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Leader of U.S. vaccine push says he’ll quit if politics trumps science

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Moncef Saloui, the scientific head of Operation Warp Speed, spent 29 years making vaccines at GlaxoSmithKline.

 

Stuart Isett CC 2.0

Science‘s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

On a nice day in early May, Moncef Slaoui was sitting by his pool when he received a phone call that would dramatically change his life—converting him from a retired executive of a big pharmaceutical company to the scientific leader of the Trump administration’s Operation Warp Speed, a multibillion-dollar crash program to develop a vaccine in record time.

What do you think about staging a Manhattan Project to make a COVID-19 vaccine? asked the caller, a person Slaoui would only describe to ScienceInsider as a former congressman who once headed the Biotechnology Innovation Organization, biotech’s powerful trade group. (James Greenwood is the only person with that resume.) Could we make a vaccine in 10, eight, or even 6 months or is it impossible? the caller pressed him.  Slaoui, an immunologist who formerly headed vaccine development at GlaxoSmithKline (GSK), gladly shared his thoughts. “I’m very passionate about preventing pandemics,” says Slaoui, who led a failed attempt to build a biopreparedness organization that explicitly aimed to rapidly make vaccines against emerging pathogens like SARS-CoV-2, the virus that causes COVID-19.

At the end of the call, the former congressman told Slaoui not to be surprised if somebody calls from the Trump administration. “Honestly, I hung up and told my wife, ‘Oh shit,’” Slaoui says. “I was hesitant around the politics.”

About 1.5 weeks later, a “senior leader” from the Department of Health and Human Services (HHS) phoned and asked Slaoui to come to Washington, D.C. He made the trip from his home in Pennsylvania, meeting with the secretaries of HHS and defense, senior presidential adviser (and son-in-law) Jared Kushner, and a few others. “My No. 1 question was, ‘Is this going to be interfered with?’” Slaoui says. “Is this empowered 100%?” He says he got the answer he needed, and 4 days later, on 15 May he stood in the Rose Garden with President Donald Trump, who announced Slaoui as the scientific head of Operation Warp Speed.

To date, Warp Speed has invested more than $10 billion in eight vaccine candidates. Much of that money goes to “at-risk” purchasing of vaccines, which means the companies will produce hundreds of millions of doses that may wind up in the garbage if those candidates do not prove safe and effective. Three of the vaccines now are in large-scale efficacy trials, and interim looks at their data by independent safety and monitoring boards could reveal efficacy signals as early as October. If that happens, a vaccine could become quickly available through what’s known as an emergency use authorization (EUA), a regulatory pathway that the Food and Drug Administration (FDA) has for diagnostics, treatments, and vaccines.

Talking to ScienceInsider today, Slaoui insisted he won’t be swayed by political pressures to rush an unsafe or ineffective vaccine, and that science will carry the day—or he’ll quit.

Slaoui has given few interviews since taking the Warp Speed job and he has taken something of a beating in the media for his financial holdings in companies working on COVID-19 vaccines—he was on the board of Moderna and has since stepped down, but he retains his GSK stock. And Warp Speed has been slammed for a lack of transparency on its decisions.

Slaoui spoke with ScienceInsider today for 25 minutes about his role, the challenges of the job, and the growing fear that politics and the upcoming elections on 3 November might influence the vaccine approval process. The interview has been edited for brevity and clarity.

Q: As the head of Operation Warp Speed, what do you actually do?

A: In partnership with General [Gustave] Perna, who is the chief operating officer and the ultimate decision-maker—I’m not a federal employee—we put together the overall plan. We said we want to build a portfolio of vaccines in order to manage the risk and also increase the chances that we have many vaccine doses. We said we need to use different platform technologies, all of which have to be very fast, that have different characteristics so we can reduce the risk of complete failure and also increase the opportunity to have vaccines for different subpopulations. Once we set that strategy, we started to operationalize it.  Surprises come every day. New questions from the FDA. Or a clinical trial site that’s not recruiting. Or imbalances in the kind of populations that we want to have in the study. Or changing the geographic location of the sites because the epidemiology is evolving. There are 25 different sites in the U.S involved in the manufacturing of these six vaccines and General Perna and myself tour all of them. Frankly, it’s actually working even better than I was hoping.

