Recent changes approved by the US Food and Drug Administration (FDA) to dosing and administration of one of two available serogroup B meningococcal (MenB) vaccines triggered an update of guidelines to clarify optimal use of each. The new guidelines, prepared by the Meningococcal Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP), were published in the US Department of Health and Human Services and the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (MMWR).1
The two different vaccines currently available have approved indications in people age 10 to 25 in the United States who are at increased risk for serogroup B meningococcal disease, the MenB-4C (Bexsero®, produced by GlaxoSmithKline Biologicals)2 and MenB-FHbp (Trumenba®, produced by Pfizer, Inc.).3
In 2016, the FDA approved both a 2-dose series of the MenB-FHbp vaccine, given at months 0 and 6, and a 3-dose version, given at months 0, 1-2, and 6. The new ACIP guidelines released in 2017 recommended the 3-dose vaccine for people 10 and older who are at increased risk for early protection and optimal short-term immunogenicity (recommendation level Category A). If the second dose is given at 6 months or longer, the third dose is not needed. Category B recommendations for adolescents (age 16 to 23) who are not at increased risk for MenB disease are for the 2-dose version of MenB-FHbp given at months 0 and 6 for short-term protection. If the second dose is given earlier than 6 months, then a third dose should be added at 4 months following the second dose.
The ACIP guidelines for the use of MenB-4C remain unchanged, as there were no changes to the MenB-4C vaccine itself, which continues to be given in a 2-dose series to people age 10 to 25.4,5
The two MenB vaccines were allowed expedited drug development and review by the FDA, and subsequently were licensed based on accelerated approval regulations in response to 2 outbreaks in 2013 of serogroup B meningococcal disease on college campuses. 4,5
In a European clinical trial, immunogenicity to all 4 strains covered by the MenB-FHbp 3-dose vaccine was 83.1% in participants who were vaccinated at 0, 1, and 6 months, which declined slightly to 81.7% in a group who were vaccinated at 0, 2, and 6 months.
Responses to the 2-dose vaccine (0, 6 months) were highest in groups receiving doses at 0 and 6 months (73.5%), compared with 58.9% of groups vaccinated at 0 and 4 months and 56.8% in groups vaccinated at 0 and 2 months. Geometric titres of all 4 strains were higher in the 3-dose groups studied than the 2-dose groups.6
The Guidelines Work Group was careful to point out that although there are no clear preferences for one vaccine over the other, they are not interchangeable. Once a first vaccine is given, the same product must be used for subsequent inoculations. A minimum of 4 weeks between any 2 vaccination doses is required in both types of inoculation.
- Patton ME, Stephens D, Moore K, MacNeil JR. Updated recommendations for use of MenB-FHbp serogroup B meningococcal vaccine – Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66:509-513. doi:10.15585/mmwr.mm6619a6
- Serruto D, Bottomley MJ, Ram S, Giuliani MM, Rappuoli R. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: immunological, functional and structural characterization of the antigens. Vaccine. 2012;30:B87-B97. doi:10.1016/j.vaccine.2012.01.033
- McNeil LK, Zagursky RJ, Lin SL, et al. Role of factor H binding protein in Neisseria meningitidis virulence and its potential as a vaccine candidate to broadly protect against meningococcal disease. Microbiol Mol Biol Rev. 2013;77:234-252. doi:10.1128/MMBR.00056-12
- Folaranmi T, Rubin L, Martin SW, Patel M, MacNeil JR; Centers for Disease Control and Prevention (CDC). Use of serogroup B meningococcal vaccines in persons aged ≥10 years at increased risk for serogroup B meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64:608-612.
- MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64:1171-1176. doi:10.15585/mmwr.mm6441a3
- Vesikari T, Østergaard L, Diez-Domingo J, et al. Meningococcal serogroup B bivalent rLP2086 vaccine elicits broad and robust serum bactericidal responses in healthy adolescents. J Pediatric Infect Dis Soc. 2016;5:152-160. doi:10.1093/jpids/piv039