MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70(8):283-288. doi: 10.15585/mmwr.mm7008e3.
Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program (4). CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020-January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious. The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.
两种 2019 冠状病毒病(COVID-19)疫苗目前已在美国获得使用授权。美国食品和药物管理局(FDA)分别于 2020 年 12 月 11 日和 12 月 18 日为辉瑞-生物科技 COVID-19 疫苗和 Moderna COVID-19 疫苗发布了紧急使用授权(EUA);两种疫苗均为 2 剂系列。免疫实践咨询委员会(Advisory Committee on Immunization Practices)分别于 2020 年 12 月 12 日和 2020 年 12 月 19 日为辉瑞-生物科技和 Moderna COVID-19 疫苗发布了临时建议;初始剂量建议用于医疗保健人员和长期护理机构(LTCF)居民(3)。在 COVID-19 全国疫苗接种计划的初始实施阶段,使用疫苗不良事件报告系统(VAERS)、一个自发报告系统,以及 v-safe*,一个主动监测系统,对这些疫苗进行了最密集和全面的安全性监测(4)。CDC 对疫苗接种第一个月(2020 年 12 月 14 日至 2021 年 1 月 13 日)的安全性数据进行了描述性分析。在此期间,共接种了 13794904 剂疫苗,VAERS 收到并处理了 6994 例接种后不良事件报告,其中 6354 例(90.8%)被归类为非严重事件,640 例(9.2%)为严重事件。向 VAERS 报告的最常见症状是头痛(22.4%)、疲劳(16.5%)和头晕(16.5%)。VAERS 共报告了 113 例死亡,其中 78 例(65%)发生在长期护理机构居民中;从 VAERS 报告和医疗保健提供者的死亡证明、尸检报告、病历和临床描述中获得的信息并未表明 COVID-19 疫苗接种与死亡之间存在任何因果关系。报告了两种疫苗接种后罕见的过敏反应病例(每百万剂接种 4.5 例报告)。在接种辉瑞-生物科技疫苗的人群中,v-safe 系统报告的反应在第二剂后比第一剂后更为常见。目前正在使用的两种 COVID-19 疫苗的初始授权后安全性概况并未表明存在意外严重不良事件的证据。这些数据为医疗保健提供者和疫苗接种者提供了接种后的安全性信息。
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