MMWR Morb Mortal Wkly Rep. 2023 Jan 13;72(2):39-43. doi: 10.15585/mmwr.mm7202a5.
On October 12, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for bivalent (mRNA encoding the spike protein from the SARS-CoV-2 ancestral strain and BA.4/BA.5 Omicron variants) formulations of Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination for children aged 5-11 years (Pfizer-BioNTech) and 6-17 years (Moderna); on December 8, 2022, FDA amended the EUAs to include children aged ≥6 months (1,2). The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose (3). The safety of bivalent mRNA booster doses among persons aged ≥12 years has previously been described (4). To characterize the safety of bivalent mRNA booster doses among children aged 5-11 years after receipt of bivalent Pfizer-BioNTech and Moderna booster doses, CDC reviewed adverse events and health impacts reported to v-safe,* a voluntary, smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and to the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system co-managed by CDC and FDA (5). During October 12-January 1, 2023, a total of 861,251 children aged 5-11 years received a bivalent Pfizer-BioNTech booster, and 92,108 children aged 6-11 years received a bivalent Moderna booster. Among 3,259 children aged 5-11 years registered in v-safe who received a bivalent booster dose, local (68.7%) and systemic reactions (49.5%) were commonly reported in the week after vaccination. Approximately 99.8% of reports to VAERS for children aged 5-11 years after bivalent booster vaccination were nonserious. There were no reports of myocarditis or death after bivalent booster vaccination. Eighty-four percent of VAERS reports were related to vaccination errors, 90.5% of which did not list an adverse health event. Local and systemic reactions reported after receipt of a bivalent booster dose are consistent with those reported after a monovalent booster dose; serious adverse events are rare. Vaccine providers should provide this information when counseling parents or guardians about bivalent booster vaccination. Preliminary safety findings from the first 11 weeks of bivalent booster vaccination among children aged 5-11 years are reassuring. Compared with the low risk of serious health effects after mRNA COVID-19 vaccination, the health effects of SARS-CoV-2 infection include death and serious long-term sequalae (6). ACIP recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose ≥2 months after completion of a COVID-19 primary series or receipt of a monovalent booster dose..
2022 年 10 月 12 日,美国食品和药物管理局(FDA)发布了辉瑞-生物技术公司和 Moderna mRNA COVID-19 疫苗的二价(编码 SARS-CoV-2 原始株和 BA.4/BA.5 奥密克戎变体的刺突蛋白的 mRNA)配方的紧急使用授权(EUA),用于 5-11 岁儿童(辉瑞-生物技术公司)和 6-17 岁儿童(Moderna)完成初级系列或单价加强针接种后≥2 个月作为单一加强针剂量使用;2022 年 12 月 8 日,FDA 修订了 EUA,将≥6 个月(1、2)的儿童纳入其中。免疫实践咨询委员会(ACIP)建议所有≥6 个月的人接种适合年龄的二价 mRNA 加强针(3)。先前已经描述了≥12 岁人群中二价 mRNA 加强针的安全性(4)。为了描述 5-11 岁儿童接种二价辉瑞-生物技术公司和 Moderna 加强针后二价 mRNA 加强针的安全性,CDC 审查了 v-safe报告的不良事件和健康影响,v-safe是由 CDC 建立的自愿、基于智能手机的美国安全监测系统,用于监测 COVID-19 疫苗接种后的不良事件,以及疫苗不良事件报告系统(VAERS),这是一个由 CDC 和 FDA 共同管理的美国被动疫苗安全监测系统(5)。2023 年 10 月 12 日至 1 月 1 日期间,共有 861,251 名 5-11 岁儿童接种了二价辉瑞-生物技术公司加强针,92,108 名 6-11 岁儿童接种了二价 Moderna 加强针。在 v-safe 中登记的 3,259 名 5-11 岁接受二价加强针的儿童中,接种后一周内常见局部(68.7%)和全身反应(49.5%)。VAERS 报告的 5-11 岁儿童接种二价疫苗后的不良事件中,约 99.8%为非严重不良事件。接种二价疫苗后,无心肌炎或死亡报告。VAERS 报告中有 84%与疫苗接种错误有关,其中 90.5%未列出不良健康事件。接种二价加强针后报告的局部和全身反应与接种单价加强针后报告的反应一致;严重不良事件罕见。疫苗提供者在为父母或监护人提供二价加强针接种咨询时,应提供这些信息。5-11 岁儿童接种二价疫苗的最初 11 周的初步安全性发现令人安心。与 mRNA COVID-19 疫苗接种的严重健康影响风险低相比,SARS-CoV-2 感染的健康影响包括死亡和严重的长期后遗症(6)。ACIP 建议所有≥6 个月的人在完成 COVID-19 初级系列或接种单价加强针后≥2 个月,接种适合年龄的二价 mRNA 加强针。
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