The EUA program, established in 2004, gives the U.S. Food and Drug Administration the power to grant temporary, accelerated approval to a medical drug or device needed in a public health emergency. The EUA review process is less rigorous than a regular approval.
During the coronavirus pandemic, the FDA has granted EUAs to hundreds of tests and two treatments. But the only immunization ever approved for emergency use was against anthrax, in 2005.
The FDA has said the decision to grant an EUA to a COVID-19 vaccine before final testing is completed “would be made on a case-by-case basis” considering factors including “the totality of the available scientific evidence.”
Philadelphia Health Commissioner Thomas Farley said he likely would not recommend the vaccine for everyone without final data.