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Coronavirus

Warp Speed’s Slaoui expects two COVID-19 vaccines this year, rebuts Sen. Warren

Operation Warp Speed scientific adviser defends record, predicts rapid vaccines authorization, denies political interference

Operation Warp Speed scientific adviser defends record, predicts rapid vaccines authorization, denies political interference

Sep 26, 2020 | 4:02 AM GMT

Two COVID-19 vaccines and two drugs that reduce mortality from the disease will be authorized by the end of 2020, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, predicted in an interview with BioCentury.

That progress, according to Slaoui, is due to the acceleration enabled by Operation Warp Speed, which is involved in every aspect of vaccine and drug development and manufacturing. 

The initiative and Slaoui have, however, been criticized. Accusations range from kowtowing to President Donald Trump to tolerating conflicts of interest.

Slaoui rejected suggestions that he and the Warp Speed team have come under political pressure to exaggerate progress or take shortcuts. He reported that he is a Democrat, that he isn’t “aligned” with Trump and “there has been no interference” from the president or anyone else in the administration.

The former pharma R&D head and chairman of vaccines at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) also responded to accusations from Sen. Elizabeth Warren (D-Mass.) that his refusal to divest shares in the company constitutes an unacceptable conflict of interest. 

Responding to Sen. Warren

Slaoui pushed back against his toughest critic.

Speaking at a Senate hearing on Sept. 23, Warren said that in addition to the shares in GSK that he has acknowledged, Slaoui owns stock in Lonza Group Ltd. (SIX:LONN), which is manufacturing a COVID-19 vaccine candidate that Moderna Inc. (NASDAQ:MRNA) is developing. She called for enactment of legislation she has introduced that would prohibit individuals with conflicts of interest from working for the government on COVID-19 issues.

“The first person to be fired should be Dr. Slaoui,” Warren said. “The American people deserve to know that COVID-19 vaccine decisions are based on science, and not on personal greed.”

Slaoui told BioCentury that he had never owned stock in Lonza and that he has recused himself from deliberations involving all companies that he has had a financial involvement with.  He said that he took the Warp Speed position on the condition that he be permitted to retain his holdings in GSK because they pay him dividends.

Government employees must divest themselves of all equity in companies that could be affected by their government service. To allow Slaoui to keep his GSK shares, the government hired him as a contractor rather than as an employee.

Slaoui’s contract stipulates that any increase in the value of GSK shares that occur during the time he is working on Warp Speed will be donated to NIH. Increases will be calculated by comparing the GSK share price to the Fidelity Select Pharmaceuticals Portfolio. Any increase in value will be donated to NIH at any time Slaoui chooses, including following his and/or his spouse’s death. 

Slaoui defended his record, citing his career spent developing vaccines for global health threats, and accused Warren of engaging in thought processes “identical to that of a racist” because she assumes that all pharmaceutical executives are corrupt and greedy. “She cannot imagine that a pharmaceutical executive can be only motivated by doing good.”

Without Warp Speed, manufacturing would be “nowhere”

Before Warp Speed became involved, the timetable for Johnson & Johnson (NYSE:JNJ) assumed that it would not have started a Phase I trial for its COVID-19 vaccine candidate by now. Because of Warp Speed’s assistance, J&J started a Phase III trial on Sept. 21.

In the absence of Warp Speed, Sanofi (Euronext:SAN; NASDAQ:SNY) would have started a Phase III trial of its COVID-19 vaccine at the end Q1 2021, Slaoui said. The trial is slated to start in November 2020.

The story for manufacturing is even more stark.

Without Warp Speed, manufacturing would be “nowhere,” Slaoui said. Because of the initiative, especially the activities of the U.S. Army, hundreds of millions of doses will have been manufactured by the middle of 2021.

Warp Speed organization

Although he is not a government employee and cannot make decisions, Slaoui said he is effectively Warp Speed’s co-leader, along with General Gustave Perna, the operation’s COO.

The scientific management of Warp Speed is run by multi-functional teams that are composed of staff from Biomedical Advanced Research and Development Authority (BARDA), NIH, NIH’s National Institute for Allergy and Infectious Diseases (NIAID), the CDC and other parts of HHS, Slaoui said. FDA is not involved in the operation. Department of Defense employees play major roles, particularly involving project management and logistics activities, he said.

