The US Food and Drug Administration has approved penmenvy (meningococcal groups a, b, c, w, and y vaccine) for active immunization agingCococcal disease (IMD), ACCRON Release from Glaxosmithkline (GSK).
Penmenvy, approved for use in individuals aged 10 through 25 years, targets five major serogroups of neisseria meningitidis (A, B, C, W, and Y), the Common Cause of IMD. The vaccine is an injectable suspension for intramuscular use that components of gsk’s two well-set meningococcal vaccines, bexsero and menveo.
The vaccine’s safety, tolerability, and immune response was supported by two phase 3 trials with more than 4,800 participants aged 10 to 25 years. The safety profile was found to be consistent with gsk’s licensed meningococcal vaccines. The most common side effects were replied was pain at the injection site, Fatigue, Headache, Muscle Pain, and Nausea.
“The Consequences of IMD can be devastating for that who contract it, for their familyians and friends,” Judy Klein, President and Founder of Unity Consortium, A Nonprofit Organization Focused On Adolysten Health and immunization in the united states, said in a statement.
“We Welcome New tools to Help Protect More Adolesments from meningococcal disease. Serogroups in one vaccine and making it Easier for Adolescents to get the cover they need. “
Approval of Penmenvy was granted to gsk.
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