Q:  You have EUAs for hydroxychloroquine and convalescent plasma that were heavily criticized as having come about because of political pressure. Does that have blowback on you and the confidence in any vaccine EUA? Are you concerned that vaccine hesitancy is going to be fueled by the president overstating the promise of hydroxychloroquine and then convalescent plasma, which he called a historic breakthrough?

A: The science is what is going to guide us. And the science is what our team is focused on and will be judged by. And at the end of the day, the facts and the data will be made available to everyone who wants to look at them and will be transparent. I am confident that it will be a completely different scenario. We’re running phase III trials with 30,000 subjects—that’s much larger than for many vaccines that have been approved in the United States under a BLA [a biologics license application is FDA’s full approval process for a vaccine]. If a vaccine is efficacious, an EUA will require that the documentation and demonstration of efficacy be flawless. The long-term evidence of safety is going to be limited because these vaccines are going to have only 6 months or 5 months of data. So, we’re working superhard on a very active pharmacovigilance system, to make sure that when the vaccines are introduced that we’ll absolutely continue to assess their safety. Our intent is to drive the companies to a BLA that should be filed one, two, 3 months from an emergency use designation.

Q: Have you discussed with the administration the possibility of saying, ‘Let’s not ask for an EUA until after 3 November?’ Let’s just clear that off the deck right now, because there’s so much worry of an October surprise and something being pushed before 3 November. It’s not going to make a difference to the pandemic if there’s a vaccine on 2 November or 4 November.

A: I have to say, maybe even despite my personal political views, that I don’t think that’s right, because 1000 people die every day [from COVID-19]. If a vaccine [had evidence of safety and efficacy] on 25 October, it should be [requested] on 25 October. If it’s 17 November, it should be 17 November. If it’s 31 December, it should be 31 December.

It needs to be absolutely shielded from the politics. I cannot control what people say. The president says things, other people will say things Trust me, there will be no EUA filed if it’s not right.

Q: China has three vaccines in efficacy trials that use the whole virus and inactivate it. You don’t have a whole virus, inactivated vaccine in your portfolio. You’re sticking to the viral spike protein being engineered in different ways. You’re leaving an egg out of the basket for political reasons. Why don’t you have an inactivated vaccine in the portfolio?

A: I really don’t think an inactivated vaccine is a good idea. There are very strict scientific reasons. In the early 1960s, an inactivated respiratory syncytial virus vaccine was given and it enhanced disease. The second reason is I think there is a biosafety issue with 20,000-liter fermenters having trillions of virus particles and then inactivating them. Technology in today’s world allows us to not have to take those kinds of risks. If I was in the company I was in before, I’d make exactly the same decision.

Q: You’re an internationalist. You’re from Morocco, you’ve lived in Europe much of your life, you’ve had great concern about global equity throughout your career. Operation Warp Speed has said from the outset that it will not consider China-made vaccines. What happens if China has efficacy data and good safety data that are reasonable, and has a vaccine it’s going to approve? What do we do? Do we have any access to that vaccine? Or do we just wait?

A: I think it’s great if this would be the first demonstration that vaccines can work. That’s great news for the world. And frankly, if China had billions of doses of vaccine after serving its population, we would take it. We are fortunate. I believe we will have vaccines and may not be in that position. I heard the president, which was important to me, saying that if we produce enough vaccine to serve the United States, it will be available to others, including China.

Q: But the United States has not joined COVAX, an international financing mechanism to help assure that low- and middle-income countries have prompt access to any vaccines that prove safe and effective. I know you well enough that you would have voted to join COVAX. Personally,  if it was your choice, wouldn’t you have?

A: I would, I would.

Q: You also have a history of being politically active. As a university student in Belgium, you were politically active. It’s in your blood: Your father, who resisted the French occupation of Morocco, was politically active. For you to now say there’s nothing political about Operation Warp Speed? Politics is all over this. And I wonder how you deal with political decisions that you disagree with.

A: I would immediately resign if there is undue interference in this process.

Q: If you see an EUA push you don’t believe in, you’re out?

