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

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.

Keywords: COVID-19, Matrix-M adjuvant; NVX-CoV2373; SARS-CoV-2; clinical trial; coronavirus; prevention; protein-based vaccine; vaccination.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Neutralizing
  • Antibodies, Viral
  • COVID-19 Vaccines / adverse effects
  • COVID-19* / prevention & control
  • Child
  • Humans
  • Immunogenicity, Vaccine
  • SARS-CoV-2
  • Vaccines*

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • COVID-19 Vaccines
  • NVX-CoV2373 adjuvated lipid nanoparticle
  • Vaccines

Supplementary concepts

  • SARS-CoV-2 variants