Narrative review of the clinical safety of MenACYW-TT: a quadrivalent meningococcal vaccine conjugated to tetanus toxoid licensed in the US and abroad.

Abstract

INTRODUCTION Routine meningococcal vaccination campaigns have substantially reduced the burden of invasive meningococcal disease in pediatric individuals, leading to relative increases in burden in older age groups. There is a need for safe, effective meningococcal vaccines that can be used across broad age ranges. MenACYW-TT, a quadrivalent tetanus-toxoid-conjugate meningococcal vaccine indicated for individuals aged ≥6 weeks, is one such option. AREAS COVERED This narrative review summarizes safety data from industry-sponsored pre- and post-licensure clinical trials of MenACYW-TT, including head-to-head studies with active comparators and coadministration studies with routine pediatric vaccines. EXPERT OPINION In >30 trials involving >17,000 participants, MenACYW-TT had a consistent safety profile across all age groups, from infants to older adults. The most frequent side effects were generally mild or moderate and transient; vaccine-related serious adverse events were rare (<0.1%). The safety of MenACYW-TT was comparable to that of other quadrivalent meningococcal conjugate vaccines. Coadministration did not materially affect the safety of MenACYW-TT or routine pediatric vaccines. Immunization remains an essential preventive strategy against the potentially life-threatening and life-altering consequences of invasive meningococcal disease. The favorable benefit-risk profile of MenACYW-TT reinforces the safety of licensed vaccines and can help to counter vaccine hesitancy.