Powerful, illuminating and sobering—that’s the description from a research group summing up its initial listening sessions with front-line workers and minority groups about a vaccine.

Tasked with tapping key audiences to learn their questions and concerns about a COVID-19 vaccine—and determine how the FDA might best respond—the nonprofit Reagan-Udall Foundation for the FDA is currently in listening mode on the project, CEO Susan Winckler said.

As the race for an effective COVID-19 vaccine continues, the public will get inside look at one a crucial part of the Food and Drug Administration's decision-making process: the first meeting of its normally obscure advisory committee.

Never before has much attention been paid this small group of vaccine experts whose job is to advise the FDA on whether a new vaccine should be green lighted.

The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.
 

“Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernathy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on Tuesday (October 13).

I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research.  I only wish that we could be together in person.

I want to thank Bill Slikker and his co-chair of the Scientific Program Committee, Marta Hugas, for their hard work in putting this event together. 

The importance of the issues you are addressing here is magnified in the context of the current public health emergency we are dealing with. 

The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings.

“Time is critical when patients have a serious or life-threatening disease or condition and do not have other therapeutic options,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement. “We want to make it easier for physicians to apply for expanded access for their patients and allow these health care providers to focus on the clinical aspects of care.”

When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum. Our expanded access program is one example. 

On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for a device if it reasonably believes that it may be effective, rather than waiting to grant full approval when it has reasonable assurance that the device is safe and effective.