The U.S. Food and Drug Administration (FDA) has approved GSK’s combination meningococcal vaccine, Penmenvy, for individuals aged 10 to 25 as reported by Biopharma Dive. This vaccine offers protection against the five most common strains of Neisseria meningitidis bacteria: serogroups A, B, C, W, and Y. Penmenvy combines components from GSK’s previously approved vaccines, Bexsero and Menveo, into a single shot.
The approval was based on 2 Phase III clinical trials involving approximately 4,800 participants, which demonstrated that Penmenvy is as effective as the individual vaccines in generating an immune response against these serogroups. The vaccine was well tolerated, with a safety profile consistent with Bexsero and Menveo. This approval provides a more convenient vaccination option, potentially improving coverage and reducing the risk of severe infections caused by these bacteria.
Tony Wood, Chief Scientific Officer at GSK stated that he is excited about the vaccine’s approval and believes it will be significant in GSK’s ongoing commitment to prevention improvement and save lives.
Meningococcal infections are rare but can lead to severe, sometimes deadly, bloodstream infections and swelling in the brain and spinal cord. The availability of these combination vaccines is expected to simplify the vaccination process and enhance protection against these serious diseases.
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