WASHINGTON — House Democrats have begun investigating “Operation Warp Speed,” the Trump administration’s effort to fund the swift creation and deployment of a coronavirus vaccine and therapeutic treatments, citing a lack of transparency and potentially “serious ethical issues” related to its chief adviser, according to correspondence released by a committee overseeing the government’s coronavirus response.
Rep. James Clyburn, D-S.C., who chairs the House Select Subcommittee on Coronavirus, sent letters this week to Health and Human Services Secretary Alex Azar and two advisers to the Warp Speed effort demanding more information about what Clyburn called an “opaque” process that could “undermine public confidence” in any eventual vaccine.
Some $9 billion in federal funds has already been committed so far to development of a vaccine against the virus, which has sickened some 5 million confirmed cases in America and killed at least 167,000, according to statistics tracked by NBC News.
“A lack of transparency in the development of a coronavirus vaccine, especially on an accelerated timeline, could contribute to the growth of anti-vaccination sentiment,” said Clyburn. HHS officials are scheduled to deliver a briefing Thursday afternoon on the status of vaccine development.
Trump has made speedy approval of a vaccine a top priority, saying as recently as last week that one would be ready “sooner than the end of the year, could be much sooner.” He’s also suggested a vaccine could be approved before the Nov. 3 election.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a top White House adviser on the coronavirus pandemic, has been more measured, saying he is “cautiously optimistic” that the U.S. could have an effective vaccine against COVID-19 by early next year.
HHS spokesman Michael Caputo, in an email to NBC News, called the investigation a “partisan attack on life saving vaccine development.”
The Warp Speed team is led by Dr. Moncef Slaoui, who headed the vaccine department at the pharmaceutical giant GlaxoSmithKline. Contracts were awarded for vaccine development to GSK and Moderna, companies in which he had financial stakes worth millions.
In a letter to Slaoui, who joined the Warp Speed effort in May and pledged to take a $1 salary, Clyburn suggests he is “poised to reap financial benefits” from any stock gains related to the federal contract awarded to GSK.
In July, the administration secured a joint agreement of up to $2.1 billion with GSK and the French pharmaceutical company Sanofi to supply the U.S. government with 100 million doses of an experimental vaccine. Slaoui owned approximately $10 million in GSK securities as recently as May, when he divested his stake in Moderna, a month after it secured a contract with the federal government and under public pressure.
A senior administration official said HHS ethics officers have determined Slaoui is in compliance with department ethical standards. Slaoui has resigned his position on Moderna’s board and committed to donate to cancer research any value accrued from his shares between when he joined Warp Speed and when the shares were sold, the official said. Since Slaoui is not a federal employee he is exempt from federal disclosure rules requiring him to share his outside positions and stock holdings.
Slaoui has also committed to donating to NIH any value of his GSK shares above the “average pharmaceutical index,” the official said. Yet Clyburn said it’s unclear how that would be enforced.
In an HHS podcast with Caputo released July 31, Slaoui said he has “never been about the money” and the claims are “insulting to the deepest of my personal fibers."
“I’ve been very surprised and then extremely disappointed” that “I’m being attacked on a personal basis in a way that frankly distracts my energy,” he said.
Slaoui did not immediately respond to a request for comment.
In his letter to Azar, Clyburn suggests that the criteria used in selecting trial vaccines have been unclear, as has who specifically is choosing which ones to develop.
Experts including a National Institutes of Health team formed specifically to assist on vaccine development weren’t included in the selection process, Clyburn said.
The senior HHS official told NBC News that vaccine candidates are selected based on their ability to meet safety, timeline and large-scale manufacturing and distribution requirements. Warp Speed’s Board of Directors make the final decisions on which to select, the official said.
From May to June, the list of vaccine candidates was narrowed from 14 to eight, even though the NIH team had conducted a review of 50 candidate vaccines, Clyburn noted.
“Successful development of a vaccine requires scientific rigor and an open and transparent process that is free from financial and political conflicts of interest,” Clyburn says in the letter.
Clyburn — who is also a close adviser to presumptive Democratic presidential nominee Joe Biden — sent a separate letter to Dr. David Harris, president of Advanced Decision Vectors LLC, an Alexandria, Va.-based company employing independent consultants advising Operation Warp Speed.
In the letters, Clyburn names other consultants with ties to the pharmaceutical industry who haven’t disclosed possible conflicts of interest because the administration “structured their contracts to avoid the ethics rules and requirements.” They include William Erhardt and Rachel Harrigan, both former Pfizer executives.
Earlier in the year, watchdog groups including Public Citizen called on the Office of Government Ethics to reclassify the “vaccine czar,” or Slaoui’s position, as a government job requiring such disclosure.