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在报告 Janssen(强生)和 mRNA COVID-19 疫苗(辉瑞-生物科技和莫德纳)成年受种者发生不良事件后使用 COVID-19 疫苗:免疫实践咨询委员会的更新-美国,2021 年 7 月。

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.

出版信息

MMWR Morb Mortal Wkly Rep. 2021 Aug 13;70(32):1094-1099. doi: 10.15585/mmwr.mm7032e4.


DOI:10.15585/mmwr.mm7032e4
PMID:34383735
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8360272/
Abstract

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public.

摘要

2020 年 12 月,食品和药物管理局(FDA)发布了辉瑞-生物技术公司和 Moderna COVID-19 疫苗的紧急使用授权(EUA),并于 2021 年 2 月发布了强生(Johnson & Johnson)COVID-19 疫苗的 EUA。在每次 EUA 之后,免疫实践咨询委员会(ACIP)都会发布疫苗使用的临时建议;目前,辉瑞-生物技术公司的疫苗被授权并推荐用于 12 岁及以上人群,Moderna 和强生的疫苗被授权用于 18 岁及以上人群(1-3)。辉瑞-生物技术公司和 Moderna 疫苗均作为 2 剂系列接种,均为基于 mRNA 的 COVID-19 疫苗,而强生 COVID-19 疫苗作为单剂接种,是一种重组复制缺陷型腺病毒载体疫苗。截至 2021 年 7 月 22 日,美国已有 1.87 亿人至少接种了一剂 COVID-19 疫苗(4);对安全性监测的密切监测表明,COVID-19 疫苗接种后严重不良事件罕见(5,6)。有三种与 COVID-19 疫苗接种相关的医疗条件已报告。其中两种(血栓性血小板减少综合征[TTS],一种以静脉或动脉血栓形成和血小板减少为特征的罕见综合征,以及吉兰-巴雷综合征[GBS],一种以进行性无力和瘫痪为特征的罕见自身免疫性神经系统疾病)已在强生 COVID-19 疫苗接种后报告。一种(心肌炎,心脏炎症)在辉瑞-生物技术公司 COVID-19 疫苗或 Moderna COVID-19 疫苗接种后,特别是在第二剂后,已报告;这些情况已一并审查,此后将统称为 mRNA COVID-19 疫苗接种。ACIP 已三次开会审查与这些严重不良事件报告相关的数据,并全面评估了这些疫苗接种的益处和风险。在 2021 年 7 月的最近一次会议上,ACIP 确定,总体而言,COVID-19 疫苗接种在预防 COVID-19 发病率和死亡率方面的益处超过了 18 岁及以上成年人中这些罕见严重不良事件的风险;这种收益与风险的平衡因年龄和性别而异。ACIP 继续建议所有 12 岁及以上的人接种 COVID-19 疫苗。CDC 和 FDA 将继续密切监测严重不良事件报告,并将任何额外数据提交给 ACIP 审议。应向提供者、疫苗接种者和公众传播有关风险及其如何因年龄和性别以及疫苗类型而异的信息。

相似文献

[1]
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.

MMWR Morb Mortal Wkly Rep. 2021-8-13

[2]
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021.

MMWR Morb Mortal Wkly Rep. 2021-7-9

[3]
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021.

MMWR Morb Mortal Wkly Rep. 2021-4-30

[4]
The Advisory Committee on Immunization Practices' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021.

MMWR Morb Mortal Wkly Rep. 2021-11-5

[5]
Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021.

MMWR Morb Mortal Wkly Rep. 2022-1-21

[6]
Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2021.

MMWR Morb Mortal Wkly Rep. 2021-9-24

[7]
Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021.

MMWR Morb Mortal Wkly Rep. 2021-5-7

[8]
COVID-19 Vaccine Safety in Adolescents Aged 12-17 Years - United States, December 14, 2020-July 16, 2021.

MMWR Morb Mortal Wkly Rep. 2021-8-6

[9]
Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults - United States, September 22, 2021-February 6, 2022.

MMWR Morb Mortal Wkly Rep. 2022-2-18

[10]
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020.

MMWR Morb Mortal Wkly Rep. 2020-12-18

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[2]
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[3]
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Int J Prev Med. 2025-3-21

[4]
Quantitative Benefit-Risk Assessment of Vaccination Against COVID-19: A Systematic Review.

Pharmacoepidemiol Drug Saf. 2025-2

[5]
Adverse events following COVID-19 vaccination: A comprehensive analysis of spontaneous reporting data in Ghana.

PLOS Glob Public Health. 2024-9-27

[6]
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Arch Toxicol. 2024-11

[7]
Safety pharmacology of human endogenous retrovirus-enveloped baculoviral DNA vaccines against SARS-CoV-2 in Sprague-Dawley rats and beagle dogs.

Vaccine X. 2024-8-3

[8]
COVID-19 Vaccines Breakthrough Infections and Adverse Effects Reported by the Birzeit University Community in Palestine.

Int J Gen Med. 2024-7-30

[9]
Vaccine patterns among older adults with Guillain-Barré syndrome and matched comparators, 2006-2019.

J Am Geriatr Soc. 2024-10

[10]
Long COVID Definition, Symptoms, Risk Factors, Epidemiology and Autoimmunity: A Narrative Review.

Am J Med Open. 2024-2-14

本文引用的文献

[1]
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021.

MMWR Morb Mortal Wkly Rep. 2021-7-9

[2]
Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021.

MMWR Morb Mortal Wkly Rep. 2021-5-7

[3]
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021.

MMWR Morb Mortal Wkly Rep. 2021-4-30

[4]
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Janssen COVID-19 Vaccine - United States, February 2021.

MMWR Morb Mortal Wkly Rep. 2021-3-5

[5]
First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021.

MMWR Morb Mortal Wkly Rep. 2021-2-26

[6]
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020.

MMWR Morb Mortal Wkly Rep. 2021-1-1

[7]
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020.

MMWR Morb Mortal Wkly Rep. 2020-12-18

[8]
Guillain-Barré syndrome: pathogenesis, diagnosis, treatment and prognosis.

Nat Rev Neurol. 2014-7-15

[9]
Population incidence of Guillain-Barré syndrome: a systematic review and meta-analysis.

Neuroepidemiology. 2011-3-21

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