FDA Approves 5-in-1 Vaccine Against Meningococcal Disease

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Feb. 18, 2025 – The FDA has approved a new 5-in-1 shot to protect against meningococcal infections or invasive meningococcal disease (IMD) in people ages 10 to 25 years.

Sold as Penmenvy, it combines the active ingredients of two previously approved vaccines, offering better protection with fewer shots and simplifying the vaccination process.

IMD is a rare but life-threatening infection caused by the bacteriaNeisseria meningitidis. It can lead to meningitis (brain swelling), septicemia (blood infection), and even death within hours. Survivors may have brain damage, amputations, hearing loss, and neurological problems. Teens and young adults ages 16 to 23 are at higher risk, especially in college dorms or through kissing and sharing drinks. Despite the danger, less than 13% get the full two-dose vaccine, and only 32% get at least one dose.

Penmenvy combines parts of the well-established Bexsero and Menveo vaccines into a single shot, protecting against the five most common strains of Neisseria meningitidis (A, B, C, W, and Y). This simplifies vaccination and could encourage more people to get immunized. All three vaccines are manufactured by GSK.

The approval request was supported by positive results from two large studies, involving over 4,800 people ages 10 to 25 years. These studies showed that the vaccine is effective, safe, and well-tolerated, with a safety profile similar to GSK’s licensed meningococcal vaccines, according to the news release by GSK.