Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review

Abstract

While invasive meningococcal disease (IMD) is uncommon, it can result in serious sequelae and even death. In 2018 in the United States, the incidence of IMD per 100,000 people was 0.03 among adolescents 11-15 years of age, 0.10 among persons 16-23 years of age, and 0.83 among infants\1 year of age. Serogroup B accounted for 86%, 62%, and 66% of cases, respectively, in those age groups. Currently, routine meningococcal vaccination covering serogroups ACWY (MenACWY) is recommended in the United States for all adolescents at 11-12 years of age, with a booster dose at 16 years of age, whereas a meningococcal serogroup B (MenB) vaccine series is recommended for persons 16-23 years of age under the shared clinical decision-making paradigm.The MenACWY vaccination program in adolescents has been successful in reducing disease burden, but does not prevent disease caused by serogroup B, which accounts for more than half of IMD cases. There are currently no approved vaccines that cover all of the most common disease-causing meningococcal serogroups, which are A, B, C, W, and Y. A pentavalent MenABCWY vaccine that is constituted from 2 licensed meningococcal vaccines-MenB-FHbp and MenACWY-TT-is being investigated in healthy persons C 10-25years of age. The addition of a MenABCWY vaccine is the next natural step in the incremental meningococcal immunization program in the United States to improve protection against the most common serogroup causing IMD, with no increase in the number of immunizations needed. With high uptake, routine use of MenABCWY could reduce IMD cases and associated mortality, the rate of long-term physical and psychosocial sequelae in survivors, and costs associated with controlling outbreaks, particularly on college campuses. A MenABCWY vaccine would also reduce the number of injections required for adolescents, potentially improving compliance.

Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review

“…Both 4CMenB and MenB-FHbp are components of pentavalent MenABCWY meningococcal vaccines under development [ 146 , 147 ] . While clinical studies evaluate immunogenicity and safety in younger adults (up to 25 years), these are reported as pooled data incorporating data from adolescents [ 148 , 149 ].…”

The Impact of Social Determinants of Health on Meningococcal Vaccination Awareness, Delivery, and Coverage in Adolescents and Young Adults in the United States: A Systematic Review

“…Similar reductions in the incidence of meningococcal disease in the US have been observed since the late 1990s [ 1 ]. Reductions in the meningococcal disease burden have been attributed to the availability of meningococcal vaccines and subsequent ACIP recommendations for their use [ 17 ].…”

“…Several publications have suggested that the suboptimal uptake of the two types of meningococcal vaccines available in the US (MenACWY and MenB) may be related to inequities or disparities in awareness or access to these vaccines in adolescents and young adults of different racial or ethnic groups, socioeconomic groups, in different geographic areas in the US [ 15 , 16 , 17 , 18 , 19 , 20 ]. For example, Pruitt et al [ 20 ], using the NIS-Teen data showed disparities in the uptake of the second dose of MenACWY vaccine by race/ethnicity and insurance status.…”

Expert Perspectives on the Vaccination of Individuals Who Are at Increased Risk of Meningococcal Disease Due to Medical Conditions: A Podcast

“…In summary, to help protect against the serogroups that most commonly cause disease, two vaccine types are currently recommended by the Advisory Committee on Immunization Practices, or ACIP, of the Centers for Disease Control and Prevention: one type protects against serogroups A, C, W, and Y, known as MenACWY vaccines, and one protects against serogroup B, known as MenB vaccines [ 4 , 12 ].…”