba (meningococcal group B vaccine) for those 10 to 25 years of age infected with meningitis caused by Neisseria meningitidis serogroup B.

Trumenba comprises two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, A05 from fHBP subfamily A and B01 from subfamily B. The vaccine has demonstrated its ability to induce immune responses as measured by a serum bactericidal assay with human complement (hSBA). Trumenba was approved last month by the U.S. Food and Drug Administration (FDA) under Priority Review and Breakthrough Therapy Designation, which allowed required data for the Biologics License Application to be submitted on a ‘rolling’ basis as they were completed. As the vaccine was authorized under the FDA’s accelerated approval, Pfizer will continue to complete its ongoing efficacy studies for Trumenba against various serogroup B strains.

Susan Silbermann, president and general manager of Pfizer Vaccines, said, “As of November 18, Trumenba is available for order by healthcare providers, retail pharmacies, hospitals, and college health centers who may be interested in stocking and administering the vaccine. We continue to work very closely with the CDC’s Advisory Committee on Immunization Practices to help inform discussions and potential recommendations regarding prevention of meningococcal group B disease through vaccination, an important step to improve access to Trumenba and help in the prevention of such a devastating disease.”

Serogroup B meningococcal meningitis is known for high fatality rates and its quick onset — typically within 24 hours. Thirty percent of patients aged 11 to 24 years old with meningococcal disease are afflicted with the serogroup B type. Ten percent of these cases end in death. Up to 60 percent of adolescent survivors of the disease, aged 15 to 19 years old, will suffer from permanent damage as a result of the disease, such as hearing loss, loss of limb, or neurologic damage.