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# FDA Sticking with Vaccine Guidance: Hahn
- URL: https://www.fdaweb.com/fda-sticking-with-vaccine-guidance-hahn/
- Published: 2020-09-29T12:00:00.000Z
- Updated: 2026-09-14T16:30:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147758

FDA commissioner **Stephen Hahn** says agency career scientists will follow the guidance on the evaluation of Covid-19 vaccines that President **Donald Trump** has threatened to overrule. Speaking 9/29 at the *Financial Times* U.S. Pharma and Biotech Summit, Hahn [said](https://www.ft.com/content/77eb55ab-9c55-430d-af7a-0f039591b337?ref=fdaweb.com) his staff will assess all vaccine applications against a set of criteria that experts have said would make it all but impossible to have a vaccine available before the 11/3 presidential election.

The agency guidelines include a requirement that companies monitor half their clinical trial participants for at least two months before making an application. “The criteria that we’ve established for a vaccine are the criteria we are going to use,” Hahn said. “We’ve been very clear about that with sponsors, very clear about that with the public. They are criteria that our career scientists are going to use to make a decision about the safety and effectiveness of the vaccine.”

Hahn reportedly said he does not know when a Covid-19 vaccine will be ready.