Sars-Cov-2 Mrna (Tozinameran 5Y-11Y) Vaccine Dosage

Usual Pediatric Dose for COVID-19

For investigational use only

5 THROUGH 11 YEARS:
Primary Series: 0.2 mL IM for 2 doses, administered 21 days apart

• Third primary series dose (if indicated): 0.2 mL IM at least 28 days after the second dose

Booster Dose: 0.2 mL IM at least 5 months after completing a primary vaccine series

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.
• There are no data available regarding interchangeability of COVID-19 vaccine products; the same vaccine product should be used for both doses.
• 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.
• 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)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known history of severe allergic reactions (e.g., anaphylaxis) to the active component or to any of the ingredients

Safety and efficacy have not been established in patients younger than 5 years; this drug is not recommended for use in younger patients.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only. Do not inject IV, intradermally, or subcutaneously.

Storage requirements:

• Minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light; do not refreeze liquid vials.
• Vial storage prior to use: The Fact Sheet for Health Care Providers should be consulted regarding storage and subsequent thawing of frozen vials.
• 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 dilution.
• After dilution, store between 2C to 25C (35F to 77F); discard vial 12 hours after dilution.

Reconstitution/preparation techniques:

• Requires dilution with sterile 0.9% Sodium Chloride Injection, USP, before administration.
• The Fact Sheet for Health Care Providers should be consulted.

General:

• This EUA pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in patients 5 through 11 years; carton labels state that this formulation is indicated for patients 5 to less than 12 years of age.
• Each 0.2 mL dose contains 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2.
• After dilution, vials contain ten 0.2 mL doses of vaccine.
• Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial; if standard syringes/needles are used, the volume may not be sufficient to extract 10 doses from the vial.
• 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.

Patient advice:

• Read the Vaccine Information Fact Sheet for Recipients and Caregivers.
• To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov

Further information

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

Medical Disclaimer