Hahn Tells Lawmakers About Remdesivir Distribution Mishaps

In a Senate hearing yesterday, FDA Commissioner Stephen Hahn said there is “a lot to be learned” from mishaps during the administration’s initial distribution of remdesivir for COVID-19 patients.

Hahn told the Senate committee of Health, Education, Labor and Pensions that the White House Coronavirus Task Force advised HHS on which states would receive the experimental antiviral after the FDA approved the antiviral for emergency use.

He said the decisions were based on where the most significant outbreaks occurred and accounted for a quarter of the available supply from Gilead Sciences, maker of the drug. It was the first time the Trump administration has responded to the widespread criticism from physicians and physician groups about the way remdesivir has been distributed.

Hahn declined to elaborate further but said there are “valuable lessons to be learned” from the experience, which will be incorporated into distributing remdesivir and other COVID-19 treatments and vaccines in the future.

He also referenced the administration’s Project Warp Speed, which is aimed at rapidly developing COVID-19 vaccines and said that identifying supply chain issues is part of the program.

Hahn said the agency has been “upfront” in identifying the supplies needed to manufacture vaccines, such as vials and syringes, and is working with the National Institutes of Health (NIH) and with manufacturers to understand their manufacturing capacity.

Anthony Fauci, director of the NIH’s National Institutes for Allergies and Infectious Diseases,  updated the panel on the progress it is making with Moderna’s messenger RNA COVID-19 vaccine candidate, which is headed into phase 2 trials to test safety in adults ages 18-55. He said the FDA and NIH are currently discussing including children in the trials.

Fauci dismissed the possibility of having a vaccine ready by the time schools and universities open for the fall semester, but did say that one could be ready within the year or two.

“The idea of having treatments or a vaccine to facilitate reentry in the fall term would be something of a bridge too far,” he said. — Jordan Williams