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FDA Vaccine Committee Head Steps Aside Over Conflict Of Interest With Moderna Role

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FDA Vaccine Committee Head Steps Aside Over Conflict Of Interest With Moderna Role

The head of the United States Food and Drug Administration’s vaccine advisory committee has recused herself from the panel due to her involvement in supervising the clinical trial of Moderna Inc’s (NASDAQ: MRNA) COVID-19 vaccine, Reuters reported Wednesday.

What Happened: Hana El Sahly, an associate professor of virology and microbiology at the Houston-based Baylor College of Medicine, assumed the chair of FDA’s Vaccines and Related Biological Products Advisory Committee last year.

The panel of outside experts is tasked with recommending whether COVID-19 vaccines should get the approval of the agency.

El Sahly also took charge as one of the three principal investigators for Moderna’s late-stage human trial of its vaccine in July, leading to concerns over conflict of interest, according to Reuters.

Why It Matters: Outside experts assume an important role since the FDA is under pressure from the Trump administration to expedite the availability of a vaccine before the upcoming Nov. 3 presidential election, Reuters noted.

The 15-member advisory committee’s recommendations are reportedly not binding on the agency. A meeting on vaccine candidates is said to be scheduled for Oct. 22, it is not expected any drugmaker would have sufficient data to seek authorization at that point.

Moncef Slaoui, who is leading the federal government's efforts to accelerate the development of COVID-19, in May divested his stake in Moderna due to similar conflict of interest concerns. 

Microsoft Corporation (NASDAQ: MSFT) co-founder Bill Gates, whose foundation is supporting multiple vaccine candidates, said this month that Pfizer Inc (NYSE: PFE) might seek emergency use authorization for its vaccine by the end of October. 

Price Action: Moderna shares closed nearly 2.30% lower at $67.16 on Wednesday and fell almost 0.9% in the after-hours session.

 

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