A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses

Author:

Wilkinson Bethanie,Patel Kinjal S.,Smith Katherine,Walker Robert,Wang Chengbin,Greene Ann M.,Smith Gale,Smith Emily R.,Gurwith Marc,Chen Robert T.

Funder

U.S. Food and Drug Administration

U.S. Department of Defense

National Institute of Allergy and Infectious Diseases

U.S. Department of Health and Human Services

Biomedical Advanced Research and Development Authority

Coalition for Epidemic Preparedness Innovations

National Institutes of Health

Centers for Disease Control and Prevention

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference69 articles.

1. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico;Dunkle;NEJM,2022

2. Safety and efficacy of NVX-COV2373 Covid-19 vaccine;Heath;NEJM,2021

3. Phase 1–2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine;Keech;NEJM,2020

4. Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial;Mallory;Lancet Infect Dis,2022

5. EMA. Summary of Product Characteristics (SmPC) Nuvaxovid. [Online]. Available: https://www.ema.europa.eu/en/documents/product-information/nuvaxovid-epar-product-information_en.pdf. [Accessed 28 September 2022].

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