The FDA today approved the recombinant vaccine, Bexsero, for prevention of Neisseria meningitidis serogroup B among individuals aged 10 to 25 years.
Bexsero (Novartis) is the second vaccine to receive accelerated approval from the FDA to prevent this disease, following an earlier meningococcal serogroup B vaccine in October 2014. Prior to these approvals, existing approved meningococcal vaccines in the United States covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W.
“With today’s approval of Bexsero, the US now has two vaccines for the prevention of serogroup B meningococcal disease,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”
The FDA based its approval of Bexsero on three studies conducted in Canada, Australia, Chile and the United Kingdom in approximately 2,600 adolescents and young adults.
In tests carried out in a laboratory, researchers found that, following vaccination, 62% to 88% of study participants who received two doses of Bexsero exhibited antibodies in their blood that killed three different N. meningitidis serogroup B strains compared with 0-23% of participants prior to vaccination.
According to the FDA, these three strains are representative of strains that cause serogroup B meningococcal disease in the US.
The safety of Bexsero was evaluated in approximately 5,000 participants who received the vaccine in studies conducted in the US and abroad. The most common adverse effects observed in the study included pain and swelling at the injection site, as well as headache, diarrhea, muscle pain, joint pain, fatigue and chills.
Additionally, safety was examined among more than 15,000 individuals who had received Bexsero prior to approval in response to two university outbreaks of serogroup B meningococcal disease in the US.