Ad.26.COV2.S 疫苗上市后安全性监测：2021 年 2 月至 2022 年 2 月向疫苗不良事件报告系统和 v-safe 报告的情况。

Post-authorization safety surveillance of Ad.26.COV2.S vaccine: Reports to the Vaccine Adverse Event Reporting System and v-safe, February 2021-February 2022.

机构信息

Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20903, United States.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1825 Century Center Blvd, Atlanta, GA 303239, United States.

出版信息

Vaccine. 2023 Jul 5;41(30):4422-4430. doi: 10.1016/j.vaccine.2023.06.023. Epub 2023 Jun 14.

DOI:10.1016/j.vaccine.2023.06.023

PMID:37321898

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10264169/

Abstract

BACKGROUND

On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system.

METHODS

VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated.

RESULTS

During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care.

CONCLUSION

Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.

摘要

背景

2021 年 2 月 27 日，FDA 授权 Janssen COVID-19 疫苗（Ad.26.COV2.S）用于 18 岁及以上人群。疫苗安全性通过疫苗不良事件报告系统（VAERS）、国家被动监测系统和基于智能手机的 v-safe 监测系统进行监测。

方法

对 2021 年 2 月 27 日至 2022 年 2 月 28 日的 VAERS 和 v-safe 数据进行了分析。描述性分析包括性别、年龄、种族/民族、严重程度、特别关注的不良事件（AESI）和死因。对于预先指定的 AESI，使用 Ad26.COV2.S 接种的总剂量计算报告率。对于心肌炎，根据已核实病例数、疫苗接种数据和已发表的背景发病率进行观察到的预期（O/E）分析。计算了 v-safe 参与者报告局部和全身反应以及健康影响的比例。

结果

在分析期间，美国共接种了 17018042 剂 Ad26.COV2.S，VAERS 在 Ad26.COV2.S 接种后收到了 67995 例 AESI 报告。大多数 AESI（59750；87.9%）为非严重事件，与临床试验中观察到的事件相似。严重 AESI 包括 COVID-19 疾病、凝血障碍（包括血栓性血小板减少综合征；TTS）、心肌梗死、贝尔氏面瘫和格林-巴利综合征（GBS）。在 AESI 中，每接种百万剂 Ad26.COV2.S 的报告率从儿童多系统炎症综合征的 0.06 到 COVID-19 疾病的 263.43。O/E 分析显示心肌炎的报告率比值（RR）升高；在 18-64 岁的成年人中，接种后 7 天的 RR 为 3.19（95%CI 2.00，4.83），接种后 21 天的 RR 为 1.79（95%CI 1.26，2.46）。在 416384 名接受 v-safe 登记的 Ad26.COV2.S 接种者中，60.9%报告有局部症状（如注射部位疼痛），75.9%报告有全身症状（如疲劳、头痛）。三分之一的参与者（141334 人；33.9%）报告了健康影响，但只有 1.4%寻求医疗。