FDA chief says he will not overrule scientists' recommendation on vaccine
FDA Chief Stephen Hahn reiterated on Thursday that any FDA decision on a COVID-19 vaccine will be based on the science and data from clinical trials.
Hahn said the career experts in FDA's Center for Biologics Research make decisions on whether to recommend vaccines for approval and he has no plan to contradict them.
"I can tell you throughout this pandemic, throughout my tenure as commissioner, I have not reversed a decision by the career scientists on medical products and I have no intention of doing that now," he said, adding, "We will independently call the balls and strikes."
He responded to concerns the FDA would speed up or slow down vaccine authorizations to impact the election.
"[W]e find ourselves in the position that we're accused of either going too fast or too slow or doing too little or too much. And I suppose, where we land up is if we're hearing criticism from both sides, we're probably in the right place," Hahn said. "At the end of the day, for us, it's about the risk benefit calculus, particularly during a pandemic like COVID-19, and we do need to call the balls and strikes on medical products and we do need to use the available data."