{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T22:33:46Z","timestamp":1794004426148,"version":"4.8.0"},"reference-count":37,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2024,6,11]],"date-time":"2024-06-11T00:00:00Z","timestamp":1718064000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013120","name":"European Medicines Agency","doi-asserted-by":"publisher","award":["EMA\/2020\/46\/TDA\/L5.01"],"award-info":[{"award-number":["EMA\/2020\/46\/TDA\/L5.01"]}],"id":[{"id":"10.13039\/501100013120","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>The mpox 2022 outbreak was declared a public health emergency in July 2022. In August 2022, the MVA\u2013BN vaccine received emergency use authorization in the United States (US) to target at-risk groups. This study (EUPAS104386) used HealthVerity\u2019s administrative US healthcare data to generate real-world evidence for MVA\u2013BN 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 \u2265 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\u2013BN 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\u2013BN vaccine.<\/jats:p>","DOI":"10.3390\/vaccines12060651","type":"journal-article","created":{"date-parts":[[2024,6,11]],"date-time":"2024-06-11T12:11:00Z","timestamp":1718107860000},"page":"651","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Effectiveness and Safety of the MVA\u2013BN Vaccine against Mpox in At-Risk Individuals in the United States (USMVAc)"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0522-5888","authenticated-orcid":false,"given":"Soowoo","family":"Back","sequence":"first","affiliation":[{"name":"Aetion, Inc., New York, NY 10001, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5870-9344","authenticated-orcid":false,"given":"Bethany","family":"Knox","sequence":"additional","affiliation":[{"name":"Aetion Iberia, S.L., 08037 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciara","family":"Coakley","sequence":"additional","affiliation":[{"name":"Aetion Iberia, S.L., 08037 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3477-7021","authenticated-orcid":false,"given":"Nicolas","family":"Deltour","sequence":"additional","affiliation":[{"name":"Aetion Iberia, S.L., 08037 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuelle","family":"Jacquot","sequence":"additional","affiliation":[{"name":"Aetion Iberia, S.L., 08037 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanaya","family":"Raad","sequence":"additional","affiliation":[{"name":"Aetion Iberia, S.L., 08037 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5871-1599","authenticated-orcid":false,"given":"Elizabeth M.","family":"Garry","sequence":"additional","affiliation":[{"name":"Aetion, Inc., New York, NY 10001, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,6,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"764","DOI":"10.15585\/mmwr.mm7123e1","article-title":"Monkeypox Outbreak\u2014Nine States, May 2022","volume":"71","author":"Minhaj","year":"2022","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_2","unstructured":"CDC (2023, October 30). Mpox Vaccination Basics. Cent Dis Control Prev 2023, Available online: https:\/\/www.cdc.gov\/poxvirus\/mpox\/vaccines\/index.html."},{"key":"ref_3","unstructured":"CDC (2024, May 30). 2022 Outbreak Cases and Data|Mpox|Poxvirus|2024, Available online: https:\/\/www.cdc.gov\/poxvirus\/mpox\/response\/2022\/index.html."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1018","DOI":"10.15585\/mmwr.mm7132e3","article-title":"Epidemiologic and Clinical Characteristics of Monkeypox Cases\u2014United States, 17 May\u201322 July 2022","volume":"71","author":"Philpott","year":"2022","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1186\/s12879-023-08083-5","article-title":"Possibility of mpox viral transmission and control from high-risk to the general population: A modeling study","volume":"23","author":"Yang","year":"2023","journal-title":"BMC Infect. Dis."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Nakamura, H., and Yamamoto, K. (2024). Mpox in people with HIV: A narrative review. HIV Med.","DOI":"10.1111\/hiv.13661"},{"key":"ref_7","unstructured":"(2024, May 31). WHO Declares End of Mpox Emergency, Calls for Sustained Efforts for Long-Term Management of the Disease\u2014PAHO\/WHO|Pan American Health Organization. Available online: https:\/\/www.paho.org\/en\/news\/11-5-2023-who-declares-end-mpox-emergency-calls-sustained-efforts-long-term-management-disease."},{"key":"ref_8","unstructured":"(2024, May 30). Substantial Rise in Mpox Cases Prompts NYC Health Alert|CIDRAP. Available online: https:\/\/www.cidrap.umn.edu\/mpox\/substantial-rise-mpox-cases-prompts-nyc-health-alert."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"e2220415120","DOI":"10.1073\/pnas.2220415120","article-title":"Virulence differences of mpox (monkeypox) virus clades I, IIa, and IIb.1 in a small animal model","volume":"120","author":"Americo","year":"2023","journal-title":"Proc. Natl. Acad. Sci. USA"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"435","DOI":"10.15585\/mmwr.mm7319a3","article-title":"U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo\u2014United States, 2024","volume":"73","author":"McQuiston","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_11","unstructured":"FDA (2024, May 31). Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply, Available online: https:\/\/www.fda.gov\/media\/160774\/download."},{"key":"ref_12","unstructured":"(2024, May 30). CDC Panel Recommends Mpox Vaccine for Routine Prevention in Risk Groups|CIDRAP. Available online: https:\/\/www.cidrap.umn.edu\/mpox\/cdc-panel-recommends-mpox-vaccine-routine-prevention-risk-groups."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"553","DOI":"10.15585\/mmwr.mm7220a3","article-title":"Estimated Effectiveness of JYNNEOS Vaccine in Preventing Mpox: A Multijurisdictional Case-Control Study\u2014United States, 19 August 2022\u201331 March 2023","volume":"72","author":"Dalton","year":"2023","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_14","unstructured":"(2024, February 28). Package Insert\u2014JYNNEOS|FDA, Available online: https:\/\/www.fda.gov\/media\/131078."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"559","DOI":"10.15585\/mmwr.mm7220a4","article-title":"Effectiveness of JYNNEOS Vaccine Against Diagnosed Mpox Infection\u2014New York, 2022","volume":"72","author":"Rosenberg","year":"2023","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"748","DOI":"10.1038\/s41591-023-02229-3","article-title":"Real-world effectiveness of a single dose of mpox vaccine in males","volume":"29","author":"Sagy","year":"2023","journal-title":"Nat. Med."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"828","DOI":"10.1016\/S1473-3099(23)00057-9","article-title":"Effectiveness of one dose of MVA\u2013BN smallpox vaccine against mpox in England using the case-coverage method: An observational study","volume":"23","author":"Bertran","year":"2023","journal-title":"Lancet Infect. Dis."},{"key":"ref_18","unstructured":"EMA (2023, October 30). Imvanex: EPAR\u2014Risk Management Plan Summary. Eur Med Agency 2023. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/rmp-summary\/imvanex-epar-risk-management-plan-summary_en.pdf."},{"key":"ref_19","unstructured":"WHO (2024, February 27). WHO Monkeypox Virtual Press Conference Transcript\u201423 July 2022. Available online: https:\/\/www.who.int\/publications\/m\/item\/monkeypox-virtual-press-conference-transcript---23-july-2022."},{"key":"ref_20","unstructured":"The White House (2023, October 30). FACT SHEET: Biden-Harris Administration\u2019s Monkeypox Outbreak Response. White House 2022, Available online: https:\/\/www.whitehouse.gov\/briefing-room\/statements-releases\/2022\/06\/28\/fact-sheet-biden-harris-administrations-monkeypox-outbreak-response\/."},{"key":"ref_21","unstructured":"EMA (2023, October 30). EMA\u2019s Emergency Task Force Advises on Intradermal Use of Imvanex\/Jynneos against Monkeypox. 19 August 2022. Available online: https:\/\/www.ema.europa.eu\/en\/news\/emas-emergency-task-force-advises-intradermal-use-imvanex-jynneos-against-monkeypox."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"e14","DOI":"10.2196\/publichealth.5365","article-title":"Estimating the Population Sizes of Men Who Have Sex With Men in US States and Counties Using Data From the American Community Survey","volume":"2","author":"Grey","year":"2016","journal-title":"JMIR Public Health Surveill."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1016\/j.jiph.2023.02.003","article-title":"Monkeypox (mpox) virus: Classification, origin, transmission, genome organization, antiviral drugs, and molecular diagnosis","volume":"16","author":"Karagoz","year":"2023","journal-title":"J. Infect. Public Health"},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Sukhdeo, S., Mishra, S., and Walmsley, S. (2022). Human monkeypox: A comparison of the characteristics of the new epidemic to the endemic disease. BMC Infect. Dis., 22.","DOI":"10.1186\/s12879-022-07900-7"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"325","DOI":"10.1002\/cpt.329","article-title":"Transparency and Reproducibility of Observational Cohort Studies Using Large Healthcare Databases","volume":"99","author":"Wang","year":"2015","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"2434","DOI":"10.1056\/NEJMoa2215201","article-title":"Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States","volume":"388","author":"Deputy","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Yeganeh, N., Yin, S., Moir, O., Danza, P., Kim, M., Finn, L., Fisher, R., Kulkarni, S., Perez, M., and Poortinga, K. (2024). Effectiveness of JYNNEOS vaccine against symptomatic mpox disease in adult men in Los Angeles County, 29 August 2022 to 1 January 2023. Vaccine.","DOI":"10.1016\/j.vaccine.2024.05.035"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1089\/vim.2023.0147","article-title":"Safety and Efficacy of the Modified Vaccinia Ankara\u2013Bavaria Nordic Vaccine Against Mpox in the Real World: Systematic Review and Meta-Analysis","volume":"37","author":"Pang","year":"2024","journal-title":"Viral Immunol."},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Mason, L.M.K., Betancur, E., Riera-Montes, M., Lienert, F., and Scheele, S. (2024). MVA\u2013BN Vaccine Effectiveness: A Systematic Review of Real-World Evidence in Outbreak Settings. medRxiv.","DOI":"10.1101\/2024.04.25.24306078"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"460","DOI":"10.15585\/mmwr.mm7320a3","article-title":"Monkeypox Virus Infections After 2 Preexposure Doses of JYNNEOS Vaccine\u2014United States, May 2022\u2013May 2024","volume":"73","author":"Guagliardo","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"474","DOI":"10.15585\/mmwr.mm7320a4","article-title":"Notes from the Field: Clade II Mpox Surveillance Update\u2014United States, October 2023\u2013April 2024","volume":"73","author":"Tuttle","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"Sudarmaji, N., Kifli, N., Hermansyah, A., Yeoh, S.F., Goh, B.-H., and Ming, L.C. (2022). Prevention and Treatment of Monkeypox: A Systematic Review of Preclinical Studies. Viruses, 14.","DOI":"10.3390\/v14112496"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1016\/j.vaccine.2023.12.068","article-title":"Prospective monitoring of adverse events following vaccination with Modified vaccinia Ankara\u2014Bavarian Nordic (MVA\u2013BN ) administered to a Canadian population at risk of Mpox: A Canadian Immunization Research Network study","volume":"42","author":"Muller","year":"2024","journal-title":"Vaccine"},{"key":"ref_34","doi-asserted-by":"crossref","unstructured":"Duffy, J., Myers, T.R., Marquez, P.M., Rouse, D., Brown, H.F.-C., Zhang, B., Shay, D.K., and Moro, P.L. (2024). JYNNEOS vaccine safety surveillance during the 2022 mpox outbreak using the Vaccine Adverse Event Reporting System (VAERS) and v-safe, United States, 2022\u20132023. Sex. Transm. Dis.","DOI":"10.1097\/OLQ.0000000000001978"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"1560","DOI":"10.15585\/mmwr.mm7149a5","article-title":"Reduced Risk for Mpox After Receipt of 1 or 2 Doses of JYNNEOS Vaccine Compared with Risk Among Unvaccinated Persons\u201443 U.S. Jurisdictions, 31 July\u20131 October 2022","volume":"71","author":"Payne","year":"2022","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"ofad528","DOI":"10.1093\/ofid\/ofad528","article-title":"Effectiveness of the Modified Vaccinia Ankara Vaccine Against Mpox in Men Who Have Sex With Men: A Retrospective Cohort Analysis, Seattle, Washington","volume":"10","author":"Ramchandani","year":"2023","journal-title":"Open Forum Infect. Dis."},{"key":"ref_37","unstructured":"CDC (2024, May 31). Mpox Vaccine Recommendations. Cent Dis Control Prev 2024, Available online: https:\/\/www.cdc.gov\/poxvirus\/mpox\/vaccines\/vaccine-recommendations.html."}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/12\/6\/651\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T14:57:02Z","timestamp":1760108222000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/12\/6\/651"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,11]]},"references-count":37,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2024,6]]}},"alternative-id":["vaccines12060651"],"URL":"https:\/\/doi.org\/10.3390\/vaccines12060651","relation":{},"ISSN":["2076-393X"],"issn-type":[{"value":"2076-393X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,11]]}}}