Sars-Cov-2 (Covid-19) Mrna (Tozinameran 6M-4Y) Bivalent Booster Vaccine Dosage

Usual Pediatric Dose for COVID-19

For investigational use only

PATIENTS 6 MONTHS TO 4 YEARS:
Patients Not Previously Vaccinated with A Coronavirus Disease 2019 (COVID-19) Vaccine:

• Maroon cap/label border color: 0.2 mL IM for 3 doses, with the initial 2 doses administered 3 weeks apart, then the third dose administered at least 8 weeks after the second.

Patients Previously Vaccinated with Pfizer-BioNTech Monovalent COVID-19 Vaccine:
1 PREVIOUS DOSE:

• Maroon cap/label border color: 0.2 mL IM for 2 doses, with the first doses administered 3 weeks after receipt of the monovalent vaccine, then the third dose administered at least 8 weeks after the first bivalent vaccine dose.

2 PREVIOUS DOSES:

• Maroon cap/label border color: 0.2 mL IM once, administered at least 8 weeks after receipt of the second dose of the monovalent vaccine.

3 PREVIOUS DOSES:

• Maroon cap/label border color: 0.2 mL IM once, administered at least 2 months after receipt of the third dose of the monovalent vaccine.

Additional series dose (if indicated):

• Maroon cap/label border color: 0.2 mL IM once, at least 1 month after receiving 3 doses of Moderna COVID-19 vaccine.

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

Dose Adjustments

Patients turning 4 to 5 years during the primary series:

• Option 1: Administer doses 1 and 2 with the maroon-capped and bordered vaccine (each 0.2 mL dose contains 3 mcg mRNA). Dose 3 should be administered with the bivalent vaccine.
• Option 2: Use a 2-dose primary series with the orange-capped and bordered vaccine (each 0.2 mL dose contains 10 mcg mRNA).

Precautions

Monovalent formulations have been voluntarily withdrawn from the US market by the manufacturer in May 2023, as there is an increased risk of administration error between this (e.g., bivalent vaccine) formulations and monovalent vaccine formulations used in the same patient population at the same dosage. Specifically, the US Centers for Disease Control and Prevention (US CDC) recommend that all monovalent vaccine inventory should be removed from storage and discarded in accordance with local, state, and federal regulations, even if they are not expired.

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 6 months.

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:

• Vials must be diluted prior to use.
• The manufacturer product information should be consulted.

General:

• This information pertains only to the vaccine product supplied in a vial with a maroon cap and label with a maroon 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