Hahn Vows FDA Won’t Cut Corners on Vaccine Reviews, Reaffirms Timeline

August 7, 2020

As concerns mount over the FDA coming under undue pressure to approve a COVID-19 vaccine, FDA Commissioner Stephen Hahn said again yesterday that the agency won’t take any shortcuts.

Hahn said the agency will hold researchers to strict scientific standards even as the research moves at lightning pace, shooting down rumors of any coercion aimed at influencing the agency’s actions.

“I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science, he wrote. “I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data,” he said.

With phase 3 trials ongoing for several vaccine candidates, the agency intends to begin evaluating candidates in the fall to determine which ones are “truly viable,” Hahn said, reaffirming that COVID-19 vaccines must demonstrate at least 50 percent efficacy to secure the agency’s approval.

Making predictions on the timing for an Emergency Use Authorization (EUA) or approval is impossible, he said, adding that “any vaccine authorized for widespread use will meet the appropriate standards for quality, safety and efficacy.”

Once agency scientists identify a candidate that meets the safety and efficacy standards required by regulations, the government will immediately set up a pathway to make the vaccine available, Hahn said.

Advocacy group Public Citizen, in a letter sent yesterday to U.S. health officials, including Hahn and Center for Biologics Evaluation and Research (CBER) Director Peter Marks, expressed concerns about the FDA considering EUAs to allow widespread vaccine distribution, rather than putting vaccine candidates through the normal approval process.

The consumer group criticized Hahn and Marks for saying that the use of EUAs for vaccines is on the table. Using that pathway to get a vaccine to the public would raise concerns about its safety and effectiveness, and could scare off patients from taking it, the group said.

“No vaccine for mitigating or preventing pandemics or epidemics of infectious disease has ever been distributed without full FDA approval based on a thorough evaluation of data from completed clinical trials,” the group noted.

Read the Public Citizen letter here: www.fdanews.com/08-06-20-Letter.pdf. — James Miessler