FDA Approves More Broadly Protective Meningococcal Vaccine, Penmenvy
By Stephanie Brown HealthDay Reporter
TUESDAY, Feb. 18, 2025 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted February 2025
Read this next
FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines
THURSDAY, May 22, 2025 — The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated...
FDA Limits COVID-19 Boosters to Seniors, Other High-Risk Groups
WEDNESDAY May 21, 2025 — The U.S. Food and Drug Administration (FDA) has decided that only seniors and people at high risk should get the latest COVID-19 booster shots this...
FDA Gives Full OK to Novavax COVID Shot for High-Risk Groups
MONDAY, May 19, 2025 — The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but only for certain people. The vaccine...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.