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.

See also:

Further information

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

Medical Disclaimer