COVID-19 Vaccine Communication from the Immunization Program Office
Today’s Topic: COVID-19 Vaccines Approved for Young Children: Moderna for ages 6 months-5 years; Pfizer-BioNTech for ages 6 months-4 years
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) of Moderna COVID-19 vaccine to include ages 6 months through 5 years of age and for the Pfizer-BioNTech COVID-19 vaccine EUA for 6 months through 4 years of age.
The CDC Advisory Committee on Immunization Practices (ACIP) has voted to recommend Moderna COVID-19 vaccine for 6 months through 5 years old as a two-dose series for most young children with a three-dose series for moderately to severely immunocompromised children. Pfizer COVID-19 vaccine is also now recommended as a 3-dose series for 6 months through 4 years old. No booster doses have been approved yet for these age groups.
Based on the scientific evidence available, the benefits of the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine in young children outweigh the potential risks. Clinical studies showed that reactogenicity was consistent with other age groups. Antibody levels after vaccination were similar to young adults. Serious adverse events were rare. There were no deaths, anaphylaxis, Bell’s palsy, myocarditis/pericarditis, or multisystem inflammatory syndrome in children (MIS-C) among study participants.
Please review the COVID-19 vaccine EUA fact sheets for the most up-to-date information on each vaccine. The current boxes and labels may have different information than what has been recommended or approved. The EUA fact sheet supersedes information listed on the box or label.
Moderna (dark blue cap w/magenta label border) COVID-19 Vaccine
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Ages 6 months through 5 years of age: A two-dose series of 25 mcg (0.25 mL) each dose, given at least 4-8 weeks apart.
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Immunocompromised 6 months through 5 years of age: A three-dose series of 25 mcg (0.25 mL) each, given at 4 weeks between doses 1 and 2 and at least 4 weeks between doses 2 and 3.
This vaccine follows the same storage and handling guidelines as the Moderna Red Cap (18+ years) product:
- Storage in a standard freezer (check the Moderna website for the expiration date)
- Refrigerator storage for up to 30 days if the vial is unpunctured
- Does not require dilution
Pfizer-BioNTech (Maroon Cap) COVID-19 Vaccine
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Ages 6 months through 4 years of age: A three-dose series of 3 mcg (0.2 mL) given at least 3-8 weeks between doses 1-2 and at least 8 weeks between doses 2-3.
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Immunocompromised ages 6 months through 4 years of age: A three-dose series of 3 mcg (0.2 mL) given at 3 weeks between doses 1 to 2 and at least 8 weeks between doses 2 to 3.
- Please note the dilution and dosing amounts are different from other Pfizer-BioNTech COVID-19 products.
This vaccine follows the same storage guidelines as the Pfizer Orange Cap (5-11 years) and Pfizer Gray Cap (12+ years) COVID-19 vaccines:
- Ultra-low temp freezer storage for 12 months
- NO storage in a normal freezer
- Refrigerator storage for 10 weeks
Some important administration differences of the Maroon Cap Pfizer product include:
- Vials must be diluted with 2.2mL of 0.9% Sodium Chloride
- The dose size is 0.2 mL of diluted vaccine injected intramuscularly
Resources:
Interim Clinical Considerations for Use of COVID-19 Vaccines Approved or Authorized in the United States
Pfizer-BioNTech COVID-19 EUA fact sheet 6 months through 4 years of age.
Moderna COVID-19 EUA fact sheet 6 months through 5 years of age.
Storage and Handling Job Aid for Pfizer Maroon Cap (6 months through 4 years).
Storage and Handling Job Aid for Moderna Blue Cap with Magenta Border (6 months through 5 years).
COVID-19 Presentations Available to Order in ASIIS
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