FDA Releases Long-Awaited COVID-19 Vaccine Guidance
NPRFDA Releases Long-Awaited COVID-19 Vaccine Guidance Enlarge this image toggle caption Eva Marie Uzcategui/Bloomberg via Getty Images Eva Marie Uzcategui/Bloomberg via Getty Images The Food and Drug Administration published guidance Tuesday detailing what's required for the emergency authorization of a coronavirus vaccine after the advice to pharmaceutical companies was delayed by White House review. Drugmakers must provide data showing they followed clinical trial participants for a median of two months after their final vaccine injection, according to guidelines posted on the FDA's website. "Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available," said a statement from Dr. Peter Marks, who directs the FDA's Center for Biologics Evaluation and Research. Following the FDA's publication of the appendix, the Pharmaceutical Research and Manufacturers of America, a trade group, released a statement supporting the agency's efforts to provide guidance and transparency to the vaccine approval process.