Sars-Cov-2(Covid-19)Mrna(Tozinameran 5Y-11Y)Bivalent Vaccine Dosage
Applies to the following strengths: preservative-free
Usual Pediatric Dose for:
Additional dosage information:
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.