They've backed down now, but initially the White House was trying to block the FDA's requirement for two months of safety data for a vaccine before it's granted an EUA.
The US Food and Drug Administration (FDA) told coronavirus vaccine developers on Tuesday it wants at least two months of safety data before authorizing any emergency use, a requirement likely to push any US vaccine availability past the 3 November presidential election.
A senior administration official confirmed that the White House had approved the plan, which undercuts Donald Trump’s hopes of getting a vaccine before the majority of voters go to polls.
The president had been hinting at a rapid announcement on a successful vaccine in recent weeks despite the fact that a candidate has yet to emerge from clinical trials and there have been growing fears that political pressure on regulators could result in a compromised process and the undermining of public confidence in a vaccine.
The FDA on Tuesday released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.
The White House had earlier blocked new FDA guidelines that jeopardized the chances of a vaccine being approved before the election. It appeared on Tuesday afternoon that it had backed down.
The proposed guidelines were submitted to the White House on 21 September, meaning the two-month period would extend beyond 3 November, when Donald Trump will seek re-election to the backdrop of a pandemic that has infected more than 7.5 million and killed more than 210,000 in the US.
Polling has consistently shown majority disapproval of Trump’s handling of the pandemic.
A senior administration official had confirmed the move to block the guidelines to the Associated Press on Monday evening, saying the White House believed there was “no clinical or medical reason” for the additional requirement. The White House action was first reported by the New York Times.
Itwas the latest example of the administration undercutting its own experts working to combat Covid-19. The FDA commissioner, Stephen Hahn, has been attempting to shore up public confidence in the FDA vaccine review, vowing career scientists, not politicians, would decide if the shots are safe and effective for mass vaccination.
Yea, so whether Trump wore a mask in the Oval Office (if he was there at all) is a state secret.
Larry Kudlow, President Donald Trump’s top economic advisor, said on Wednesday that the president returned to the Oval Office on Tuesday.
Kudlow declined to comment on whether the president wore a mask during his visit to the White House.
“The president actually showed up in the Oval Office yesterday with extra precautions with respect to his Covid-19,” Kudlow said. “And he’s getting a lot better, he’s much strong. So there was some limited activity.”
Asked by CNBC’s Joe Kernen if the president donned a mask while in the Oval Office, Kudlow said he “can’t be specific, Joe. It’s the work of the top rung of the federal government.”
But Trump’s principal economic advisor was quickly contradicted by the White House, which in a tweet said that Trump had not, in fact, visited the Oval Office as Kudlow had asserted.
“While the President wanted to be in the Oval Office yesterday, he was not there—he stayed back in the residence working from there,” Ben Williamson, a White House spokesman, said in a tweet. “Safety preparations have been underway in the event he moves to working out of the Oval in the coming days.”