- White House Chief of Staff Mark Meadows abruptly summoned FDA Commissioner Dr. Stephen Hahn to the White House Tuesday to discuss the Covid vaccine approval process, NBC News confirmed.
- Pfizer, which is working with German drugmaker BioNtech, applied for emergency clearance from the FDA on Nov. 20.
- The FDA has scheduled a meeting for Dec. 10 to discuss Pfizer and BioNtech's request for authorization.
White House Chief of Staff Mark Meadows summoned Food and Drug Administration Commissioner Dr. Stephen Hahn to discuss why the agency hasn't moved faster to authorize Pfizer's coronavirus vaccine, a person familiar with the matter confirmed to NBC News.
Pfizer, which is working with German drugmaker BioNtech, applied for emergency clearance from the FDA on Nov. 20. The FDA has scheduled a meeting for Dec. 10 to discuss Pfizer and BioNtech's request for authorization.
Hahn arrived at the White House shortly before the 9:30 a.m. meeting with Meadows and left the West Wing a few minutes before 11:00 a.m.
Hahn prepared for the meeting by assembling talking points "focused purely on vaccines and therapies," a senior administration official told CNBC. The FDA commissioner planned to give Meadows "just an update on where things stand."
Axios first reported the meeting, along with a preemptive statement from Hahn, who told Axios: "Let me be clear — our career scientists have to make the decision and they will take the time that's needed to make the right call on this important decision."
Axios reported that Meadows wanted to ask why Hahn spent a week working remotely from North Carolina in mid-November, the implication being that Hahn took a vacation at a crucial time for vaccine approvals.
But Hahn's trip to the Carolina coast was not a vacation, said Michael Felberbaum, a spokesman for the FDA. Hahn "recently quarantined out of an abundance of caution following a potential exposure to COVID-19 while working at the FDA's White Oak campus."
"Dr. Hahn chose a remote location to quarantine and he continued working, as he has done throughout the pandemic," Felberbaum said in a statement. "The agency followed its contact tracing and notification protocols, following CDC guidelines, for the very small number of other potentially impacted employees."
The agency's White Oak campus in Silver Spring, Maryland "is a ghost town... so we are all very surprised that an exposure is even possible," the senior agency official said.
Another top official working on vaccines, Operation Warp Speed advisor Dr. Moncef Slaoui, was asked about the Meadows and Hahn meeting during an event Tuesday morning hosted by The Washington Post. Slaoui said this was the first he'd heard of it.
A White House spokesman declined to comment on Hahn's and Meadows' meeting.
Tuesday's meeting carried an added element of suspense because President Donald Trump has made no secret of his frustration with top officials at several of the nation's premier health agencies.
Trump has even publicly accused Hahn of deliberately slow-walking the Covid-19 vaccine approval process in order to damage Trump's reelection chances, an allegation which has no basis in fact.
"The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics," Trump tweeted on Aug. 22. "Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!"
The president added Hahn's public twitter handle to the tweet, singling out the FDA commissioner.