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The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States 2020

机译:免疫实践咨询委员会分配Covid-19疫苗初始供应的临时建议 - 美国2020

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摘要

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.
机译:SARS-COV-2的出现,导致冠状病毒疾病2019(Covid-19)的病毒导致了一个扰乱了所有社会部门的全球大流行。在第一次测序SARS-COV-2基因组后不到1年,已经向候选疫苗进行了紧急使用授权的申请*已提交食品和药物管理局(FDA)。但是,即使一个或多个疫苗候选人接受紧急使用授权,也有望在国家疫苗接种计划的第一个月内超过供应。免疫惯例(ACIP)咨询委员会(ACIP)建议CDC对疫苗使用的人口群体和情况。†ACIP于2020年12月1日召开,提前完成FDA对紧急使用授权申请的审查,为联邦提供临时指导,州和地方司法管辖区分配初始剂量的Covid-19疫苗。 Acip建议,当Covid-19疫苗被FDA授权并由Acip,1)保健人员§和2)长期护理设备(LTCF)居民的居民在Covid的初始阶段提供疫苗-19疫苗接种计划(第1A阶段**)。††在其审议中,ACIP认为SARS-COV-2流行病学,疫苗接种计划实施和道德原则的科学证据.§§临时建议可能会在未来周内更新关于III期临床试验和FDA紧急使用授权的额外安全性和疗效数据。

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