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NEW YORK — Pfizer Inc. has released Trumenba, a meningococcal group B vaccine, to pharmacies and other health care providers in the United States.
Pfizer said Tuesday that Trumenba marks the first and only Food and Drug Adminstration-approved vaccine for active immunization to prevent serogroup B meningococcal meningitis in people ages 10 to 25.
The company noted that this form of meningitis is characterized by high fatality rates and rapid onset, often within 24 hours. For people ages 11 to 24, about 30% of meningococcal disease is serogroup B in the United States, and 10% of those cases result in death.1 As many as 60% of adolescent survivors of meningococcal disease, ages 15 to 19, experience permanent, lif- altering consequences such as hearing loss, neurologic damage or the loss of a limb.
"We have been working around the clock since Trumenba was approved by the U.S. Food and Drug Administration on Oct. 29 to supply Trumenba in the U.S., as the most frequent question we have been asked following approval is when the vaccine would be available here," stated Susan Silbermann, president and general manager of Pfizer Vaccines. "As of Nov. 18, Trumenba is available for order by health care providers, retail pharmacies, hospitals and college health centers who may be interested in stocking and administering the vaccine."
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Pfizer said the vaccine’s approval 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.
"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," Silbermann added.
