Sars-Cov-2 Mrna (Tozinameran 6M-4Y) Vaccine Dosage

Usual Pediatric Dose for COVID-19

For investigational use only

6 months through 4 years: 0.2 mL IM for 3 doses, with the initial 2 doses administered 3 weeks apart, and then the third dose administered at least 8 weeks after the second dose

Comments:

• This drug is not approved by the FDA to prevent coronavirus disease 2019 (COVID-19) in patients younger than 5 years old. The FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
• There are no data are available regarding interchangeability of COVID-19 vaccine products; the same vaccine product should be used for all 3 doses.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: Active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Patients turning 4 to 5 years during the primary series:

• Option 1: Use a 2-dose primary series with the orange-capped and bordered vaccine (each 0.2 mL dose contains 10 mcg mRNA)
• Option 2: Administer dose 1 with the maroon-capped and bordered vaccine (each 0.2 mL dose contains 3 mcg mRNA). Doses 2 and 3 may be administered with either:
• Maroon-capped vaccine (3 mcg mRNA/0.2 mL) for patients 6 months to 4 years
• Orange-capped vaccine (10 mcg mRNA/0.2 mL) for patients 5 to 11 years

Precautions

CONTRAINDICATIONS:

• Known history of severe allergic reaction (e.g., anaphylaxis) to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 6 months; an EUA is in effect for the use of an experimental vaccine to prevent COVID-19 in patients from 6 months to less than 5 years of age; this drug is not recommended for use in younger patients.

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.

Storage requirements:

• Vials prior to dilution and after: The manufacturer product information should be consulted regarding storage and subsequent thawing of frozen vials.
• Vials after dilution: Store between 2C to 25C (35F to 77F); store in carton to protect from light and discard any vaccine remaining in vial after 12 hours.
• Contains no preservative.

Reconstitution/preparation techniques:

• Requires dilution with sterile 0.9% Sodium Chloride Injection, USP, before administration.
• The manufacturer product information should be consulted.

General:

• After dilution, vials contain ten-0.2 mL doses of vaccine.
• Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial; if standard syringes/needles are used, the volume may not be sufficient to extract 10 doses from the vial.
• Each dose must contain 0.2 mL of vaccine.
• If the vaccine remaining in the vial cannot provide a full 0.2 mL dose, discard the vial; do not pool excess vaccine from multiple vials.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients and their caregivers should report suspected adverse reactions by contacting 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