Sars-Cov-2 Mrna (Tozinameran-Tris-Sucrose) Vaccine Dosage

Usual Adult Dose for COVID-19

0.3 mL IM for 2 doses, administered 21 days apart

Comments:

• No data are available regarding interchangeability of coronavirus disease 2019 (COVID-19) vaccine products to complete the vaccination series; patients who received 1 dose of this vaccine should receive a second dose of this vaccine to complete the vaccination series.

Use: For active immunization to prevent COVID-19 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

FOR INVESTIGATIONAL USE ONLY

Primary Series: 0.3 mL IM for 2 doses, administered 21 days apart

• Third primary series dose (if indicated): 0.3 mL IM at least 28 days after the second dose

Booster Doses:

• First Booster Dose: 0.3 mL IM at least 5 months after completing a primary vaccine series
• Second Booster Dose: 0.3 mL IM at least 4 months after administration of a first booster dose

Comments:

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this product for active immunization to prevent COVID-19.
• When prepared according to their respective instructions for use, the US FDA-approved product and the EUA-authorized product can be used interchangeably.
• A third primary series dose is authorized for patients who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
• A first booster dose may be administered to patients 18 years and older as a heterologous booster dose in those who have completed primary vaccination with another authorized/approved COVID-19 vaccine.
• A second booster dose may be administered to patients 50 years and older and to patients 12 years and older with certain kinds of immunocompromised who have received a booster dose with any authorized/approved COVID-19 vaccine.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: Active immunization for the prevention of COVID-19 due to SARS-CoV-2

Usual Pediatric Dose for COVID-19

16 years and older: 0.3 mL IM for 2 doses, administered 21 days apart

Comments:

• No data are available regarding interchangeability of COVID-19 vaccine products to complete the vaccination series; patients who received 1 dose of this vaccine should receive a second dose of this vaccine to complete the vaccination series.

Use: For active immunization to prevent COVID-19 due to SARS-CoV-2

FOR INVESTIGATIONAL USE ONLY

12 years and older:

• Primary Series: 0.3 mL IM for 2 doses, administered 21 days apart
• Third primary series dose (if indicated): 0.3 mL IM at least 28 days after the second dose
• Booster Doses:
• First Booster Dose: 0.3 mL IM at least 5 months after completing a primary vaccine series
• Second Booster Dose: 0.3 mL IM at least 4 months after administration of a first booster dose

Comments:

• The US FDA issued an EUA to allow the emergency use of this product for active immunization to prevent COVID-19.
• When prepared according to their respective instructions for use, the US FDA-approved product and the EUA-authorized product can be used interchangeably.
• A third primary series dose is authorized for patients who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
• A first booster dose may be administered to patients who have completed a primary series with this product (either the US FDA-approved product or the EUA-authorized product).
• A second booster dose may be administered to patients at least 12 years of age with certain kinds of immunocompromise who have received a booster dose with any authorized/approved COVID-19 vaccine.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: Active immunization for the prevention of COVID-19 due to SARS-CoV-2 in patients 12 years of age and older

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

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 12 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only.

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 multiple dose vial with a gray cap and label with a gray border, which is US FDA approved in patients 16 years and older and has an EUA for use in patients 12 years and older.
• Each 0.3 mL dose contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.

Patient advice:

• For a 2-dose primary series in patients 12 through 15 years of age, a third primary series dose, and booster dose(s): Read the Vaccine Information Fact Sheet for Recipients and Caregivers.

Further information

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

Medical Disclaimer