The Food and Drug Administration has approved GSK’s 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 U.S. federal customers, with broader availability anticipated in mid-2023.
Invasive meningococcal disease, 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. Among those who contract meningitis, one in 10 will die, despite treatment, sometimes in as little as 24 hours. One in five (up to 20%) of meningitis survivors suffer long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems.
“Outbreaks of this dangerous disease continue to occur, impacting families, health systems and society,” said Roger Connor, president of vaccines and global health at GSK. “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.