Federal health officials have approved an updated dosing schedule for meningococcal B vaccine Bexsero, that would put it in line with Trumenba.

The Centers for Disease Control and Prevention (CDC) director also approved updated 2025 immunization schedules following recommendations from the Advisory Committee on Immunization Practices (ACIP). Thursday’s all-day meeting also included discussion of possible changes to HPV vaccine recommendations.

Meningococcal vaccines

Meningococcal disease is rare but can be serious. About 10%-15% of meningococcal disease cases are fatal, and about 20% of survivors have long-term effects like cognitive deficits, hearing loss and limb amputations, according to the CDC.

In August, the Food and Drug Administration (FDA) changed the label for GSK’s Bexsero vaccine (MenB-4C) based on new immunogenicity data. The updated label calls for a longer period between doses for healthy adolescents and young adults and a three-dose series instead of two for certain high-risk populations.

ACIP members recommend using this new dosing regimen, saying it would simplify recommendations if Bexsero and Pfizer’s Trumenba (MenB-FHbp) have the same schedule. However, the two vaccines are not interchangeable. The same product should be used for all doses in the scenarios below.

Under the new recommendations, healthy people ages 16-23 years who choose to receive Bexsero based on shared clinical decision-making, will receive two doses six months apart. However, if the second dose is given earlier than six months, a third should be given at least four months after the second dose.

For people ages 10 years and older at high risk of severe disease, intervals for the three doses are zero, one to two months, and six months. This group includes people with anatomic or functional asplenia, complement component deficiencies or complement inhibitor use; microbiologists routinely exposed to Neisseria meningitidis isolates; and people at increased risk during an outbreak.

The CDC said healthy and high-risk patients would not need to be re-vaccinated if they received doses on the old schedule. They should continue booster vaccination as previously recommended.

For patients looking for more rapid protection, such as those about to leave for college, clinicians can choose to use a three-dose series of Bexsero or Trumenba (interval of zero, one to two months, and six months).

ACIP members also discussed GSK’s pentavalent MenABCWY vaccine, which has been proposed for people ages 10-25 years and could receive licensure from the FDA in the next several months. Members of an ACIP work group called for using it in the same way as Pfizer’s pentavalent vaccine — as an option for people recommended to receive both MenACWY and MenB vaccines at the same visit. However, they were split on whether it should be an option for people recommended to receive MenB only.

ACIP will continue to discuss this vaccine when it meets in February 2025. Next year, it also plans a larger revamp of the schedule for meningococcal vaccines.

Immunization schedules

The 2025 immunization schedules for children and adolescents incorporate policy changes made since October 2023 along with tweaks to tables and footnotes to improve clarity.

These include the Bexsero changes detailed above and additional COVID vaccine doses approved Wednesday for people who are immunocompromised. In addition, the updated schedules reflect the switch from quadrivalent to trivalent influenza vaccines this season. Vaxelis also is included as one of two preferred vaccines to protect American Indian/Alaska Native infants from Haemophilus influenzae type b (Hib).

The AAP is one of several groups that has been reviewing the schedules and providing feedback. It will publish a policy detailing the changes for pediatricians.

HPV vaccines

ACIP is considering reducing the number of HPV vaccine doses it recommends.

Gardasil 9 from Merck protects against HPV-related cancer and anogenital warts. HPV is estimated to have caused about 37,800 cancer cases in the U.S. annually from 2017-’21, most commonly cervical cancer for females and oropharyngeal cancer for males, according to CDC data. However, HPV vaccination rates have lagged rates of other recommended adolescent vaccines.

The CDC recommends routine vaccination for people ages 11 or 12 years, but it can be started at 9 years. People starting before their 15^th birthday receive two doses, and those starting on or after their 15^th birthday receive three doses.

Interest in a single dose recommendation has been increasing. Studies from several countries presented to ACIP Thursday showed high efficacy of a single dose and indications protection could last more than 10 years. Merck also is conducting trials on a single dose.

In 2022, the World Health Organization recommended a two-dose schedule but also allowed an off-label option for a single dose for people ages 9-20 years. Fifty-eight countries have a one-dose schedule for those ages 9-14 years, including England, Ireland and Australia.

ACIP is considering a single dose for some age groups and a two-dose schedule for some age groups older than 14 years.

The group also is looking at changing the wording on the age for routine vaccination. Instead of recommending vaccination at 11 or 12 years with an allowance for starting at 9 years, it simply may recommend vaccination at 9-12 years, which is in line with the AAP wording.

The committee will continue to discuss these issues when it meets in February 2025 and could vote at a later meeting.