Sars-Cov-2 (Covid-19) Mrna(Tozinameran12Y+) Bivalent Vaccine Dosage
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for COVID-19
For investigational use only
Booster Dose: 0.3 mL IM once, at least 2 months after administration of completion 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
Usual Pediatric Dose for COVID-19
For investigational use only
12 years and older:
- Booster Dose: 0.3 mL IM once, at least 2 months after administration of completion of a primary vaccination or booster dose
Comments:
- The US FDA issued an EUA 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: Active immunization to prevent COVID-19 caused by 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 12 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 a gray cap and label with a gray border stating "Bivalent."
- Multiple dose vials contain six-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.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
