疫苗安全数据链接中 COVID-19 疫苗接种后吉兰-巴雷综合征的发生率。

Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink.

机构信息

Marshfield Clinic Research Institute, Marshfield, Wisconsin.

Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California.

出版信息

JAMA Netw Open. 2022 Apr 1;5(4):e228879. doi: 10.1001/jamanetworkopen.2022.8879.

DOI:10.1001/jamanetworkopen.2022.8879

PMID:35471572

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9044108/

Abstract

IMPORTANCE

Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as Guillain-Barré syndrome (GBS), which has a background rate of 1 to 2 per 100 000 person-years.

OBJECTIVE

To describe cases and incidence of GBS following COVID-19 vaccination and assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used surveillance data from the Vaccine Safety Datalink at 8 participating integrated health care systems in the United States. There were 10 158 003 participants aged at least 12 years. Data analysis was performed from November 2021 to February 2022.

EXPOSURES

Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine, including mRNA vaccine doses 1 and 2, December 13, 2020, to November 13, 2021.

MAIN OUTCOMES AND MEASURES

GBS with symptom onset in the 1 to 84 days after vaccination, confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared with the background rate, rate ratios (RRs) comparing GBS incidence in the 1 to 21 vs 22 to 42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs mRNA vaccination, using Poisson regression adjusted for age, sex, race and ethnicity, site, and calendar day.

RESULTS

From December 13, 2020, through November 13, 2021, 15 120 073 doses of COVID-19 vaccines were administered to 7 894 989 individuals (mean [SE] age, 46.5 [0.02] years; 8 138 318 doses received [53.8%] by female individuals; 3 671 199 doses received [24.3%] by Hispanic or Latino individuals, 2 215 064 doses received [14.7%] by Asian individuals, 6 266 424 doses received [41.4%] by White individuals), including 483 053 Ad.26.COV2.S doses, 8 806 595 BNT162b2 doses, and 5 830 425 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of GBS per 100 000 person-years in the 1 to 21 days after Ad.26.COV2.S was 32.4 (95% CI, 14.8-61.5), significantly higher than the background rate, and the adjusted RR in the 1 to 21 vs 22 to 42 days following Ad.26.COV2.S was 6.03 (95% CI, 0.79-147.79). Thirty-six cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate per 100 000 person-years in the 1 to 21 days after mRNA vaccines was 1.3 (95% CI, 0.7-2.4) and the adjusted RR in the 1 to 21 vs 22 to 42 days following mRNA vaccines was 0.56 (95% CI, 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs mRNA vaccines, the adjusted RR was 20.56 (95% CI, 6.94-64.66).

CONCLUSIONS AND RELEVANCE

In this cohort study of COVID-19 vaccines, the incidence of GBS was elevated after receiving the Ad.26.COV2.S vaccine. Surveillance is ongoing.

摘要

重要性

在大规模人群中进行疫苗接种后的授权后监测，可能会发现临床试验中未识别到的罕见不良事件，例如吉兰-巴雷综合征 (GBS)，其背景发生率为每 100000 人年 1 至 2 例。

目的

描述 COVID-19 疫苗接种后 GBS 的病例和发生率，并评估 Ad.26.COV2.S (Janssen) 和 mRNA 疫苗接种后 GBS 的风险。

设计、地点和参与者：这项队列研究使用了美国 8 个参与综合医疗保健系统的疫苗安全数据链接的监测数据。参与者至少为 12 岁，共有 10458003 人。数据分析于 2021 年 11 月至 2022 年 2 月进行。

暴露

Ad.26.COV2.S、BNT162b2（辉瑞-生物技术）或 mRNA-1273（Moderna）COVID-19 疫苗，包括 mRNA 疫苗的第 1 剂和第 2 剂，于 2020 年 12 月 13 日至 2021 年 11 月 13 日接种。

主要结果和措施

接种后 1 至 84 天出现 GBS 症状，通过病历回顾和裁决确认。描述确诊病例的特征，每种疫苗接种后接种后风险间隔期间的 GBS 发生率与背景率相比、1 至 21 天与 22 至 42 天接种后 GBS 发生率的比值比（RR），以及 Ad.26.COV2.S 与 mRNA 疫苗接种后 GBS 风险的直接比较，使用泊松回归调整年龄、性别、种族和民族、地点和日历日。

结果

从 2020 年 12 月 13 日至 2021 年 11 月 13 日，共有 15120073 剂 COVID-19 疫苗接种给 7894989 人（平均[SE]年龄，46.5[0.02]岁；8138318 剂由女性接种[53.8%]；3671199 剂由西班牙裔或拉丁裔接种[24.3%]，2215064 剂由亚裔接种[14.7%]，6266424 剂由白人接种[41.4%]），其中包括 483053 剂 Ad.26.COV2.S、8806595 剂 BNT162b2 和 5830425 剂 mRNA-1273。确认了 11 例 Ad.26.COV2.S 接种后的 GBS 病例。Ad.26.COV2.S 接种后 1 至 21 天内 GBS 的未调整发病率为每 100000 人年 32.4（95%CI，14.8-61.5），显著高于背景率，Ad.26.COV2.S 接种后 1 至 21 天与 22 至 42 天的调整 RR 为 6.03（95%CI，0.79-147.79）。mRNA 疫苗接种后确认了 36 例 GBS 病例。mRNA 疫苗接种后 1 至 21 天内 GBS 的未调整发病率为每 100000 人年 1.3（95%CI，0.7-2.4），mRNA 疫苗接种后 1 至 21 天与 22 至 42 天的调整 RR 为 0.56（95%CI，0.21-1.48）。在 Ad.26.COV2.S 与 mRNA 疫苗的头对头比较中，调整后的 RR 为 20.56（95%CI，6.94-64.66）。