Today, on August 31, the Federal Drug and Food Administration (FDA) authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose given 2 months after completion of the primary series or the most recent booster dose of an approved or authorized monovalent (original) COVID-19 vaccine.
- Moderna Bivalent Booster is authorized for those 18 years and older.
- Pfizer Bivalent Booster is authorized for those 12 years and older.
The Advisory Committee on Immunization Practices (ACIP) will meet on recommendations for the use of Bivalent Boosters on September 1st and possibly September 2nd. The Western States Scientific Safety Review Workgroup (WSSSRW) will meet immediately afterwards.
Monovalent mRNA COVID-19 vaccines are no longer authorized by FDA as booster doses for individuals 12 years of age and older.
- Appointments for monovalent Pfizer-BioNTech or Moderna boosters in people 12 years of age and older must be rescheduled until providers have supplies of the bivalent COVID-19 vaccines available and they are recommended for use by ACIP.
- Remaining supplies of adult-dose monovalent mRNA COVID-19 vaccine can only be used for primary series doses but not for adult booster doses. Monovalent Moderna 50 mcg doses no longer authorized asadult booster doses may continue to be used for children ages 6-11 years. Other pediatric formulations of monovalent vaccine for children younger than 12 years may continue to be used for now as previously recommended.
Bivalent Deliveries beginning now: Please note that some orders placed for Bivalent Boosters may arrive as early as this week, earlier than previously anticipated.
Label and cap alert: Please continue to carefully check vial labels to ensure that the intended product is being given: Cap colors, label colors and outdated language can be easily confused.
Current Procedural Terminology (CPT) codes for the COVID-19 Bivalent Boosters are:
- Moderna COVID-19, Bivalent Booster for 18+ Years
- 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
- 0134A - Immunization administration by intramuscular injection of 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, booster dose
- Pfizer COVID-19, Bivalent Booster for 12+ Years
- 91312 - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, for intramuscular use
- 0124A - Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, booster dose
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