Skip to main content
Premium Trial:

Request an Annual Quote

Justification for Stricter Standards Sought

White House chief of staff Mark Meadows last week asked the US Food and Drug Administration to justify why the agency was seeking stricter standards for the emergency authorization of a coronavirus vaccine, the Washington Post reports.

The agency said it was going to institute new guidelines for the process, including requiring vaccine makers to follow trial volunteers for a median two months after receiving their last dose before authorization could be sought. This, CNN noted last week, would make it unlikely that any vaccine would receive an Emergency Use Authorization before the US elections. The announcement was also aimed at quashing concerns that the vaccine development and authorization process was being rushed and politicized, as the Post said last week in a separate article.

However, Politico reported that President Donald Trump said he might not approve these stricter standards from FDA. Additionally, in a phone call to FDA Commissioner Stephen Hahn, Meadows asked for a detailed justification for the stricter standards, the Post reports.

On CBS Face the Nation yesterday, Meadows said that they wanted to ensure the vaccines are safe, but also questioned why the FDA was issuing new guidelines. "My challenge to the FDA is just make sure it's based on science and real numbers," he said

The New York Times notes that, on the same show, former FDA Commissioner Scott Gottlieb said the new guidelines are not "a revision in the agency standards or any kind of higher bar" but are "an articulation of the principles and standards that the FDA has been using for a long time and frankly been communicating to the companies that are developing vaccines."