Dec. 1, 2020

FDA Chief Vows Transparency in Vaccine Approvals

FDA Chief Vows Transparency in Vaccine Approvals

As pharmaceutical companies move at warp speed to develop a vaccine, the U.S. agency at the center of emergency approvals is "working around the clock" to evaluate whether the limited data meets the standard for emergency approval, FDA commissioner Dr. Stephen Hahn tells our weekly podcast Track the Vax. So far, U.S.- based Moderna as well as Pfizer and BioNTech have both submitted requests for emergency FDA authorization for their respective vaccines. "We're looking at the data right now and it's too early to draw any conclusions but I can assure you our team is working night and day on this," Hahn said. "When the data analysis is ready... we'll make that available to the american people and the committee." The first immunisations using the BioNTech and Pfizer vaccine could take place in the U.K as early as this week. The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss the request for emergency use authorization on December 10. Hahn told us he won’t prejudge what their decision will be, but says their job is to weigh a variety of criteria as it reviews the data, including the participants included in the studies.