Home FDA Approves Menveo Single-Vial Meningococcal Vaccine for Ages 10–55, Offering Ready-to-Use Convenience

FDA Approves Menveo Single-Vial Meningococcal Vaccine for Ages 10–55, Offering Ready-to-Use Convenience

Oct 27, 2022 10:08 CST Updated 10:08
GSK

Pharmaceutical R&D Manufacturer

FDA

U.S. Food and Drug Administration

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News on October 20, 2022 /BioValleyBIOON/ -- GlaxoSmithKline (GSK) recently announced that the U.S. Food and DrugManagementBureau (FDA) has been approvedMenveo, a new single-vial formulation for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, Y, and W in individuals aged 10-55 years.

 

Menveo single-vial formulation is a ready-to-use single vial that will provide healthcare providers with a more convenient option.According to the announcement, the single-vial formulation of Menveo will initially be available to U.S. federal customers, with broader availability expected by mid-2023.

 

The original two-vial Menveo, which requires reconstitution, was approved by the FDA in 2010 and is still available for use in individuals aged 2 months to 55 years.. The two-bottle Menveo has been approved in more than 60 countries, and since 2010, more than 72 million doses have been distributed worldwide, providing broadImmunityOriginal evidence and distinctive safety features. It should be noted that Menveo does not prevent Neisseria meningitidis serogroup B infection.

Invasive Meningococcal Disease (IMD), also known as meningitis, is a rare but serious condition that can lead to life-threatening complications and even death.IMD is caused by Neisseria meningitidis, and in most parts of the world, the majority of cases are caused by five serogroups (A, B, C, W, Y).In patients infected with meningitis, despite receiving treatment, one in ten patients will die within 24 hours. One in five (20%) meningitis survivors will suffer long-term consequences such as brain damage, amputation, hearing loss, and neurological problems.

 

Roger Connor, President of GSK Vaccines and Global Health, stated: "The outbreak of this dangerous disease continues, affecting families, health systems, and societies. The FDA-approved single-vial formulation of Menveo will provide greater convenience for healthcare providers and help prevent this disease in high-risk populations." (Bioon.com)

 

Source of Original Text:US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W