Vaccine Advisory Committee Chair Steps Aside Over Connection to Moderna Trial

The head of the FDA’s vaccine advisory committee has recused herself from its upcoming COVID-19 vaccine review to avoid any appearance of a conflict of interest stemming from her leadership role in Moderna’s vaccine trial.

Hana El Sahly, who also serves as principal investigator of Baylor College of Medicine (BCM)’s vaccine and treatment evaluation unit and as an investigator at its vaccine research center, will not attend the committee’s Oct. 22 meeting on COVID-19 vaccines. El Sahly is recusing herself due to her position as a co-chair of Moderna’s late-stage vaccine trial, according to a university spokesperson.

“She has been recused to avoid any perceived appearance of conflict of interest although her funding comes from the [National Institutes of Health],” Dipali Pathak, BCM’s head of communications, told FDAnews.

The meeting scheduled for Oct. 22 will “discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19,” and specific vaccine applications will not be discussed, the FDA said.

Moderna’s COVID-19 vaccine candidate, mRNA-1273, is currently in a phase 3 trial in the U.S. The company recently released an update on its progress, noting that the late-stage trial has enrolled more than 75 percent of its participants and that 11,879 of the participants had received their second vaccine dose as of Sept. 18. — James Miessler