GSK plc announced that the US Food and Drug Administration has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option. The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.
Invasive meningococcal disease (IMD), known as meningitis, is an uncommon but serious illness that can cause life-threatening complications or even death. IMD is caused by Neisseria meningitidis, with the majority of cases caused by serogroups (A, B, C, W, Y) in most of the world.[1] Among those who contract meningitis, one in ten will die, despite treatment, sometimes in as little as 24 hours.[1] One in five (up to 20%) of meningitis survivors suffer long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems.[1]
Roger Connor, President, Vaccines and Global Health, GSK, said: “Outbreaks of this dangerous disease continue to occur, impacting families, health systems and society. This FDA approval of Menveo one-vial presentation offers greater convenience to healthcare providers to help prevent this disease in at-risk populations in the United States.”
The original two-vial presentation of Menveo requiring reconstitution, was approved by the FDA in 2010 and remains available for use in individuals from two months to 55 years of age.
