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# Tighter Covid Vaccine Approval Standards Coming: Report
- URL: https://www.fdaweb.com/tighter-covid-vaccine-approval-standards-coming-report/
- Published: 2020-09-22T12:00:00.000Z
- Updated: 2026-09-14T16:29:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147710

FDA is expected to issue a guidance later this week laying out tougher new standards for emergency authorization of a Covid-19 vaccine. The *Washington Post* [says](https://www.washingtonpost.com/health/2020/09/22/fda-covid-vaccine-approval-standard/?ref=fdaweb.com) the new standards “will make it exceedingly difficult for any vaccine to be cleared before Election Day.”

The *Post* article says the new guidance will be issued “to boost transparency and public trust as \[FDA\] approaches the momentous decision of whether a prospective vaccine is safe and effective.”

Under the new guidance, the agency reportedly would ask manufacturers seeking an emergency authorization to follow participants in late-stage clinical trials for a median of at least two months starting after they receive a second vaccine shot. And the agency reportedly will also look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people.

“These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable any vaccine will be authorized before the election,” the article says.

An FDA spokesperson declined to comment to the *Post* on its report, which was based on information from two individuals who are familiar with the situation and asked to comment anonymously.