In addition to at least two months of safety data, the agency plans to conduct a panel review of any applications for emergency use of the COVID-19 vaccine, according to documents released Tuesday by the U.S. Food and Drug Administration. The document is the agency’s most detailed public statement to date, explaining how vaccine approvals will be conducted under the Emergency Use Authorization (EUA) fast-track.
The FDA has been working on a separate “guidance” document detailing the approval requirements, but the document is still under White House review and it is unclear when or if it will be released.
Although the exact contents of the guidance document have not yet been released, the FDA said it had communicated the requirements to drugmakers. While the official documents remain in the White House, the release of the requests in Tuesday’s documents amounts to a public release of the guidance documents.
It also makes it clear that the FDA will add an additional step to the approval process. The FDA said in a filing Tuesday that it will ask the Vaccine and Related Biological Products Advisory Committee to add a follow-up meeting to study specific applications from drugmakers.