ACIP recommends meningitis B vaccine as category B

The Advisory Committee on Immunization Practices voted 14-1 to accept proposed recommendations for serogroup B meningococcal vaccine.

Serogroup B meningococcal vaccines series were approved by the committee as “category B” vaccination, defined as a vaccine for use on the basis of individual clinical decision-making, not for routine use among the recommended age group.

The recommendations stated that the serogroup B meningococcal vaccine series is for patients aged 16 to 23 years, although ACIP suggests patients aged 16 to 18 years as the preferred recipients of the vaccine.

ACIP’s recommendation must be approved by the CDC before it becomes official policy.

Language in the recommendation classifies serogroup B meningococcal vaccines series for short-term protection against most strains of serogroup B meningococcal disease. When questioned by the committee about why short-term protection is specified, Jessica MacNeil, MPH, an epidemiologist with National Center for Immunization and Respiratory Diseases at the CDC, clarified that the vaccine may not be effective in the long term and may not prevent all cases of serogroup B meningococcal disease.

Committee members also recommended that serogroup B meningococcal vaccine series be added to the immunization schedule table, as opposed to being added as a footnote.

“As a pediatrician who attends in clinics, there’s a difference of having something that is on the schedule be on the footnote vs. on the table,” Marietta Vázquez, MD, of the ACIP and Yale University School of Medicine, said during the hearing. “I think it is very important for practitioners trying to figure what to counsel their patients and parents on that we are all in agreement that if the vote [passes], these vaccines will appear on the table and not solely on the footnote.”

After recent outbreaks of meningococcal B infection, the vaccine series was granted breakthrough therapy designations by the FDA, which expedited the review and licensing process. Currently, Trumenba (MenB-FHbp, Pfizer) and Bexsero (GlaxoSmithKline) are approved by the FDA as vaccines for meningitis B. The advisory committee members cautioned that there is still insufficient data to fully understand the safety issues with meningococcal B vaccines, and that more research is required before considering the vaccines for category A designation. – by David Costill