FDA Approval of Pfizer BioNTech COVID-19 Vaccine
for Ages 16 and Older
August 24, 2021
Yesterday, August 23, 2021, the US Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The Pfizer BioNTech COVID-19 vaccine, to be marketed under the name Comirnaty, is fully approved for the prevention of COVID-19 Disease for those for those 16 years and older. 
Key Recommendations for Providers
COVID-19 vaccine should continue to be offered to all eligible individuals. FDA approval of the Pfizer BioNTech COVID-19 vaccine is for those 16 years and older. This vaccine can continue to be offered to those 12 through 15 years of age under the existing Emergency Use Authorization (EUA). A third dose can continue to be administered to those who are moderately to severely immunocompromised under the EUA.
Additional Recommendations
  • COVID-19 vaccination continues to be effective at decreasing the risk of COVID-19 disease, particularly hospitalizations and deaths, from the circulating variants of SARS-CoV-2.
  • Providers should use the updated Vaccine Information Fact Sheet available here for recipients and caregivers.
  • Providers not currently offering COVID-19 vaccines may apply to receive vaccine through the California Vaccine Management System, MyCAvax here.
  • Providers not offering COVID-19 vaccines can direct patients here to find convenient locations to receive COVID-19 vaccines.
  • Additionally, Cartons and vials of Pfizer COVID-19 vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as authorized storage conditions between -90°C to -60°C (-130°F to -76°F) have been maintained. COVID-19 vaccine providers can visit here to confirm the latest expiration dates of vaccines.
Additional Information
The FDA has posted prescribing information including the package insert and Fact Sheet for Recipients and Caregivers here. 

For questions or concerns, please contact the Communicable Disease Control Division at 714-834-8180.
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