Emergency Use Authorization for Vaccines to Prevent COVID-19 - Guidance for Industry

“III. Criteria and Considerations for the Issuance of an EUA for a COVID-19 Vaccine… Based on this declaration and determination, FDA may issue an EUA after FDA has determined that the following statutory requirements are met (section 564 of the FD&C Act (21 U.S.C. 360bbb-3)) (Ref. 3): …

• There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.”