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美国 JYNNEOS 疫苗对猴痘疾病的有效性。

Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States.

机构信息

From the Mpox Emergency Response Team, Centers for Disease Control and Prevention, Atlanta (N.P.D., A.N.C., D.L.M., A.F.D., A.C.C., A.L.C., D.C.P., L.R.F.); the Public Health Service Commissioned Corps, Rockville, MD (N.P.D., A.N.C., A.C.C., A.L.C., L.R.F.); and Epic Research, Epic Systems, Verona, WI (J.D., N.S., E.B., C.S., D.R.L., D.S., J.L.G.).

出版信息

N Engl J Med. 2023 Jun 29;388(26):2434-2443. doi: 10.1056/NEJMoa2215201. Epub 2023 May 18.

Abstract

BACKGROUND

In the United States, more than 30,000 cases of mpox (formerly known as monkeypox) had occurred as of March 1, 2023, in an outbreak disproportionately affecting transgender persons and gay, bisexual, and other men who have sex with men. In 2019, the JYNNEOS vaccine was approved for subcutaneous administration (0.5 ml per dose) to prevent mpox infection. On August 9, 2022, an emergency use authorization was issued for intradermal administration (0.1 ml per dose); however, real-world effectiveness data are limited for either route.

METHODS

We conducted a case-control study based on data from Cosmos, a nationwide Epic electronic health record (EHR) database, to assess the effectiveness of JYNNEOS vaccination in preventing medically attended mpox disease among adults. Case patients had an mpox diagnosis code or positive orthopoxvirus or mpox virus laboratory result, and control patients had an incident diagnosis of human immunodeficiency virus (HIV) infection or a new or refill order for preexposure prophylaxis against HIV infection between August 15, 2022, and November 19, 2022. Odds ratios and 95% confidence intervals were estimated from conditional logistic-regression models, adjusted for confounders; vaccine effectiveness was calculated as (1 - odds ratio for vaccination in case patients vs. controls) × 100.

RESULTS

Among 2193 case patients and 8319 control patients, 25 case patients and 335 control patients received two doses (full vaccination), among whom the estimated adjusted vaccine effectiveness was 66.0% (95% confidence interval [CI], 47.4 to 78.1), and 146 case patients and 1000 control patients received one dose (partial vaccination), among whom the estimated adjusted vaccine effectiveness was 35.8% (95% CI, 22.1 to 47.1).

CONCLUSIONS

In this study using nationwide EHR data, patients with mpox were less likely to have received one or two doses of JYNNEOS vaccine than control patients. The findings suggest that JYNNEOS vaccine was effective in preventing mpox disease, and a two-dose series appeared to provide better protection. (Funded by the Centers for Disease Control and Prevention and Epic Research.).

摘要

背景

截至 2023 年 3 月 1 日,美国已出现超过 30000 例猴痘(以前称为猴痘)病例,此次疫情主要影响跨性别者、男同性恋、双性恋和其他与男性发生性关系的男性。2019 年,JYNNEOS 疫苗获得批准,可用于皮下注射(每次 0.5 毫升),以预防猴痘感染。2022 年 8 月 9 日,发布了皮下注射(每次 0.1 毫升)的紧急使用授权;然而,对于这两种途径,实际效果数据都很有限。

方法

我们基于全国性的 Epic 电子健康记录(EHR)数据库 Cosmos 中的数据进行了一项病例对照研究,以评估 JYNNEOS 疫苗接种在预防成年人中出现需要就医的猴痘疾病方面的有效性。病例患者有猴痘诊断代码或阳性正痘病毒或猴痘病毒实验室结果,对照组患者在 2022 年 8 月 15 日至 2022 年 11 月 19 日之间有新的或补充的人类免疫缺陷病毒(HIV)感染诊断或 HIV 感染暴露前预防用药的新处方或补充处方。比值比和 95%置信区间是通过条件逻辑回归模型估计的,调整了混杂因素;疫苗效力计算为(病例患者中接种疫苗的比值比-1)×100。

结果

在 2193 例病例患者和 8319 例对照患者中,25 例病例患者和 335 例对照患者接受了两剂(完全接种),估计调整后的疫苗效力为 66.0%(95%置信区间[CI],47.4 至 78.1),146 例病例患者和 1000 例对照患者接受了一剂(部分接种),估计调整后的疫苗效力为 35.8%(95%置信区间[CI],22.1 至 47.1)。

结论

在这项使用全国性 EHR 数据的研究中,与对照患者相比,猴痘患者更不可能接种一剂或两剂 JYNNEOS 疫苗。这些发现表明 JYNNEOS 疫苗在预防猴痘疾病方面是有效的,两剂系列疫苗似乎提供了更好的保护。(由疾病控制和预防中心和 Epic 研究资助)。

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