Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 309) Dosage

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

Usual Adult Dose for COVID-19

Single dose: 0.3 mL IM once, at least 2 months after receiving the last previous dose of coronavirus disease 2019 (COVID-19)

Comments:

• The US FDA issued a Biologics License Application (BLA) 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.
• 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Usual Pediatric Dose for COVID-19

12 years and older:

• Single dose: 0.3 mL IM once, at least 2 months after receiving the last previous dose of coronavirus disease 2019 (COVID-19)

Comments:

• The US FDA issued a BLA 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.
• 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

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.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only. Do not inject IV, intradermally, or subcutaneously.
• Gently swirl the vial between doses; do not shake.

Storage requirements:

• During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light.
• Do not refreeze thawed vials.
• Vial storage before use: Consult the manufacturer product information and/or the Fact Sheet for Health Care Providers.
• After first puncture, store between 2C to 25C (35F to 77F); discard vial 12 hours after first puncture.

Reconstitution/preparation techniques:

• Vials and prefilled syringes should not be diluted prior to use.
• The manufacturer product information should be consulted.

General:

• This information pertains only to the vaccine product supplied in a vial with a gray label border stating "2023-2024 Formula."
• Multiple dose vials contain ten-0.3 mL doses of vaccine.
• Each dose must contain 0.3 mL of vaccine.
• If the vaccine remaining in the vial cannot provide a full 0.3 mL dose, discard the vial; do not pool excess vaccine from multiple vials.
• This vaccine does not contain preservatives.

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