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FDA Approves GSK’s Single Vial Meningitis Vaccine

FDA Approves GSK’s Single Vial Meningitis Vaccine

The FDA has approved GSK’s Menveo single vial vaccine for individuals 10 to 55 years old to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W.

The original form of the vaccine approved in 2010 is in two vials that require reconstitution. That form is still available for individuals from two months to 55 years old.

The Menveo single vial version will be rolled out first to federal customers with broader availability expected in mid-2023, the company said.

About Menveo

The Menveo vaccine (supplied in a two-vial presentation) 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. It offers extensive evidence of immunogenicity and a well-characterised safety profile. Menveo does not prevent Neisseria meningitidis serogroup B infections.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. 

October 24, 2022

https://www.fdanews.com/

https://www.gsk.com/

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