President Donald Trump on Wednesday claimed that the FDA was being “political” in planning to roll out tougher guidelines for vaccine authorization and suggested he may overrule the health agency, CNN reports.
The FDA is considering new guidelines that would toughen the standards for an emergency use authorization for a coronavirus vaccine.
The new guidelines would require vaccine manufacturers to monitor large-scale clinical trial participants for two months after the second dose, meaning the earliest vaccine would not arrive until at least mid-November, after the election.
Trump accuses FDA of political hit:
"We're looking at that and that has to be approved by the White House. We may or may not approve it," Trump told reporters at the White House. "That sounds like a political move."
The FDA confirmed to CNN that the White House Office of Management and Budget has to review the FDA guidelines before they are published.
FDA vows safety:
"FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,” said FDA Chief Stephen Hahn. "FDA will not authorize or approve any Covid-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes, and science will guide our decisions.”
"FDA will not permit any pressure from anyone to change that," he added.