November 10, 2014

FDA Approves New Meningitis Vaccine

The federal Food and Drug Administration (FDA) recently approved the first vaccine licensed in the U.S. to prevent invasive bacterial meningitis in people ages 10 through 25 caused by the N. meningitides serogroup B bacteria. Previously, approved vaccines used in the U.S.  covered only four of the five main serogroups of N. meningitides bacteria: A, C, Y, and W.

Meningitis is a life-threating illness caused by bacteria that infect the (1) blood and (2) lining of the brain and spinal cord. It is transmitted between people via respiratory or throat secretions, such as kissing, coughing, or sharing utensils. Treatment with antibiotics may reduce the risk of death or serious, long-term effects of the illness, but only when administered immediately.

The new vaccine, Trumenba, is manufactured by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. The FDA used an accelerated process to approve the vaccine. Its safety was assessed by studies conducted in the U.S., Europe, and Australia, that included 4,500 participants who received the vaccine. The most common reported side effects included: pain and swelling at the injection site, headache, diarrhea, muscle and joint pain, fatigue, and chills.