FDA Approves First Meningococcal B Vaccine

(HealthDay News) — The U.S. Food and Drug Administration has approved a first of its kind vaccine to protect against invasive meningococcal disease caused by serogroup B Neisseria meningitidis in individuals 10 through 25 years of age.

Of some 500 U.S. cases of meningitis recorded in 2012, 160 were caused by serogroup B, the FDA said in a news release. Trumenba protects against four strains in serogroup B and is sanctioned for people aged 10 through 25.

Trumenba was evaluated in clinical studies among more than 6,000 participants in the United States, Europe, and Australia. The most common side effects were injection-site pain and swelling, headache, diarrhea, muscle and joint pain, fatigue, and chills. The new meningitis vaccine, granted accelerated approval, will be further evaluated by the manufacturer against additional serotype B strains, the FDA said.

“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”

Trumenba is manufactured by Wyeth Pharmaceuticals, a Philadelphia-based subsidiary of Pfizer.

For more information visit FDA.gov.