COVID-19 Vaccines


The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

Date of First EUA Issuance Most Recent letter of Authorization (PDF) Authorized Use Fact Sheets and Manufacturer Instructions/ Package Insert (PDF)
02/27/2021 Janssen COVID-19 Vaccine For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older Healthcare Providers
Recipients and Caregivers
Frequently Asked Questions on the Janssen COVID-19 Vaccine
Decision Memorandum 
More information about the Janssen COVID-19 Vaccine  
12/18/2020 Moderna COVID-19 Vaccine (Reissued February 25, 2021) For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older Healthcare Providers 
View the Fact Sheet for Healthcare Providers Administering Vaccine in multiple additional languages
Recipients and Caregivers 
View the Fact Sheet for Recipients and Caregivers in multiple additional languages
Decision Memorandum  Frequently Asked Questions on the Moderna COVID-19 Vaccine
More information about the Moderna COVID-19 Vaccine  
02/11/2020 Pfizer-BioNTech COVID-19 Vaccine (Reissued February 25, 2021)   Letter Granting EUA Amendment (January 6, 2021)   Letter Granting EUA Amendment (January 22, 2021) For the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older Healthcare Providers  Recipients and Caregivers 
View the Fact Sheet for Recipients and Caregivers in multiple additional languages Decision Memorandum  Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine
More information about the Pfizer-BioNTech COVID-19 Vaccine