Why did FDA change the dosing schedule for Bexsero (GSK) in August 2024, and do I need to recall my patients who received Bexsero under the old schedule?

In August 2024, FDA revised the licensed schedule for Bexsero to be the same as the schedule and dosing intervals of the other MenB vaccine product, Trumenba (Pfizer). The change was made due to evidence of a small, but significant, improvement in the immune response to Bexsero when 2 doses were given 6 months apart, instead of 1 month apart, as previously licensed. No additional doses are recommended for people who completed the 2-dose Bexsero series using a 1-month interval, as licensed and recommended at the time.

A 3-dose schedule of Bexsero (dose 2 given 1-2 months after dose 1, and dose 3 given at least 6 months after dose 1 and 4 months after dose 2) is recommended for people who require accelerated protection from meningococcal B disease (those at increased risk).

Under the current Bexsero and Trumenba schedules, any MenB vaccine recipient whose second dose is administered less than 6 months after dose 1 should receive a third dose at least 6 months after dose 1 and 4 months after dose 2.