​Pfizer and Moderna Monovalent COVID-19 Vaccines No Longer Authorized for Use, CR 116981

On April 18, 2023, the Food and Drug Administration (FDA) announced changes to simplify the use of Bivalent mRNA COVID-19 vaccines. As a result, the Monovalent COVID-19 vaccines produced by Pfizer BioN-Tech and Moderna are no longer authorized for use in individuals aged six months and older. See the codes below that are no longer authorized for use:  

  

Code  

Description  

Effective Date  

End Date  

91300  

Pfizer-BioNTech- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use  

12/11/2020  

04/18/23  

  

0001A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; first dose  

12/11/2020  

04/18/23  

  

0002A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted; second dose  

12/11/2020  

04/18/23  

  

0003A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted: third dose  

8/12/2021  

04/18/23  

  

91301  

Moderna- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use  

12/18/2020  

04/18/23  

  

0011A  

Moderna- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; first dose  

12/18/2020  

04/18/23  

  

0012A  

Moderna- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage; second dose  

12/18/2020  

04/18/23  

  

0013A  

Moderna- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; third dose  

8/12/2021  

04/18/23  

  

91305  

Pfizer- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, trissucrose formulation, for intramuscular use  

1/3/2022  

04/18/23  

  

0051A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation; first dose  

1/3/2022  

04/18/23  

  

0052A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation; second dose  

1/3/2022  

04/18/23  

  

0053A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation; third dose  

1/3/2022  

04/18/23  

  

91307  

Pfizer-BioNTech- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use  

10/29/2021  

04/18/23  

  

0071A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation: first dose  

10/29/2021  

04/18/23  

  

0072A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation: second dose  

10/29/2021  

04/18/23  

  

0073A  

Pfizer-BioNTech- Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose  

1/3/2022  

04/18/23  

  

91308  

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use  

6/17/2022  

04/18/23  

  

0081A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose  

6/17/2022  

04/18/23  

  

0082A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose  

6/17/2022  

04/18/23  

  

91309  

Moderna-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage, for intramuscular use  

3/29/2022  

04/18/23  

  

0091A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage; first dose, when administered to individuals 6 through 11 years  

6/17/2022  

04/18/23  

  

0092A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage; second dose, when administered to individuals 6 through 11 years  

6/17/2022  

04/18/23  

  

0093A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage; third dose, when administered to individuals 6 through 11 years  

6/17/2022  

04/18/23  

  

91311  

Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 25 mcg/0.25 mL dosage, for intramuscular use  

6/17/2022  

04/18/23  

  

0111A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; first dose  

6/17/2022  

04/18/23  

  

0112A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; second dose  

6/17/2022  

04/18/23  

  

0113A  

Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; third dose  

6/17/2022  

04/18/23  

 

  

Providers may visit the Maine CDC Immunization Program Website for up-to-date information on administering and ordering COVID-19 vaccines and booster doses.      

If you have questions about the use of Monovalent or Bivalent COVID-19 vaccine booster doses, please contact your Provider Relations Specialist.     

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