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辉瑞-BioNTech COVID-19 疫苗加强针在 5-11 岁儿童中的安全性监测 - 美国,2022 年 5 月 17 日至 7 月 31 日。

Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5-11 Years - United States, May 17-July 31, 2022.

出版信息

MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1047-1051. doi: 10.15585/mmwr.mm7133a3.


DOI:10.15585/mmwr.mm7133a3
PMID:35980875
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9400528/
Abstract

On May 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine to authorize a homologous* booster dose for children aged 5-11 years ≥5 months after receipt of the second primary series dose (1) based on findings from a clinical trial conducted among 401 children aged 5-11 years (2). To further characterize the safety of booster vaccination in this age group, CDC reviewed adverse events and health impact assessments after receipt of a Pfizer-BioNTech third dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events occurring after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system comanaged by CDC and FDA. During May 17-July 31, 2022, approximately 657,302 U.S. children aged 5-11 years received a third Pfizer-BioNTech dose (either a third primary series dose administered to immunocompromised children or a booster dose administered to immunocompetent children); 3,249 Pfizer-BioNTech third doses were reported to v-safe for children in this age group. Local and systemic reactions were reported to v-safe after a second dose and a third dose with similar frequency; some reactions (e.g., pain) were reported to be moderate or severe more frequently after a third dose. VAERS received 581 reports of adverse events after receipt of a Pfizer-BioNTech third dose by children aged 5-11 years; 578 (99.5%) reports were considered nonserious, and the most common events reported were vaccine administration errors. Three (0.5%) reports were considered serious; no reports of myocarditis or death were received. Local and systemic reactions were common among children after Pfizer-BioNTech third dose vaccination, but reports of serious adverse events were rare. Initial safety findings are consistent with those of the clinical trial (2).

摘要

2022 年 5 月 17 日,美国食品和药物管理局(FDA)修订了 BNT162b2(辉瑞-生物科技)COVID-19 疫苗的紧急使用授权(EUA),授权 5 至 11 岁儿童在完成第二剂基础系列疫苗(1)后≥5 个月接种同源*加强针。这是基于在 401 名 5-11 岁儿童中进行的临床试验结果(2)。为了进一步描述该年龄段加强针接种的安全性,CDC 审查了 v-safe 报告的接种辉瑞-生物科技第三剂后出现的不良事件和健康影响评估,v-safe 是一个用于监测 COVID-19 疫苗接种后不良事件的自愿性基于智能手机的安全监测系统,以及向疫苗不良事件报告系统(VAERS)报告的不良事件,VAERS 是一个由 CDC 和 FDA 共同管理的被动疫苗安全性监测系统。在 2022 年 5 月 17 日至 7 月 31 日期间,美国约有 657302 名 5-11 岁儿童接种了第三剂辉瑞-生物科技疫苗(要么是给免疫功能低下儿童接种的第三剂基础系列疫苗,要么是给免疫功能正常儿童接种的加强针);在这个年龄段,v-safe 报告了 3249 例辉瑞-生物科技第三剂接种。第二剂和第三剂后,局部和全身反应以相似的频率报告给 v-safe;一些反应(如疼痛)在第三剂后报告为中度或重度的频率更高。VAERS 收到了 581 例 5-11 岁儿童接种辉瑞-生物科技第三剂后的不良事件报告;578 例(99.5%)报告被认为是非严重的,最常见的报告事件是疫苗接种错误。有 3 例(0.5%)报告被认为是严重的;没有收到心肌炎或死亡的报告。在儿童接种辉瑞-生物科技第三剂后,局部和全身反应很常见,但严重不良事件报告罕见。初步安全性发现与临床试验一致(2)。

相似文献

[1]
Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5-11 Years - United States, May 17-July 31, 2022.

MMWR Morb Mortal Wkly Rep. 2022-8-19

[2]
Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022.

MMWR Morb Mortal Wkly Rep. 2022-3-4

[3]
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5-11 Years - United States, October 12-January 1, 2023.

MMWR Morb Mortal Wkly Rep. 2023-1-13

[4]
COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021.

MMWR Morb Mortal Wkly Rep. 2021-12-31

[5]
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

[6]
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

[7]
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022.

MMWR Morb Mortal Wkly Rep. 2022-11-4

[8]
Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months-5 Years - United States, June 17, 2022-May 7, 2023.

MMWR Morb Mortal Wkly Rep. 2023-6-9

[9]
Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status - United States, January 12, 2022-March 28, 2022.

MMWR Morb Mortal Wkly Rep. 2022-7-15

[10]
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

引用本文的文献

[1]
Association Between the "We Can Do This" Campaign and COVID-19 Booster Uptake, U.S., 2021-2022.

AJPM Focus. 2024-1-4

[2]
COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic.

Vaccine. 2024-9-17

[3]
Effectiveness of the BNT162b2 vaccine in preventing morbidity and mortality associated with COVID-19 in children aged 5 to 11 years: A systematic review and meta-analysis.

PLOS Glob Public Health. 2023-12-4

[4]
A Rapid Environmental Scan of South Florida HIV Organizations' Mpox Messaging During the August 2022 Peak of the U.S. Outbreak.

AIDS Behav. 2024-5

[5]
Impact of SARS-CoV-2 Infection in Children with Asthma and Impact of COVID-19 Vaccination: Current Evidence and Review of the Literature.

Microorganisms. 2023-7-4

[6]
Using Digital Technology to Build COVID-19 Vaccine Confidence: A Qualitative Study among Latinx Parents of Children Aged 5-11 in Under-Resourced Communities across Los Angeles County.

Vaccines (Basel). 2023-5-30

[7]
Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months-5 Years - United States, June 17, 2022-May 7, 2023.

MMWR Morb Mortal Wkly Rep. 2023-6-9

[8]
Safety and effectiveness of vaccines against COVID-19 in children aged 5-11 years: a systematic review and meta-analysis.

Lancet Child Adolesc Health. 2023-6

[9]
Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds.

J Pediatric Infect Dis Soc. 2023-4-28

[10]
Advancing pediatric medication safety using real-world data: Current problems and potential solutions.

J Hosp Med. 2023-9

本文引用的文献

[1]
Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years.

Pediatrics. 2022-8-1

[2]
Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021.

JAMA. 2022-1-25

[3]
COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021.

MMWR Morb Mortal Wkly Rep. 2021-12-31

[4]
Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

N Engl J Med. 2022-1-6

[5]
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Vaccine. 2015-8-26

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