EUAs are issued during emergencies if the FDA determines that a product, such as a vaccine, “may be effective in diagnosing, treating, or preventing . . . such disease or condition” (emphasis added) and that “the known and potential benefits of the product . . . outweigh the known and potential risks of the product.” FDA guidance acknowledges that EUA’s “may be effective” standard requires a “lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals” and that EUAs require less substantial safety information than approvals.
The subcommittee’s accusation relies heavily on interviews with Dr. Marion Gruber, former director of the FDA Office of Vaccines Research and Review, and Dr. Philip Krause, the former deputy director. They testified that they were pressured to rush the approval of the Pfizer vaccine despite the recognized risk of heart inflammation (myocarditis/pericarditis), particularly in young men, a group known to have minimal risk of severe Covid-19 disease or death.
In subsequent testimony, Krause claimed that the FDA abbreviated the normal vaccine-approval timelines it would usually follow for high-priority products.
