Every single day, I grow more confident that we will achieve the most important goal of Operation Warp Speed: delivering substantial quantities of a safe and effective vaccine by the end of this year.
Good morning, everyone, and thank you so much for inviting me to address all of you today.
As America and the world continue our fight against COVID-19, I want to focus on what may be the most remarkable aspect of our efforts so far: President Trump’s Operation Warp Speed initiative to deliver vaccines, therapeutics, and diagnostics on unprecedented timelines.
When we launched Operation Warp Speed in May, skeptics questioned the viability of our undertaking. The goals we set were optimistic and unprecedented—they were stretch goals.
But every single day, I grow more confident that we will achieve the most important goal of Operation Warp Speed: delivering substantial quantities of a safe and effective vaccine by the end of this year.
Today, I want to give you a sense of how we’ve made this happen so far. To explain that, I have to go back to the beginning, and how we determined what we needed to make the OWS goal possible.
The idea was driven by President Trump’s leadership.
The race to develop vaccines and therapeutics had begun just days after we became aware of the novel coronavirus in China. Even before the viral sequence had been shared by researchers, NIH had reached out to Moderna to begin designing a vaccine. On January 11, the morning after the sequence was shared, NIH researchers began work.
So we were already proceeding rapidly. But this past spring, when we presented the likely timelines for vaccines and therapeutics to the President, here’s what he said: Not good enough. Figure out how you can do it faster.
So that’s what we did. I and other leaders at HHS realized that we would need to draw on more than just the extraordinary resources we have as a department, which include the world’s greatest biomedical research institution in NIH; the world’s gold-standard regulatory agency at FDA; the most successful public-private countermeasure development effort, in BARDA; and the leading public health authority in the world, the Centers for Disease Control and Prevention.
We needed to look outside our walls: We would need to enlist the Department of Defense to coordinate with CDC on the logistics of manufacturing and distribution, and we would need outside expertise to advise this partnership, because the government would be playing a much larger role in the process of drug development than usual.
That is how we ended up with the leadership of Operation Warp Speed: Secretary Esper and I, and then the U.S. Army’s head of logistics, General Gustave Perna, as chief operating officer; and Moncef Slaoui, the most successful and prolific vaccine developer in history, as chief scientific advisor.
Together, we sought out every avenue for accelerating the development of vaccines and therapeutics without compromising our exacting standards for safety and efficacy.
We came up with three strategies: First, build a broad portfolio of candidate vaccines and therapeutics, to mitigate the risk of technical failure.
Second, provide unprecedented support for clinical trials and process development, allowing these efforts to proceed faster than ever before.
Third, provide support, at the government’s risk, to begin manufacturing products before they receive authorization or approval so that, if and when they do, there’s not a day wasted.
To build the portfolio we needed, we began examining more than 100 vaccine candidates that were in various stages of development in May 2020. From them, we chose fourteen promising candidates, from which we have announced support for six candidates.
We wanted candidates that had already shown promise in animal models or early-stage human studies, that were already far along in the development process, that had the potential to rapidly scale, and that were part of a reliable scientific platform that we believed could deliver results.
To mitigate risk and provide the fastest possible results, we spread investment across the three platforms for vaccine delivery: messenger RNA, the fastest and most ambitious; virus-vector-based, which is ambitious but proven; and protein-based, a common, well-tested approach.
We have been immensely pleased with our success so far: Four candidates are in U.S. Phase 3 trials, and more will be shortly.
As part of our second strategy to accelerate progress, we’ve provided unprecedented support for these trials.
Through a collaborative effort by NIH and the companies involved, we harmonized the trial endpoints and the assays used. We are running much larger Phase 3 trials than one usually would, with FDA setting the expectation that more than 30,000 participants will be enrolled in each, when a typical vaccine trial may have more like 15,000 enrollees. As a statistical matter, this means faster results: A vaccine trial can be analyzed once you have enough infection events in the placebo arm of the trial, and the more enrollees, the faster you hit that number.
We’ve also helped companies recruit diverse populations for these trials, relying on clinical trial networks with established community engagement programs that NIH has helped build over the years.
Besides the scale, nothing is different about these clinical trials and the standards we set for them than we would have for any other countermeasure development effort.
Last month, I had the chance to visit with some physicians running one clinical trial site, at Vanderbilt University Medical Center, where they said the safety protocols for the trial are the most stringent they’ve ever seen.
That means that there will, of course, be some delays. We saw this with the pause in the AstraZeneca Phase 3 trial here in the U.S. after an adverse event in their U.K. trial. The process is working as it should and just as it would with any other clinical trial.
Once the Phase 3 trials have reached pre-established endpoints, as would be the case with any other trial, the trial data are assessed by an independent Data Safety and Monitoring Board, which also reviews the data at predetermined points.
In a historic act of transparency, the companies have made public their protocols, including the points for these planned interim analyses.
Finally, that data will be reviewed by the career scientists at the FDA, who will make their science-based decisions on safety and efficacy.
