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COVID-19 疫苗追加剂量的安全性监测 - 美国,2021 年 8 月 12 日至 9 月 19 日。

Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021.

机构信息

CDC COVID-19 Response Team.

出版信息

MMWR Morb Mortal Wkly Rep. 2021 Oct 1;70(39):1379-1384. doi: 10.15585/mmwr.mm7039e4.


DOI:10.15585/mmwr.mm7039e4
PMID:34591835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8486391/
Abstract

On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose after completion of a primary vaccination series to eligible persons with moderate to severe immunocompromising conditions (1,2). On September 22, 2021, FDA authorized an additional dose of Pfizer-BioNTech vaccine ≥6 months after completion of the primary series among persons aged ≥65 years, at high risk for severe COVID-19, or whose occupational or institutional exposure puts them at high risk for COVID-19 (1). Results from a phase 3 clinical trial conducted by Pfizer-BioNTech that included 306 persons aged 18-55 years showed that adverse reactions after receipt of a third dose administered 5-8 months after completion of a 2-dose primary mRNA vaccination series were similar to those reported after receipt of dose 2; these adverse reactions included mild to moderate injection site and systemic reactions (3). CDC developed v-safe, a voluntary, smartphone-based safety surveillance system, to provide information on adverse reactions after COVID-19 vaccination. Coincident with authorization of an additional dose for persons with immunocompromising conditions, the v-safe platform was updated to allow registrants to enter information about additional doses of COVID-19 vaccine received. During August 12-September 19, 2021, a total of 22,191 v-safe registrants reported receipt of an additional dose of COVID-19 vaccine. Most (97.6%) reported a primary 2-dose mRNA vaccination series followed by a third dose of the same vaccine. Among those who completed a health check-in survey for all 3 doses (12,591; 58.1%), 79.4% and 74.1% reported local or systemic reactions, respectively, after dose 3, compared with 77.6% and 76.5% who reported local or systemic reactions, respectively, after dose 2. These initial findings indicate no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine; most of these adverse reactions were mild or moderate. CDC will continue to monitor vaccine safety, including the safety of additional doses of COVID-19 vaccine, and provide data to guide vaccine recommendations and protect public health.

摘要

2021 年 8 月 12 日,食品和药物管理局 (FDA) 修订了辉瑞-生物科技和 Moderna COVID-19 疫苗的紧急使用授权 (EUA),授权在符合条件的中度至重度免疫功能低下人群完成初级疫苗接种系列后,额外接种一剂疫苗(1,2)。2021 年 9 月 22 日,FDA 授权 Pfizer-BioNTech 疫苗在完成初级系列 ≥6 个月后,为年龄 ≥65 岁的人群、有发生严重 COVID-19 的高危人群或职业或机构暴露使他们有感染 COVID-19 的高风险的人群接种额外一剂(1)。辉瑞-生物科技公司开展的一项 3 期临床试验纳入了 306 名 18-55 岁人群,结果显示,在完成 2 剂 mRNA 初级疫苗接种系列 5-8 个月后接种第 3 剂,不良反应与接种第 2 剂后报告的不良反应相似;这些不良反应包括轻度至中度注射部位和全身反应(3)。为提供 COVID-19 疫苗接种后不良反应信息,CDC 开发了 v-safe,一个基于智能手机的自愿安全性监测系统。与免疫功能低下人群接种额外剂量授权同时,v-safe 平台已更新,允许注册者输入已接种的 COVID-19 疫苗额外剂量信息。2021 年 8 月 12 日至 9 月 19 日,共有 22191 名 v-safe 注册者报告接种了额外剂量的 COVID-19 疫苗。大多数(97.6%)报告接种了 2 剂 mRNA 初级疫苗系列,随后接种了相同疫苗的第 3 剂。在完成所有 3 剂疫苗健康登记调查的人群中(12591 人,占 58.1%),第 3 剂后分别有 79.4%和 74.1%报告出现局部或全身反应,而第 2 剂后分别有 77.6%和 76.5%报告出现局部或全身反应(4)。这些初步发现表明,COVID-19 疫苗额外剂量接种后无不良反应的意外模式;大多数不良反应为轻度或中度。CDC 将继续监测疫苗安全性,包括 COVID-19 疫苗额外剂量的安全性,并提供数据以指导疫苗推荐,保护公众健康。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0abf/8486391/df3b2f6a715a/mm7039e4-F.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0abf/8486391/df3b2f6a715a/mm7039e4-F.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0abf/8486391/df3b2f6a715a/mm7039e4-F.jpg

相似文献

[1]
Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021.

MMWR Morb Mortal Wkly Rep. 2021-10-1

[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Genome-wide association study of common side effects following COVID-19 booster vaccination in a cohort of corporate employees in Japan.

Sci Rep. 2025-4-13

[2]
Attitudes and beliefs regarding COVID-19 and COVID-19 Omicron booster vaccine among adults in the vaccine safety datalink, 2022-2023.

Hum Vaccin Immunother. 2025-12

[3]
COVID-19 clinical presentation, management, and epidemiology: a concise compendium.

Front Public Health. 2025-1-31

[4]
COVID-19 vaccines: current and future challenges.

Front Pharmacol. 2024-11-6

[5]
Clinical presentation, associated factors, and course of cutaneous reaction after the booster dose of COVID-19 vaccination.

Clin Exp Vaccine Res. 2024-10

[6]
Seroconversion and safety of Covid-19 vaccines in pa-tients with chronic liver disease and liver transplant: A systematic review.

Qatar Med J. 2023-12-12

[7]
Integration of Cellular and Humoral Immune Responses as an Immunomonitoring Tool for SARS-CoV-2 Vaccination in Healthy and Fragile Subjects.

Viruses. 2023-5-30

[8]
Prevalence and risk factors of adverse effects after the first COVID-19 booster dose: evidence from Greece.

Vacunas. 2023-5-26

[9]
Systematic review and meta-analysis of myocarditis and pericarditis in adolescents following COVID-19 BNT162b2 vaccination.

NPJ Vaccines. 2023-6-9

[10]
Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea.

Epidemiol Health. 2023

本文引用的文献

[1]
Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance - Eight U.S. Locations, December 2020-August 2021.

MMWR Morb Mortal Wkly Rep. 2021-8-27

[2]
Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings - Barnstable County, Massachusetts, July 2021.

MMWR Morb Mortal Wkly Rep. 2021-8-6

[3]
Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines.

JAMA. 2021-6-1

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