Moderna's COVID-19 vaccine investigator leaves FDA advisory committee over conflict of interest

FDA commissioner Stephen Hahn
FDA Commissioner Stephen Hahn, M.D. (FDA)

The FDA’s advisory committee chair has stepped down from reviewing the upcoming pandemic vaccines given her prominent role in Moderna’s late-stage COVID-19 test.

Hana El Sahly, M.D., associate professor of virology and microbiology at Baylor College of Medicine in Houston, became chairwoman of the FDA’s Vaccines and Related Biological Products Advisory Committee last year.

Her recusal, first reported by Reuters, comes three months after she was named as one of the investigators for biotech Moderna’s late-stage COVID-19 trial for its mRNA vaccine hopeful, which is likely to be one of the first pandemic shots assessed by the FDA’s advisory committee.

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A meeting on COVID-19 vaccine candidates is scheduled for Oct. 22, but given that the three leading contenders for a vaccine—namely Pfizer/BioNTech, AstraZeneca/University of Oxford and Moderna/National Institutes of Health—are not expecting enough data until later in the fall or early next year, it is highly unlikely there will be enough data to see on that date.

Sahly confirmed that she would now not be leading that committee, but the FDA has not said who her replacement will be. This week, under political pressure and with President Donald Trump seemingly keen to have a vaccine in place by or very close to the upcoming November election, the FDA has said it will not be easily swayed into approving an emergency use for any new vaccine.

Leaks suggest the FDA will consider granting emergency use authorization to sponsors that have a median of two months follow-up, starting at the second dose, on their late-phase study subjects.

But the White House hit back at this yesterday, with Trump saying at a press conference: “It sounds like a political move. When you have Pfizer, Johnson & Johnson (which just started a major phase 3 trial) and Moderna, these great companies coming up with vaccines—and they have done testing and everything else, why would the FDA have to add great length to the process?

“We want to have people not get sick, the vaccine is very important, it's the final step. When the companies come back and say we have something that absolutely works, with numbers, statistics and tests, I don't see any reason why it should be delayed further. If they delay it a week, or two weeks, or three weeks … that's a lot of lives you're talking about.”

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