Why does the FDA need three weeks to approve Pfizer's vaccine?

 

• In an op-ed for The Dispatch, Johns Hopkins Professor Marty Makary slammed the FDA for "holding up COVID-19 vaccine approval" and dubbed the agency's progress "Operation Turtle Speed."
• "Pfizer (NYSE:PFE) submitted data detailing the safety and effectiveness of its vaccine on Nov. 22. But rather than immediately convening experts, the FDA scheduled a review meeting on Dec. 10, almost three weeks later. As Pfizer's application sits on the shelf at the FDA awaiting authorization, about 27,000 Americans will have died. So what is the FDA doing for three weeks?"
• "Contrary to popular belief, the FDA process is not hands-on - it does not interview vaccine trial patients or look under a microscope at the immune cells. It's doing a statistical analysis and looking at data. For the vaccine trial, the data set is small and straightforward. If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour."
• "The FDA also reviews manufacturing data from Pfizer on how they made the drug. But not only can that data be reviewed in a few hours, it should have been done months ago when it was available. While the FDA was waiting for Pfizer’s long-term vaccine results to come in, the agency should have anticipated this step and done it early."
• "The final step of the FDA review is to look at the outcomes of the study volunteers, including rates and severity of infection and side effects in the vaccine and placebo groups. Again, there is no plausible reason why this basic analysis cannot be done in 24 hours. The FDA and external scientists have a simple task: confirm or reject the review already conducted by the trial’s independent data safety monitoring board before FDA submission."
• Note: Bahrain became the second country to grant emergency-use authorization to Pfizer and BioNTech's (NASDAQ:BNTX) vaccine on Friday. The U.K. became the first this past Wednesday.
• https://seekingalpha.com/news/3641957-operation-turtle-speed-why-fda-need-three-weeks-to-approve-pfizers-vaccine