Former BARDA Director Warns of Overly Aggressive COVID Vaccine Development Schedule

Rick Bright, former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), told lawmakers in a hearing yesterday that the frequently cited 12- to 18-month timeline for developing a COVID-19 vaccine is unlikely to pan out.

Bright told the Energy and Commerce subcommittee on Health that developing a vaccine in that timeframe would only produce enough trial data to support it for emergency use, not for a full FDA approval.

Much of the hearing focused on hydroxychloroquine as a potential COVID-19 treatment. Bright said he initially supported the drug because he believed the National Institutes of Health (NIH) would conduct a randomized, controlled clinical trial, but he then opposed the administration’s plan to make it more freely available through an expanded-access program.

He said that he worked with the FDA, NIH and the Centers for Diseases Control and Prevention to instead secure an Emergency Use Authorization (EUA) so that the drug would be administered to COVID-19 patients by doctors in hospital settings.

“There was never sufficient evidence from a randomized, controlled study to show its benefits would actually outweigh its potential risk,” he said.

Bright also detailed his whistleblower complaint, claiming he was removed from his role as head of the federal vaccine development agency in part for pushing for a more aggressive response to COVID-19. He said HHS repeatedly ignored his early warnings about the dangers of COVID-19 and the widespread shortages arising from the epidemic.

Bright was reassigned last month to lead an initiative on COVID-19 diagnostics at NIH. The HHS Office of Special Counsel (OSC) recommended that he be temporarily reinstated as BARDA director while it investigates the whistleblower complaint (DID, May 6). — Jordan Williams