India, April 2 -- The U.S. Food and Drug Administration has delayed its review of Novavax's Covid-19 vaccine after a senior official requested further data, according to sources familiar with the matter.
Dr. Sara Brenner, the agency's Principal Deputy Commissioner, made the unusual decision to pause the approval process, diverging from the FDA's standard practice of deferring to career scientists responsible for evaluating drug and vaccine applications.
The delay coincides with leadership changes at the Department of Health and Human Services, including the removal of Dr. Peter Marks, who previously oversaw vaccine approvals, and the appointment of Dr. Scott Steele as acting director of the FDA's Center for Biologics Evaluation and Resear...