This is an unprecedented achievement—and, in the field of public health, it is an unprecedented marriage of the best of America’s private and public sectors. I believe we will remember many elements of our pandemic response, including Operation Warp Speed, not just as unprecedented, but also as uniquely American accomplishments.
Hello, everyone, and thank you for inviting me to join you today.
Mike Milken and his generosity with the Milken Institute have played a huge role in improving American healthcare, but these efforts are perhaps best known for accelerating the pace of biomedical innovation, through initiatives like FasterCures.
This year, as COVID-19 has touched the lives of every American, we’ve all become quite personally interested in speedy drug development.
Today, I want to give you some of the backstory on how the Trump Administration has coordinated this work: through the unprecedented project that is Operation Warp Speed.
To accelerate the development of vaccines, therapeutics, and diagnostics for COVID-19, the public and private sector have come together to do things we’ve simply never done before.
I’ll focus on how we designed the central element of this effort: the development, manufacturing, and eventual distribution of safe and effective vaccines within a year after the virus was discovered.
American researchers began work on COVID-19 vaccines days after we learned about the virus. On January 4, researchers at NIH reached out to partners at Moderna to collaborate on a vaccine for the novel virus. This was two weeks before the Chinese government had even admitted there was human-to-human transmission. Actual work on this vaccine began on January 11, the morning after the viral sequence was shared by Chinese researchers.
While this early work began, we started thinking strategically about what looked like a realistic timeframe for a vaccine.
I can tell you what the President thought: He’d heard talk from our leading experts that 18 months just for vaccine development would be very optimistic—and that wasn’t even accounting for manufacturing.
The President demanded better, and I knew we could do better. With almost 10 years in HHS and 10 years in leadership in the biopharmaceutical industry, I knew the potential tools that the government could bring to the table, and I knew what the barriers were to accelerated drug development.
In the Bush Administration, I was instrumental in forming market interventions to accelerate chemical, biological, radiological, and nuclear countermeasures through Project Bioshield and BARDA. I had seen the role that the government can play in fixing a market failure, where the market won’t make products we need without the U.S. government as a guaranteed purchaser.
As the architect of Secretary Leavitt’s and President Bush’s pandemic influenza plan, I knew the critical role the federal government and its resources can play in incentivizing the production of countermeasures for Black Swan events, such as a pandemic, and how to boost manufacturing. I also knew the critical role of states in distributing an eventual vaccine in a pandemic, thanks to the pandemic flu plans and pandemic flu summits we organized in every state.
So I approached this problem with three critical partnerships in mind: 1) a partnership across the U.S. government, deploying the totality of government resources, capabilities, and personnel; 2) a partnership between the public and private sectors, harnessing America’s world-leading biopharmaceutical industry; and 3) a partnership between the federal government and the states around vaccine distribution.
HHS started providing financial support to various vaccine developers in February, including Johnson & Johnson and Sanofi Pasteur.
Thanks to incredibly early work by scientists at NIH and Moderna, their vaccine set a record in starting Phase 1 trials, on March 16, just over two months after the viral sequence was shared.
I knew, however, that this project was going to be more complex than any development process HHS had ever supported.
This became apparent when I spoke with the CEO of Johnson & Johnson at the end of March, when we inked a contract with them to support advanced development of their vaccine candidate.
As I examined the framework established by BARDA, I saw that J&J would enter Phase I only in September at the earliest, which, while accelerated compared with normal circumstances, was not fast enough.
I didn’t see the timeline accountabilities I’m accustomed to demanding as a business leader and secretary. I saw no provisions regarding acquisition and pricing of an ultimate vaccine.
As I mentioned, we were awarding this support through BARDA, the Biomedical Advanced Research and Development Authority. BARDA has been highly successful at bringing products all the way from the lab to the marketplace, but it’s a small agency that was under-resourced for the scale of the project we were about to undertake.
At the pharmaceutical company where I had spent the better part of the previous decade, even a $100 million Phase 3 investment would have to go the board of directors and pass through the Science and Technology Committee of the board.
So, in early April, I assembled a Secretary’s Scientific Advisory Board for this project, including some of the top doctors and experts across HHS: Dr. Fauci, Dr. Collins, Dr. Hahn, Dr. Redfield, Dr. Bob Kadlec from our emergency response office, Dr. Nancy Messonnier from the CDC, Dr. Peter Marks from FDA’s biologics center, and others. Together, we wanted to make sure that the support we were awarding for vaccines—and therapeutics and diagnostics—could deliver the results we needed.
As this group reviewed our portfolio, it became apparent to me that we could be more proactive in bringing our plans to private sector partners, and getting them to deliver the results we wanted—rather than letting the usual suspects come to us and tell us what they thought they could do on their own corporate timelines.
We had to work with the private sector—but the government could and should set the high-level, ambitious strategy.
