FDA Head: Outside Pressures Won't Rush COVID Vaccine

Hamburg also attributed the accelerated vaccine development to partnerships between the FDA and the scientific community. “I want to underscore that another reason why I think that there has been an ability to move much more swiftly is that it’s also about partnership,” she said.

“And it’s about the sort of elements of the vaccine research and development and review ecosystem all working together and really the importance, which is often forgotten, of the FDA not just as a bureaucratic regulatory body that says yay or nay to the final product but actually as a science-based public health agency.”

The vaccine candidates will have to proceed through a well-designed, well-performed randomized, controlled phase 3 trial to qualify for either a biological use application or the shorter process of an emergency use authorization (EUA) from the FDA. At least 30,000 people will be needed to test the vaccine, and millions will be followed for adverse effects over time, Hahn said.

“Although the timelines to development have been compressed, there are no changes to our standards, and we have been very clear in our guidance, and I think this transparency is important—what will be our criteria for an emergency use authorization and what will be our criteria for safety and efficacy,” he said.

Earlier this week, the FDA released more guidance on vaccine development. While an EUA is more flexible than a biological use application, it still involves a risk/benefit standard that is in some ways more stringent because the vaccine will not be used to cure people who are already sick but to prevent sickness in healthy people, Hahn said. And the vaccine will have to achieve a threshold efficacy of at least 50% in a phase 3 trial and prove safe after at least 2 months of follow-up.

“The decision will ultimately be determined by the scientists when we get the dataset,” he said.

Diverse Testing Populations, Need for Multiple Vaccines
Hahn added that, in addition to safety and efficacy, the vaccine must have been thoroughly tested in diverse populations, including people of different ethnicities and ages, pregnant women, and people with different underlying illnesses. “At the end of the day, in order for us to achieve our public health mission, the data we see and the decisions we make have to be representative of all Americans who could potentially receive a vaccine,” he said.

Even if one vaccine were approved, placebo-controlled clinical trials should proceed, if it is ethical to do so, Hahn said. Hamburg agreed, saying  “We are going to need more than one vaccine, ultimately, and I think that, you know, the reality is that the first vaccine over the finish line is not necessarily going to be the best vaccine in terms of our national and global needs,” she said.

In closing, Hahn said, “Science will guide our decision, and I will not, and the FDA will not, allow pressure from anybody to change that. We plan to fight for science, we will fight for the integrity of the agency, we will always put the interest of the American people ahead of anything, and that includes personal considerations.”

Mary Van Beusekom is a news writer at CIDRAP. This article  is published courtesy of the University of Minnesota’s Center for Infectious Diseases Research and Policy (CIDRAP).