FDA approves first vaccine for preventing serogroup B meningococcal disease
Meningococcal group B vaccine (Trumenba, Pfizer) has been granted accelerated approval by FDA as the first vaccine licensed in the United States for active immunization to prevent invasive meningococcal B disease from Neisseria meningitidis serogroup B.
Meningococcal group B vaccine (Trumenba, Pfizer) has been granted accelerated approval by FDA as the first vaccine licensed in the United States for active immunization to prevent invasive meningococcal B disease from Neisseria meningitidis serogroup B.
Because the vaccine had been granted status as a breakthrough therapy and utilizing the accelerated approval regulatory pathway, FDA could evaluate its effectiveness and safety quickly, approving it in less than 6 months. FDA approval has been based on the demonstration of immune response with this vaccine, which was measured by the serum bactericidal activity against 4 serogroup B strains known to be representative of US-prevalent strains.
Studies undertaken on the vaccine include 3 randomized studies reflecting a total of about 2800 adolescents in the United States and Europe. After vaccination with 3 doses, it was found that 82% of subjects had antibodies that effectively killed 4 strains of N. meningitidis serogroup B, versus just less than 1% prior to vaccination.
The patient group affected by N meningitidis includes persons from ages 10 through 25 years. Outbreaks and cases of meningococcal group B disease have occurred at various university settings in the US in 2013 and 2014.
As the director of FDA’s Center for Biologics Evaluation and Research, Karen Midthun, MD, commented, “Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease.” The approval of the vaccine, she added, “provides a safe and effective way to help prevent the disease in the United States.”
N meningitides is a leading cause of bacterial meningitis, which is transmitted through respiratory or throat secretions including kissing, coughing, or sharing eating utensils. The bacteria infect the bloodstream as well as the lining surrounding the brain and spinal cord. The resultant invasive meningococcal disease is life threatening.
Vaccination has been shown to prevent meningococcal disease most effectively, although the illness can be treated with antibiotics, thus reducing the risk of serious, long-term consequences and death.
The manufacturer is required by FDA to conduct more studies to confirm the effectiveness of its meningococcal group B vaccine against diverse strains of N meningitidis serogroup B.
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