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

Open Access PDF

Concepts	Keywords
Headache	Coronavirus
Mallory	COVID-19 Vaccine
November	NVX-CoV2373
Vaccine	Protein vaccine safety
	SARS-CoV-2
	Vaccine benefit/risk
	Vaccine efficacy
	Vaccine immunogenicity

Semantics

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

Original Article

(Visited 1 times, 1 visits today)