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COVID-19 疫苗的早期临床试验数据和真实世界评估:来自传染病药师学会的见解。

Early clinical trial data and real-world assessment of COVID-19 vaccines: Insights from the Society of Infectious Diseases Pharmacists.

机构信息

Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, California, USA.

WakeMed Health & Hospitals, Raleigh, North Carolina, USA.

出版信息

Pharmacotherapy. 2021 Oct;41(10):837-850. doi: 10.1002/phar.2622.

Abstract

As of August 2021, there were three COVID-19 vaccines available in the United States for the prevention of coronavirus 2019 (COVID-19). The purpose of this narrative review is to examine the early experience from the Emergency Use Authorization (EUA) of BNT162b2 (Pfizer, Inc./BioNTech), mRNA-1273 (Moderna, Inc.), and Ad26.COV2.S (Johnson and Johnson/Janssen Global Services, LLC) through July 2021. The EUA data from the clinical trials have largely been corroborated by real-world effectiveness investigations post-authorization. These studies indicate that immunity is obtained within 2 weeks post-vaccination and may endure for 6 months. The immunity conferred by the vaccines may also be effective against SARS-CoV-2 variants of concern. Additionally, populations not included in the emergency use authorization studies may also benefit from vaccination. This look back at the initial clinical experience can be used by the global community to inform and develop COVID-19 vaccine programs.

摘要

截至 2021 年 8 月,美国有三种 COVID-19 疫苗可用于预防 2019 年冠状病毒病(COVID-19)。本叙述性评论的目的是通过 2021 年 7 月之前的紧急使用授权(EUA),检查 BNT162b2(辉瑞公司/生物技术公司)、mRNA-1273(莫德纳公司)和 Ad26.COV2.S(强生公司/杨森全球服务有限责任公司)的早期经验。临床试验的 EUA 数据在很大程度上得到了授权后真实世界有效性调查的证实。这些研究表明,接种疫苗后 2 周内即可获得免疫力,并且可能持续 6 个月。疫苗提供的免疫力也可能对关注的 SARS-CoV-2 变体有效。此外,未纳入紧急使用授权研究的人群也可能从疫苗接种中受益。对初始临床经验的回顾可以为全球社区提供信息并制定 COVID-19 疫苗计划。

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