NewsCoronavirus

Actions

FDA Commissioner: COVID-19 vaccines may change speed of future authorizations

Posted at 3:24 PM, Dec 18, 2020
and last updated 2020-12-18 19:09:19-05

WASHINGTON (LEX 18) — As the first dose of the Pfizer COVID-19 vaccination begins to be distributed and the Moderna vaccine remains under final scrutiny before expected approval, U.S. Food and Drug Administration Commissioner Dr. Stephen Hahn projected confidence for both vaccines and the future for more efficient authorization processes.

"When we make our decisions at FDA again Americans can have confidence in those decisions. We will be as transparent as possible," said Hahn.

He explained the FDA authorized the Pfizer BioNTech vaccine in a matter of three weeks. Typically, that process takes three to six months because he said the FDA goes "line-by-line on the data."

"We looked at all the specifics around who was in the trial -- what the safety issues are -- so that we can answer questions that you would naturally have," he said. "As a recipient of the vaccine .... What about the elderly? What about people with kidney failure or heart disease; hypertension? What about kids? What about pregnant women? And so we just don't take the conclusions of a company we actually do the data analysis ourselves. And we also promised the American people unprecedented transparency, which is not characteristic of regulatory agencies around the world."

Hahn said 2020 has been a year he could never have expected or prepared for and the fall has been tense for his team working night and day.

"There was a lot of discussion about this leading up to the vaccine advisory committee," he explained of the Pfizer vaccination. "I think what we're seeing and I'm certainly hearing from colleagues around the country, a great deal of enthusiasm and confidence. I have complete and 100% confidence in the decision that our career scientists made with respect to the Pfizer BioNTech vaccine, and when it's appropriate for me to get the vaccine, I will be in line receiving it without hesitation."

In regard to the Moderna vaccine, Hahn said Thursday, "We found that after two shots that the Moderna vaccine that there was over 94% effectiveness. The safety profile looked good."

Later Thursday, an FDA advisory committee recommended emergency use authorization of the Moderna vaccine -- something the CDC will review before greenlighting the vaccination to the public.

"My sincerest hope, and what I think is that this is the beginning of the end of the pandemic. If we are to have an authorization in a second vaccine, more vaccine available to health care workers and the most vulnerable," said Hahn.

The speed at which both vaccinations developed raised red flags for countless Americans who are used to reading research and background information on vaccines that have been out for years before taking them.

Hahn said he understands the hesitation but explained his utmost confidence in what has already been approved explaining the only way to end the pandemic is to have herd immunity "and that means vaccinating as many people as possible, including those who might be hesitant to receive the vaccine," he said.

Hahn also explained his agency learned a great deal in 2020 that may project the future of medical product development.

"We've learned a lot about it, both as a country, but also as an agency at FDA," he said. "And so we think there are definitely efficiencies to be had moving forward, because really what this is about ... We've seen the innovation that the private sector can bring forward in combination with government. We've seen how that can work in a quick fashion. We need to be able to capture that again moving forward because bringing innovative medical products to the American people is so important. And we at FDA have to make sure that we uphold our gold standard of safety and efficacy, but do that in a reasonable timeframe that doesn't delay innovation."

To read more from the FDA about the approved Pfizer vaccine and pending Moderna vaccine, click here.