Did the FDA amend the Emergency Use Authorizations for the Moderna and Pfizer COVID-19 vaccine booster doses?
Yes. Effective October 12, 2022, emergency use authorizations (EUAs) have been amended for the COVID-19 Moderna and Pfizer bivalent vaccines authorizing their use as a single booster dose in younger age groups.
Please note: None of the code descriptors in this article have changed. They are merely listed as a matter of convenience for our customers.
Moderna
Previously, the Moderna vaccine was approved for ages 18 years and older. The amended EUA has lowered the age range for the Moderna COVID-19 bivalent vaccine to children aged 6 years and older.
- 91313 -- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID]-19) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 50 mcg/0.5 mL dosage, for intramuscular use
The associated vaccine administration code is 0134A.
- 0134A -- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, bivalent, preservative free, 50 mcg/0.5 mL dosage, booster dose
Pfizer BioNTech
Previously, the Pfizer vaccine was approved for ages 12 years and older. The amended EUA has lowered the age range for the Pfizer COVID-19 bivalent vaccine to children aged 5 years and older.
- 91312 -- Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, for intramuscular use
The associated vaccine administration code is 0124A.
- 0124A -- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, booster dose
The monovalent Pfizer vaccine is no longer authorized as a booster dose for children aged 5 through 11 years of age.
Helpful resources:
FDA News Release, October 12, 2022