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ABSTRACT
Two quadrivalent meningococcal conjugate vaccines (MenACWY) that prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W have been licensed in the U.S. in the past 10–15 years. We systematically reviewed published studies conducted in the U.S. to evaluate the real-world safety evidence of meningococcal conjugate vaccines. We performed a literature search in PubMed of publications from 01/01/2005 to 02/29/2020 and identified 18 studies meeting inclusion criteria. Populations included high-risk persons aged 2 months to 10 years, adolescents/adults aged ≥11 years, pregnant populations, and hematopoietic cell transplant recipients. We extracted information about study setting, study design, exposure, outcomes, comparison group, follow-up/look back period, study population, sample size, available demographic/indication information, results, key conclusion, and reference. These published studies found no new significant safety concerns related to MenACWY. Consideration for future research includes a post-licensure safety evaluation of a new MenACWY product approved in April 2020.
Disclosure of potential conflicts of interest
This work was supported by Kaiser Permanente Southern California.
TBC, LSS, ZS and HFT received research funding from GSK for meningococcal vaccine studies and other unrelated vaccine studies. LSS, HFT, and ZS received research support from Novavax for studies unrelated to this paper. HFS and LSS received research support from Seqirus for studies unrelated to this paper. LSS and ZS received research support from Dynavax for studies unrelated to this paper. HFT received research support from Genentech for studies unrelated to this paper. ZS received research support from Gilead for studies unrelated to this paper.