The US Food and Drug Administration (FDA) 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 US.
Pfizer Vaccines president and general manager Susan Silbermann 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."
Meningococcal disease may result in life-altering, significant long-term and permanent medical disabilities.
About 10%-15% of patients with this disease die, while 11-19% of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.
The company said that the effectiveness of Trumenba against diverse serogroup B strains has not been confirmed.