The Food and Drug Administration has approved a new vaccine to fight meningitis. Trumenba is a vaccine that protects against Neisseria meningitidis serogroup B in individuals 10 to 25 years of age.
“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research in a press release. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”
Trumenba was reviewed and approved under an FDA fast track program that is designed to help potentially life-saving vaccines and medicines come to market faster in order to help more individuals. Although the vaccine did not go through quite as many trials as non-fast tracked medicines would, there was still a rigorous testing process, and this efficacy testing will continue within Pfizer, the manufacturer of this vaccine.
According to the FDA, three randomized studies on the vaccine took place in the United States and Europe involving about 2,800 adolescents. Among those who received three doses of Trumenba, 82% had antibodies in their blood that killed four different variations of the N. meningitidis B strain, compared to less than 1% before vaccination.
“Meningococcal meningitis B is a devastating disease, which, though rare, significantly impacts affected individuals and families,” said Frankie Milley in a press release. Ms. Milley is the Founder and National Executive Director of Meningitis Angels and was mother to a child who died from meningitis. “Vaccines have been available and recommended since 2005 to help protect against four other serogroups of meningococcal disease, and we hope that TRUMENBA will become a recommended vaccine in routine adolescent immunization programs to help prevent meningococcal B disease.”
Trumenba will be administered in a 3-dose series at months 0, 2 and 6 in the 10 through 25 year age group. It has proven effective against four strains of N. meningitidis serogroup B, but the effectiveness of the vaccine against other, diverse serogroup B strains has yet to be confirmed.
Approximately 40% of N. meningitidis cases in the United States are caused by serogroup B. While the disease can affect any age group, it is most common among infants younger than one year, adolescents, young adults and the elderly. Meningococcal disease can result in life-altering and significant long-term disabilities and can kill in as little time as 24 hours. It has a 10 to 15 percent mortality rate and 11 to 19 percent of victims are afflicted with long term disabilities like brain damage, hearing loss, learning disabilities or limb amputations.
For more information about the vaccine, please visit this link.
Any updates regarding the availability of the Trumenba vaccine in Passport Health clinics will be posted to the blog as they become available.