Meadows to meet with FDA chief as Trump questions state of emergency vaccine approval

by



[ad_1]

Meadows summed up Hahn for a progress update over the weekend. Hahn requested that their meeting be held over the phone, a source said, but the White House said the chief of staff preferred to meet in person. This appears to have led the FDA to worry that the meeting could become tense, leading Hahn to issue a statement to Axios on Monday evening defending the FDA’s schedule.

“Let me be clear – our career scientists have to make the decision and they will take the time necessary to make the right call on this important decision,” Hahn said in the statement.
Pfizer applied for emergency use authorization on November 20. The emergency use clearance from the FDA is not the same as full approval, but allows products to be used in specific circumstances before all the evidence is available for approval, according to previous CNN reports. The FDA has previously said it has scheduled a meeting of its external advisory group to discuss Pfizer and BioNTech’s request for emergency use authorization for a coronavirus vaccine on December 10.

But Trump has become privately frustrated with the length of the process, sources told CNN. He proudly and publicly admitted to pressuring the FDA to step up.

“It could have taken four or five years to get there,” Trump told reporters on vaccine progress at Thanksgiving. “Normally it would have probably taken four or five years, just to get it through the FDA. We pushed really hard.”

Amid complaints from the president that the FDA is working too slowly, White House press secretary Kayleigh McEnany told Fox News on Tuesday that the agency was working “around the clock” but Trump “was not working. ‘will never apologize for setting these agencies on fire.

“We want a safe vaccine, absolutely. We also want a rapid vaccine because lives are at stake and a vaccine by the end of the year is essential and paramount,” said McEnany.

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

“The FDA has been preparing for the EUA review for Covid-19 vaccines for several months and stands ready to do so as soon as an EUA application is submitted,” Hahn said in a statement shortly after. Pfizer applied for emergency use authorization for the vaccine in late November. “While we cannot predict how long the FDA review will take, the FDA will review the application as quickly as possible, while still doing so in a thorough and scientific manner, so that we can help make a vaccine available. that the American people. deserve ASAP. “

[ad_2]

Source link