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

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

• 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

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

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.

• 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.

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

• 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.

• Read the Fact Sheet for Recipients and Caregivers.