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.

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.

Publication date: Sep 20, 2023

Novavax, a global vaccine company, began evaluating NVX-CoV2373 in human studies in May 2020 and the pivotal placebo-controlled phase 3 studies started in November 2020; five clinical studies provided adult and adolescent clinical data for over 31,000 participants who were administered NVX-CoV2373. This extensive data has demonstrated a well-tolerated response to NVX-CoV2373 and high vaccine efficacy against mild, moderate, or severe COVID-19 using a two-dose series (Dunkle et al. , 2022) [1], (Heath et al. , 2021) [2], (Keech et al. , 2020) [3], (Mallory et al. , 2022) [4]. The most common adverse events seen after administration with NVX-CoV2373 were injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, nausea, or vomiting. In addition, immunogenicity against variants of interest (VOI) and variants of concern (VOC) was established with high titers of ACE2 receptor-inhibiting and neutralizing antibodies in these studies (EMA, 2022) [5], (FDA, 2023) [6]. Further studies on correlates of protection determined that titers of anti-Spike IgG and neutralizing antibodies correlated with efficacy against symptomatic COVID-19 established in clinical trials (p

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Concepts Keywords
Headache Coronavirus
Mallory COVID-19 Vaccine
November NVX-CoV2373
Vaccine Protein vaccine safety
Vaccine benefit/risk
Vaccine efficacy
Vaccine immunogenicity


Type Source Name
disease VO COVID-19 vaccine
disease VO NVX-CoV2373
disease VO vaccine
disease VO Viruses
disease VO company
disease VO vaccine efficacy
disease MESH COVID-19
disease VO dose
disease VO injection
disease IDO site
disease MESH arthralgia
disease VO USA
drug DRUGBANK Coenzyme M
disease VO organization
disease VO effective
disease VO vaccination
disease VO population
disease MESH Hepatitis
disease VO storage
disease VO vaccine strain
disease MESH viral diseases
disease VO Influenza virus vaccine
disease MESH Middle East Respiratory Syndrome
disease VO Glycoprotein
drug DRUGBANK Proline
drug DRUGBANK Angiotensin II
disease IDO host
disease IDO production
disease VO primary vaccination
disease VO vaccinated
drug DRUGBANK Methionine
disease MESH infection
disease VO Optaflu
disease MESH influenza
disease VO influenza vaccines
drug DRUGBANK Aspartame
disease MESH Myocarditis
disease MESH pericarditis
disease MESH chest pain
disease IDO immune response
drug DRUGBANK Tropicamide
disease IDO quality
disease VO Bacteria
drug DRUGBANK Thimerosal
drug DRUGBANK Phenol
drug DRUGBANK Phenoxyethanol
drug DRUGBANK Sodium phosphate dibasic
drug DRUGBANK Phosphate ion
drug DRUGBANK Sodium Chloride
drug DRUGBANK Cholesterol
drug DRUGBANK Tocopherol
drug DRUGBANK Monopotassium phosphate
drug DRUGBANK Potassium Chloride
drug DRUGBANK Sodium hydroxide
disease IDO pathogen
disease MESH Sore throat
disease VO nose
disease MESH Pneumonia
disease MESH acute respiratory distress syndrome
disease MESH pulmonary embolism
disease MESH syndrome
disease MESH cerebrovascular disease
disease MESH ataxia
disease MESH epilepsy
disease MESH Cardiac arrhythmias
disease MESH venous thromboembolism
disease MESH cardiogenic shock
disease MESH cardiac arrest
disease MESH ischemia
disease MESH Acute renal failure
disease MESH death
disease VO frequency
drug DRUGBANK Fibrinogen Human
disease MESH inflammation
disease MESH fatal outcome
disease MESH preeclampsia
disease MESH preterm birth
disease MESH stillbirth
disease MESH gestational diabetes
disease MESH breakthrough infections
disease MESH cancer
disease MESH chronic kidney disease
disease MESH liver disease
disease MESH lung diseases
disease MESH cystic fibrosis
disease MESH dementia
disease MESH cerebral palsy
disease MESH cardiovascular diseases
disease MESH HIV infection
disease MESH schizophrenia
disease MESH overweight
disease MESH obesity
disease MESH thalassemia
disease IDO blood
disease MESH tuberculosis
pathway KEGG Tuberculosis
disease MESH asymptomatic infections
disease IDO symptom
disease IDO replication
disease IDO infectivity
disease MESH Social Vulnerability
disease IDO cell
disease MESH asymptomatic disease
disease MESH seroconversion
disease MESH Hematologic malignancy
pathway KEGG Viral replication
disease VO immunized
disease MESH weight loss
disease VO vaccine antigen
disease IDO process
disease MESH autoimmune response
drug DRUGBANK Amiloride
disease VO Respiratory syncytial virus
disease MESH Malaria
pathway KEGG Malaria
disease VO organ
disease MESH hyperplasia
disease VO active immunization
disease VO prime boost regimen
disease MESH anaphylaxis
disease MESH allergic reaction
disease VO immunization
drug DRUGBANK Isoxaflutole
disease MESH body weight changes
disease IDO history
disease VO passive immunization
disease VO unimmunized
disease VO effectiveness
disease VO adverse event
disease VO vaccinee

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