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FDA approves first Neisseria meningitidis vaccine
The FDA announced accelerated approval of Trumenba, a vaccine manufactured by Wyeth Pharmaceuticals, for prevention of Neisseria meningitidis serogroup B among individuals aged 10 to 25 years.
Three randomized studies conducted in the United States and Europe determined efficacy of Trumenba. The studies included approximately 2,800 adolescents. Following receipt of three doses of Trumenba, 82% of patients had antibodies in their blood that combatted four different strains of N. meningitidis serogroup B. Prior to vaccination, only 1% had these antibodies.
Safety of Trumenba was assessed among 4,500 individuals during various studies conducted in the United States, Europe and Australia. Most commonly reported side effects included pain and swelling at injection site, headache, diarrhea, muscle pain, joint pan, fatigue and chills.
Trumenba is a 3-dose series administered at months 0, 2 and 6 among individuals aged 10 through 25 years.
Stan L. Block
“Meningococcal disease can progress from initial symptoms to death within 24 hours, and it is often challenging to diagnose and distinguish from diseases that are more common and less serious, making preventative vaccination critically important,” study researcher and Infectious Diseases in Children Editorial Board member Stan L. Block, MD, FAAP, said in a press release. “In clinical trials, Trumenba demonstrated the ability to induce functional immune responses to four serogroup B strains representative of prevalent strains in the United States. As a physician, I am pleased that a meningococcal meningitis B vaccine is now available to help protect adolescents and young adults.”