The U.S. Food and Drug Administration today approved Bexsero, a
vaccine to prevent invasive meningococcal disease caused by Neisseria
meningitidis serogroup B in individuals 10 through 25 years of age. Bexsero
is the second vaccine approved by the FDA in the past three months to
prevent this disease.
The agency approved the first meningococcal
serogroup B vaccine in October 2014. Before these approvals, existing
approved meningococcal vaccines in the U.S. covered only four of the
five main serogroups of N. meningitidis bacteria that cause
meningococcal disease: A, C, Y and W.
Meningococcal disease is a
life-threatening illness caused by bacteria that can infect the
bloodstream (sepsis) and the lining that surrounds the brain and spinal
cord (meningitis). N. meningitidis is a leading cause of bacterial
meningitis. The bacteria are transmitted from person to person through
respiratory or throat secretions (e.g., by coughing, kissing or sharing
eating utensils). According to the Centers for Disease Control and
Prevention, about 500 total cases of meningococcal disease were reported
in the U.S. in 2012, of which 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 or
serious long-term problems, but even with immediate medical attention
these outcomes are not always prevented. Vaccination is the most
effective way to prevent meningococcal disease.
Three studies
evaluating Bexsero’s effectiveness were conducted in Canada, Australia,
Chile, and the United Kingdom in approximately 2,600 adolescents and
young adults. Among study participants who received two doses of
Bexsero, after vaccination, 62 to 88 percent had antibodies in their
blood that killed three different N. meningitidis serogroup B strains in
tests carried out in a laboratory, compared with 0 to 23 percent before
vaccination. These three strains are representative of strains that
cause serogroup B meningococcal disease in the U.S.
The safety of
Bexsero was assessed in approximately 5,000 participants who received
the vaccine in studies conducted in the U.S. and abroad. The most
commonly reported side effects by those who received Bexsero were pain
and swelling at the injection site, headache, diarrhea, muscle pain,
joint pain, fatigue, and chills. In addition, safety was monitored in
more than 15,000 individuals who received Bexsero prior to approval in
response to two university outbreaks of serogroup B meningococcal
disease in the U.S.
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. In the FDA’s
evaluation for accelerated approval, evidence of effectiveness was
demonstrated by the ability of Bexsero recipients’ antibodies to kill
the three representative N. meningitidis serogroup B test strains. As
part of the accelerated approval process, the manufacturer will conduct
further studies to verify Bexsero’s effectiveness against additional
strains of N. meningitidis serogroup B.
Bexsero was granted
breakthrough therapy status, which is intended to expedite the
development and review of medical products that address a serious or
life-threatening condition. The FDA worked closely with the company
during the vaccine’s development, and was able to evaluate Bexsero’s
safety and effectiveness and approve it two months in advance of its
priority review goal date. At the time Bexsero was granted breakthrough
therapy status, there were no other FDA-approved vaccines available to
prevent serogroup B meningococcal disease.
Bexsero is manufactured by Novartis Vaccines and Diagnostics Inc., based in Cambridge, Massachusetts.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.