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
This Flu Season Is Worst In A Decade
FRIDAY, Feb. 21, 2025 -- The current flu season is shaping up to be the worst in a decade. So far, there have been at least 29 million illnesses and 370,000 hospitalizations...
As Bird Flu Outbreak Worsens, Zoetis Gets Green Light for Poultry Vaccine
TUESDAY, Feb. 18, 2025 -- The U.S. Department of Agriculture (USDA) has granted conditional approval for a new bird flu vaccine for poultry. This new avian flu vaccine, developed...
Trump Blocks Federal Funds for Schools That Require COVID Vaccines
TUESDAY, Feb. 18, 2025 -- President Donald Trump signed an executive order withholding funding from schools and universities that require students to be vaccinated against...
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.