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MVA-BN Vaccine Effectiveness: A Systematic Review of Real-World Evidence in Outbreak Settings
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Abstract
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 symptomatic 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 an informal qualitative approach.
Results: The literature search identified a total of 16 records that fit the inclusion criteria. The studies took place in high-income countries and were heterogenous in design, setting, and definition of at-risk populations. MVA-BN VE estimates against symptomatic mpox infection ≥14 days post-vaccination 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 symptomatic mpox infection for one or two doses of MVA-BN support deployment of MVA-BN for mpox outbreak control.
... In this study using administrative US healthcare data, high vaccine effectiveness of 89% was observed in the primary analysis among a small cohort of subjects who received full vaccination with two doses relative to a matched sample of unvaccinated subjects considered to be at a similar risk. While the interpretation of these results may be limited by the small sample size, they are consistent with existing US studies of subjects fully vaccinated, including two case-control studies that reported vaccine effectiveness of 66% using a nationwide Epic electronic health record database and 86% using health department case registries from 12 states, and a study conducted in New York State that reported 76% vaccine effectiveness in men diagnosed with mpox compared to negative controls with rectal gonorrhea or primary syphilis [13,15,26,27], in addition to other recent systematic reviews and meta-analysis of current literature on real-world evidence of MVA-BN vaccine prevention of mpox that reported vaccine effectiveness ranging from 66% to 90% [28,29]. Further, these results align with recent CDC Morbidity and Mortality Weekly Reports that show that breakthrough mpox infections in the US after two doses of the MVA-BN vaccine are rare [30,31]. ...
The mpox 2022 outbreak was declared a public health emergency in July 2022. In August 2022, the MVA–BN vaccine received emergency use authorization in the United States (US) to target at-risk groups. This study (EUPAS104386) used HealthVerity’s administrative US healthcare data to generate real-world evidence for MVA–BN vaccine effectiveness and safety to prevent mpox disease in men who have sex with men (MSM) and transgender women, the most affected population during the 2022 mpox outbreak. Fully vaccinated subjects (two doses ≥ 28 days apart) were initially matched with five unvaccinated subjects on calendar date, age, US region, and insurance type. Subjects were followed from index date (14 days after the second dose) until death or data end to ascertain mpox occurrence. After propensity score adjustment, the MVA–BN vaccine effectiveness against mpox disease was 89% (95% CI: 12%, 99%) among those fully vaccinated; attenuated to 64% (95% CI: 40%, 78%) among those with any dose and 70% (95% CI: 44%, 84%) for those with only a single dose. One pericarditis adverse event of special interest was observed when the risk window was extended to 28 days. These results contribute to the totality of evidence supporting the favorable benefit/risk profile of the MVA–BN vaccine.
Up to 27 May 2022, Portugal has detected 96 confirmed cases of monkeypox. We describe 27 confirmed cases (median age: 33 years (range: 22–51); all males), with an earliest symptom onset date of 29 April. Almost all cases (n = 25) live in the Lisbon and Tagus Valley health region. Most cases were neither part of identified transmission chains, nor linked to travel or had contact with symptomatic persons or with animals, suggesting the possible previously undetected spread of monkeypox. © 2022 European Centre for Disease Prevention and Control (ECDC). All rights reserved.
The recent apparent increase in human monkeypox cases across a wide geographic area, the potential for further spread, and the lack of reliable surveillance have raised the level of concern for this emerging zoonosis. In November 2017, the World Health Organization (WHO), in collaboration with CDC, hosted an informal consultation on monkeypox with researchers, global health partners, ministries of health, and orthopoxvirus experts to review and discuss human monkeypox in African countries where cases have been recently detected and also identify components of surveillance and response that need improvement. Endemic human monkeypox has been reported from more countries in the past decade than during the previous 40 years. Since 2016, confirmed cases of monkeypox have occurred in Central African Republic, Democratic Republic of the Congo, Liberia, Nigeria, Republic of the Congo, and Sierra Leone and in captive chimpanzees in Cameroon. Many countries with endemic monkeypox lack recent experience and specific knowledge about the disease to detect cases, treat patients, and prevent further spread of the virus. Specific improvements in surveillance capacity, laboratory diagnostics, and infection control measures are needed to launch an efficient response. Further, gaps in knowledge about the epidemiology and ecology of the virus need to be addressed to design, recommend, and implement needed prevention and control measures.
During May and June 2003, an outbreak of febrile illness with vesiculopustular eruptions occurred among persons in the midwestern United States who had had contact with ill pet prairie dogs obtained through a common distributor. Zoonotic transmission of a bacterial or viral pathogen was suspected.
We reviewed medical records, conducted interviews and examinations, and collected blood and tissue samples for analysis from 11 patients and one prairie dog. Histopathological and electron-microscopical examinations, microbiologic cultures, and molecular assays were performed to identify the etiologic agent.
The initial Wisconsin cases evaluated in this outbreak occurred in five males and six females ranging in age from 3 to 43 years. All patients reported having direct contact with ill prairie dogs before experiencing a febrile illness with skin eruptions. We found immunohistochemical or ultrastructural evidence of poxvirus infection in skin-lesion tissue from four patients. Monkeypox virus was recovered in cell cultures of seven samples from patients and from the prairie dog. The virus was identified by detection of monkeypox-specific DNA sequences in tissues or isolates from six patients and the prairie dog. Epidemiologic investigation suggested that the prairie dogs had been exposed to at least one species of rodent recently imported into the United States from West Africa.
Our investigation documents the isolation and identification of monkeypox virus from humans in the Western Hemisphere. Infection of humans was associated with direct contact with ill prairie dogs that were being kept or sold as pets.
Healthcare-associated transmission of monkeypox has been observed on multiple occasions in areas where the disease is endemic. Data collected by the US Centers for Disease Control and Prevention (CDC) from an ongoing CDC-supported program of enhanced surveillance in the Tshuapa Province of the Democratic Republic of the Congo, where the annual incidence of human monkeypox is estimated to be 3.5–5/10,000, suggests that there is approximately one healthcare worker infection for every 100 confirmed monkeypox cases. Herein, we describe a study that commenced in February 2017, the intent of which is to evaluate the effectiveness, immunogenicity, and safety of a third-generation smallpox vaccine, IMVAMUNE®, in healthcare personnel at risk of monkeypox virus (MPXV) infection. We describe procedures for documenting exposures to monkeypox virus infection in study participants, and outline lessons learned that may be of relevance for studies of other investigational medical countermeasures in hard to reach, under-resourced populations.
Monkeypox: epidemiology, pathogenesis, treatment and 419 prevention
- Y Huang
- L Mu
Huang, Y., Mu, L., and Wang, W., Monkeypox: epidemiology, pathogenesis, treatment and
419
prevention. Signal Transduct Target Ther, 2022. 7(1): p. 373. https://doi.org/10.1038/s41392-420
Monkeypox epidemiology, clinical presentation, and transmission: a 422 systematic review
- A Sharma
Sharma, A., et al., Monkeypox epidemiology, clinical presentation, and transmission: a
422
systematic review. Int J Emerg Med, 2023. 16(1): p. 20. https://doi.org/10.1186/s12245-023-423
- O Mitja
Mitja, O., et al., Monkeypox. Lancet, 2023. 401(10370): p. 60-74.