Warp Speed has a dedicated project team for each of the companies it is supporting. The teams that are supporting vaccine companies report to Mathew Hepburn, who previously developed vaccines at the Defense Advanced Research Projects Agency (DARPA), while those that are supporting therapeutics developers report to Janet Woodcock, who has temporarily stepped away from her job as director of FDA’s Center for Drug Evaluation and Research (CDER).

Warp Speed’s leadership team is led by Perna and Slaoui. Members include Gary Disbrow, acting director of BARDA, Woodcock and Hepburn.

Perna and Slaoui report to a board that is co-chaired by HHS Secretary Alex Azar and Defense Secretary Mark Esper. Board members include Deborah Birx, coordinator of the White House Coronavirus Taskforce, Anthony Fauci, director of NIAID, John Mascola, director of NIAID’s Vaccine Research Center, and Francis Collins, director of NIH.

The following transcript has been edited for clarity and concision. 

BioCentury: On Wednesday, Senator Elizabeth Warren said that you should be fired from Operation Warp Speed because your ownership of stock in GlaxoSmithKline and in Lonza constitutes a conflict of interest. What's your response?

Moncef Slaoui:  My response is that it is extremely unfortunate that politics are overtaking rationality and factuality. First of all, I never asked to do this role. I was retired from GSK and I had joined a number of boards on a personal basis. I joined a venture capital firm and I was having a nice, quiet life after working for 30 years in GSK.

During my tenure in GSK, global health was always at the top of my agenda. I worked very hard on the Ebola crisis. I worked for 27 years on a malaria vaccine that has had absolutely no return on investment. I worked on Zika. I made proposals to the U.S. on how to tackle pandemics in the future.

When somebody called me it was Jim Greenwood, the CEO of BIO and before that a congressman asking me whether a Manhattan Project would make sense to make vaccines against COVID-19 because the country and the world is in crisis, I thought it was a great idea.

I told him of course someone should do it. And at the end of that call he said you're going to have a call from the administration. I am a Democrat and I hung up and I told my wife, [crap], this is a problem, what do I do if they call me?  They didn't call for two weeks and I thought, that’s pretty good. And then I got a call, and I had to say yes. I said yes, because of my commitment to global health.

I informed them of everything I own. I said, first thing if I do this I would have to, of course, exit the Moderna board, exit the Lonza board and get rid of all my shares in Moderna.

I didn't have to get rid of my shares in Lonza because they hadn't yet been issued to me. I was supposed to join the Lonza board, I believe somewhere in April, and I resigned from it in mid-May. I resigned from the Moderna board before my role was announced.

I informed the HHS lawyers of every position I hold and every equity I hold.

In my life, I have never bought pharmaceutical equity. Every equity I own, I have earned by working. I should also tell you that other than the Moderna shares, and maybe 20 years ago options from GSK, I have never sold shares. I am not a dealer in shares. I have significant earnings and cash. I have a financial adviser that invests in various I don't even know frankly how you call them, but you know, bunches of shares that are marketed by banks and I specifically advised my investor from day one never to invest in pharmaceutical or biotech because I never wanted to have conflicts of interest with my role in GSK.

When I informed the HHS lawyers, they said you need to divest yourself from anything that has to do with COVID, which I did. And they said, GSK is a challenge, how can we think about it? I said I can make sure that I don't make any penny on anything that is related to COVID, but I do not want to divest GSK.  

I can tell you why. As I explained, I'm not an investor. I've never played with money. I just want to have a quiet time having worked very hard. I like the fact that GSK pays dividends. I make several hundred thousand dollars a year in dividends from my GSK shares and I don't want to sell them. So I committed to gift to research, to NIH, every single penny of accretion in value of GSK shares that happens between the time I take the role and the time I leave the role as compared to the pharmaceutical index. And frankly, the lawyers told me that's fine.

I have also withdrawn myself from any negotiation with Moderna, from any negotiation with GSK, because these were the two companies in which I owned shares. I can tell you, mathematically I cannot make any money out of this. In fact, if you look at GSK shares, the shares went down.

