Sars-Cov-2 (Covid-19) Mrna-Lnp Vaccine (Cvx 308) Dosage
Medically reviewed by Drugs.com. Last updated on Sep 3, 2024.
Applies to the following strengths: preservative-free 3 mcg/0.3 mL
Usual Pediatric Dose for:
Additional dosage information:
Usual Pediatric Dose for COVID-19
For investigational use only
YELLOW CAP/BORDER COLOR:
6 months to 4 years:
Patients 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 8 weeks after Dose 2
Patients Previously Vaccinated with Pfizer-BioNTech Monovalent or Bivalent COVID-19 Vaccine:
1 PREVIOUS DOSE:
- Dose 1: 0.3 mL IM ONCE, administered 3 weeks after receipt of the previous COVID-19 vaccine,
- Dose 2: 0.3 mL IM ONCE, administered at least 8 weeks after Dose 1.
2 OR MORE PREVIOUS DOSES:
- Single dose: 0.3 mL IM ONCE, at least 8 weeks after receiving the last previous dose of 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 t he 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: Emergency use for 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 4 to 5 years:
- PATIENTS WHO RECEIVED 1 OR 2 DOSES OF VACCINE: 0.3 mL IM ONCE with the BLUE capped and bordered vaccine (each 0.3 mL dose contains 10 mcg mRNA) on/after the date that the patient turns 5 years of age.
- PATIENTS TURNING 5 DURING THE VACCINATION SERIES: Complete the series with the BLUE capped and bordered vaccine (each 0.3 mL dose contains 10 mcg mRNA) on/after the date that the patient turns 5 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 6 months.
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 during use: If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature (up to 25C [77F]) for 30 minutes.
- After first puncture, store between 2C to 25C (35F to 77F); discard vial 12 hours after first puncture.
Reconstitution/preparation techniques:
- Vials must 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 yellow label border stating "2024-2025 Formula."
- Multiple dose vials contain three-0.3 mL doses of vaccine.
- 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.