MVA-BN vaccine effectiveness: A systematic review of real-world evidence in outbreak settings

Background: Mpox is a disease endemic to Central and West Africa. It caused outbreaks in non-endemic countries, mainly in 2022. The endemic Democratic Republic of Congo is currently experiencing its largest outbreak yet. The vaccine Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) is approved for active immunization against mpox and smallpox. Since the outbreak in 2022, real-world studies have assessed MVA-BN's vaccine effectiveness (VE) against mpox, and this systematic literature review aims to summarize the most current evidence. Methods: Medline (via PubMed), Embase, and LILACS were searched, as well as grey literature sources and publications' bibliographies to identify observational studies published between 1/Jan/2022 and 28/Feb/2024 that estimate the VE of MVA-BN against mpox or provide risk measures that allow calculation of these VE estimates. Data were presented descriptively in tables and text; the methodological quality of included records was assessed using NHLBI/NIH quality assessment tools. Results: The literature search identified 16 records that fit the inclusion criteria. The studies took place in high-income countries and were heterogeneous in design, setting, and definition of at-risk populations. MVA-BN VE estimates against mpox infection were assessed. Where the study population was exclusively or primarily those receiving pre-exposure prophylactic vaccination, the adjusted VE estimates ranged from 35 % to 86 % (n = 8 studies) for one dose and from 66 % to 90 % (n = 5) for two doses. Where only post-exposure prophylactic vaccination was assessed, adjusted VE estimates were reported for one dose only at 78 % and 89 % (n = 2). Additionally, MVA-BN reduced the risk of mpox-related hospitalization in one study and the severity of mpox clinical manifestations in two studies. Conclusions: Despite heterogeneity in study design, setting, and at-risk populations, the reported VE estimates against mpox infection demonstrated the effectiveness of one or two doses of MVA-BN in the context of an outbreak across multiple countries.