In an interview Thursday on WPHT’s The Rich Zeoli Show, US Food and Drug Administration Commissioner Dr. Stephen Hahn responded to questions about the agency considering new guidelines for the authorization of a Covid-19 vaccine.
“We're building upon our June 30 guidance. This isn't really new information, per se,” said Hahn. “What it is, is providing clarity to the developers of vaccines about what are we going to need to see to have assurances around safety and effectiveness.”
The FDA issued guidance on June 30 about the requirements for emergency use authorization of vaccines. Sources have told CNN that the updated guidance would likely push approval of a Covid-19 vaccine candidate Election Day.
“We're trying to give manufacturers a sense of what would need to be seen in order to assure our scientists and then the American people that the vaccine is safe and effective,” said Hahn.
“This is evolving,” Hahn added. “We haven't seen the data from the clinical trials, and we won't until they come to us.”
President Trump suggested Wednesday that the FDA may be politically motivated to delay the approval of a Covid-19 vaccine, and that the White House may not approve FDA’s guidelines.
When asked if politics will interfere in the vaccine development process, Hahn said that the FDA’s conversations with vaccine manufacturers are not political.
“Our experts, who know about vaccines, will make this determination, and it'll be only based upon the science and the data, not politics. That's my pledge,” said Hahn.
On Thursday, Hahn declined through an FDA spokesperson to comment to CNN about Trump’s remarks.