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临床试验中 SARS-CoV-2 疫苗的免疫原性和安全性。

Immunogenicity and safety of SARS-CoV-2 vaccines in clinical trials.

机构信息

Centre for Virus and Vaccine Research, School of Medical and Life Sciences, Sunway University, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia.

Allergy and Immunology Research Centre, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.

出版信息

Front Biosci (Landmark Ed). 2021 Nov 30;26(11):1286-1304. doi: 10.52586/5024.

DOI:10.52586/5024
PMID:34856768
Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections were first detected in Wuhan, China in December 2019 and resulted in a worldwide pandemic in 2020. SARS-CoV-2 infections totalled more than 180 million with 3.9 million deaths as of June 24, 2021. Tremendous research efforts have resulted in the development of at least 64 vaccine candidates that have reached Phase I to III clinical trials within 14 months. The primary efficacy endpoint for a random placebo-controlled clinical trial of a COVID-19 vaccine to be approved by US FDA should confer at least 50% protection against COVID-19. Three COVID-19 vaccines (BNT162b2, mRNA-1273 and Sputnik V) in clinical Phase III trials have now achieved >90% efficacy in preventing COVID-19. Since SARS-CoV-2 is highly contagious, vaccines are expected to achieve at least 80% herd immunity in the world's population to effectively prevent SARS-CoV-2 infections. An overview of safety, immunogenicity and efficacy of the current frontrunner vaccines are reviewed.

摘要

严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2)感染于 2019 年 12 月在中国武汉首次被发现,并于 2020 年在全球范围内引发大流行。截至 2021 年 6 月 24 日,SARS-CoV-2 感染总数超过 1.8 亿,死亡 390 万。巨大的研究努力导致至少有 64 种疫苗候选物在 14 个月内达到了 I 期至 III 期临床试验。要获得美国 FDA 批准的 COVID-19 疫苗的随机安慰剂对照临床试验的主要疗效终点应该至少能预防 50%的 COVID-19。在临床 III 期试验中,三种 COVID-19 疫苗(BNT162b2、mRNA-1273 和 Sputnik V)目前已达到 >90%的预防 COVID-19 的疗效。由于 SARS-CoV-2 具有高度传染性,预计疫苗将在全球人口中至少实现 80%的群体免疫,以有效预防 SARS-CoV-2 感染。本文综述了目前领先疫苗的安全性、免疫原性和疗效。

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