Sars-Cov-2 (Covid-19) Nvx-Cov2373 Vaccine, Recombinant Dosage

Medically reviewed by Drugs.com. Last updated on Apr 4, 2023.

Usual Adult Dose for COVID-19

For investigational use only

Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apart
Booster dose: 0.5 mL IM once, at least 6 months after completing a primary series with an authorized/approved COVID-19 vaccine

Comments:

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this unapproved product for active immunization to prevent coronavirus disease 2019 (COVID-19); this product is not approved by the US FDA for this use.
• This vaccine is authorized to provide a 2-dose primary series.
• This vaccine is authorized to provide a first booster dose to adult patients for whom a US FDA-authorized messenger RNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to adult patients who elect to receive this vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine.
• Authorized bivalent COVID-19 vaccines encode the spike protein of the original severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the Omicron BA.4/BA.5 SARS-CoV-2.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent COVID-19 caused by SARS-CoV-2

Usual Pediatric Dose for COVID-19

For investigational use only

12 years or older:

• Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apart

Comments:

• The US FDA issued an EUA to allow the emergency use of this unapproved product for active immunization to prevent COVID-19; this product is not approved by the US FDA for this use.
• This vaccine is authorized to provide a 2-dose primary series.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent COVID-19 caused by SARS-CoV-2

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine

Safety and efficacy have not been established in patients younger than 12 years.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only
• Gently swirl the multidose vial before each dose withdrawal; do not shake.
• Monitor patients for immediate adverse reactions according to the US CDC guidelines.

Storage requirements:

• Unpunctured vials: Store in a refrigerator between 2C to 8C (36F to 46F); do not freeze. Protect from light.
• After first needle puncture of the vial: Store vial between 2C to 25C (36F to 77F) for up to 6 hours; discard vial 6 hours after first puncture.

Reconstitution/preparation techniques:

• The Fact Sheet for Health Care Providers should be consulted.

General:

• Each 0.5 mL dose contains 5 mcg of SARS-CoV-2 recombinant spike (rS) protein and an adjuvant.
• Excess vaccine from multiple vials should not be pooled.
• This vaccine may not protect all recipients.

Patient advice:

• Read the Fact Sheet for Recipients and Caregivers.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer