The U.S. Food and Drug Administration today approved Bexsero, the vaccine to prevent meningococcal disease in people ages 10 to 25 that was used at Princeton University after an outbreak at the school.
Bexsero is the second vaccine approved by the FDA in the past three months to prevent the disease. The agency approved the Pfizer vaccine Trumenba in October. Before these approvals, existing approved meningococcal vaccines in the U.S. covered only four of the five main serogroups of bacteria that cause meningococcal disease.
Meningococcal disease is a life-threatening illness caused by bacteria that can infect the bloodstream and the lining that surrounds the brain and spinal cord. The bacteria are transmitted from person to person through respiratory or throat secretions. According to the Centers for Disease Control and Prevention, about 500 total cases of meningococcal disease were reported in the U.S. in 2012. About 160 cases 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, 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 or serious long-term problems, but even with immediate medical attention, death or medical complications are not always preventable. Vaccination is the most effective way to prevent meningococcal disease.
The meningitis outbreak at Princeton that began in March of 2013 led to a mass vaccination of students at the school. There was also a meningitis B outbreak at the University of California, Santa Barbara the same year. Novartis provided students and staff at both campuses with doses of Bexsero under the “investigational new drug” designation from the FDA. More than nearly 30,000 doses were distributed to both campuses.
Seven Princeton University students and a campus visitor contracted meningitis B between March of 2013 and December of 2013.
Drexel University student Stephanie Ross came in contact with a Princeton University football player at a mixer in Philadelphia and died in March of 2014 after being infected with the same strain of meningitis from the Princeton University outbreak.
The FDA used the accelerated approval regulatory pathway to approve Bexsero. Accelerated approval allows the agency to approve products for serious or life-threatening diseases based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public.
The National Meningitis Association applauded today’s announcement about the approval of the vaccine.
“I have heard over and over from parents that they thought their children were fully protected because they were vaccinated with the currently recommended vaccine, which protects against four major strains of meningococcal disease, but does not protect against serogroup B,” said National Meningitis Association President Lynn Bozof. “Now that we have the tools to fully protect our children, we encourage policymakers to do the right thing and recommend these vaccines for adolescents who are at high risk for infection.”
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to make its first recommendation for use of serogroup B vaccines in February. Since 2005, the CDC has recommended routine vaccination with a conjugate vaccine that protects against serogroups A, C, W and Y at age 11 to 12 with a booster at age 16.
“As a percentage of all of the students that populate our country’s college campuses, we realize that these deaths represent a small number,” said Stephen Ross, father of Drexel University student Stephanie Ross. “But when it is your child, any number above zero is unacceptable – especially if it could have been prevented.”