House Panel Seeks Answers On Virus Vaccine Campaign

By Adam Lidgett
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Law360 (August 13, 2020, 8:59 PM EDT ) A House COVID-19 response oversight panel is probing the Trump administration's multibillion-dollar campaign to rapidly create and distribute one or more coronavirus vaccines for possible conflict of interest.

Democrats on the House Select Subcommittee on the Coronavirus Crisis, led by Chairman Jim Clyburn, D-S.C., on Thursday said they have sent out a series of letters looking for information on the government's "Operation Warp Speed," which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January.

In one letter to U.S. Department of Health and Human Services Secretary Alex Azar, Clyburn said the process for choosing vaccine candidates has not been transparent, and that "the reasons for selecting or rejecting particular candidates" was not made public by the administration.

"The select subcommittee strongly supports efforts to develop and distribute a life-saving coronavirus vaccine, but I am concerned that the selection of candidate vaccines for Operation Warp Speed lacked transparency and excluded many vaccine experts," the letter to Azar read.

In another letter, Clyburn raised concerns about Operation Warp Speed's chief adviser Moncef Slaoui, who had been an executive at pharmaceutical company GlaxoSmithKline and a board member at Moderna.

While Slaoui left GlaxoSmithKline before joining Operation Warp Speed and agreed to give some of his GSK stock gains over to the National Institutes of Health after he is finished with the campaign, Clyburn said, "It is unclear whether there is any enforceable requirement for you to do so." The Trump administration had agreed to boost Sanofi SA and GlaxoSmithKline's coronavirus vaccine development by $2.1 billion.

And even though Slaoui left Moderna and has divested his holdings from the company, Clyburn said he still had concerns. Moderna also has been contracted to develop a vaccine candidate.

"I am concerned that these conflicts of interests were not addressed before you were appointed to run Operation Warp Speed," Clyburn wrote. "It remains unclear whether you have undisclosed conflicts, as the administration has structured your employment agreement to avoid the ethics rules and requirements to disclose outside positions, stock holdings, and other potential conflicts that are applicable to federal employees."

Clyburn sent a final letter to David Harris, the CEO of Advanced Decision Vectors LLC, which won a contract from the federal government to provide advice on COVID-19 vaccine candidates. There were "questions about potential conflicts of interest among consultants engaged through Advanced Decision Vectors," Clyburn said.

An HHS official said in a statement to Law360 on Thursday that "Slaoui has resigned from his position as an independent member of the board of directors for Moderna" and divested his equity holdings in the company.

"Additionally, if his GSK shares accrue more value than the average pharmaceutical index, Dr. Slaoui has committed to donating the difference to the National Institutes of Health for continued research," the HHS official said. "HHS ethics officers have determined Dr. Slaoui's contractor status, divestiture and board resignations put him in compliance with our robust department ethical standards. The American people are fortunate to have him as a leader of President Trump's effort to discover vaccines, therapeutics and diagnostics to defeat the coronavirus."

A spokesperson for the subcommittee declined to comment beyond the letters.

A representative for Advanced Decision Vectors did not immediately respond to requests for comment, and contact information for Slaoui was not immediately available.

--Additional reporting by Jeff Overley, Hailey Konnath and Alyssa Aquino. Editing by Kelly Duncan.

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