Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 312) Dosage

Medically reviewed by Drugs.com. Last updated on Jan 30, 2024.

Usual Adult Dose for COVID-19

12 years and older:
Dark blue cap/label multidose vial (50 mcg/0.5 mL): 0.5 mL IM once, administered at least 2 months after the last dose of vaccine

Comments:

• This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued a BLA for the use of this drug to prevent COVID-19.
• 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 SARS-CoV-2, including the COVID-19 Omicron (XBB.1.5) virus strain variant

Usual Pediatric Dose for COVID-19

For investigational use only

12 years and older:
Dark blue cap/label multidose vial (50 mcg/0.5 mL): 0.5 mL IM once, administered at least 2 months after the last dose of vaccine.

Comments:

• This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued an EUA for the use of this drug to prevent COVID-19.
• 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 SARS-CoV-2, including the COVID-19 Omicron (XBB.1.5) virus strain variant

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Patients with a known history of severe allergic reaction to the active component or any of the ingredients
• Patients with a severe allergic reaction (e.g., anaphylaxis) following administration of a COVID-19 vaccine

Safety and efficacy have not been established in patients younger than 12 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer IM.
• Gently swirl the vial between doses; do not shake.

Storage requirements:

• Store frozen between -50C to -15C (-58F to 5F); store in original package to protect from sun and ultraviolet light.
• Thaw each vial before use; once thawed, do not return vial to freezer.
• Thawed vials may be handled in room light conditions.
• After thawing, vials may be stored between 8C and 25C (46F to 77F) for a total of 24 hours, or vials may be stored in the refrigerator between 2C to 8C (36F to 46F) for up to 30 days prior to first use.
• In use vial (needle-punctured): Store between 2C to 25C (36F to 77F); discard vial 12 hours after first puncture.
• Do not refreeze.

Reconstitution/preparation techniques:

• Do not dilute.
• Consult the Fact Sheet for Health Care Providers.

General:

• This information pertains only to the vaccine product supplied in a vial with a dark blue cap and label stating "Spikevax COVID-19 Vaccine 2023-2024 Formula, For 12 years and older".
• This vaccine may contain white or translucent particulates.

Patient advice:

• To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov

Further information

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

Medical Disclaimer