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NVX-CoV2373 疫苗的安全性、有效性和免疫原性。

Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine.

机构信息

Novavax, Inc, Gaithersburg, MD, USA.

South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

出版信息

Expert Rev Vaccines. 2023 Jan-Dec;22(1):501-517. doi: 10.1080/14760584.2023.2218913.

Abstract

INTRODUCTION

The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in significant morbidity and mortality worldwide. As SARS-CoV-2 moves into endemic status, vaccination remains a key element in protecting the health of individuals, societies, and economies worldwide.

AREAS COVERED

NVX-CoV2373 (Novavax, Gaithersburg, MD) is a recombinant protein vaccine composed of SARS-CoV-2 spike trimer nanoparticles formulated with saponin-based Matrix-M™ adjuvant (Novavax, Gaithersburg, MD). NVX-CoV2373 is authorized for emergency use in adults and adolescents aged ≥12 years in the United States and numerous other countries.

EXPERT OPINION

In clinical trials, NVX-CoV2373 showed tolerable reactogenicity and favorable safety profiles characterized by mostly mild-to-moderate adverse events of short duration and by low rates of severe and serious adverse events comparable to those seen with placebo. The two-dose primary vaccination series resulted in robust increases in anti-spike protein immunoglobulin G, neutralizing antibody titers, and cellular immune responses. NVX-CoV2373 vaccination was associated with complete protection against severe disease and a high (90%) rate of protection against symptomatic disease in adults, including symptomatic disease caused by SARS-CoV-2 variants. Additionally, the NVX-CoV2373 adjuvanted recombinant protein platform offers a means to address issues of COVID-19 vaccination hesitancy and global vaccine equity.

摘要

简介

由严重急性呼吸综合征冠状病毒 2 型(SARS-CoV-2)引起的 2019 年冠状病毒病(COVID-19)大流行,已在全球范围内导致了大量的发病率和死亡率。随着 SARS-CoV-2 进入地方病状态,疫苗接种仍然是保护全球个人、社会和经济健康的关键要素。

涵盖领域

NVX-CoV2373(Novavax,马里兰州盖瑟斯堡)是一种由 SARS-CoV-2 刺突三聚体纳米颗粒组成的重组蛋白疫苗,与基于皂苷的 Matrix-M ™佐剂(Novavax,马里兰州盖瑟斯堡)联合配制。NVX-CoV2373 在美国和其他许多国家被授权紧急用于 12 岁及以上的成年人和青少年。

专家意见

在临床试验中,NVX-CoV2373 表现出可耐受的反应原性和良好的安全性特征,主要表现为短暂的轻度至中度不良反应,严重和严重不良事件的发生率低,与安慰剂相似。两剂基础接种系列可显著增加抗刺突蛋白免疫球蛋白 G、中和抗体滴度和细胞免疫反应。NVX-CoV2373 疫苗接种可完全预防重症疾病,对成年人包括由 SARS-CoV-2 变体引起的有症状疾病的保护率高达 90%。此外,NVX-CoV2373 佐剂重组蛋白平台提供了一种解决 COVID-19 疫苗犹豫和全球疫苗公平问题的方法。

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