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

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.