MMWR Morb Mortal Wkly Rep. 2020 Dec 11;69(49):1857-1859. doi: 10.15585/mmwr.mm6949e1.
The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic that has disrupted all sectors of society. Less than 1 year after the SARS-CoV-2 genome was first sequenced, an application* for Emergency Use Authorization for a candidate vaccine has been filed with the Food and Drug Administration (FDA). However, even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program. The Advisory Committee on Immunization Practices (ACIP) advises CDC on population groups and circumstances for vaccine use. ACIP convened on December 1, 2020, in advance of the completion of FDA's review of the Emergency Use Authorization application, to provide interim guidance to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both 1) health care personnel and 2) residents of long-term care facilities (LTCFs) be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a**). In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles. The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization.
SARS-CoV-2 的出现导致了 2019 年冠状病毒病(COVID-19)的全球大流行,扰乱了社会的各个领域。在首次对 SARS-CoV-2 基因组进行测序不到 1 年后,已向美国食品和药物管理局(FDA)提交了一种候选疫苗的紧急使用授权申请。但是,即使有一个或多个疫苗候选者获得紧急使用授权,在国家疫苗接种计划的头几个月,对 COVID-19 疫苗的需求预计将超过供应。免疫实践咨询委员会(ACIP)就疫苗使用的人群和情况向 CDC 提供建议。ACIP 于 2020 年 12 月 1 日在 FDA 审查紧急使用授权申请完成之前召开会议,就 COVID-19 疫苗的初始剂量分配向联邦、州和地方司法管辖区提供临时指导。ACIP 建议,当 FDA 授权和 ACIP 推荐 COVID-19 疫苗时,1)医护人员和 2)长期护理机构(LTCF)的居民应在 COVID-19 疫苗接种计划的初始阶段(阶段 1a**)接种疫苗。在审议过程中,ACIP 考虑了 SARS-CoV-2 流行病学、疫苗接种计划实施和伦理原则的科学证据。根据 III 期临床试验的更多安全性和有效性数据以及 FDA 紧急使用授权的条件,临时建议可能会在未来几周内更新。