Now that the Pfizer vaccine has received final approval by the FDA, does this affect the emergency use authorization (EUA) and does it change what we are currently doing?

No, it does not currently change what you are doing, and the EUA is still in effect since the FDA-approved Pfizer vaccine does not cover all components of vaccine administration. Here are some key facts related to the FDA approval:

  • Comirnaty is the licensed name for the FDA-approved COVID-19 Pfizer vaccine
  • The updated  Healthcare Provider Fact Sheet provides additional information on both the FDA-approved and EUA authorized vaccine
  • FDA approval is for ages 16 and up
  • The EUA is still in effect for administering the Pfizer vaccine for patients 12 through 15 years of age and to provide a third dose for 12 years of age and older for individuals with certain immunocompromised conditions
  • The Pfizer vaccine and the newly licensed Comirnaty vaccine have the same formulation and can be used interchangeably without presenting any safety or effectiveness concerns
  • For ages 16 years and older, providers can now use doses distributed under the EUA to administer the vaccination series as if the doses were the licensed vaccine
  • The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine
  • Vaccination providers are required to provide the “Vaccine Information Fact Sheet” prior to the individual receiving each dose of the Pfizer Vaccine
  • Vaccination providers enrolled in the federal COVID-19 Vaccination Program are still required to report:
    • All vaccine administration errors
    • All serious adverse events
    • Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
    • Cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 vaccine

Curi has updated the two-dose consent to incorporate the FDA approval of the Pfizer vaccine.

Additional resources:

Q&A for Comirnaty (COVID-19 Vaccine mRNA)

Package Insert – Comirnaty

News & Knowledge
All Curi recommendations are based on current CDC criteria at the time of publication. CDC guidance for SARS-CoV-2 infection may, or may not, be adopted by state and local health departments to respond to rapidly changing local circumstances. Providers should always check with their local health department to see if the CDC’s guidance on any given topic has been modified (particularly if more restrictive) from the CDC’s recommended guidelines. Follow this link https://www.cdc.gov/publichealthgateway/healthdirectories/index.html for contact information to your state/local health department. If local recommendations vary from those of the CDC, and you are unsure what recommendations to follow, then it is safer to follow the more restrictive guidelines/recommendations.