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WASHINGTON — For months, Democrats have called for the ouster of Moncef Slaoui, the former pharmaceutical executive who President Trump installed to run his multibillion-dollar vaccine development initiative, Operation Warp Speed.

But if former Vice President Joe Biden wins the presidency, can he afford to fire him?

Slaoui has been dogged by ethics questions since his appointment in May. The former GlaxoSmithKline executive has adamantly refused to sell off a $10 million investment in his former employer, even as that company has taken in major Warp Speed funding.

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The president’s political opponents are outraged. His employment contract is being investigated by House Democrats, advocacy groups have called his hiring illegal, and Sen. Elizabeth Warren (D-Mass.) has said he should be the “first person to be fired.”

“Slaoui is the sitting, walking, conflict of interest in Operation Warp Speed. So he’s gotta be dealt with first,” said Craig Holman, the government affairs lobbyist at Public Citizen, a nonpartisan advocacy group that is frequently critical of the Trump administration. “He is the reason why I worry about those $10 billion of contracts being awarded based on merit or self-dealing.”

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Yet despite such concerns, many public health professionals told STAT that Slaoui is also the perfect person for the Warp Speed job. They point to his experience bringing 14 different vaccines to market at GSK. He’s also one of the only scientists who has had a first-hand role in dramatically accelerating a vaccine development program: He led GSK’s sprint to develop an Ebola vaccine in 2014.

“The longer we can keep someone like Moncef Slaoui in this operation … the better it is for the country,” said Tom Ingelsby, the director of the Johns Hopkins Center for Health Security. “He is the kind of experienced person that we want in a job where we have very little time for mistakes.”

These discordant views could put the Biden team in a precarious position. Do they insist he adhere to the same ethics rules as other government employees? And if Slaoui refuses to follow those rules, does the Biden administration respond to outcries from his supporters and fire Slaoui?

“It’s a big dilemma: you risk loss of coordination and time if you replace the person who is really leading the charge on vaccines, and it’s time that we don’t have,” said Arthur Caplan, a professor of bioethics at NYU Langone Health, who added that he would advise the Biden team to take this conundrum “hugely” seriously. “This is going to be one of their major decisions.”

Biden’s advisers are not waiting for the election to wade into Operation Warp Speed.

They are already having conversations with companies involved in the initiative, two companies funded by Warp Speed told STAT.

Two Biden advisers, who spoke on the condition of anonymity because they were not authorized to speak on behalf of the campaign, also confirmed that the staff is learning as much as they can about the vaccine development effort as quickly as possible.

“The team is intent on hitting the ground running, and on having a clear, transparent and operational national plan. It’s fair to say that a lot of preparatory background work is underway to be prepared for all that needs to happen after the election,” one adviser told STAT.

Biden has not publicly signaled what he will do with the Warp Speed leader, should he win the presidency. While the Democratic nominee has said he trusts career scientists more than he trusts the Trump administration itself, he has not commented specifically on Slaoui, who, though a scientist, is much closer to a political appointee than a career health official. STAT could not find a single instance of Biden even mentioning Slaoui by name.

The tension over Slaoui is all the more fraught because the questions over leadership come at a critical juncture, both for the initiative and the country.

If Biden is elected, he would likely take office as the first coronavirus vaccines are distributed to U.S. citizens. Drastically shaking up Warp Speed, which would coordinate distribution of those vaccines, could delay vaccinations for at-risk populations. Any such discord could also set off vaccine hesitancy among Americans who could see a firing of Slaoui as a vote of no confidence by the Biden team.

“The most important thing is a seamless transition when you are in the middle of a crisis,” said Rep. Donna Shalala (D-Fla.), who served as HHS secretary under Bill Clinton, though she added that ultimately, Biden’s team will find “scientific leaders that fit their ethics standards.” She added that she has no problem with Slaoui being fired and that “the Biden administration needs to clean house.”

The Biden campaign has suggested it would make changes in Operation Warp Speed if Biden wins. His website says the initiative “lacks sound leadership, global vision, or a strategy for securing the necessary funding to see this mission through or secure trust from Americans who depend on its success.”

Slaoui has said he hopes to depart from the initiative when there are two vaccines and one or two therapeutics approved, and when “the transition of the operation, regardless of politics, is assured.”

“Once I know that things are rolling, it will be time for me to move on,” Slaoui told Axios earlier this month. “It may happen prior to the Christmas break, it may happen after.” He said he had not yet had any contact with the Biden team.

Beyond Slaoui, there are myriad Warp Speed-related quandaries facing the Biden team as it begins to plan a potential transition.

“There’s going to be a whole lot to fix,” said Eli Zupnick, a spokesperson for Accountable.US, a progressive watchdog group. “Doing that while continuing to go as quickly as possible to develop a vaccine and get us out of this crisis is a real challenge.’’

