Sars-Cov-2(Covid-19)Mrna(Tozinameran 5Y-11Y)Bivalent Vaccine Dosage

Usual Pediatric Dose for COVID-19

For investigational use only

5 years to 11 years:

• Booster Dose: 0.2 mL IM once, at least 2 months after administration of a primary vaccination or booster dose

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: Active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) original and Omicron BA.4/BA.5

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: Patients with known history of severe allergic reaction to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 5 years; this formulation is not recommended for use in patients younger than 5 years or older than 11 years.

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.
• May store at room temperature (8C to 25C [46F to 77F]) for 12 hours total before the first puncture
• After first puncture, store between 2C to 25C (35F to 77F); discard vial 12 hours after first puncture.

Reconstitution/preparation techniques:

• Do not dilute.
• The manufacturer product information should be consulted.

General:

• This information pertains only to the vaccine product supplied in a vial with an orange cap and label with an orange border stating "Bivalent."
• Multiple dose vials contain ten-0.2 mL doses of vaccine.
• 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.

Further information

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

Medical Disclaimer