Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine — Advisory Committee on Immunization Practices, 2016

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

“…Selection of a 2‐ vs 3‐dose MenB‐FHbp schedule depends to some extent on patient exposure to risk and disease susceptibility, whereby it may be necessary to weigh the convenience of a 2‐dose schedule vs the slightly higher levels of protective antibodies observed in the clinical study following three MenB‐FHbp doses (72.9% of subjects achieved a composite response to all four vaccine‐heterologous MenB test strains after two doses on a 0‐, 6‐month schedule vs 80.3%‐81.8% after three doses on a 0‐, 1‐, 6‐ or 0‐, 2‐, 6‐month schedule), with overlapping CIs between schedules . Two doses given in rapid succession will induce greater responses than a single dose and are therefore more appropriate for outbreak situations . However, a longer interval between doses (the 0‐, 6‐month 2‐dose schedule or the 3‐dose schedules) will ultimately result in a more robust response …”

“…An extension study of the dosing schedule study mentioned in the previous section evaluated persistence of the immune response to MenB‐FHbp through 48 months after primary vaccination, as well as the safety and immunogenicity of a booster dose given approximately 48 months after the primary series . At 1 month after primary vaccination, the majority of subjects who received MenB‐FHbp under a 0‐, 6‐month or 0‐, 2‐, 6‐month primary schedule had protective immune responses against the primary MenB test strains.…”

“…In early 2015, ACIP issued a Category A recommendation for MenB vaccination of individuals ≥10 years of age at increased risk for IMD (Table ). Although both MenB vaccines are approved for use in individuals 10‐25 years of age, ACIP supported the routine use of MenB vaccines in persons aged ≥10 years who are at increased risk for meningococcal disease on the premise that there are no theoretical differences in safety for those aged >25 years .…”

“…In October 2016, ACIP provided updated recommendations for MenB‐FHbp in response to FDA approval earlier that year of both a 2‐dose (0 and 6 months) and a modified 3‐dose (0, 1‐2 and 6 months) MenB‐FHbp series . Previously, only a 3‐dose series of MenB‐FHbp at 0, 2 and 6 months was recommended .…”

“…Previously, only a 3‐dose series of MenB‐FHbp at 0, 2 and 6 months was recommended . The 2‐dose MenB‐FHbp schedule is now recommended when vaccinating healthy individuals, whereas the tailored 3‐dose schedule is recommended for high‐risk individuals or outbreak control . Recommendations regarding the use of 4CMenB (two doses given at least 1 month apart) remained unchanged …”