Senator Warren said GSK has [received] $2 billion [from Operation Warp Speed]. It's not true. Sanofi has a $2 billion agreement with Operation Warp Speed. GSK supplies an adjuvant called ASA03 that the U.S. government already procured for pandemic flu. The agreement is for $300 million in doses. By the way, the government was able to negotiate, independent of me, a deal where the the government pays less for that adjuvant for COVID than it pays for flu

So my answer is, first of all, Senator Warren didn't even take the time to assess whether I had Lonza shares or not. She saw I was on the Lonza board and assumed I had shares, which means she has a predefined objective. Secondly, she knows I cannot make money on my GSK shares. Thirdly, she knows I'm not the decision-maker.

Fundamentally, her attitude and her thought process is identical to that of a racist thought process in the sense that you were an executive in the pharmaceutical industry, therefore you must be crooked, therefore you must be corrupt, therefore you must be greedy. She is insulting the number one industry in her state. She cannot imagine that a pharmaceutical executive can be only motivated by doing good.

BC: It is September 2020, there are four Warp Speed-funded vaccines in Phase III trials and more Phase II trials will be started soon. Hundreds of millions of vaccine doses are being manufactured at risk. Where would we be today if Warp Speed hadn't been established? What has happened as a result of the initiative that wouldn't have happened in its absence?

MS: If I look to the vaccine area, I would say, just as an example, the Janssen [unit of Johnson & Johnson] vaccine that started a Phase III trial on Monday would not yet have started its Phase I trial. 

The Sanofi program, the latest program we have in the portfolio, would have been starting its Phase III in the end of the first quarter of 2021. Currently its Phase III trial is projected to start in the end of November.

That's just the clinical trials.

On manufacturing, we would frankly be nowhere.

We have put together a network of 25 different manufacturing sites and we have equipped it, thanks to the Army.

We have scaled-up manufacturing at enormous financial risk, while we were for most of the program not yet in the clinic. 

Operation Warp Speed’s involvement has been at the level of the science, in very close collaboration with the companies; in clinical trials design; harmonization of endpoints; across the board on manufacturing; working with the companies to solve scaling issues; on the regulatory strategy; and planning and project management, where the Army has been incredibly helpful.

BC: What are your personal goals for Warp Speed? What do you hope to accomplish and how will you know that you're done?

MS: My objective is to help get a vaccine. That's my number one objective. Also therapeutics, but I would say a vaccine is what's going to help us get back to a normal life over time.

I would like to have at least two or three vaccines approved.

After we have two vaccines approved and in use, I would assume that my role is done.

I would hope by then that I would also have six vaccines identified and in Phase III trials, being manufactured and stockpiled. From then it will be really a matter of continuing to execute.

I would also hope to have one or two medicines with an impact on mortality approved .

BC: Do you mean approved, or authorized — for both vaccines and therapies?

MS: I actually mean authorized. I think the approvals will come a few months later.

I would think that if that happens — and I hope it happens before the end of the year, or very early in 2021 — I would have achieved my objective. And I must say it's the objective of thousands of people involved from HHS, from DOD, from the companies that are sponsors of the vaccines, from the companies involved in manufacturing, from the principal investigators and the hundreds of clinical trial sites, and from the 150,000 volunteers that will participate in the trials.

BC: So you are saying you think all of those goals will be achieved by the end of 2020?

MS: I think we should have two vaccines authorized either by the end of this year, 2020, or by the end of the first quarter of 2021. And I think we will have one or two medicines with an impact on mortality, also by the end of this year or within the first quarter of 2021.

BC: Have you directly or indirectly been pressured by President Trump or anyone else to make decisions that you believe were politically motivated?

MS: Well, listen, before taking the role, I did say I can take the role only if I was empowered and if there is no interference – if we can make the decisions and there is no interference. And I was guaranteed by the two secretaries [of HHS and DOD] and by Jared [Kushner] that there would be no interference. And guess what? Honestly, there has been no interference.

The President doesn't interfere. I met him four or five times to give him an update. And, you know, frankly I'm not aligned with [him], so I'm not there to praise anybody at all, but there's been no interference.

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