Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 308) Dosage

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

Usual Pediatric Dose for COVID-19

For investigational use only

6 months to 4 years:
Patients Not Previously Vaccinated with A Coronavirus Disease 2019 (COVID-19) Vaccine:

• Yellow cap/border color: 0.3 mL IM for 3 doses, with the initial 2 doses administered 3 weeks apart, then the third dose administered at least 8 weeks after the second

Patients Previously Vaccinated with Pfizer-BioNTech Monovalent or Bivalent COVID-19 Vaccine:
1 PREVIOUS DOSE:

• Yellow cap/label border color: 0.3 mL IM for 2 doses, with the first doses administered 3 weeks after receipt of the previous vaccine, then the third dose administered at least 8 weeks after the first bivalent vaccine dose

2 TO 4 PREVIOUS DOSES:

• Yellow cap/label border color: 0.3 mL IM once, administered at least 8 weeks after receipt of the last previous dose of the vaccine

Additional series dose (if indicated):

• Yellow cap/label border color: 0.3 mL IM once, at least 2 months after receiving the last previous dose of 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.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For the emergency use for the active immunization to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including the COVID-19 Omicron (XBB.1.5) variant

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Patients turning 4 to 5 years during the primary series: Administer all 3 doses with the yellow-capped and bordered vaccine (each 0.3 mL dose contains 3 mcg mRNA).

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 6 months.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only. Do not inject IV, intradermally, or subcutaneously.

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.
• Vial storage during use: If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature (up to 25C [77F]) for 30 minutes.
• After first puncture, store between 2C to 25C (35F to 77F); discard vial 12 hours after first puncture.

Reconstitution/preparation techniques:

• Vials must 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 yellow 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