The following information is excerpted from fda.gov, detailing the Emergency Use Authorization (EUA) as it relates to COVID-19 vaccine:
Coronavirus Disease 2019 (COVID-19) EUA Information
FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA’s ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.
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.
- Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (February 4, 2020)
- Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the FD&C Act (effective March 15, 2023; Federal Register notice March 20, 2023)
- Emergency Use Authorization Declaration (March 27, 2020)
For additional information about COVID-19 vaccines, see:
- COVID-19 Vaccines
- Emergency Use Authorization for Vaccines Explained
- Infographic: The Path for a COVID-19 Vaccine From Research to Emergency Use Authorization (PDF, 723 KB)
- Vaccine EUA Questions and Answers for Stakeholders
- Coronavirus (COVID-19) | CBER-Regulated Biologics (including archived fact sheets for monovalent mRNA COVID-19 vaccines, located in a drop-down section at the bottom of the page)
- Emergency Use Authorization–Archived Information (information about terminated or revoked EUAs)