WASHINGTON — President Donald Trump said Wednesday he might not sign off on stricter Food and Drug Administration guidelines for approving a coronavirus vaccine.
The FDA is expected this week to roll out tougher new standards aimed at boosting public confidence in a vaccination, The Washington Post reported. The guidance is likely to make it exceedingly difficult for any vaccine to be approved by Election Day.
Trump’s repeated promises that a vaccine will be ready by the end of the year — and possibly as early as next month — and the administration’s alleged interference in federal science agencies have left many Americans feeling uneasy about receiving a vaccine. An Axios-Ipsos poll earlier this week found that only 39% of Americans would get a first-generation COVID-19 vaccine as soon as it’s available -- and that number has been on a steady downward trajectory in recent weeks.
Speaking to reporters in the White House briefing room, Trump said Wednesday that the White House “may or may not” approve new FDA guidelines.
“We are looking at that, but I think that was a political move more than anything else,” he said.
Testifying on Capitol Hill earlier Wednesday, four doctors leading the federal coronavirus response endorsed tighter safety procedures to ensure a vaccine is safe and effective.
An FDA official told CNN that, generally speaking, agency guidelines do not go through the White House Office of Management and Budget for approval.
The tougher FDA guidelines would require drugmakers to track Phase 3 clinical trial participants for a median of at least two months after they’ve received the second vaccine shot and mandate that at least five severe COVID-19 cases in the placebo group, as well as a sampling of older people with the virus, to prove its efficacy, The Washington Post reported.