FDA to soon issue tougher emergency vaccine standards: report
The Food and Drug Administration (FDA) will issue tougher new standards for the emergency authorization of a coronavirus vaccine as soon as this week, The Washington Post reported on Tuesday.
The FDA had previously said it planned to issue the new guidance laying out the requirements for issuing an emergency authorization for a coronavirus vaccine, but the Post reported new details on Tuesday that indicate the agency is setting a higher bar that could make it difficult to authorize a vaccine before Election Day.
The Post reported that the guidance will call for a median of two months of data on the participants in clinical trials for the vaccines, a requirement seeking to make sure there is enough time to assess any safety side effects. The agency is also looking for at least five severe cases of the coronavirus in the clinical trials’ placebo group, the Post reported.
The standards come as the FDA is looking to reassure the public that it is following the science and will make sure any vaccine is safe and effective before authorizing it amid fears of political pressure from President Trump.
Trump has accused the FDA of harboring a “deep state” that is slowing down the approval of treatments and vaccines.
A group of career FDA officials took the unusual step earlier this month of writing a joint USA Today op-ed committing to relying on “sound science” when making decisions.
One of those FDA officials, Peter Marks, also said this month at a Duke University event that the agency would adopt tougher standards for a coronavirus vaccine than it usually has for other emergency authorizations.
He said the agency will require “substantial information about efficacy” before authorizing any vaccine and will be cautious about ensuring safety given that “hundreds of millions” of people will eventually get the vaccine.