MMWR Morb Mortal Wkly Rep. 2022 Nov 4;71(44):1401-1406. doi: 10.15585/mmwr.mm7144a3.
On August 31, 2022, the Food and Drug Administration (FDA) authorized bivalent formulations of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines; these vaccines include mRNA encoding the spike protein from the original (ancestral) strain of SARS-CoV-2 (the virus that causes COVID-19) and from the B.1.1.529 (Omicron) variants BA.4 and BA.5 (BA.4/BA.5). These bivalent mRNA vaccines were authorized for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination; Pfizer-BioNTech bivalent booster was authorized for persons aged ≥12 years and Moderna for adults aged ≥18 years.* On September 1, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended that all persons aged ≥12 years receive an age-appropriate bivalent mRNA booster dose. To characterize the safety of bivalent mRNA booster doses, CDC reviewed adverse events and health impacts reported after receipt of bivalent Pfizer-BioNTech and Moderna booster doses during August 31-October 23, 2022, to v-safe, a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and the Vaccine Adverse Event Reporting System (VAERS),** a U.S. passive vaccine safety surveillance system managed by CDC and FDA (1). During August 31-October 23, 2022, approximately 14.4 million persons aged ≥12 years received a bivalent Pfizer-BioNTech booster dose, and 8.2 million adults aged ≥18 years received a bivalent Moderna booster dose. Among the 211,959 registrants aged ≥12 years who reported receiving a bivalent booster dose to v-safe, injection site and systemic reactions were frequently reported in the week after vaccination (60.8% and 54.8%, respectively); fewer than 1% of v-safe registrants reported receiving medical care. VAERS received 5,542 reports of adverse events after bivalent booster vaccination among persons aged ≥12 years; 95.5% of reports were nonserious and 4.5% were serious events. Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses. Health impacts after COVID-19 vaccination are less frequent and less severe than those associated with COVID-19 illness (2).
2022 年 8 月 31 日，食品和药物管理局（FDA）授权使用二价 BNT162b2（辉瑞-生物科技）和 mRNA-1273（莫德纳）COVID-19 疫苗；这些疫苗包含编码原始（祖先）株 SARS-CoV-2 刺突蛋白的 mRNA（引发 COVID-19 的病毒）和 B.1.1.529（奥密克戎）变异株 BA.4 和 BA.5（BA.4/BA.5）。这些二价 mRNA 疫苗被授权作为单剂加强针使用，在完成基础系列或单价加强针接种后至少 2 个月；辉瑞-生物科技的二价加强针被授权用于 12 岁及以上人群，而莫德纳用于 18 岁及以上成年人。*2022 年 9 月 1 日，免疫实践咨询委员会（ACIP）建议所有 12 岁及以上人群接种一剂适合年龄的二价 mRNA 加强针。为了描述二价 mRNA 加强针的安全性，CDC 通过 v-safe 对 2022 年 8 月 31 日至 10 月 23 日期间接种二价辉瑞-生物科技和莫德纳加强针后报告的不良事件和健康影响进行了审查，v-safe 是 CDC 建立的一款自愿使用的基于智能手机的美国安全性监测系统，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），**一个由 CDC 和 FDA 管理的美国被动疫苗安全性监测系统（1）。在 2022 年 8 月 31 日至 10 月 23 日期间，约有 1440 万 12 岁及以上人群接种了二价辉瑞-生物科技加强针，820 万 18 岁及以上成年人接种了二价莫德纳加强针。在向 v-safe 报告接种二价加强针的 211959 名 12 岁及以上登记人群中，接种后一周内经常报告注射部位和全身反应（分别为 60.8%和 54.8%）；不到 1%的 v-safe 登记人群表示接受了医疗护理。VAERS 收到了 12 岁及以上人群接种二价加强针后 5542 份不良事件报告；95.5%的报告是非严重事件，4.5%为严重事件。可以向医疗服务提供者和患者保证，二价加强针接种后报告的不良事件与单价疫苗接种后报告的不良事件一致。COVID-19 疫苗接种后的健康影响比 COVID-19 疾病相关的健康影响更不频繁，也更不严重（2）。
