On August 8, TrialSite News published an article outlining both ethical and transparency issues with Operation Warp Speed. Then, as reported by NBC News, on August 12 US House Democratic Representative James Clyburn of South Carolina sent a letter to HHS Secretary Alex Azar complaining about these same issues and seeking answers. This is part of a Democrat investigation of OWS in the House. The letter demanded extensive documents and answers to questions about what they called an “opaque” process that might undermine public confidence. So far, $9 billion in federal monies have been committed to COVID-19 vaccine development. Clyburn said that, “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.” The Representative is a close advisor to presidential candidate Joe Biden.
From GSK to Operation Warp Speed
President Trump has made finding a COVID-19 vaccine a top priority, asserting recently that one should be approved, “sooner than the end of the year, could be much sooner.” He has also hinted that one might be, “approved before the Nov. 3 election.” Dr. Fauci at NIAID is a bit less hopeful, stating he is “cautiously optimistic” that we might have a vaccine by early 2021. HHS spokesperson Michael Caputo has called the House investigation a “partisan attack of life saving vaccine development.” OWS is led by “Dr. Moncef Slaoui, who headed the vaccine department at the pharmaceutical giant GlaxoSmithKline.” Despite that, contracts for vaccine research and development went to GSK and Moderna, “companies in which had financial stakes worth millions.” In July, the Trump administration made a deal with GSK and Sanofi worth up to $2.1 billion for “100 million doses of an experimental vaccine.” In May, Slaoui still owned about $10 million in GSK securities, and at that time he divested his interest in Moderna which had just gotten a federal contract.
HHS ethics officers have found that Dr. Slaoui is, “in compliance with department ethical standards.” The doctor has pledged to donate the money he made between join OWS and his later Moderna stock sale. As an advisor, Slaoui is not a federal worker and is exempt from rules requiring disclosure of, “outside positions and stock trading.” As to GSK shares, he is also promising to donate to NIH any value above the, “average pharmaceutical index.” It is, “unclear how that would be enforced.” In a July 31 HHS podcast, Dr. Slaoui stated that he has, “never been about the money,” and that such claims are “insulting to the deepest of my personal fibers.” In the letter, Clyburn asserts that vaccine trial criteria have been “unclear,” especially as to who is choosing which products to develop. He also noted that an NIH team, “formed specifically to assist on vaccine development weren’t (sic) included in the selection process.”
Undisclosed Conflicts and Call to Reclassify Dr. Slaoui
According to a senior HHS official, OWS candidates are chosen based on meeting safety, timeline, and large-scale production benchmarks. OWS’ Board of Directors has the final say in which vaccine products to choose. Clyburn noted that while NIH had reviewed 50 candidates, from May through June the list, “was narrowed from 14 to eight.” “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 added in the letter. He sent another letter to Advanced Decision Vectors LLC, a firm that employs consultants advising OWS. The Representative also names other consultants who have pharma connections and who have not “disclosed possible conflicts of interest” as their contracts were structured to avoid, “ethics rules and requirements.” The consultants include former Pfizer executives William Erhardt and Rachel Harrigan. Earlier this year the watchdog group Public Citizen, along with others, asked “the Office of Government Ethics to reclassify the ‘vaccine czar,’ or Slaoui’s position, as a government job requiring” ethics disclosures.
Given Rep. Clyburn’s close relationship with Joe Biden, and President Trump’s zealous commitment to OWS, we can presume that politics is one of the forces at play here. At the same time, the letters raise important issues that need answers. Here at TrialSite, we are concerned as to not only a lack of transparency from the top but also a lack of diversity, first and foremost in the form of the physicians and medical professionals representing the clinics of America. For example, we wrote about the formation of the National Institute’s of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines or ACTIV and how this powerful federally focused group reviews and chooses how much research for federal funding. We identified that among the 116 in a participatory role, there was no real representation from the clinic: from health systems, hospitals, county health agencies or community clinics. This is where health care occurs and what we believe an unhealthy chasm has emerged between the clinic and COVID-19 research decision makers. Moreover, there are calls for diversity across the country for COVID-19 vaccine trials, yet this same group includes less than five Hispanics and African Americans again out of 116 participating members. TrialSite writes about this subject in combination for the need of transparency with OWS while also pointing that none of this can turn into political agendas without the American people paying the biggest price.