A coalition of experts is calling for U.S. officials to update the labels for the Pfizer and Moderna COVID-19 vaccines to acknowledge limitations to clinical trials, including stating clearly that the phase III trials that led to clearance didn’t provide evidence of efficacy against death.
“Incomplete, inaccurate, or misleading labeling of any medical product can negatively impact the health and safety of Americans, with global ramifications considering the international importance of FDA [Food and Drug Administration] decisions,” Peter Doshi, an associate professor at the University of Maryland School of Pharmacy whose expertise includes clinical trials, and eight other experts wrote in a petition.
