“We’re seeing it and it needs to be approved by the White House. It may or may not,” the President said at a White House press conference about the new FDA guidelines. “It sounds like a political move.”
The FDA has declined to comment “Politely” on Trump’s claim. In general, however, agency guidelines go through a review process by the White House Administrative Budget Office, an FDA official told CNN on Wednesday.
On Wednesday, FDA Chairman Dr Stephen Hahn promised the United States that “the FDA will either approve or will not approve a vaccine that we feel uncomfortable with giving our family members.”
“The FDA does not approve or approve a Covid-19 vaccine until it meets FDA’s strict expectations for safety and effectiveness. The decision to approve or approve such a vaccine or treatment is made through a thorough review by dedicated FDA experienced staff. Processes and science will guide our decision. “Hahn specifically pledged to the Senate Health Committee.
“The FDA will not allow anyone pressure to change it,” he added.
Dr Francis Collins, Director of National Institutes of Health, said CNN’s Wolf Blitzer in the “control room” believes the FDA will apply the highest safety and efficacy standards for all coronavirus vaccines. Or, the White House had final say on vaccine approval.
“I am not a lawyer or a constitutional scholar,” he said. “I don’t really know the answer.”
Despite the reassurance of federal officials, there are concerns that the usual route of review and approval of the Covid-19 vaccine will be avoided or at least bent under political pressure.
“What I’m concerned about is that the vaccine may have some gray areas that appear to be partially protected and could be put on the market without a formal review,” said Dr. Peter Hotez, a vaccination scientist at Baylor Medical School.
CNN’s Elizabeth Cohen, Kaitlan Collins, John Bonifield, and Jeremy Diamond contributed to this report.