STN: BL 125546 Proper Name: Meningococcal Group B Vaccine Trade Name: BEXSERO Manufacture: Novartis Vaccines and Diagnostics, Inc Indication: Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Product Information Package Insert – BEXSERO Supporting Documents May 31, 2018 Approval Letter – BEXSERO October
August 28, 2018 – Emerging clinical experience with vaccines against group B meningococcal disease “While recent data from the United Kingdom supports the potential for protein-based vaccines to provide direct protection against MenB disease in immunised children, further research is required to understand the breadth and duration of this protection. A more detailed
Neisseria meningitidis, the bacteria that causes meningitis, has 13 clinically significant serogroups. These are classified according to the structure on the surface of their capsule. Six serogroups, A, B, C, Y, W135, and X are responsible for virtually all cases of the disease in humans. The most common cause of
Meningitis is inflammation of the meninges, the lining which surrounds the brain. The disease should not be confused with encephalitis which is inflammation of the brain itself. Essentially, there are two distinct types of meningitis; aseptic (usually caused by viral infections) and bacterial. Bacterial meningitis, while it is comparatively rare, is
Menomune (MPSV4) is a polysaccharide vaccine for serogroups A, C, Y and W-135 that has been available since 1970. The vaccine is approved for use in persons 2 years of age and older. The duration of immunity mediated by Menomune is three years or less in children aged under 5
Menveo, manufactured by Novartis, received approval for use in 2010 to vaccinate against Neisseria meningitidis serogroups A, C, Y and W-135. It is approved for use in people 11 to 55 years of age. Menveo Vaccine Package Insert Approval History, Letters, Reviews, and Related Documents – Menveo March 27, 2017