Clicky

November 13, 2024
The headquarters of German company BioNtech is pictured in Mainz, Germany, on November 12.

BioNTech/Pfizer submit application that could see vaccine in use across Europe by end of 2020

White House Chief of Staff Mark Meadows wears a protective mask as he departs the Senate Republican policy luncheon in the Hart Senate Office Building on Oct. 21 in Washington, DC.
White House Chief of Staff Mark Meadows wears a protective mask as he departs the Senate Republican policy luncheon in the Hart Senate Office Building on Oct. 21 in Washington, DC. Stefani Reynolds/Getty Images

White House Chief of Staff Mark Meadows is scheduled to meet with FDA Commissioner Dr. Stephen Hahn Tuesday, as President Donald Trump has privately demanded to know why his agency hasn’t granted emergency use for Pfizer’s coronavirus vaccine yet, according to two sources. 

Meadows summoned Hahn for a progress update over the weekend. Hahn requested their meeting happen over the phone, one source said, but was told by the White House that the chief of staff preferred to meet in person. That appears to have led to concern within the FDA that the meeting could become tense, leading Hahn to issue a statement to Axios tonight defending the FDA’s timeline. 

“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,” Hahn said.

Pfizer applied for the EUA on Nov. 20. 

Emergency use authorization from the FDA is not the same as full approval, but allows products to be used under particular circumstances before all the evidence is available for approval, according to previous CNN reporting. 

The FDA has previously said it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine for Dec. 10.

But Trump has become privately frustrated over how long the process is taking, sources told CNN. He has proudly and publicly admitted to pressuring the FDA to move faster. 

“It could have taken four or five years to do this,” Trump told reporters about vaccine progress on Thanksgiving. “Normally, it probably would have taken four or five years, just getting it through the FDA. We pushed it very hard.”

It’s not clear how the meeting between Meadows and Hahn will go until it takes place. A sense of distrust between Trump’s closest advisers and career scientists on the FDA already existed before the FDA issued public statements about the meeting on Monday night.