FDA commish hints that vax could be approved before phase 3 trials complete

Sept. 1, 2020

The FDA’s commissioner, Stephen Hahn, has indicated that the agency is willing to fast-track approval for a coronavirus vaccine. In an interview with the Financial Times, Hahn stated that the FDA could even grant an emergency use authorization for a vaccine candidate before the end of phase 3 trials — provided that the benefits appear to outweigh the risks.

Despite ongoing concerns that the agency could be pressured by the White House to give a vaccine the green light before the Nov. 3 election, Hahn reiterated that any decision by the agency will be based on science. He also pointed out that an EUA would not be a full approval and that an EUA might only be granted for certain segments of the population.

Russia raised eyebrows earlier this month in the global health community when it approved a vaccine candidate before its late-stage trials were complete. Scientists are now expressing new concerns over Russia’s vaccine. Because it’s based on a form of adenovirus type 5, a common cold virus, some health experts worry that the Russian vax, along with one being developed in China, will not be as effective as other candidates.

There are currently nine coronavirus vaccines in phase 3 trials around the world, including candidates from Moderna and Pfizer/BioNTech.

Read the full Reuters report.