I told the team that we should approach this problem as if money were no object. Congress had just spent $2 trillion on relief, so literally any amount of money we could credibly spend on vaccines to get out of this would have essentially an infinite return on investment. We should be limited only by the laws of science and physics, I told the team.
After a couple meetings of that group, we had a meeting of a smaller team, on April 10, where I heard from these leaders, including Peter Marks of FDA, that we could be even bolder. If we wanted to press incredibly aggressively on speed, we could not do that within our existing structures, and we needed to be proactive in directing industry.
We would need a wholly new project, with the scale, ambition, and creativity of the Manhattan Project or the Apollo Program.
I commissioned this team to develop a Manhattan Project 2, or MP2 as we then called it, and they came back to me on April 13 with a PowerPoint plan. That is what became Operation Warp Speed.
Immediately after that meeting, I started talking with White House leaders, including Jared Kushner and Mark Meadows, about what we needed for this project to be successful. These leaders, and eventually the President, were eager to support as bold a vision as we needed.
I’ll note just one point for context: When you examine the pandemic planning that had been done over the years, there was a recognition of the need for accelerating the development of countermeasures like vaccines. In the Bush Administration pandemic flu plan I mentioned earlier, we specifically invested billions in our ability to scale up production of flu vaccines.
But what we had to do with Operation Warp Speed was unprecedented: We had to support the research, development, manufacturing, and distribution of a vaccine for a novel virus on a population-level scale and we had to do it quickly. No one had written a plan on how to do this—and they hadn’t planned for how we would need to engage so many partners to do it.
As I mentioned, the past 20-plus years of my life prepared me rather well to understand what we needed to do. First, I spent a decade in the biopharmaceutical industry—at a company that did a lot of biological manufacturing, giving me a sense of just how complex it would be to make hundreds of millions of doses within months.
Second, I spent almost a decade total at HHS. I learned what our department could do well—like research, partner, plan, incentivize, and coordinate—and what we generally didn’t do, which is execute on complex operational, logistical, and procurement projects.
We needed to compress the process of developing a vaccine, which would normally take years, into just months. The federal government, for the most part, is in the business of basic research and early-stage investments, not end-to-end drug development. NIH doesn’t do it; DOD rarely does it. BARDA does it routinely and does it well, but doing it on such a tight timeframe would require more government involvement than ever before.
And we would need to support the large-scale manufacturing of a biologic vaccine, the production of supplies like needles and syringes, the distribution of the vaccines, and then their administration, all with the smallest possible delays.
In other words, for those of you who know your Manhattan Project history, we knew we needed our J. Robert Oppenheimer—a brilliant scientist who could lead others—and we needed our General Leslie Groves—a top-flight logistical leader.
I needed buy-in from across the administration, and we needed to draw on the right expertise wherever it was. So one Saturday—April 25—I took a long walk, and I started making calls. I more or less went through the first few pages of the Plum Book: I spoke to the National Security Advisor, Robert O’Brien, and the director of the National Economic Council, Larry Kudlow. I talked to OMB Director Russ Vought and to Ambassador Birx. I talked to Defense Secretary Esper; I talked to the DHS Secretary, the VA Secretary, the Energy Secretary, and the Agriculture Secretary.
By the end of a very long walk, I had secured eager buy-in from everyone I’d talked to, I had some ideas of what we needed to execute on our plan, and I’d activated a wonderful case of plantar fasciitis.
I came to understand that we had three specific problems to solve: First, we needed to speed development by de-risking the investment decisions that pharmaceutical companies were making. Pharma companies will traditionally get the results from each phase of clinical trials before investing and planning for the next phase. By the federal government assuming the risk of technical failure, we could move from one phase to the next literally in hours.
Second, we needed to solve the issue of commercial-scale manufacturing of protein biologics. The manufacture of biologics is as much art as it is science. Or, as Dr. Slaoui says, proteins are very moody. The inability to scale from preclinical to commercial scale manufacturing with biologics is a major cause of delay and failure. No company would invest significant human resources or capital in commercial-scale manufacturing early in the development of a vaccine—certainly not in the first few months of development—but we could de-risk that decision. On top of that, we could add the procurement power of the U.S. government, through the Defense Production Act and our practically unlimited budget.
Third, I knew we had a gap at HHS in terms of logistics, operations, and procurement at this scale. We do great work, but this would be the largest biopharmaceutical mobilization in history. We needed absolute pros when it came to logistics, operations, and procurement.
It became clear from my conversations that the Defense Department would be a perfect counterpart to HHS, supplementing what we lacked in operational, procurement, and logistics expertise. Secretary Esper agreed to meet the next week to discuss potential leaders and where we should physically house the operation.
On May 1, I met with Secretary Esper, his deputy secretary, the Chairman of the Joint Chiefs of Staff, and Jared Kushner. Secretary Esper told me immediately: I’ve got your operations guy—it’s Gus Perna, head of the Army’s logistics command.
That meant we just needed to find a leader for development and a leader for manufacturing. I’d been calling around to my contacts for several weeks, and we generated a number of names we brought in for interviews.
