(1150) Rationale for Use of a Pentavalent Meningococcal Serogroup ABCWY Vaccine in the United States: A Review for Pharmacists

Objectives: Invasive meningococcal disease (IMD) is a serious, rapidly progressing illness that is fatal in ~8% of cases. Furthermore, many survivors experience permanent sequelae, such as hearing loss and limb amputation. The US Advisory Committee on Immunization Practices is currently considering whether an investigational meningococcal serogroups A/B/C/W/Y (MenABCWY) vaccine comprised of licensed tetanus-toxoid conjugated MenACWY (MenACWY-TT; Nimenrix®) and MenB factor H binding protein (MenB-fHbp; Trumenba®) vaccines could be an option for existing meningococcal vaccine recommendations once FDA approved. Because pharmacists play a key role in vaccination, it is important to raise their awareness of this MenABCWY vaccine in the context of current US IMD epidemiology as well as meningococcal vaccine recommendations and their implementation.

Methods: A literature review was performed to assess recent US IMD epidemiology, existing US meningococcal recommendations and their implementation, and potential use of a MenABCWY vaccine. Searches included publicly available data on government websites and peer-reviewed publications.

Results: IMD incidence in the US has decreased by ~10-fold during the last 25 years to ~0.1 cases per 100,000 population. During this time period, diphtheria-toxoid conjugated MenACWY vaccine was first licensed in the US, followed by several conjugate and protein-based vaccines, with MenACWY-TT most recently licensed. Although US cases decreased during the COVID-19 pandemic (2020−2022), disease is rebounding, with more provisional cases reported through Week 37 in 2023 compared with 2019. Children aged ≤4 years, adolescents/young adults aged 15−24 years, and adults aged ≥70 years face an elevated risk of disease. MenA/B/C/W/Y have collectively dominated the US IMD landscape both historically and contemporarily, with MenB causing more cases among 11−23-year-olds each year during 2015−2021 than any other identifiable serogroup.
Meningococcal vaccines currently available in the US include separate MenACWY polysaccharide conjugate vaccines and MenB protein vaccines, each subject to different recommendations and schedules. Current US recommendations include routine MenACWY vaccination at ages 11 and 16 years and a 2- or 3-dose MenB vaccination series at age 16−23 years (16−18 preferred) based on shared clinical decision-making (SCDM). Vaccination rates differ dramatically between vaccines, with the 2022 National Immunization Survey−Teen demonstrating 88.6% uptake of ≥1 MenACWY dose among 13−17-year-olds and 60.8% uptake of ≥2 MenACWY doses among 17-year-olds compared with 29.4% and 11.9% for ≥1 and ≥2 MenB doses, respectively, among 17-year-olds. A 2021 review of US MenB vaccine implementation experience suggested that low MenB vaccination rates may stem from a demonstrated lack of understanding among healthcare providers surrounding the SCDM recommendation and insurance coverage for MenB vaccines, which likely constrains their ability to provide education and guidance that parents rely on for vaccination decisions. Additionally, several studies have collectively found that MenB vaccine awareness and receipt is generally higher among White and wealthier groups, suggesting access disparities based on racial and socioeconomic factors.
A pentavalent MenABCWY vaccine could simplify vaccination strategies and reduce the number of required injections while providing protection against all 5 serogroups; as a combination vaccine, MenABCWY may additionally help raise vaccination rates, particularly for MenB. MenABCWY implementation could also potentially reduce MenB vaccine access disparities resulting from the SCDM recommendation. A recent publication demonstrated positive safety and immunogenicity data from the first-in-human MenABCWY clinical study, and additional studies are completed or ongoing.

Conclusions: The MenABCWY vaccine in development shows promising potential to provide comprehensive protection against disease-causing serogroups with a single vaccine and fewer injections than current recommendations, which may help address existing challenges in meningococcal vaccination of US adolescents. Importantly, besides the clinical profile of the MenABCWY vaccine, pharmacists will also need to become familiar with the novel, 1-needle vial adapter system that will be used for its preparation and administration.
Funded by Pfizer.