Pfizer Inc. announced that Trumenba (Meningococcal Group B Vaccine), the first and only FDA-approved vaccine for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age, is now available for order by healthcare providers in the United States.
Serogroup B meningococcal meningitis is characterized by high fatality rates and rapid onset, often within 24 hours. For individuals 11-24 years of age, approximately 30 per cent of meningococcal disease is serogroup B in the US, and 10 per cent of these cases result in death. As many as 60 per cent of adolescent survivors of meningococcal disease, 15-19 years of age, suffer from permanent life altering consequences such as hearing loss, neurologic damage, or loss of a limb.
“We have been working around the clock since Trumenba was approved by the US Food and Drug Administration on October 29 to supply Trumenba in the US, as the most frequent question we have been asked following approval is when the vaccine would be available here,” said Susan Silbermann, president and general manager, Pfizer Vaccines. “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.”
Trumenba (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidisserogroup B in individuals aged 10 through 25 years of age. Approval of Trumenba is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of Trumenba against diverse serogroup B strains has not been confirmed.
Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidisserogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with Trumenba is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.
As with any vaccine, Trumenba may not prevent disease in all vaccinated individuals. The frequency of meningococcal disease caused by serogroup B varies geographically, and could influence the ability to evaluate effectiveness of the vaccine in any given country. Based on the low incidence of meningococcal disease, placebo-controlled clinical trials for Trumenba were considered unfeasible due to the size of the study that would be required and were not performed. Licensure of Trumenba was based on demonstration of immune responses measured using a serum bactericidal assay with human complement (hSBA).
Trumenba was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programmes.