MMWR Morb Mortal Wkly Rep. 2023 May 19;72(20):553-558. doi: 10.15585/mmwr.mm7220a3.
As of March 31, 2023, more than 30,000 monkeypox (mpox) cases had been reported in the United States in an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) and transgender persons (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) was approved by the Food and Drug Administration (FDA) in 2019 for the prevention of smallpox and mpox via subcutaneous injection as a 2-dose series (0.5 mL per dose, administered 4 weeks apart) (2). To expand vaccine access, an Emergency Use Authorization was issued by FDA on August 9, 2022, for dose-sparing intradermal injection of JYNNEOS as a 2-dose series (0.1 mL per dose, administered 4 weeks apart) (3). Vaccination was available to persons with known or presumed exposure to a person with mpox (postexposure prophylaxis [PEP]), as well as persons at increased risk for mpox or who might benefit from vaccination (preexposure mpox prophylaxis [PrEP]) (4). Because information on JYNNEOS vaccine effectiveness (VE) is limited, a matched case-control study was conducted in 12 U.S. jurisdictions, including nine Emerging Infections Program sites and three Epidemiology and Laboratory Capacity sites, to evaluate VE against mpox among MSM and transgender adults aged 18-49 years. During August 19, 2022-March 31, 2023, a total of 309 case-patients were matched to 608 control patients. Adjusted VE was 75.2% (95% CI = 61.2% to 84.2%) for partial vaccination (1 dose) and 85.9% (95% CI = 73.8% to 92.4%) for full vaccination (2 doses). Adjusted VE for full vaccination by subcutaneous, intradermal, and heterologous routes of administration was 88.9% (95% CI = 56.0% to 97.2%), 80.3% (95% CI = 22.9% to 95.0%), and 86.9% (95% CI = 69.1% to 94.5%), respectively. Adjusted VE for full vaccination among immunocompromised participants was 70.2% (95% CI = -37.9% to 93.6%) and among immunocompetent participants was 87.8% (95% CI = 57.5% to 96.5%). JYNNEOS is effective at reducing the risk for mpox. Because duration of protection of 1 versus 2 doses remains unknown, persons at increased risk for mpox exposure should receive the 2-dose series as recommended by the Advisory Committee on Immunization Practices (ACIP), regardless of administration route or immunocompromise status.
截至 2023 年 3 月 31 日,美国爆发的猴痘疫情已报告超过 30000 例病例,该疫情 disproportionately 影响男同性恋者、双性恋者和其他与男性发生性关系的男性(MSM)以及跨性别者(1)。JYNNEOS 疫苗(改良安卡拉痘苗病毒疫苗,巴伐利亚 Nordic)于 2019 年经美国食品和药物管理局(FDA)批准,通过皮下注射作为两剂系列(每剂 0.5 毫升,相隔 4 周)预防天花和猴痘(2)。为扩大疫苗接种范围,FDA 于 2022 年 8 月 9 日发布了紧急使用授权,对 JYNNEOS 进行皮下注射剂量节约的皮内注射,作为两剂系列(每剂 0.1 毫升,相隔 4 周)(3)。疫苗接种适用于已知或疑似接触过猴痘患者的人(接触后预防 [PEP]),以及有感染猴痘风险或可能受益于疫苗接种的人(暴露前猴痘预防 [PrEP])(4)。由于 JYNNEOS 疫苗有效性(VE)的信息有限,在美国 12 个司法管辖区进行了一项匹配病例对照研究,包括九个新兴传染病计划地点和三个流行病学和实验室能力地点,以评估 MSM 和跨性别成年人中 JYNNEOS 对猴痘的 VE 年龄在 18-49 岁之间。2022 年 8 月 19 日至 2023 年 3 月 31 日,共有 309 例病例患者与 608 例对照患者匹配。部分接种(1 剂)的调整后 VE 为 75.2%(95%CI=61.2%至 84.2%),完全接种(2 剂)的调整后 VE 为 85.9%(95%CI=73.8%至 92.4%)。皮下、皮内和异源途径接种完全疫苗的调整后 VE 分别为 88.9%(95%CI=56.0%至 97.2%)、80.3%(95%CI=22.9%至 95.0%)和 86.9%(95%CI=69.1%至 94.5%)。免疫功能低下参与者完全接种疫苗的调整后 VE 为 70.2%(95%CI=-37.9%至 93.6%),免疫功能正常参与者为 87.8%(95%CI=57.5%至 96.5%)。JYNNEOS 可有效降低猴痘的风险。由于 1 剂和 2 剂的保护持续时间尚不清楚,有感染猴痘风险的人应按照免疫接种咨询委员会(ACIP)的建议接种 2 剂系列,无论接种途径或免疫功能低下状态如何。