Operation Warp Speed has a goal of delivering 300 million doses of a coronavirus vaccine starting in January 2021. Public health experts insist the initiative will almost certainly still be critical come Inauguration Day.

The first coronavirus vaccine likely won’t be authorized until at least mid to late-November, and some companies funded by Warp Speed, like Sanofi, don’t expect to have a product authorized until later next year. There’s also no telling if the first generation of vaccines will be effective enough to justify shutting down the initiative altogether.

“If the first generation of vaccines comes out and ends up being 50% to 60% effective, that’s going to help, but it’s not going to be nearly good enough, you’re going to want to continue making major investments in vaccines,” said Ashish Jha, dean of the Brown University School of Public Health.

“There’s no reason to shut it down,” Jha said, regarding Warp Speed. “It should be totally bipartisan, there’s nothing philosophical about this.”

Warp Speed is also expected to play an outsized role in the eventual distribution of a Covid-19 vaccine, and that work will be far from completed by January: Slaoui has publicly said he believes the majority of the U.S. population won’t be vaccinated until mid-2021.

All of these factors signal that Biden, should he win the election, will have to decide what to do with the initiative.

That’s no small feat: Warp Speed isn’t like a normal government operation. It’s overseen by two federal departments, the Department of Defense and the Department of Health and Human Services, and its labyrinth chain of command includes a military general, Gus Perna, who was slated for retirement this spring and Slaoui, who is serving as a government contractor. Warp Speed also has at least 15 contracts with drug makers large and small, as well as a drug distributor and even companies like Corning, which makes glass vials.

There are early signs that both sides are taking the transition efforts seriously. Both Trump and Biden have announced their formal transition teams. Biden’s team has five co-chairs including Ted Kaufman, who was the vice president’s chief of staff when he was a senator, and New Mexico Gov. Michelle Lujan Grisham. Trump’s team is headed by chief of staff Mark Meadows and Chris Liddell, the White House deputy chief of staff for policy coordination, who served as the executive director of the Romney transition team in 2012.

Slaoui is also clearly thinking about the transition, even now. He has said that if Biden wins, “I would expect, as of November 4, to start making sure that the future new administration is up to speed.” HHS Secretary Alex Azar recently told NBC that he, too, has not yet briefed the Biden transition team and has not been asked to. He added he would “follow whatever protocols there are for cooperation.”

Slaoui is currently employed through a consulting firm, Advanced Decision Vectors LLC. Under the agreement, Slaoui was required to resign from a number of biotech boards, including Moderna, which is being funded by Operation Warp Speed. But he was allowed to keep his stock in GSK, so long as he donates any profits he makes on that stock while he’s advising the government.

A House select committee tasked with overseeing the administration’s coronavirus response has opened an investigation into Slaoui’s ethics agreement. The advocacy group Public Citizen, which claims the agreement is illegal, has filed two ethics complaints against Slaoui. And progressive firebrand Rep. Katie Porter (D-Calif.) has demanded that the HHS Office of Inspector General open a probe into the agreement.

Publicly, Slaoui has appeared intractable on the issue of selling his stock, and he has frequently accused journalists covering his potential conflicts of interest of distracting him from his work.

“He seems aggrieved by the idea that there would be scrutiny,” said Accountable.US’s Zupnick. “It seemed like he did not understand that when you are spending taxpayer dollars … there is a responsibility to be transparent.”

Slaoui isn’t the only outside contractor intimately involved in the Warp Speed effort. One of the effort’s top manufacturing advisors, Carlo de Notaristefani, is also employed as a contractor through Advanced Decision Vectors. So are William Erhardt and Rachel Harrigan, longtime Pfizer executives who now advise the initiative on Warp Speed’s therapeutics research.

Critics of Warp Speed’s questionable ties to industry argue that they threaten to diminish public trust in an eventual vaccine.

“If our communities cannot trust the process used to develop the vaccine, people simply will not get it. This threatens to destroy the enormous investment we have made and the possible return to normalcy,” Porter in her letter demanding an investigation of Slaoui’s contract.

The Biden team did not respond to requests for comment on this article.

A potential Biden administration will also need to examine the 15 or so contracts Slaoui has signed under the Warp Speed banner, multiple advocacy groups told STAT. Together they are worth more than $10 billion, but the Trump administration has fought to keep many of these contracts secret. Advocacy group Public Citizen is now suing the administration to gain access to some of these contracts.

“It will be important for the Biden transition team to go in and rigorously vet Operation Warp Speed,” said Topher Spiro, vice president of health policy at the Center for American Progress. “One thing is for certain: the initiative needs to have much more transparency and focus much more on building public trust.”

That lack of transparency makes it difficult to discern how easily it will be for the Biden administration to renegotiate or even cancel any contracts it deems inappropriate, though a law professor told STAT it’s usually “incredibly easy” to cancel contracts, even just for “convenience.”

