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