New Guidance for COVID-19 vaccines

May 3, 2023

Impacted: All lines of business 

FDA and ACIP/CDC have provided new guidance for COVID-19 vaccines 

On April 18, 2023 the Food and Drug Administration (FDA) issued several updates to Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines.  

There are two parts to this announcement: 

  • The Pfizer-BioNTech and Moderna monovalent mRNA vaccines are no longer authorized for use in the United States.   
  • The authorized Pfizer-BioNTech and Moderna bivalent mRNA vaccines should be used for all doses administered to individuals 6 months of age and older. 

Following the FDA’s updates, the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC) also issued an update of the Interim Clinical Considerations for use of COVID-19 Vaccines on Saturday, April 22, 2023.   

In response to the FDA and ACIP/CDC announcements Prime has made the following changes to Prime Standard Commercial and Medicaid COVID-19 vaccine drug lists.  

Prime Standard (PS) COVID-19 vaccine drug list changes: 

Monovalent formulations:  

  • All monovalent mRNA Pfizer-BioNTech and Moderna COVID-19 vaccines, including Comirnaty and Spikevax, were termed from the PS Commercial and Medicaid COVID-19 vaccine drug lists. 
    • Medicare: Monovalent mRNA Pfizer-Biotech and Moderna COVID-19 vaccines, except Comirnaty and Spikevax, were termed from the PS Medicare COVID-19 vaccine drug list, pending further guidance from the Centers for Medicare & Medicaid Services (CMS). 
  • Following their removal from drug lists, these monovalent mRNA products will not be covered and will reject at the point of sale. 

Bivalent formulations:  

  • Prime updated quantity limits to 3 doses per rolling 365 days on the following; 
    • Pfizer-BioNTech COVID-19 mRNA Bivalent Vaccines 
      • NDCs (59267030401, 59267030402, 59267140401, 59267140402, 59267056501, 59267056502, 59267060901, 59267060902) 
    • Moderna COVID-19 mRNA Bivalent Vaccines 
      • NDCs (80777028205, 80777028299) 
  • The following bivalent Moderna product is now authorized for use for those age 6 months and older. Prime will apply an age edit of 6 months and older accordingly when a RxClaim system enhancement has been implemented. 
    • Moderna COVID-19 mRNA Bivalent Vaccine  
      • NDCs (80777028205, 80777028299) 

Note: ACIP and CDC are still finalizing a recommendation for the immunocompromised population. Prime will continue to monitor and will adjust QLs if applicable.  

If you have additional questions, please reach out to your Prime Client Engagement representative.