Here was the interview question: Your goal is to get out as many doses of vaccine as quickly as possible, without cutting any corners on safety or efficacy. You are unconstrained except by physics and science. You have the manpower of HHS and DoD at your disposal. You have unlimited financial resources. Tell me what’s possible and how you’ll do it.
One person’s answer so obviously stood out. When I’d begun to make calls to ask for names, Moncef Slaoui’s name had kept coming up. There’s a reason for that: If you look up the major novel vaccines that have been launched over the past two decades, his name comes up right next to a lot of them.
Moncef matter-of-factly laid out the path forward, and it was identical to the vision I had articulated to my cabinet colleagues: We would prefund all stages of development upfront. We would begin commercial manufacturing upon early contractual commitment. We would put the United States at the front of every line. We would manufacture in America if at all possible.
We would build a broad portfolio of vaccines, mitigating the risk that several of them could fail. We would have multiple bets on each of these platforms. We would work with manufacturers closely to ensure that they had everything they needed to start production as soon as possible, given the complexity of vaccine making.
Moncef was the key to our development strategy. But we also needed someone who could speed the manufacturing side, with expertise in biologic manufacturing.
Another name that came to the forefront, which you haven’t heard much about, is Carlo de Notarestefani. He had been the longtime global head of manufacturing for Bristol Myers Squibb, a leading branded biologic company. But what really interested me was the fact that he had recently retired as the head of global supply chain management for Teva, a leading generic company, where he would stand up literally hundreds of new production lines each year, including biologics. This was the sense of non-PhRMA urgency that I was looking for.
The President agreed that we needed these outside leaders. He knew we needed leaders who could put their heads down; focus on development, manufacturing, and distribution; and harness the full force and resources of the federal government and military however we needed.
He also knew we needed this team to have the independence to move with speed and agility, so we formed a board chaired by myself and the Secretary of Defense, with Dr. Birx and Jared Kushner, reporting directly to the President.
In the same week that we interviewed Moncef, the President joined us in the Rose Garden to announce Operation Warp Speed, and we were off.
Even at that time, in May, experts were still saying that a vaccine would be a year or more away. The President demanded better, he supported the plan to deliver it, and that’s what he got.
Today, we have a growing arsenal of authorized treatments and three vaccine candidates with promising data from Phase 3 trials.
The Johnson & Johnson Phase 1 trial that I mentioned, which maybe wasn’t going to start until September? It started in June. With the assistance of OWS, J&J started their Phase 3 trial in September.
Two vaccines, from Moderna and Pfizer, are now before the FDA—one being examined by the FDA’s advisory committee tomorrow.
With favorable decisions from FDA, we will have enough of those vaccines to vaccinate 20 million of the most vulnerable Americans by the end of this year, and approximately 50 million Americans total by the end of January.
These production timelines would not be possible without the design of OWS. As the private sector went to work on manufacturing, we’ve supported them however they needed. Every day, the Pentagon ensures that manufacturing supplies go where they need to go, including between private-sector companies, so that the guns, bullets, food, and everything else the military needs are produced and delivered on time.
They’re now doing the same thing for vaccine manufacturing, through the Defense Production Act and other informal actions to prioritize supplies. When one manufacturer needed particular parts to bring a new bioreactor online, for instance, OWS staff ensured that the parts maker prioritized the order.
At one point, an OWS partner had ordered a particular kind of pump that it needed to make vaccines, but found out that the train that was shipping said pump had broken down and wouldn’t arrive on time. We sent OWS staff to find the train, literally search the train to find that pump, and put it on a plane to where it needed to go.
Because of this support, production of vaccines will continue to ramp up dramatically in 2021—as will availability of authorized therapeutics.
As soon as we have authorization from FDA, we plan to ship vaccines to our 64 public health jurisdictions within 24 hours.
OWS has worked with CDC and with these jurisdictions so that we have everything needed to administer the vaccine: agreements with administration sites like chain pharmacies; tens of millions of vaccine kits with needles, syringes, and PPE; and plans for how to get the vaccine to harder-to-reach areas and populations, like members of tribal nations and residents in long-term-care facilities.
This is an unprecedented achievement—and, in the field of public health, it is an unprecedented marriage of the best of America’s private and public sectors.
I believe we will remember many elements of our pandemic response, including Operation Warp Speed, not just as unprecedented, but also as uniquely American accomplishments.
The American people owe a debt of gratitude to the team of leaders who have gotten us here so far—to Dr. Slaoui, to Carlo de Notaristefani, to General Perna, and to the countless public servants and private partners who have worked day and night for the past year to get us this close to victory.
Because of heroic contributions—from healthcare providers who haven’t had a day off in months, to manufacturing workers doing overtime, to ordinary Americans making sacrifices to protect loved ones—we draw closer to victory every day.
Thank you for what so many of you have done as part of this response so far, and know that the end is in sight. Thank you.