Drug Class: Viral vaccines
Usual Pediatric Dose for COVID-19
For investigational use only
6 months to 5 years:
- Booster Dose: 0.2 mL IM once, at least 2 months after completing a primary vaccination series with this coronavirus disease 2019 (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 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.
- 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 (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 6 months.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer IM.
- Gently swirl the vial between doses; do not shake.
Storage requirements:
- Store frozen between -50C to -15C (-58F to 5F); store in original package to protect from light.
- Thaw each vial before use; once thawed, do not return vial to freezer.
- Thawed vials may be handled in room light conditions.
- Vials may be stored between 8C and 25C (46F to 77F) for a total of 24 hours.
- May store vials in refrigerator between 2C to 8C (36F to 46F) for up to 30 days prior to first use.
- In-use vial (needle-punctured): Store between 2C to 25C (36F to 77F); discard vial 8 hours after first puncture.
- Do not refreeze.
Reconstitution/preparation techniques:
- Do not dilute.
General:
- This information pertains only to the vaccine product supplied in a vial with a dark pink cap and label with a yellow border stating "Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)."
- Multiple dose vials contain two-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.
- This vaccine may contain white or translucent particulates.
Patient advice:
- Read the Fact Sheet for Recipients and Caregivers.
- To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov
