"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," a second administration official said.An FDA spokesperson denied Hahn was vacationing and responded: "On the point about Dr. Hahn’s recent remote work schedule, Dr. Hahn was recently exposed to COVID 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. Dr. Hahn has worked every single day of this pandemic, including weekends, holidays and more."When Meadows requested the meeting, Hahn said he wanted to do it over the telephone. Meadows insisted it be in person.An agency spokesperson tells Axios, "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."Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects."
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