Meningococcal vaccine Bexsero gets FDA approval

SILVER SPRING, Md. — The Food and Drug Administration last week announced approval for Bexsero, a vaccine intended to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 years through 25 years of age. Bexsero is the second vaccine approved by the FDA in the past three months to prevent the disease. The first was approved in October 2014. 

 

Meningococcal disease is a life-threatening illness caused by bacteria that can infect the bloodstream, as well as the lining that surrounds the brain and spinal cord. The bacteria are transmitted person to person through respiratory or throat secretions. The Centers for Disease Control and Prevention says that close to 500 cases of meningococcal disease were reported in the United States in 2012. Out of those cases, 160 were caused by serogroup B.

 

“With today’s approval of Bexsero, the U.S. now has two vaccines for the prevention of serogroup B meningococcal disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”

 

Meningococcal disease can be treated with antibiotics to reduce the risk of death and long-term complications, but even then these outcomes are not always prevented. Vaccination is the most effective way to prevent the disease, the FDA said.

 

Bexsero is manufactured by Novartis Vaccines and Diagnostics Inc.