Single-vial Presentation Approved to Prevent Disease Caused by Meningococcal Bacteria

GSK plc recently announced that the U.S. Food and Drug Administration (FDA) had approved a new presentation of Menveo [Meningococcal 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 will initially be available to U.S. federal customers, with broader availability anticipated in mid-2023.

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.

The Menveo vaccine for meningococcal groups A, C, Y, and W has been approved in over 60 countries, with more than 72 million doses distributed worldwide since 2010.

Roger Connor, President, Vaccines and Global Health, GSK, said in a press release on October 17, 2022, "Outbreaks of this dangerous disease continue to occur, impacting families, health systems, and society."

The U.S. CDC says the meningococcal disease is rare and has declined in the U.S. since the 1990s. However, anyone can get meningococcal disease. 

It can cause meningitis (infection of the lining of the brain and spinal cord) and blood infections.

Even when treated, meningococcal disease has a fatality rate of about 15% of infected people.

And of those who survive, disabilities such as hearing loss, brain damage, kidney damage, loss of limbs, nervous system problems, or severe scars from skin grafts are prevalent.