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White Home asks FDA to clarify COVID-19 vaccine assessment tempo


White House Chief of Staff Mark Meadows is meeting Tuesday at the White House with Food and Drug Administration Commissioner Stephen Hahn to discuss the speed of COVID-19 vaccine approval by the agency as US infections surge.

Pfizer and partner BioNTech applied for emergency approval for a coronavirus vaccine candidate on Nov. 20, but the FDA didn’t schedule an approval meeting until Dec. 10. Clinical trials found the vaccine is about 95 percent effective and has no serious safety issues, the companies said.

Another company, Moderna, applied for emergency approval for a vaccine candidate on Monday. The FDA scheduled a meeting 18 days later on Dec. 17 for its Vaccines and Related Biological Products Advisory Committee. Moderna says its vaccine also has about 95 percent effectiveness.

A senior Trump administration official told Axios, “There are some who are complaining the FDA is not working around the clock to get things approved and because of that, Meadows has asked Dr. Hahn for a briefing.”

One source accused Hahn of going on vacation to the Outer Banks in North Carolina in November as the companies raced to submit vaccine applications.

The White House did not immediately respond to a request for comment from The Post.

An FDA spokesperson defended what to outsiders appears to be foot-dragging amid a public health crisis.

Hahn said in a statement to Axios, “We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.”


An FDA spokesperson told the outlet, “The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines. Once the reviews by the various experts are completed, they are then integrated into an overall review.”

The FDA spokesperson also denied Hahn took a beach vacation last month, saying he was quarantining at the shore after exposure to COVID-19.

“Dr. Hahn chose a remote location to quarantine and he continued working, as he has done throughout the pandemic. Dr. Hahn has worked every single day of this pandemic, including weekends, holidays and more,” his spokesperson said.

Since March the respiratory virus has infected 13.5 million Americans and killed more than 268,000 while causing significant economic, social and educational disruption.


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