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The FDA commissioner was called to The White House to conduct a coronavirus briefing on vaccine approval, according to Fox News.
Moderna now applying for Emergency Vaccine Approval.. @US_FDA MUST ACT QUICKLY!!! “Operation Warp Speed has been a great modern day miracle.”
— Donald J. Trump (@realDonaldTrump) November 30, 2020
Makary said, “The FDA has been too bureaucratic, taking too much time. And I don’t know if they’re scheduling around vacation times and tee times of the reviewers, but they should turn the application around in 24 hours.”
Hahn said, “Let me be clear – our scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision.”
“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.”
“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.”
More from Fox News:
The FDA is scheduled to meet on Dec. 10 regarding Pfizer’s application for emergency use authorization (EUA) of its coronavirus vaccine, three weeks after the company filed for it. The FDA plans to meet on Dec. 17 to discuss Moderna’s EUA. Critics have questioned the delay in scheduling, including Fox News medical contributor Dr. Marty Makary, who said the agency is being “too bureaucratic.”
And on Monday, following Moderna’s announcement that it was ready to file for EUA, President Trump tweeted that the FDA must act quickly.