A: I’m out. I have to say there has been absolutely no interference. Despite my past, which is still my present, I am still the same person with the same values. The pandemic is much bigger than that. Before being a political person with convictions, humanity has always been my objective.

Q: The monkey model data initially were going to be used as criteria for vaccine-candidate selection for Warp Speed. But it seems to me now that it’s almost, ‘Well, everything kind of works in monkeys. And nothing has a really serious safety signal.’ How are you using the monkey model to make decisions, or is it just there as a failsafe?

A: It’s a piece of the puzzle. If we did a monkey challenge and it didn’t work or it showed enhanced disease, we’d stop. But that hasn’t happened.

Q: There’s been a lot of handwringing about the fact that several of the vaccines Warp Speed is backing must be kept at extremely low temperatures before being used. Is the cold chain a problem?

A: It’s a challenge. One of the vaccines requires –80°C and two vaccines require –20°C. I think all the companies whose vaccines need –20°C or –80°C are working very hard and are set to have formulations that will be stable.

Q: You’ve been involved in many vaccine efforts: HIV, malaria, human papillomavirus. You worked on vaccines that didn’t even succeed. On the spectrum here, does SARS-CoV-2 look like it’s easy to beat, middle, or difficult?

A: This one has benefited from many things. One is the advance of platform technologies in vaccinology, particularly over the past 10 years. The second thing it has really benefited from is SARS and MERS [two respiratory diseases causes by coronaviruses related to SARS-CoV-2]. Vaccines were designed for those. So, knowing how to how to construct the [structure] of the spike was super important. From that perspective, it’s easier because past experience has been extremely relevant to this.

From the perspective of how to design the trials, how to manufacture [the vaccines], how to find the endpoints of the study based on disease, how to optimize for the epidemiology, clinical trial sites, and things like that, we haven’t yet hit the wall. One of the reasons we said we needed six or eight vaccines is because some of them may or will hit the wall.

 

Source: – Science Magazine

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Amy Coney Barrett’s expected nomination to Supreme Court is a perfect reflection of the divisions in U.S. politics – The Globe and Mail

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This image provided by Rachel Malehorn shows Judge Amy Coney Barrett in Milwaukee, on Aug. 24, 2018. (Rachel Malehorn, rachelmalehorn.smugmug.com, via AP)

The Canadian Press

Now, the 2020 effort to fill the Supreme Court seat once held by a jurist famed for her love of the opera takes on the air if not the arias of Giuseppe Verdi’s 1867 Don Carlo: a mix of death and politics.

Already, Washington is braced for dramatics worthy of La Scala, created by a set of unlikely stage circumstances worthy of the most imaginative librettos.

A year ago, nobody expected the leitmotif of this U.S. election year to be a once-obscure respiratory ailment with the ungainly name COVID-19. Seven months ago, few expected former vice-president Joe Biden, three-quarters of a century old and looking every year of it, to be the designated saviour of the Democrats in the Donald Trump era.

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And only a week ago, nobody expected the election to turn on the destiny of Amy Coney Barrett.

Amy Coney Barrett? An Indiana jurist known to few Americans outside conservative legal circles until late last week, Justice Barrett, 48, was expected to be nominated Saturday by Mr. Trump to fill the Supreme Court vacancy created by the death just more than a week ago of Justice Ruth Bader Ginsburg. And if the scales of justice require an elegant balance, then Mr. Trump’s selection fits comfortably opposite Justice Ginsburg on the weighing pan of U.S. jurisprudence.

Though both are women, Justice Barrett – like the late Justice Antonin Scalia, Justice Ginsburg’s opera companion, and the conservative jurist for whom Justice Barrett clerked – is a judicial originalist, the opposite of Justice Ginsburg’s profile as a judicial activist.

Justice Barrett was educated at tiny Rhodes College and the University of Notre Dame, and is a product of Memphis and the Midwest. Justice Ginsburg was educated at Cornell, Harvard and Columbia, the product of the Ivy League and the Eastern establishment. Justice Barrett has qualms about what she derided in a Notre Dame speech as abortion-on-demand and has an expansive view of the Second Amendment that is the basis of widespread gun ownership. Justice Ginsburg was a fervent supporter of abortion rights and didn’t believe the Second Amendment should be interpreted to permit widespread ownership of guns.