As many of you likely know, FDA has put out guidance on these standards for both full approval of a COVID-19 vaccine as well as for the standards it would use, on a case-by-case basis, for assessing an application for Emergency Use Authorization.
As Dr. Slaoui has laid out, we believe an EUA would be appropriate in only specific circumstances: where we have sufficient quantities of vaccine already manufactured so that it could actually be provided to populations where the benefit-risk profile of the product makes sense.
The good news is that we are doing everything we can to ensure that we have supplies manufactured. Pending FDA authorizations, we believe we may have up to 100 million doses by the end of the year—enough to cover especially vulnerable populations—and we project having enough for every American who wants a vaccine by March to April 2021.
How are we doing this? By doing something that should make any Goldman analyst recoil in horror: investing in manufacturing and buying doses of vaccines regardless of whether they can eventually be distributed or not.
Industrial-scale manufacturing of a product while it’s still in clinical trials is rare in drug development, because it would make so little business sense to pay for a product that there’s a chance you can never use.
Manufacturing has now begun on an industrial scale for all six OWS-supported vaccines. More than 23 manufacturing facilities across the U.S. have been augmented and scaled up with our support.
We’re also supporting the procurement and manufacturing of the ancillary supplies needed for vaccines, such as vials and syringes, with more than a billion currently under procurement.
Scaling up the manufacturing of vaccines and other medical materials is a complex endeavor—and especially so during a global pandemic.
Thankfully, because of the way we designed OWS, the Department of Defense is ensuring that OWS manufacturers have what they need by using the same supply chain and logistics expertise that keeps the U.S. military the best-equipped force in the world.
One of the U.S. military’s strategic advantages has always been its logistics capability: having the right equipment, from bombs and bullets to food and fuel, in the right place at the right time, all across the world.
That requires a great deal of coordination of suppliers, and when necessary, application of government authorities to prioritize orders or redirect supplies.
We’re applying these same tools to OWS, ensuring that manufacturers have what they need, when they need it. So, for instance, if a shipment from overseas might normally take six weeks on a ship but is needed much faster, we ensure it’s put on a plane instead.
Planning and coordination across HHS, DOD, and the private sector is underway for vaccine distribution and administration, too.
This effort, led by CDC and DOD, will use an existing CDC vaccine partnership with McKesson to ensure vaccines get where they need to go, supported by private sector partners like UPS and FedEx.
We’re working closely with the 64 jurisdictions that CDC partners with on immunization—states, a few large cities, and other jurisdictions—which have extensive experience managing and implementing vaccination programs, including pandemic planning. When it comes to actual administration of vaccines, we are leveraging the strong existing U.S. vaccine system with public-private partnerships that have been built over decades.
For example, we’re working closely with chain and independent pharmacies to ensure that the vaccine can be available, where appropriate, from trusted community partners who provide vaccines for flu and other diseases every year. Vaccines will be available at provider offices, pharmacies, community health centers, public health sites, ad hoc or mobile clinics, and elsewhere as needed.
While we make this world-leading progress on vaccines, I want to note that we have applied the same methods to supporting therapeutics, too.
That includes, for instance, support for both development and manufacturing of Regeneron’s antibody cocktail, of which we could have tens or hundreds of thousands of doses this fall, pending FDA authorization.
OWS-supported clinical trials continue for remdesivir in combination with other drugs, in addition to anticoagulants and other options. We’re also supporting several randomized controlled clinical trials to produce more data on convalescent plasma, a promising treatment to which Americans have enjoyed broader access than anywhere else on earth.
Finally, OWS is coordinating unprecedented support for the development of potentially groundbreaking diagnostics. This is occurring through NIH’s RADx initiative, which has already invested more than $476 million with 22 companies to support development and manufacturing. These options could include much more rapid or convenient tests, including the possibility of at-home testing.
The progress on each of these fronts is not only unprecedented in history—it is also unmatched anywhere in the world. No one is as close as the United States and our partner companies are today to delivering large quantities of a gold-standard vaccine.
No country has played a larger role in supporting therapeutics targeted at COVID-19, and no country is providing greater support for next-generation testing.
All of this is unprecedented in medicine—but it’s part of a great American tradition. When we face a new threat, no other nation on Earth can combine the focused power of government with the ingenuity of the private sector like we can.
We built the Arsenal of Democracy, which launched a Liberty ship almost every day at the height of World War II. In under a decade, we went from putting our first man in space to building a spacecraft that could take men to the moon and back. American industry has time and again proven its ability to deliver results in unprecedented times, on almost unbelievable schedules.
Together, all of us—America’s scientists, public health experts, and industry leaders—are once again writing a unique, made-in-America story. Our combined efforts have the chance to save millions of lives—here in America, and around the world.
Every day, I grow more confident that we can deliver results faster than we ever expected, and I am grateful to every American who has played a part in this success so far.
Thank you all for inviting me to address you today.