Philip R. Krause, M.D., Former FDA Deputy Chief for Vaccines

"The vaccines that induce the passage of the vaccine injury compensation program needed this kind of protection. There were lawsuits and yet these are vaccines that were safe and effective and are viewed as a public good...

When the FDA reviews these vaccines, there's a statutory standard that the vaccines have to meet of safety and efficacy and that standard is different under an EUA as it is under a BLA. And yet the FDA has to show that these vaccines meet that standard...

Obviously the Prep Act provided the companies the shield from this kind of accountability and yet the FDA still had the authority to look at the data, make sure that the fact sheets...

Certain aspects of the process were not followed although those did not influence the safety or the efficacy of the vaccines that eventually were authorized or approved. And there certainly was at least a strong impression of political interference..."