It is those differences – the positioning of Justice Barrett on the opposite side of virtually all the vital judicial issues of 21st-century America – that makes her “the nominee that social conservatives have been waiting and fighting for,” as John Yoo, deputy assistant attorney-general in the George W. Bush administration and law professor at the University of California, Berkeley, put it.

And that is what so energizes conservatives in the United States and so horrifies liberals.

It is, moreover, those differences that add definition, passion and perhaps direction to an election that, like virtually no other in U.S. history, could turn on the future of the Supreme Court.

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Already, Mr. Biden has tied the Supreme Court confirmation battle to the survival in the high court of the Obamacare health-insurance law, emphasizing the urgency that the issue possesses in the time of the coronavirus. And already, both sides in the abortion battle are stoking passions among their adherents, declaring that abortion rights, established in 1973, now could be in the balance.

To be sure, throughout the past 90 years, the composition of the Supreme Court has been an important issue: in the New Deal years, when the high court ruled on the Great Depression remedies of Franklin Delano Roosevelt; in the Dwight Eisenhower years, when the first important racial-integration rulings were handed down; in the Richard Nixon years, when abortion was legalized and the President’s prerogatives were curtailed.

Polls show Mr. Biden holding as much as a 17-point advantage over the President among women, raising the prospect of a record gender gap. Choosing a jurist such as Thomas Hardiman – a moderate that Mr. Trump has considered in the past and whose ideological profile would be less onerous to conservative Democrats in the Senate – would only make it more difficult for Mr. Trump to narrow that gap.

If the very prospect of replacing Justice Ginsburg is a flashpoint in U.S. politics, the selection of Justice Barrett is a lightning strike – a perfect reflection of the divisions in U.S. politics today and of the tensions that define the struggle for the White House. In every way that this nomination mobilizes Democrats infuriated at the President’s selection and Senate Majority Leader Mitch McConnell’s determination to hold a confirmation vote for Justice Barrett, it also galvanizes conservatives.

She is, in the characterization of conservative Hoover Institution scholar Peter Robinson, “committed to the originalist interpretation of the Constitution, with an extensive and brilliant written record, the correct gender, and has demonstrated the character, resolve and sheer cussed stubbornness to withstand the calumnies of the confirmation hearings.”

Justice Barrett also “helps Trump in the culture wars, especially on behalf of white Christians, and she’s based in the Midwest, where he needs to do well,” said Daniel Urman, a constitutional scholar at Boston’s Northeastern University. Indeed, Democratic Senator Dianne Feinstein of California helped ignite sympathy for Justice Barrett and for devout Catholics when she told Justice Barrett during her 2017 nomination hearings for the 7th Circuit Court of Appeals that “the dogma lives loudly within you.”

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Ms. Feinstein concluded that “dogma lives loudly” phrase with the words “and that’s a concern.” But that phrase – swiftly seized upon by Catholic and conservative groups, appearing on T-shirts and coffee mugs – is an enormous advantage on the American right.

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McKenna School of Philosophy, Politics and Economics announced at Mount Allison University – SaltWire Network

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SACKVILLE, NB — Mount Allison University’s philosophy, politics, and economics programs have received a significant boost from one of New Brunswick’s most accomplished political and business leaders.

Former premier Frank McKenna and the university jointly announced the establishment of the Frank McKenna School of Philosophy, Politics, and Economics on Friday. It is expected to be officially launched in 2021.

“The world we live in today needs collaborative solutions. Our society needs more world-class ‘generalists,’ people who have some background in economics, a philosophical base, and an understanding of politics at large,” McKenna said in announcing a $1 million leadership gift in support of the initiative. “This program brings all of that together, along with exceptional teaching and experiential learning opportunities for students. My family and I are delighted to support this new initiative at Mount Allison University and look forward to seeing the paths students from the school will lead.”

To date, $5 million has been raised to support the Mount Allison school concept from a number of donors across Canada including McKenna and his family, which is inspiring others to give.

