FDA Approves More Broadly Protective Meningococcal Vaccine

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The U.S. Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization against invasive meningococcal disease (IMD), according to a press 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 combines components of GSK’s two well-established meningococcal vaccines, Bexsero and Menveo.

The vaccine’s safety, tolerability, and immune response were 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 reported were pain at the injection site, fatigue, headache, muscle pain, and nausea.

“The consequences of IMD can be devastating for those who contract it, for their families and friends,” Judy Klein, president and founder of Unity Consortium, a nonprofit organization focused on adolescent health and immunization in the United States, said in a statement. “We welcome new tools to help protect more adolescents from meningococcal disease. Pentavalent MenABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”

Approval of Penmenvy was granted to GSK.

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Source: HealthDay

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