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news.The US Food and Drug Administration (FDA) has granted accelerated approval for Pfizer's Trumenba (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years.
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The approval is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the US.
The company said that effectiveness of Trumenba against diverse serogroup B strains has not been confirmed yet.
Under the accelerated approval process, the company will complete its ongoing trials to confirm the effectiveness of Trumenba against diverse serogroup B strains.
The drug has also been reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.
Pfizer Vaccine Research and Development senior vice-president Dr Emilio Emini said: "The approval of Trumenba is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B.
"Pfizer is proud to have developed the first and only FDA-approved vaccine that addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease in the US.
"As a next step, we look forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations."