Use of JYNNEOS (Smallpox and Mpox Vaccine, Live, Nonreplicating) for Persons Aged ≥18 Years at Risk for Mpox During an Mpox Outbreak: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023

Abstract

Since the worldwide eradication of smallpox in 1980, orthopoxvirus vaccines had been used nearly exclusively by persons at risk for occupational exposure to orthopoxviruses, including Monkeypox virus, the virus that causes mpox. However, during recent years, the epidemiology of mpox has been changing in countries where the animal reservoirs are believed to live and where endemic transmission has been known to occur for decades. CDC issues outbreak-specific vaccination recommendations based on the epidemiology at the time specific cases or clusters are identified; however, because of the increased risk for U.S. mpox outbreaks, the Advisory Committee on Immunization Practices (ACIP) reviewed results from a previously performed modified Grading of Recommendations Assessment, Development, and Evaluation of the 2-dose JYNNEOS (smallpox and mpox vaccine, live, nonreplicating) vaccination series and an Evidence to Recommendations (EtR) framework addressing multiple domains (e.g., benefits, harms, and target population values and preferences). Based on this assessment, ACIP recommended the use of JYNNEOS (a live, replication-deficient vaccinia virus vaccine) for persons aged ≥18 years at risk for mpox during an mpox outbreak (irrespective of clade). Because the cause of future mpox outbreaks and the populations affected by these outbreaks remain uncertain, public health authorities will continue to issue outbreak-specific vaccination guidance when outbreaks occur. A clade IIb mpox outbreak that began in 2022 continued to cause substantial morbidity and mortality >1 year later. Although CDC had issued outbreak-specific vaccination guidance, it was anticipated that the outbreak would be protracted. For this reason, ACIP reviewed a second EtR framework about outbreaks and in 2023 recommended JYNNEOS for persons aged ≥18 years at risk for acquiring mpox during the multinational clade IIb outbreak. As of 2025, cases continue to occur; however, the future need for the recommendation will be reassessed as the outbreak evolves. Mpox vaccination is not routinely recommended for health care personnel during mpox outbreaks, including during the ongoing clade IIb outbreak.