WASHINGTON - Several top officials leading the administration's effort to develop a coronavirus vaccine at record speed had financial ties to the pharmaceutical companies now competing to develop the much-needed drug, according to disclosures released Tuesday.
The Department of Health and Human Services financial disclosures, which were released by the House Select Subcommittee on the Coronavirus Crisis, show that several Operation Warp Speed advisers who were selected by President Donald Trump either held board positions with firms that are currently engaged in coronavirus work, or held securities in firms now contracted to produce vaccines.
The documents "have heightened concerns that these advisers may have significant undisclosed financial conflicts of interest that, contrary to the administration's public statements, have not been adequately addressed," said Rep. James Clyburn, D-S.C., chairman of the subcommittee.
In a filing dated May 16 that the committee released Tuesday, Operation Warp Speed chief adviser and former head of GlaxoSmithKline vaccine development, Dr. Moncef Slaoui, reported to HHS that he held securities in GlaxoSmithKline and Moderna, Inc., which have contracts with the U.S. government for coronavirus vaccine work, and in the Lonza Group, which was contracted by Moderna to manufacture its vaccine candidate.
Moderna was the first company to enter its vaccine candidate into Phase III trials in the United States. GlaxoSmithKline, in partnership with Sanofi, has agreed to provide up to 100 million doses of a vaccine still in development for the U.S. government, in a $2.1 billion contract.
Slaoui is chief adviser for the coronavirus vaccine development program under Operation Warp Speed, the federal interagency program that is responsible for expediting the discovery, production and distribution of a vaccine for COVID-19.
A senior HHS official said that Slaoui has resigned from his position as an independent member of the board of directors for Moderna.
"Further, he divested of his equity holdings in Moderna and committed to donate to cancer research all incremental value accrued from his Moderna shares between the evening of Thursday, May 14, prior to the announcement of his position on Operation Warp Speed and the time of sale," the official said. "He also left all advisory boards and boards of directors of companies with even the appearance of conflict."
The official did not say what date Slaoui completed the sale of his holdings. Regarding the investment that Slaoui has with his former firm GlaxoSmithKline, "if 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 official said.
Three other Operation Warp Speed advisers - former Teva Pharmaceuticals Inc. Chief Executive Officer Dr. Carlo de Notaristefani and former Pfizer Inc., executives Dr. William Erhardt and Dr. Rachel Harrigan - also filed disclosures in late May that were released by the subcommittee. The reports showed that they, too, held securities in the firms that are developing the vaccine, including Pfizer, which was the second company to enter a candidate into Phase III trials.
"HHS ethics officers have determined that Drs. Carlo de Notaristefani, William Erhardt and Rachel Harrigan are all in compliance with the relevant federal ethical standards," the HHS official said.
Calls to Pfizer and Teva to ask if those equities had been divested were not immediately returned.
To serve on Operation Warp Speed, each member is required to disclose any stocks they hold with firms conducting COVID-19 business and will be required to donate any gains made by those investments due to coronavirus work to the National Institutes of Health.
But the terms of the donation are vague, and at present allow each adviser or their surviving spouse to hold on to the gains until their deaths, according to the HHS disclosures.
The financial ties are likely to make it more difficult to convince the American public it can trust a COVID-19 vaccine, said Mandy Smithberger, director of the Straus Military Reform Project at the Project on Government Oversight.
"Unfortunately those ongoing questions are likely to contribute to the lack of public confidence in taking a vaccine once one is ready," Smithberger said.
Public confidence in the development of vaccines has already dropped sharply since the beginning of the year due to the perception of political influence over the process. Several surveys released in the past month have shown declining confidence, including a recent poll released by the Pew Research Center that found only 21% of Americans say they plan on "definitely" getting a coronavirus vaccine once one is available, while 49% of Americans say they "definitely or probably" will wait.
The select committee also sent a second request to Alexandria, Virginia-based Advanced Decision Vectors, LLC, a consulting firm that has been awarded up to $684,000 by the Department of Health and Human Services to "provide expert advice regarding development and mass production of new COVID-19 vaccine candidates, therapeutics and diagnostics."
Chief Executive Officer David S. Harris of the consulting firm has not so far provided the subcommittee any documentation on what, if any, pharmaceutical equities or business relationships he or his firm may have to any companies currently pursuing a COVID-19 vaccine.
In a congressional letter sent to Harris' firm Monday, Clyburn warned that the correspondence was a final opportunity for Harris "to comply before the select subcommittee considers compulsory process."
A phone call and email to Advanced Decision Vectors for comment were not immediately returned.
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