University president and vice-chancellor Jean-Paul Boudreau said the announcement represents a tremendous opportunity for Mount Allison students.

“The McKenna School of Philosophy, Politics, and Economics at Mount Allison represents a fantastic opportunity to help lift our students from the launchpad of New Brunswick onto the global stage, offering an exceptional academic experience partnered with experiential and work-integrated learning opportunities in these key fields,” Boudreau said. “

The Frank McKenna School of Philosophy, Politics, and Economics at Mount Allison will advance the university’s capacity for new scholarly activity and supports for students in the program.

Honouring one of New Brunswick’s most accomplished individuals, Boudreau said the investment will enable new international and work-integrated learning opportunities and global internships for philosophy, politics, and economics students.

The gift will also fund the new McKenna Scholars program, providing scholarships and bursaries for students throughout their degree.

McKenna is currently the deputy chair, wholesale, TD Bank Group. He is a former Canadian ambassador to the United States and a former premier of New Brunswick — a position he held for 10 years.

Under his leadership, he brought thousands of jobs to the province and nurtured the growth of business and industry, universities and youth.

He is also a Mount Allison honorary degree recipient. McKenna double-majored in politics and economics in his undergraduate degree and also completed courses in philosophy.
The philosophy, politics and economics program was established at Mount Allison in 2013 and is the only PPE program in Canada east of Ontario, and only one of three in Canada.

It offers students the opportunity of a multidisciplinary immersion in these three academic areas, helping to prepare them for myriad of career paths. Courses in the PPE program are drawn from established courses in all three disciplines, with special topics courses offered in upper years.

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McKenna School of Philosophy, Politics and Economics announced at Mount Allison University – TheChronicleHerald.ca

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SACKVILLE, NB — Mount Allison University’s philosophy, politics, and economics programs have received a significant boost from one of New Brunswick’s most accomplished political and business leaders.

Former premier Frank McKenna and the university jointly announced the establishment of the Frank McKenna School of Philosophy, Politics, and Economics on Friday. It is expected to be officially launched in 2021.

“The world we live in today needs collaborative solutions. Our society needs more world-class ‘generalists,’ people who have some background in economics, a philosophical base, and an understanding of politics at large,” McKenna said in announcing a $1 million leadership gift in support of the initiative. “This program brings all of that together, along with exceptional teaching and experiential learning opportunities for students. My family and I are delighted to support this new initiative at Mount Allison University and look forward to seeing the paths students from the school will lead.”

To date, $5 million has been raised to support the Mount Allison school concept from a number of donors across Canada including McKenna and his family, which is inspiring others to give.

University president and vice-chancellor Jean-Paul Boudreau said the announcement represents a tremendous opportunity for Mount Allison students.

“The McKenna School of Philosophy, Politics, and Economics at Mount Allison represents a fantastic opportunity to help lift our students from the launchpad of New Brunswick onto the global stage, offering an exceptional academic experience partnered with experiential and work-integrated learning opportunities in these key fields,” Boudreau said. “

The Frank McKenna School of Philosophy, Politics, and Economics at Mount Allison will advance the university’s capacity for new scholarly activity and supports for students in the program.

Honouring one of New Brunswick’s most accomplished individuals, Boudreau said the investment will enable new international and work-integrated learning opportunities and global internships for philosophy, politics, and economics students.

The gift will also fund the new McKenna Scholars program, providing scholarships and bursaries for students throughout their degree.

McKenna is currently the deputy chair, wholesale, TD Bank Group. He is a former Canadian ambassador to the United States and a former premier of New Brunswick — a position he held for 10 years.

Under his leadership, he brought thousands of jobs to the province and nurtured the growth of business and industry, universities and youth.

He is also a Mount Allison honorary degree recipient. McKenna double-majored in politics and economics in his undergraduate degree and also completed courses in philosophy.
The philosophy, politics and economics program was established at Mount Allison in 2013 and is the only PPE program in Canada east of Ontario, and only one of three in Canada.

It offers students the opportunity of a multidisciplinary immersion in these three academic areas, helping to prepare them for myriad of career paths. Courses in the PPE program are drawn from established courses in all three disciplines, with special topics courses offered in upper years.

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