Trump questions need for tougher FDA standards on coronavirus vaccine
President Trump on Wednesday questioned the need for the Food and Drug Administration (FDA) to issue tougher standards for the emergency authorization of a coronavirus vaccine, saying the move appeared “political” and would need to be approved by the White House.
“We’re looking at that. That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” Trump told reporters at a White House briefing when asked if he agreed with the FDA’s plan to issue the new guidelines, reported by The Washington Post earlier this week.
Trump went on to assert that the standards would cause unnecessary delay in the delivery of a possible vaccine. Multiple companies are currently in clinical trials for vaccine candidates.
“Why would [companies] have to be adding great length to the process? We want to have people not get sick. The vaccine is very important,” Trump said, adding, “I think that was a political move more than anything else.”
The Post reported Tuesday that the guidance will call for a median of two months of data on the participants in vaccine clinical trials, in order to ensure there is enough time to assess the safety of the vaccine candidates. The new guidance, meant to increase public trust and transparency in the vaccine process, would make it more difficult for a vaccine to be cleared for distribution before Election Day.
Asked if his administration needed to improve trust in the vaccine, Trump said he has “tremendous trust” in companies testing the vaccines.
“I have tremendous trust in these massive companies that are so brilliantly organized in terms of what they have been doing with the tests,” Trump said.
“I don’t see any reason it should be delayed further,” Trump said, adding that a delay in a vaccine for a few weeks could cost lives due to the coronavirus.
Trump has predicted a vaccine could be ready during the month of October and publicly pressured the FDA over the approval process. Democrats have raised concerns about political pressure in the race for a vaccine.
Top health officials appeared before a Senate panel earlier Wednesday and sought to reassure Americans skeptical of the politicization of a vaccine.
Trump has repeatedly broken with top health officials on public health guidelines and his assessments about the threat posed by the virus.
Last week, Trump took issue with CDC Director Robert Redfield’s prediction that a possible vaccine would not be available to the general public until the end of the second quarter or third quarter of 2021. Trump insisted Redfield made a “mistake” and was “confused” by questioning at a congressional hearing.
An FDA spokesperson declined to comment when asked about Trump’s remarks.