FDA Can – and Must — Pick Up the Pace on Vaccine Approval
The good news is the Food and Drug Administration is giving emergency use approval for two coronavirus vaccines. The bad news is the FDA could have approved the drugs much sooner, and into production much earlier.
The problem is that even in the midst of a global pandemic, the FDA’s bureaucracy refuses to pick up the pace. Johns Hopkins University School of Medicine professor Marty Makary writes:
Pfizer 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?
As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency’s review can be done within 24 to 48 hours without cutting any corners. They just need to work harder.
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.
Makary said the FDA “should be convening a single, day-long meeting immediately when the data is submitted, in the same way American businesses have emergency board meetings when a crisis occurs.”
More vaccines are currently in various trial stages. They, too, will need FDA approval before being administered to the public.