TrialSite was generally upbeat about the “Operation Warp Speed” announcement as it was understood by many, but the COVID-19 pandemic required a coordinated national response. In fact, TrialSite suggested if the program was designed and executed in a holistic manner to help pull the US out of this crisis, it could represent a “game changer” for President Trump. Although still with promise, numerous media reports, along with investigation by TrialSite, raise important concerns about openness and fairness in the distribution of Warp Speed funds. On July 31, Politico published “Vaccine project contract raises transparency questions.” They note that the Trump administration has hired drug-industry tied consultants, “to steer its effort.” $611,500 was paid under a contract that did not require disclosing conflicts of interest. This raised questions as to the roles of “outside contractors, including top coronavirus vaccine advisor Moncef Slaoui, who are helping steer the government’s $10 billion program. Longtime pharma executive Slaoui joined Warp Speed on May 15, “at the top clinical adviser and pledged to take a $1 salary.” Along with, e.g., Carlo de Notaristefani, another consultant who is overseeing manufacturing, these federal consultants “can sidestep the ethics disclosures required of federal workers.” The current President came as an “outsider” to clean the swamp. Now with so much money flowing and so little transparency, new murky issues are forming.
A Government Official Under Another Name?
Slaoui’s deal allows him to invest in pharma when he is helping to craft “the government’s sprawling vaccine effort.” And his personal expenses have even been an issue. Eli Zupnick, of Accountable.US and its campaign “Patients over Pharma,” points out that part of the deal was “free” housing provided by a private contractor who got a “vague $600,000 government contract.”
Additionally, he holds over 155,000 Moderna shares, which, of course, has directly benefited in nearly $900 million in government payments. Insiders have been making huge sums before any vaccine is even proven, while just a few days after Slaoui was named to the postpositive, Moderna news boosted his shares by about $2.4 million. To Mr. Slaoui’s credit, according to an HHS contact, he was divesting and donating the gains to charity as reported in Politico.
“Examples like these are exactly why [Operation Warp Speed] needs to be brought out of the shadows,” Zupnick said. Per HHS, the housing and hotel bill amounted to about $17,000. Democrats have argued that Slaoup should have been a “special government employee” instead of a contractor, as this would require some disclosures and ethics guidelines.
As a GlaxoSmithKline exec, he has an unknown amount of stock, and the firm “was awarded up to $2.1 billion on Friday, to be shared with its partner Sanofi, in Operation Warp Speed’s largest deal to date.” Slaoui says that as a consultant, he is offering advice and “not making decisions.” But Craig Homan of Pubic Citizen, says, “He is a co-director of Operation Warp Speed. He is in one of the most powerful positions of the current federal government. The notion that he can’t direct anybody to do anything is unbelievable.” A former senior HHS official says, “if he’s a contractor, he can’t direct any federal employee,” adding, “If he’s not directing any federal employee, then you have to ask can he actually do his job?”
US Senate Scrutinizes Opacity of Warp Speed, Sole Focus on New Tech
On July 2, Science took a look at how “Operation Warp Speed’s opaque choices of COVID-19 vaccines draw Senate scrutiny. At a US Senate hearing of that date, scientists gave “limited answers” when questioned about included vaccine candidates and the selection criteria. Headed by Senator Patty Murray, she said of vaccine candidates, “what the risks are of narrowing down that shortlist or concerns about potential conflicts in contracts that predate this crisis.” Senator Tammy Baldwin asked Gary Disbrow, “who oversees Warp Speed vaccine investments as the acting director of the Biomedical Advanced Research and Development Authority (BARDA), about the vaccine the program’s portfolio.” In May, Warp Speed announced it had picked 14 candidates and expected to advance about eight to trials. But, “I cannot specifically mention the companies,” said Disbrow. “We’re in active negotiations with many of them.”
Even though BARDA had made public that Moderna and Johnson & Johnson have Warp Speed deals of up to $500 million each, Disbrow only named AstraZeneca, which has a contract worth up to $1.2 billion. “So those company names in terms of the vaccine prospects are not public?” asked Baldwin. Disbrow replied that BARDA has made investments public and that, regarding the composition of the portfolio under Warp Speed, “That I cannot today talk about, but we are very quickly moving and negotiating contracts.” He added that the process is, “procurement sensitive” and could affect the stock market; “You will see the press releases when we award these contracts.” Finally, Senator Murray also shared concerns about not including older, proven technologies, referring to BARDA only including mRNA-type vaccines and products that, “synthetically produce the surface protein of SARS-CoV-2.”
Patients Over Pharma Group Raises More Issues
Other concerns have been that Warp Speed’s projects may be in unproductive competition with more privately funded efforts and that non-US opportunities will not be pursued. There will be no partnerships with Chinese organizations, WHO, or the European Commission. And the US chose to exclude Warp Speed from the Solidarity trial. Patients over pharma offered further details in a recent press release. Quoting USA Today, they note, “How the operation functions, its budget, what power it has and what resources it controls have either not been determined or not been made public.” Also, “Trump removed [a] BARDA leader who blew whistle” and it’s alleged that “drug company Novavax attempted to ‘circumvent federal law’ on the vaccine development process.” Citing, “no assurance that patients or taxpayers will be put ahead of drug company profits,” Zupnick also says, “With billions of taxpayer dollars and the health of hundreds of millions of Americans at stake, the Trump Administration needs to stop shrouding ‘Operation Warp Speed’ in secrecy and blocking basic transparency, accountability, and oversight.” PoP’s goals include the release of contracts with Pharma firms, records of talks between Assistant Secretary Robert Kadlec and Novavax that could violate federal law, and who, exactly has oversight authority of Operation Warp Speed.
Europe Focuses on Loans, Not Grants
A July 6 press release from the European Commission highlights their deal with CureVac. The European Investment Bank (EIB) and CureVac signed a “€75 million loan agreement for the development and large-scale production of vaccines, including CureVac’s vaccine candidate against SARS-CoV-2.” The money will also go to CureVac’s fourth production site, in Tübingen, Germany. The funds will be doled out in €25 million amounts, “upon completion of pre-defined milestones.”
Chief Financial Officer of CureVac, Pierre Kemula, notes: “We are very pleased with the EIB financing. It allows us to further invest in our mRNA technology platform to fight life-threatening diseases. We are working intensively to develop a safe and effective low dose mRNA vaccine against SARS-CoV-2 and started a Phase 1 clinical trial of CVnCoV in June. We are looking forward to expediting the completion of our industrial-scale production site to provide critically needed supply of innovative mRNA-based vaccines.” The Infectious Diseases Finance Facility (IDFF) of the EU’s Horizon 2020 program backs the CureVac loan. This Finance Facility has “supported 13 companies with total lending of €316 million for developing cures, vaccines and diagnostics against various infectious diseases, most prominently the coronavirus.” The EIB is the EU’s “long-term lending institution,” and is owned by the member states.
Transparency, Accessibility and Public Investment
That Operation Warp Speed leverages public monies (e.g., taxpayers), a basic level of transparency should be in place to ensure that precious capital is allocated in a manner most beneficial to the broadest base of Americans. With such large sums of money now being handed out, lack of sufficient deal terms and the somewhat nebulous levels of governance and conflict of interest dynamics makes the whole affair fertile ground for various morally and ethically questionable deals. Hopefully, that won’t be the case.