White House blocks stricter guidelines for COVID-19 vaccine approval

It seems the White House is trying to clear a regulatory "hurdle" to fast track the approval of a COVID-19 vaccine before the November 3 presidential election. 

White House officials are blocking new stricter federal guidelines for the emergency release of a coronavirus vaccine, the New York Times reported on Monday. 

The guidelines were submitted by the U.S. Food and Drug Administration to the Office of Management and Budget more than two weeks ago, but they stalled with White House Chief of Staff Mark Meadows, the Times reported, citing people familiar with the approval process. 

“A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for about two months after the final dose before any authorization is granted,” the Times reported, citing a senior administration official and others familiar with the situation. 

That means no vaccine could be authorized before the election day.

An administration official said that the approval process was still pending and denied any Election Day connection. 

The FDA is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards with an outside advisory committee of experts – perhaps as soon as this week – that is supposed to meet publicly before any vaccine is authorized for emergency use, according to the report. 

"The struggle over the guidelines is part of a months-long tug of war between the White House and federal agencies on the front lines of the pandemic response," the report said, noting that White House officials have "repeatedly intervened to shape decisions and public announcements in ways that paint the administration's response to the pandemic in a positive light."

(With input from Reuters.)

(Cover: A small bottle labeled with a "Vaccine" sticker is held near a medical syringe in front of displayed "Coronavirus COVID-19" words in this illustration taken April 10, 2020./Reuters)