COVID-19 vaccine, adjuvanted-Novavax

Action and Spectrum

Actions and Spectrum: 

Actions: 

Novavax’s adjuvanted COVID-19 vaccine, known as NVX-CoV2373, stimulates the recipient’s immune system to produce an immunological response against the SARS-CoV-2 virus, which causes COVID-19. 

Spectrum: 

Novavax’s adjuvanted COVID-19 vaccine, known as NVX-CoV2373, stimulates the recipient’s immune system to produce an immunological response against the SARS-CoV-2 virus, which causes COVID-19. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

12-17 years 

Fatigue or malaise grade 3 (2.3-16%) 

Pain or tenderness any grade (64.3-75%) 

Muscle pain any grade (34-49%) 

Fever any grade (0.8-16.9%) 

Headache (30.4-56.9%) 

Nausea or Vomiting (7.8-19.9%) 

Fatigue or malaise any grade (28.9-57.9%)  

18-64 years  

Fatigue or malaise grade 3 (1.6-10.5%) 

Pain or tenderness any grade (60.5-80.8%) 

Muscle pain any grade (24.1-50.7%) 

Headache (26.2-47.1%) 

Nausea or Vomiting (12%) 

Fatigue or malaise any grade (60.5-80.8%)  

>=64% 

Fatigue or malaise grade 3 (24.5%) 

Pain or tenderness any grade (37.9-61.4%) 

Muscle pain any grade (12.6-27.4%) 

Headache (15.3%) 

Fatigue or malaise any grade (19.7-34.9%)  

1-10% 

12-17 years  

Nausea or vomiting grade 3 (0.1-1%) 

Swelling any grade (1.4-8%) 

Headache grade 3 (0.9-6.2%) 

Pain or tenderness grade 3 (1.5-7.7%) 

Fever grade 3 (0.07-2.2%) 

Joint pain grade 3 (0.4-2.9%) 

Erythema any grade (1-7.5%) 

Muscle pain  grade 3 (1.2 -7.5 %)  

18-64 years  

Swelling any grade (0.9-6.2%) 

Headache grade 3 (0.8-3.2%) 

Pain or tenderness grade 3 (1.1-6.3%) 

Fever grade 3 (0.4-6.2%) 

Joint pain grade 3 (0.3-2.6%) 

Erythema any grade (1.6-9%) 

Muscle pain  grade 3 (0.5-5.3%)  

>=64 years 

Nausea or vomiting grade 3 (3.6-5.3%) 

Swelling any grade (0.8-5.4%) 

Pain or tenderness grade 3 (0.6-2.1%) 

Fever grade 3 (0.4-2%) 

Fatigue or malaise grade 3 (1-3.3%) 

Erythema any grade (0.7-4.8%) 

Muscle pain  grade 3 (0.1-1.6%)  

<1% 

12-17 years 

Nausea or vomiting grade 4 (0.07%) 

Fever grade 4 (0.1%) 

Erythema grade 3 (0.7%) 

Headache grade 4 (0.07%) 

Swelling grade 3 (0.6%)  

18-64 years  

Nausea or vomiting grade 3 (0.1-0.2%) 

Swelling any grade (0.04-0.5%) 

Headache grade 4 (0.03%) 

Fever grade 4 (0.03%) 

Pain or tenderness grade 3 (1.5-7.7%) 

Fever grade 3 (0.04-0.4%) 

Nausea or vomiting grade 4 (0.3-0.5%) 

Joint pain grade 3 (<0.01-0.03%) 

Erythema grade 3 (0.02-0.9%) 

Muscle pain grade 4 (0.01-0.3%) 

Fatigue or malaise grade 4 (0.05%)  

>=64 years 

Joint pain grade 4 (0.05%) 

Headache grade 4 (0.04-0.05%) 

Fever grade 3 (0.04-0.1%) 

Joint pain grade 3 (0.2-0.8%) 

Headache grade 3 (0.5-0.9%) 

Erythema grade 3 (0.4%) 

Nausea or vomiting grade 3 (0.1%) 

Swelling grade 3 (0.04-0.4%) 

Black Box Warning

Black Box Warning: 

Data from clinical trials show an increased risk of myocarditis and pericarditis after receiving Novavax COVID-19 Vaccine, Adjuvanted. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 

Cautions 

• MIS-C 
• Myocarditis 
• Pericarditis 
• Renal impairment 
• Hepatic impairment 
• Drug interactions 
• Pregnancy  
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

The pharmacology of Novavax’s adjuvanted COVID-19 vaccine, NVX-CoV2373, is based on its mode of action and impact on the human immune system. This vaccination is intended to elicit an immune response against the COVID-19-causing SARS-CoV-2 virus.  

Pharmacodynamics: 

The NVX-CoV2373 virus contains a harmless fragment of the SARS-CoV-2 virus’s spike protein. This spike protein acts as an antigen, which the immune system detects as foreign. The pharmacodynamics of this antigen entail its presentation to the immune system. 

When the antigen (spike protein) is delivered into the body by vaccination, the immune system’s components, including B cells, T cells, and other immune cells, respond to it. 

The vaccine promotes antibody synthesis, particularly neutralizing antibodies. These antibodies are spike protein specific and capable of binding to and neutralizing the SARS-CoV-2 virus. Pharmacodynamics also include cellular immunity activation. T cells recognize and respond to infected cells, including CD4+ helper T cells and CD8+ cytotoxic T cells. 

Pharmacokinetics: 

Limited data is available. 

Adminstartion

Administration: 

For IM only. Suspension should be colorless to slightly yellow, transparent to faintly opalescent, and particle-free.  

Before each dose withdrawal, gently spin the multi-dose vial; DO NOT shake.  

Before administering, visually inspect the vial for particle debris and discolouration; reject the vial if one of these conditions exists.  

On the vial label, record the date and time of the initial puncture.  

Each multi-dose vial contains five 0.5-mL doses.  

Do not combine vaccination from numerous vials. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: COVID-19 vaccine, adjuvanted-Novavax 

Pronounced: see-oh-vee-eye-dee-19 vak-seen, ad-joo-van-ted-No-va-vax 

Why do we use COVID-19 vaccine, adjuvanted-Novavax? 

Novavax’s COVID-19 vaccine, known as “NVX-CoV2373,” is adjuvanted, which means it contains an adjuvant to boost the body’s immune response to the vaccine. The SARS-CoV-2 virus, which causes COVID-19, is protected against by this adjuvanted COVID-19 vaccination.