The FDA commissioner was called to the White House on Tuesday to give a briefing on the coronavirus vaccine approval process. President Trump’s chief of staff, Mark Meadows, called Dr. Stephen Hahn at 9:30 a.m. to inform officials the same day that the Advisory Centers for Disease Prevention and Control (CDC) meeting is scheduled to meet about vaccine distribution plans.
The FDA is scheduled to meet on December 10 for an application for an emergency use authorization (EUA) for Pfizer’s coronavirus vaccine, three weeks after the company submitted it. The FDA plans to discuss the Moderna EUA on December 17th. Critics have questioned the delay in scheduling, including Fox News medical staff member Dr. Marty Makary, who says the agency is “too bureaucratic”.
“The FDA was too bureaucratic, it took too much time,” Makary said Monday while appearing on “Bill Hemmer Reports.” “And I don’t know if the reviewers are planning vacation and rest time, but they should turn the app over within 24 hours.”
DR. MARTY MAKARY GOVERNS FDA SCHEDULE FOR CORONAVIRUS VACCINE APPROVAL
And on Monday, after Moderna announced it was ready to submit the EUA, President Trump tweeted that the FDA needed to act quickly.
But on Tuesday before the briefing, Hahn said FDA scientists are taking time for approval.
DR. TO SEE DECISIONS AS A SPECIAL CONSULTANT AT SCOTT ATLAS FOR THE CROWN VIRUS
“Let me be clear: our scientists need to make the decision and are devoting enough time to making this important decision right,” Hahn said in a statement to Fox News. “We want to move fast because it’s a national emergency, but we’re going to make sure our scientists take the time to make the right decision. It’s our job to get that right and make the right decision about the safety and effectiveness of vaccinations.”
Scientists at the agency worked non-stop on “huge amounts of data,” according to Fox News. The fastest approval process for this amount of data ever completed was 3.5 months, adapting the current schedule to historic speeds.
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An FDA spokesman added that thousands of pages of data need to be shared and reviewed by experts in different disciplines and then integrated into a comprehensive review.
“Completion of these reviews shall include the adequacy of the manufacturing process and production control, the verification of the statistical analyzes performed to ensure that it is performed properly and, if necessary, additional analyzes to examine the effect of the vaccine. For subgroups at higher risk said the spokesman.
On Tuesday, the United States counted more than 13.5 million new cases of coronavirus and more than 268,103 deaths, nearly 100,000 more deaths than the second highest death in Brazil.
John Roberts of Fox News contributed to the report.