Usual Adult Dose for COVID-19

Monovalent formulations are no longer available for use in the US. The US Centers for Disease Control and Prevention (US CDC) recommend that patients should receive the corresponding bivalent vaccine in place of this vaccine.

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 primary series dose

• A third dose administered at least 28 days following the first 2 doses of this vaccine 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 information on dosing of the bivalent vaccine(s), please see the appropriate product information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Usual Pediatric Dose for COVID-19

Monovalent formulations are no longer available for use in the US. The US CDC recommend that patients should receive the corresponding bivalent vaccine in place of this vaccine.

12 years and older:

• Primary Series: 0.3 mL IM for 2 doses, administered 21 days apart

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

• Third primary series dose (if indicated): 0.3 mL IM at least 28 days after the second primary series dose

• The US FDA issued an EUA to allow the emergency use of this unapproved product for active immunization to prevent COVID-19 due to SARS-CoV-2 (third primary series dose).
• A third dose administered at least 28 days following the first 2 doses of this vaccine 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 information on dosing of the bivalent vaccine(s), please see the appropriate product information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Monovalent formulations of this drug were voluntarily withdrawn from the US market by the manufacturer in May 2023 due to an increased risk of administration error between these formulations and bivalent boosters used in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:

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

Dialysis

Data not available

Other Comments

Administration advice:

• Administer IM.
• Gently swirl the vial between doses; do not shake.

• Store frozen between -50C to -58C (-13F to 5F); store in original package to protect from light.
• Do not store on dry ice or below -50C (-58F).
• 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.
• Thaw in refrigerator between 2C to 8C (36F to 46F) for 2.5 hours for the maximum 11-dose vial (3 hours for maximum 15-dose vial) and let vial stand at room temperature for 15 minutes before administration; discard after 12 hours.
• Alternatively, thaw at room temperature between 15C to 25C (59F to 77F) for 1 hour for the maximum 11-dose vial (90 minutes for maximum 15-dose vial); total storage time should not exceed 12 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 12 hours after first puncture.
• Do not refreeze.

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

• This vaccine may contain white or translucent particulates.
• Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death following administration of this vaccine.

• 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