MMWR Morb Mortal Wkly Rep. 2021 Dec 31;70(5152):1755-1760. doi: 10.15585/mmwr.mm705152a1.
On October 29, 2021, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) mRNA vaccine to expand its use to children aged 5-11 years, administered as 2 doses (10 μg, 0.2mL each) 3 weeks apart (1). As of December 19, 2021, only the Pfizer-BioNTech COVID-19 vaccine is authorized for administration to children aged 5-17 years (2,3). In preauthorization clinical trials, Pfizer-BioNTech COVID-19 vaccine was administered to 3,109 children aged 5-11 years; most adverse events were mild to moderate, and no serious adverse events related to vaccination were reported (4). To further characterize safety of the vaccine in children aged 5-11 years, CDC reviewed adverse events after receipt of Pfizer-BioNTech COVID-19 vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system co-managed by CDC and FDA, and adverse events and health impact assessments reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination,* during November 3-December 19, 2021. Approximately 8.7 million doses of Pfizer-BioNTech COVID-19 vaccine were administered to children aged 5-11 years during this period; VAERS received 4,249 reports of adverse events after vaccination with Pfizer-BioNTech COVID-19 vaccine in this age group, 4,149 (97.6%) of which were not serious. Approximately 42,504 children aged 5-11 years were enrolled in v-safe after vaccination with Pfizer-BioNTech COVID-19 vaccine; after dose 2, a total of 17,180 (57.5%) local and 12,223 systemic (40.9%) reactions (including injection-site pain, fatigue, or headache) were reported. The preliminary safety findings are similar to those from preauthorization clinical trials (4,5). The Advisory Committee on Immunization Practices (ACIP) recommends the Pfizer-BioNTech COVID-19 vaccine for children aged 5-11 years for the prevention of COVID-19 (6). Parents and guardians of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 vaccine should be advised that local and systemic reactions are expected after vaccination. Vaccination is the most effective way to prevent COVID-19. CDC and FDA will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations.
2021 年 10 月 29 日，食品和药物管理局（FDA）修订了辉瑞-生物技术公司 COVID-19（BNT162b2）mRNA 疫苗的紧急使用授权（EUA），将其使用范围扩大到 5-11 岁儿童，接种剂量为 2 剂（10 μg，每剂 0.2 mL），间隔 3 周（1）。截至 2021 年 12 月 19 日，只有辉瑞-生物技术公司 COVID-19 疫苗被授权用于 5-17 岁儿童（2,3）。在预授权临床试验中，辉瑞-生物技术公司 COVID-19 疫苗接种给 3109 名 5-11 岁儿童；大多数不良事件为轻度至中度，未报告与接种疫苗相关的严重不良事件（4）。为了进一步描述 5-11 岁儿童接种疫苗的安全性，CDC 审查了 2021 年 11 月 3 日至 12 月 19 日期间通过疫苗不良事件报告系统（VAERS）报告的辉瑞-生物技术公司 COVID-19 疫苗接种后不良事件，VAERS 是由 CDC 和 FDA 共同管理的被动疫苗安全性监测系统，以及通过 v-safe 报告的不良事件和健康影响评估，v-safe 是 COVID-19 疫苗接种后不良事件的自愿智能手机监测系统，在这一年龄组中，VAERS 收到了 4249 例辉瑞-生物技术公司 COVID-19 疫苗接种后不良事件报告，其中 4149 例（97.6%）为非严重不良事件。约有 42504 名 5-11 岁儿童在接种辉瑞-生物技术公司 COVID-19 疫苗后在 v-safe 中注册；接种第 2 剂后，共有 17180 例（57.5%）局部和 12223 例（40.9%）全身（包括注射部位疼痛、疲劳或头痛）反应报告。初步安全性发现与预授权临床试验相似（4,5）。免疫实践咨询委员会（ACIP）建议为 5-11 岁儿童接种辉瑞-生物技术公司 COVID-19 疫苗，以预防 COVID-19（6）。父母和监护人应告知 5-11 岁接种辉瑞-生物技术公司 COVID-19 疫苗的儿童，接种后预计会出现局部和全身反应。接种疫苗是预防 COVID-19 的最有效方法。CDC 和 FDA 将继续监测疫苗安全性，并根据需要提供更新信息，以指导 COVID-19 疫苗接种建议。
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