Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 310) Dosage
Medically reviewed by Drugs.com. Last updated on Sep 3, 2024.
Applies to the following strengths: preservative-free 10 mcg/0.3 mL
Usual Pediatric Dose for:
Additional dosage information:
Usual Pediatric Dose for COVID-19
For investigational use only
BLUE CAP/BORDER COLOR:
5 years to 11 years:
- All Patients (Irrespective of COVID-19 Vaccine Status): 0.3 mL IM once, at least 2 months after receiving the last previous dose of COVID-19 vaccine.
Patients With Certain Immunocompromising Conditions Who Are Not Previously Vaccinated with A COVID-19 Vaccine:
- Dose 1: 0.3 mL IM ONCE on Week 0
- Dose 2: 0.3 mL IM ONCE on Week 3
- Dose 3: 0.3 mL IM ONCE at least 4 weeks after Dose 2
Patients Previously Vaccinated with Pfizer-BioNTech Monovalent or Bivalent COVID-19 Vaccine:
1 PREVIOUS DOSE: 0.3 mL IM for 2 doses, with the first doses administered 3 weeks after receipt of the previous vaccine, then the third dose administered at least 4 weeks after the first bivalent vaccine dose.
2 OR MORE PREVIOUS DOSES: 0.3 mL IM once, administered at least 2 months after receipt of the last previous dose of the 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: For the emergency use for the active immunization to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including the COVID-19 Omicron variant lineage KP.2
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Patients turning 11 to 12 years:
- PATIENTS WHO RECEIVED 1 OR 2 DOSES OF VACCINE: 0.3 mL IM ONCE with the WHITE bordered COMIRNATY 2024-2025 Formula vaccine on/after the date that the patient turns 12 years of age.
- PATIENTS TURNING 12 DURING THE VACCINATION SERIES: Complete the series with the WHITE bordered COMIRNATY 2024-2025 Formula vaccine on/after the date that the patient turns 12 years of age.
Precautions
CONTRAINDICATIONS:
- Patients with a known history of severe allergic reaction to the active component or any of the ingredients.
- Patients with a severe allergic reaction (e.g., anaphylaxis) following administration of a COVID-19 vaccine.
Safety and efficacy have not been established in patients younger than 5 years.
Dialysis
Data not available
Other Comments
Administration advice:
- For IM administration only. Do not inject IV, intradermally, or subcutaneously.
Storage requirements:
- During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light.
- Do not refreeze thawed vials.
- Vial storage before use: Consult the manufacturer product information and/or the Fact Sheet for Health Care Providers.
- After first puncture, store between 2C to 25C (35F to 77F); discard vial 12 hours after first puncture.
Reconstitution/preparation techniques:
- Vials and prefilled syringes should not be diluted prior to use.
- The manufacturer product information should be consulted.
General:
- This information pertains only to the vaccine product supplied in a vial with a blue label border stating "2024-2025 Formula, DO NOT DILUTE."
- Each dose must contain 0.3 mL of vaccine.
- If the vaccine remaining in the vial cannot provide a full 0.3 mL dose, discard the vial; do not pool excess vaccine from multiple vials.
- This vaccine does not contain preservatives.
Patient advice:
- To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.