MMWR Morb Mortal Wkly Rep. 2022 Feb 18;71(7):249-254. doi: 10.15585/mmwr.mm7107e1.
During September 22, 2021-February 6, 2022, approximately 82.6 million U.S. residents aged ≥18 years received a COVID-19 vaccine booster dose.* The Food and Drug Administration (FDA) has authorized a booster dose of either the same product administered for the primary series (homologous) or a booster dose that differs from the product administered for the primary series (heterologous). These booster authorizations apply to all three COVID-19 vaccines used in the United States (1-3). The Advisory Committee on Immunization Practices (ACIP) recommended preferential use of an mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer-BioNTech]) for a booster, even for persons who received the Ad26.COV2.S (Janssen [Johnson & Johnson]) COVID-19 vaccine for their single-dose primary series. To characterize the safety of COVID-19 vaccine boosters among persons aged ≥18 years during September 22, 2021-February 6, 2022, CDC reviewed adverse events and health impact assessments following receipt of a booster that were reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. Among 721,562 v-safe registrants aged ≥18 years who reported receiving a booster, 88.8% received homologous COVID-19 mRNA vaccination. Among registrants who reported a homologous COVID-19 mRNA booster dose, systemic reactions were less frequent following the booster (58.4% [Pfizer-BioNTech] and 64.4% [Moderna], respectively) than were those following dose 2 (66.7% and 78.4%, respectively). The adjusted odds of reporting a systemic reaction were higher following a Moderna COVID-19 vaccine booster, irrespective of the vaccine received for the primary series. VAERS has received 39,286 reports of adverse events after a COVID-19 mRNA booster vaccination for adults aged ≥18 years, including 36,282 (92.4%) nonserious and 3,004 (7.6%) serious events. Vaccination providers should educate patients that local and systemic reactions are expected following a homologous COVID-19 mRNA vaccine booster; however, these reactions appear less common than those following dose 2 of an mRNA-based vaccine. CDC and FDA will continue to monitor vaccine safety and provide data to guide vaccine recommendations and protect public health.
在 2021 年 9 月 22 日至 2022 年 2 月 6 日期间，大约有 8260 万 18 岁及以上的美国居民接种了 COVID-19 疫苗加强针。*美国食品和药物管理局（FDA）已经授权接种与基础系列相同的产品（同源）或与基础系列产品不同的加强针（异源）。这些加强针的授权适用于美国使用的三种 COVID-19 疫苗（1-3）。免疫实践咨询委员会（ACIP）建议优先使用 mRNA COVID-19 疫苗（mRNA-1273[Moderna]或 BNT162b2[辉瑞-BioNTech]）作为加强针，即使是那些接受过 Ad26.COV2.S（Janssen[强生]）COVID-19 疫苗进行单剂基础系列接种的人。为了描述 2021 年 9 月 22 日至 2022 年 2 月 6 日期间 18 岁及以上人群接种 COVID-19 疫苗加强针的安全性，CDC 审查了 v-safe 报告的不良事件和健康影响评估，v-safe 是一个自愿的基于智能手机的 COVID-19 疫苗接种后不良事件安全监测系统，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 管理的被动疫苗安全监测系统。在 721562 名报告接种加强针的 18 岁及以上 v-safe 注册者中，88.8%接种了同源 COVID-19 mRNA 疫苗。在报告接种同源 COVID-19 mRNA 加强针的注册者中，加强针后的全身反应（分别为 58.4%[辉瑞-BioNTech]和 64.4%[Moderna]）比第二针后的全身反应（分别为 66.7%和 78.4%）更不常见。接种 Moderna COVID-19 疫苗加强针后报告全身反应的调整后几率更高，而不论基础系列接种的疫苗如何。VAERS 收到了 39286 份 18 岁及以上成年人接种 COVID-19 mRNA 加强针后的不良事件报告，其中 36282 份（92.4%）为非严重事件，3004 份（7.6%）为严重事件。疫苗接种提供者应告知患者，接种同源 COVID-19 mRNA 疫苗加强针后会出现局部和全身反应；然而，这些反应似乎比 mRNA 疫苗的第二针更不常见。CDC 和 FDA 将继续监测疫苗安全性，并提供数据以指导疫苗建议并保护公众健康。
