White House acquiesces to FDA’s guidelines for vetting Covid-19 vaccines
The Wall Street Journal reports:
The White House endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.
The FDA promptly issued the guidelines on Tuesday afternoon, saying it hopes the release “helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”
The White House didn’t immediately respond to a request for comment.
For two weeks, Trump administration officials had expressed opposition to the plan, in large part because it called for a two-month observation period to see whether people who got the vaccine had suffered negative side effects, The Wall Street Journal has reported.
That two-month waiting period would make it all but certain that any vaccine couldn’t be approved for use in the U.S. before the election, a target that President Trump had been aiming for.
After raising the objections, White House officials refused to sign off on the guidelines and didn’t seek changes that could lead to an administration go-ahead, according to people familiar with the matter.
The FDA, however, was prepared to follow its guidelines even though the White House hadn’t signed off, and the agency had notified vaccine makers about the details. [Continue reading…]