Sars-Cov-2 Mrna-1273 (Booster Only) Vaccine Dosage

Applies to the following strengths: preservative-free 50 mcg/0.5 mL

Usual Adult Dose for COVID-19

For investigational use only

First Booster Dose: 0.25 mL IM, at least 5 months after completing a primary vaccination series with this or another authorized/approved coronavirus disease 2019 (COVID-19) vaccine.
Second Booster Dose: 0.25 mL IM, at least 4 months after receiving a booster dose with this or another authorized/approved 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.
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)

Usual Pediatric Dose for COVID-19

For investigational use only

6 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

Comments:

The US FDA issued an 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.
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 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 any of the ingredients

Safety and efficacy of this formulation have not been established in patients younger than 5 years.

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 -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 hours 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 45 minutes; 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.

Reconstitution/preparation techniques:

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

General:

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.

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