This isn’t the first time a president has been faced with hard decisions on whether to keep industry-aligned leaders who are integral and yet controversial. President Obama famously kept on several of the Goldman Sachs bankers that President George W. Bush hired to help manage the 2008 financial crisis, according to Josh Gotbaum, who helmed the 2008 transition for the Treasury Department.

“Had it not been for the continuity of personnel,” he said, “it undoubtedly would have gone much more poorly.”

  • The exact person who runs this is not as important as having someone fully committed to deploying a safe, effective vaccine as quickly as possible. Personally, I think that Slaoui is doing a great job and the ethics issues are a lot of nothing. My worry is that the Democrats are going to drag this out in order to keep up locked down as long as possible. From the way this is playing out throughout the world, the masks and social distancing are not enough by themselves. We need to deploy a vaccine as soon as possible.

  • How times have changed! In the similar effort during World War II, probably the closest precedent to the current vaccine efforts (with parallel paths pursued), Vannevar Bush and several members of the Committee on Medical Research had very close ties to several firms, esp. Merck, which was one of the developers of penicillin. (Bush was later chair of Merck’s Board when Merck himself died.) Our thinking about conflict of interest has changed dramatically.

    Stat has covered the people in Operation Warp Speed. Hard for us outsiders to know whether it’s effective or not. Some reporting along those lines would be really useful.

  • I volunteered for the Pfizer vaccine phase 3 study and would have done human challenge, IF I was sure i got a vaccine, not placebo, with proven efficacy.
    So, from my standpoint, Trump’s response was not aggressive enough.
    As for Biden reforming Warp Speed – everyone seems far ahead of themselves – if Biden wins, he will not take office until Jan. 20 – the epidemic may be over by then = we could have 3 vaccines, or more, approved (some by foreign entities but it makes sense for FDA to approve them if data is good) by then, and may have given out many tens of millions of doses – with the death rate among people under 19 something like 1 in 20,000 – that is for the entire population, including those with serious risk factors, – and for those under 40 well under 1 in 1,000, again including everyone – a few tens of millions of vaccines can protect almost all the truly vulnerable.
    It could be two more months before we have herd immunity – unless there is some indication of big problems with the vaccines, Biden wil likley allow them to be used, as they will already be on hand and the chance of problems is fairly low.
    The UK, Thank God, is now doing human challenge testing – so we will have data from that to work with as well.
    Assuming no vaccines by Jan 21, 2021, the need for one will be yet greater.
    I think Trump mismanaged the epidemic, but whoever is President after Jan 20 is probably pretty much irrelevant.

    • Sorry, I meant to say eight more months for herd immunity – I understand that many people would have to die and people would need to actually get immune for a long time to attain that. Two more months for a vaccine.

    • Your timelines are so optimistic that “dreaming of miracles” seems applicable – however unfortunate. Nothing will be ready or be a guarantee by Jan 20, 2021. Maybe in 2022. It is amazing how the work of scientifically sound trials leading to solidly trustworthy effective vaccines is underestimated. And IMO the more urgent target is for effective Covid-19 medication. That keeps people alive while the vaccines are in development.

  • “Slaoui is the sitting, walking, conflict of interest in Operation Warp Speed. So he’s gotta be dealt with first,” said Craig Holman, the government affairs lobbyist at Public Citizen, a nonpartisan advocacy group that is frequently critical of the Trump administration.

    If this is a nonpartisan advocacy group, I’d like to see what a partisan group looks like.

  • ‘Critics of Warp Speed’s questionable ties to industry argue that they threaten to diminish public trust in an eventual vaccine.’

    I’m not sure I buy that. Suppose that this pandemic had happened under a Democrat President. I find it very hard to believe that they would have done anything other than establish something akin to OWS and that it would have been headed by someone who was an ‘insider’ on reasonable definitions. If big pharma and vaccine specialists not going to be producing vaccines then who is? The Chinese? The political party holding office doesn’t change much to my mind. If there is someone better than Slaoui then that’s another matter – but I think I’d want a meaningful scientific justification for that. For me, having OWS as another front in the culture was does not seem smart.

    Ultimately I guess that science and scientists need to end the pretence that there is a wall between science and politics. We used to talk of a military-industrial complex, we now perhaps have something not far removed from a medical-industrial complex. What to do about that is the question.

    What of course would help all of this is non hyper-partisan politics and no culture war. But we’re not in that world sad to say and for Jha to talk about, ‘It should be totally bipartisan, there’s nothing philosophical about this,’ is just naive. What is the relationship between science and government and science and politics? That is the real question emerging from the pandemic.

  • If anyone understands the way DC works along with the lobbyists who permanently live on k street and buy influence in congress and all branches of government ; 10 million is irrelevant ; most industries spend 100’s of millions a year buying influence in law writing most notably both the heath care and defense industries

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