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