Operation Warp Speed leader Moncef Slaoui listens to US President Donald Trump in the White House Rose Garden. Photo / Getty Images
Sitting in the shadow of the brutalist health department building in Washington, with only a leather jacket for protection against an autumnal breeze, Moncef Slaoui cuts a defiant figure.
Six months after the former GlaxoSmithKline executive left the private sector to become President Donald Trump's coronavirus vaccine tsar, Slaouifeels his decision has been vindicated, and critics of the ability of Operation Warp Speed to develop a vaccine in record time having been proved wrong.
"The easy answer for experts was to say it was impossible and find reasons why the operation would never work," he told the Financial Times.
But the vaccine push is now hailed as the bright spot in the Trump administration's Covid-19 response, as products from Pfizer and BioNTech, Moderna, and AstraZeneca and Oxford university move closer to approval.
Operation Warp Speed is a more than US$10 billion ($14.2b) investment programme with a remit to fund vaccines, therapeutics — such as two recently approved antibody treatments — and diagnostics.
So far it has spent the vast majority of its money on Covid-19 vaccines.
As well as funding some vaccine developers directly, it has also signed pre-orders for the products others are working on, guaranteeing them an income from an approved vaccine when the normal commercial decision might be to not take the risk.
Slaoui's team also helped manufacturers secure supplies and sped up responses to usually laborious regulatory queries.
Scientists had warned that, with much still to learn about Covid-19, a vaccine might take longer to develop, manufacture and distribute than Slaoui — and his boss, the president — might have hoped.
The central achievement of Operation Warp Speed had been accelerating investment in manufacturing, said Angela Rasmussen, a virologist at the Columbia University School of Public Health.
"Normally, that would be a huge investment for a vaccine manufacturer to make, and potentially be a huge loss for them if they developed a vaccine that never went on to the market," she said.
Even Pfizer, which did not take direct investment from Operation Warp Speed, benefited from having a US$2b pre-order for when its vaccine gets approved, said Peter Bach, director of the Centre for Health Policy and Outcomes at Memorial Sloan Kettering.
"Even if J&J or someone else beat them to the punch, they were going to get paid," he said.
Stéphane Bancel, chief executive of Moderna, the lossmaking biotech which took about US$2.5b in government funding from different bodies, said the money was "very helpful", covering the costs of trials and helping it buy raw materials.
"The entire planet is going to benefit from it," he told the FT. "We are going to file [for approval] in the UK based on the US data paid for by the US government. We're going to file in Europe and hopefully have a vaccine available in France and Spain and Italy, all paid for by the US government."
Backing many horses
Slaoui breaks off from his conversation with the FT to take an urgent call. "The White House," he explains.
Later that afternoon he would appear in the White House Rose Garden alongside Trump to give an update on Operation Warp Speed — a sign of how he has managed to navigate the politics of the pandemic.
Despite being a registered Democrat, he became one of few scientific experts in the administration to retain both their closeness to the president and their professional reputation. Slaoui said he took the job on the condition that there would be no "political interference" and he believes that has been fully met.
Slaoui spent almost 30 years at GSK, where his biggest research triumph was developing the first malaria vaccine. Francesco De Rubertis, a partner at Medicxi, a venture capital group, where he worked alongside Slaoui, said it was his "mission" to deliver the vaccine, even though it took decades.
Jean-Paul Clozel, chief executive of the Swiss biotech company Idorsia, worked with Slaoui when he was at GSK. He said Operation Warp Speed's plan to back so many horses looks to have been inspired by how Slaoui ran R&D at the UK drugmaker, where he splintered the department into smaller teams to compete against each other.
"You had to fight for money for your research," Clozel said.
While he brings expertise from industry, Slaoui has been sharply criticised for his financial interests in vaccine makers. Elizabeth Warren, the Democratic senator, has called for an investigation into why he was hired as a contractor rather than as a government employee — a distinction which she claims helped him evade government ethics requirements.
When he took the job, he quit the board of Moderna, an Operation Warp Speed participant, but he did not sell his US$12.4 million stake until after positive early vaccine data had sent the stock price soaring. He has since pledged the extra capital gain from the time of his appointment to the stake sale to cancer research.
Slaoui retains the shares he owns in GSK — reported to be about US$10m — even though GSK is also a participant in Operation Warp Speed in partnership with Sanofi. He has committed to giving any gains higher than the average of the pharmaceutical index to the National Institutes of Health.
Slaoui said he had always held himself to the highest ethical standards. "That has not changed upon my assumption of this role. [Health department] career ethics officers have determined my contractor status, divestures and resignations have put me in compliance with the department's robust ethical standards."
'Indispensable role'
Critics wish that Operation Warp Speed had sought more for its money. They think it could have secured lower vaccine prices, and shared technology to improve access to the vaccines for the developing world.
Zain Rizvi, a researcher at consumer advocacy group Public Citizen, said it was "uncontroversial" that Operation Warp Speed played an "indispensable role" in creating vaccines for the pandemic — but it could have used the investment to steer the industry in a different direction.
"Warp Speed could have required the corporations, who are receiving really unprecedented amounts of public money, to commit to setting a reasonable price for their products, not just now, but also in the future," he said.
Many point out that Operation Warp Speed stands on the shoulders of investments made by others, including other arms of government such as the National Institutes of Health.
Some lament that, if those other investments had been greater, either in vaccine technology and manufacturing or in pandemic preparedness more generally, then Operation Warp Speed might not have been necessary to compensate.
But most experts now save their harshest criticism for the name "Warp Speed". Slaoui did not pick the moniker — and didn't even know at first that it was borrowed from Star Trek.
While everyone involved in the operation insists it is focused on safety as well as speed, outsiders worry the name might muddy the message. Rasmussen of Columbia University called the name a "really bad idea" since "it implies that we're cutting corners. We need to address that to make sure ... people are actually willing to take the vaccine."
Whatever the criticisms, Slaoui insists the project has been a success — so much so that he now sees his role as coming to a natural end.
While he has called for his officials to be allowed access to Joe Biden's presidential transition team, he suggests he might not be making the transition himself, or at least not for very long.
"I would feel that I have achieved most of what I was hoping to achieve if we have two vaccines approved and two medicines approved," he said. "This is a transient role, and frankly the operation is a transient mission."
Big spender
Which companies got Operation Warp Speed money? • Johnson & Johnson: US$456m investment for development, US$1b for manufacturing and delivery, including a pre-order for 100m doses • Moderna: Up to US$955m investment for development, US$1.5b for manufacturing and delivery, including a pre-order for 100m doses • AstraZeneca and Oxford university: Up to US$1.2b for development and manufacturing, including a pre-order for 300m doses • Novavax: US$1.6b for manufacturing, including a pre-order for 100m doses • Pfizer and BioNTech: US$2b pre-order for 100m doses, if the vaccine is approved • Sanofi and GSK: US$2b for development and manufacturing, including a pre-order for 100m doses