Exclusive: The FDA's Stephen Hahn tells @McClatchy that emergency authorization for COVID-19 vaccines will not be automatic: “The bottom line is we can’t determine at this point, despite the very optimistic reporting in the press and what we’ve heard.” https://www.mcclatchydc.com/news/politics-government/white-house/article247526955.html
FDA scientists are going over the raw data from Pfizer and Moderna's clinical trials, investigating any adverse events that transpired over the course of the trials and different levels of effectiveness among populations and age groups. https://www.mcclatchydc.com/news/politics-government/white-house/article247526955.html
Past coronavirus vaccine candidates for SARS and MERS showed evidence of increasing respiratory infections – a subject of interest for FDA scientists reviewing the COVID-19 vaccines. https://www.mcclatchydc.com/news/politics-government/white-house/article247526955.html
The FDA is "unlikely" to provide guidance with its emergency approval on how long the vaccines are expected to last. "We may need to fill those gaps of information with our surveillance of the vaccine," Hahn said. https://www.mcclatchydc.com/news/politics-government/white-house/article247526955.html
"The urgency of the situation is a pressure that I think is substantial on all of us," Hahn said. "Our career staff recognize that and are working with great speed. But also we’ve maintained a commitment to using data and science." https://www.mcclatchydc.com/news/politics-government/white-house/article247526955.html
The interview came hours before Hahn met with White House chief of staff Mark Meadows, according to an administration official, amid calls from President Donald Trump for the FDA to “act quickly” in the approval process. https://www.mcclatchydc.com/news/politics-government/white-house/article247526955.html