Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 312) Dosage
Medically reviewed by Drugs.com. Last updated on Jan 30, 2024.
Applies to the following strengths: preservative-free 50 mcg/0.5 mL
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
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
More about sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 312)
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.