Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 311) Dosage

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

Usual Pediatric Dose for COVID-19

For investigational use only

PATIENTS 6 MONTHS TO 4 YEARS:
Patients Previously Vaccinated with Any Moderna COVID-19 Vaccine:
0 PREVIOUS DOSES:

• Dark blue cap/label with green box: 0.25 mL IM for 2 doses, with the second dose administered after the first dose

1 PREVIOUS DOSE:

• Dark blue cap/label with green box: 0.25 mL IM once, administered at least 1 month after the monovalent vaccine

2 PREVIOUS DOSES:

• Dark blue cap/label with green box: 0.25 mL IM once, administered at least 2 months after receipt of the monovalent vaccine

PATIENTS 5 YEARS TO 11 YEARS:
All Patients (Irrespective of COVID-19 Vaccine Status):

• Dark blue cap/label with green box: 0.25 mL IM once, at least 2 months after receiving the last previous dose of COVID-19 vaccine

PATIENTS WITH IMMUNOCOMPROMISING CONDITIONS:
Patients Not Previously Vaccinated with Any Authorized/Approved Coronavirus Disease 2019 (COVID-19) Vaccine:

• Dark blue cap/label with green box: 0.25 mL IM for 3 doses

Patients Previously Vaccinated with any Moderna COVID-19 Vaccine:
0 PREVIOUS DOSES:

• Dark blue cap/label with green box: 0.25 mL IM for 2 doses, with the second dose administered after the first dose

1 PREVIOUS DOSE:

• Dark blue cap/label with green box: 0.25 mL IM once, administered at least 1 month after the monovalent vaccine

2 OR MORE PREVIOUS DOSES:

• Dark blue cap/label with green box: 0.25 mL IM once, administered at least 2 months after receipt of the monovalent vaccine

Additional series dose (if indicated):

• Dark blue cap/label with green box: 0.25 mL IM once, at least 2 months after completing at least 2 doses of Moderna COVID-19 vaccine

Comments:

• This drug is not approved by the US FDA to prevent coronavirus disease 2019 (COVID-19). The US FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
• An additional 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: For active immunization to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including the COVID-19 Omicron (XBB.1.5) variant

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Patients turning 4 to 5 years during the primary series: Administer all 3 doses with the dark blue-capped and labeled vaccine (each 0.25 mL dose contains 25 mcg mRNA).

Patients turning 11 to 12 years during the primary series: Administer all 3 doses with the blue-capped and labeled vaccine (each 0.25 mL dose contains 25 mcg mRNA).

Precautions

CONTRAINDICATIONS:

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

Safety and efficacy have not been established in patients younger than 6 months; this drug is not recommended for use in these patients.

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 sun and ultraviolet light.
• Thaw each vial before use; once thawed, do not return vial to freezer.
• Thawed vials may be handled in room light conditions.
• After thawing, vials may be stored between 8C and 25C (46F to 77F) for a total of 24 hours, or vials may be stored in the 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 12 hours after first puncture.
• Do not refreeze.

Reconstitution/preparation techniques:

• Do not dilute.
• Consult the Fact Sheet for Health Care Providers.

General:

• This information pertains only to the vaccine product supplied in a vial with a dark blue cap and label with a green box stating "Moderna COVID-19 Vaccine 2023-2024 Formula, For 6m through 11y".
• This vaccine may contain white or translucent particulates.

Patient advice:

• 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