Operation Warp Speed Leaders Discuss Vaccine Development With the Heritage Foundation

Oct. 27, 2020
Army General Gustave F. Perna, Chief Operating Officer, Operation Warp Speed; Tom Spoehr, Director, Center for National Defense, Heritage Foundation; Ed Haislmaier, Senior Research Fellow, Health Policy Studies, Heritage Foundation; Dr. Matt Hepburn, Head of Vaccine Development, Operation Warp Speed

THOMAS SPOEHR:  Well, good afternoon everyone and thanks for joining us today at Heritage Events Live.  My name is Tom Spoehr, and together with my co-moderator, Ed Haislmaier, we'd like to welcome you to today's event, the fight to get a COVID-19 vaccine, the inside story of the administration's Operation Warp Speed.

By way of introduction, Operation Warp Speed's goal is to produce and deliver over 300 million doses of safe and effective vaccines with the initial doses available by January 2021.  We have a great program in store for you and we want to get right to it, so let's do that.

With that I'm delighted to tell you a little bit about our first speaker, General Gustave or Gus Perna is an Army Four-Star General confirmed by the Senate on July the 2nd to serve as the Chief Operating Officer of Operation Warp Speed.  Prior to this assignment, General Perna served as the Commanding General of the Army's Materiel Command for nearly four years, leading 190,000 military, civilian, and contractor employees with a mission to provide logistics, sustainment, and maintenance for a globally deployed Army.  General Perna is a career logistician who has led complex supply, distribution, and maintenance operations in multiple combat tours with Army and joint forces, and has served as at the national level, supporting Department of Defense supply and distribution efforts.  Well, as this -- as his background, it's easy to see why he was selected for this critically important position.  General Perna graduated from the Valley Forge Military Academy and has a master's degree in Logistics from the Florida Institute of Technology. 

General Perna is going to provide some introductory comments, and then he's going to be followed by Dr. Hepburn, the Head of Vaccine Development.  Following Dr. Hepburn, General Perna is going to come back specifically to talk about vaccine distribution, and then we're going to move into a question-and-answer period with Ed and I asking questions.  And then after a bit, we'll turn to your audience questions, and that's what makes it so important that you enter your questions at the right block kind of platform so we can get to your questions.  That's our plan.

And, General Perna, I now turn the floor over to you, Sir.

GENERAL GUSTAVE F. PERNA:  Hey, Sir, thank you for that very gracious welcome.  It's a real honor for myself and Dr. Matt Hepburn to be here and talk to the Heritage Foundation Group.  So, you know, first and foremost, it's just an honor to co-lead the task force with, as you said, the mission to develop, manufacture, and deliver safe and effective vaccines to the American people.

First and foremost, I just want to highlight this is a whole-of-America approach.  And in that light, I would be remiss if I did not introduce to the conversation here my other co-lead, because without him, without all that he brings to the table, without his leadership and direction, we would not be successful.  That individual is Dr. Moncef Slaoui.

Truly a co-leader with me, he serves as the Chief Science Adviser.  And every day I learn from him, and I am in awe at what he brings to the task force here.  His efforts, tireless as demonstrated by the progress we made, are really going to make a difference for us and, in my opinion, deserves the most credit for our success.

With that, I say this as a whole-of-America approach, and we will exceed because of the unparalleled expertise of health and human services, scientists and logisticians, Department of Defense planning and logistics capability, as well as American industry ingenuity and innovation from the academia.  It's this collective effort that will really ensure we're are successful in our end state, and I'm proud to be a part of it.

I like you to think of it this way.  Our world's best scientists and doctors working beside the world's best military with the support of American industry and academia, that is Operation Warp Speed.  And we are really proud to be working together and as a collective team to drive towards a solution of safe and effective vaccine for the American people.  And I am very confident that we are going to be successful to this end.

And today, we'd like to talk to you a little bit about our approach and where we're at to this herculean task that we've been working on for the last four to five months.  And we are really just at the brink of finally seeing the fruits of our labor.

So more to follow from me, but I turn it back over to you, General Spoehr.

MR. SPOEHR:  Great.  General Perna, thank you so much.

Ed, why don't you take it from here?

ED HAISLMAIER:  Thank you.  If I could introduce Dr. Hepburn, he has an undergraduate degree and his medical degree from Duke University and a 23-year career in the United States Army.  And in that career, he has had extensive experience in developing vaccines and therapeutic solutions, particularly against current and future potential biologic threats, including serving as Director of Medical Preparedness on the White House National Security Staff from 2010 to 2013, also serving as Clinical Research Director for the U.S. Army Medical Research Institute for Infectious Diseases from 2007 to 2009.  So he comes to his current position as the Vaccine Development lead for Operation Warp Speed with quite a depth of experience in this area.

Dr. Hepburn, thank you so much for being with us.

DR. MATT HEPBURN:  It is just a privilege to be here and certainly looking forward to answering the questions, and we'll get there soon.

I want to limit my comments actually to probably the most important question or at least the question that I receive most often, whether it's at my daughter texting me from college or all of these different public meetings that we've had and communications over the last six months or so.  And the simple question is how can you achieve the impossible?  How can you take a vaccine development process that typically can take five years, eight years, 10 years, and truncate that into the time lines of Operation Warp Speed?

I want to basically put my answer into four categories and, hopefully, I can convince you that, number one, we've made incredible progress so far, but that we can meet the ambitious challenge of Operation Warp Speed.

So there's four categories of how we do it.  The first is in terms of vaccine technology.  I think it's very helpful to point out that the efforts that have gone on for decades in terms of developing vaccines, we stand on the shoulders of giants of the people that worked on polio, measles, the smallpox eradication campaign, all of that that we learned in terms of how to develop vaccines.  And there's been massive progress even before we started Operation Warp Speed in terms of how you can accelerate vaccine development.

There's been investments.  This is a key point that those science and technology's investments pay off, it certainly does.  These are investments that had been made by health and human services come with the National Institutes of Health.  And actually I'm very proud of DOD investments, especially at DARPA but elsewhere.  Investments that said how can we make vaccines at record time, how can we accelerate, especially the early technology's process?

And these investments were used for Ebola in the Ebola vaccine development processes, and now I feel like they're really paying off.  That's how we're in Phase 3 clinical trials now because of decisions that were – because of those investments and those technologies that were started in the spring that are now really paying off, both for their ability to be developed quickly and prove that they work in animal models, but also that they can be manufactured at a very large scale.

The second point is in terms of manufacturing.  We've talked about this a lot publicly, but I want to highlight not just one point but two.  Typically, what we highlight is instead of doing the typical parallel process of vaccine product development where you do a clinical trial and then you decide to manufacture at a larger scale and another clinic clinical trial in larger scale that we've run these processes in parallel and really made investments where large amounts of vaccines are being made much sooner.

Now it is possible that some of those vaccines, if they turn out not to work, that we won't use those doses.  But by those investments, we're able to have millions of doses available much sooner than we ever would.

But I think the second part that doesn't get highlighted as much is really the beauty of bringing together the best of the Department of Defense and Health and Human Services by bringing as we talked about in the introduction, the supply and logistics expertise of a globally deployed force and applying that to the critical supply chain issues and potentially critical shortages in vaccine manufacturing, critical equipment being delivered months earlier than it otherwise would, that has massively accelerated our vaccine manufacturing timelines.

The third is in the space of clinical trials, and I want to foot stomp on this a little bit because I think everybody, hopefully, has been tracking that both the AstraZeneca and the Janssen clinical trials have been given the green light to proceed from the Food and Drug Administration.  Both of those products had been on a safety pause and that the safety pause has now been withdrawn, but it also emphasizes very much the prioritization that we have safe and effective vaccines, that we are following the highest ethical standards to ensure that these vaccines are safe, and that those clinical trials are conducted to the highest regulatory and ethical standards as well.

So our Janssen and AstraZeneca vaccines are back on track.  These are not small clinical trials.  Again, in a typical product development, you may see a vaccine trial of let's say 5,000 volunteers or maybe 8,000 volunteers.  Our standard has been 30,000 volunteers in our clinical trials.  That's because we want to gather as much safety information as we possibly can, and we also want to know if they work.  With the more people you enroll, the sooner you're going to be able to evaluate the effectiveness.

What we have done so far, and I think again most of you have probably tracked this, that Moderna has now completed their Phase 3 clinical trial in terms of 30,000 patients or 30,000 volunteers enrolled.  Pfizer is still enrolling, but they're above 40,000 volunteers now.

What that shows you, for me, and I don't know if this message is appreciated, but I want to emphasize it, is that that shows me that over 60,000 Americans have decided to say, "I will volunteer.  I don't know if I'm going to receive the vaccine or I may receive a placebo, but that I'm going to do my part in fighting this pandemic."

I think we feel extraordinary appreciation for the volunteers.  And -- but today, as I mentioned, the Janssen and AstraZeneca trials are going to need another many thousand volunteers for each one.  So we're hoping that we can send the message through the participants in this meeting of the importance in volunteering for vaccine clinical trials and to encourage those. We're very proud of that spirit of volunteerism that we see in America.

We also always emphasize the word "volunteer" means it is a personal choice, that everyone makes that choice individually.  But we think this venue and many others are great opportunities to strongly encourage people to look into that opportunity.

Let me give you one more specific example.  For our Janssen clinical trial, we're having multiple sites in our V.A.  medical centers that will be enrolling.  And for our nation veterans, this is another way that they can continue to serve in this way fighting the pandemic as a volunteer.

My final point, of those four, on how we can achieve the impossible is through teamwork.  I think this session is called "Fighting the Pandemic." We're fighting the virus, and the way we fight the virus is really getting the best from all of us.  I think what we've seen is extraordinary integration and cooperation between our Department of Defense and our Health and Human Services.  It's the best that our government has to offer.

But when General Perna mentioned the whole-of-nation, all of us fighting this together -- the public sector, the private sector, the foundations, everybody altogether finding that virus, I've seen some of the best teamwork that I've ever been a part of as part of Operation Warp Speed, and it is the essential fourth ingredient on how we achieve the impossible.

Thank you.

MR. SPOEHR:  Dr. Hepburn, thank you so much for that.  I'm now going to invite General Perna to come back and make some very specific remarks regarding vaccine distribution.  Over to you, Sir.

DR. HEPBURN:  Hey, thank you, Sir.  I really -- what a powerful update by Dr. Hepburn.  He's a great teammate that I have just been really blessed to work with over the last five months.  So, Matt, thank you.

So I'd like to quickly hit where Dr. Hepburn talked about manufacturing.  I know it's not lost on anybody listening to this conversation, but in order to really take the risk in manufacturing, we had to do a lot of things parallel.  He described, I thought, incredibly well the risks that we took and that, you know, we proceeded with six vaccines while simultaneously implementing the manufacturing capacity that was required to meet our mission.

So just simply said, right, we had to make sure that we had the right capacity to manufacture the vaccine, which we didn't have five months ago.  So what we have done, we have actually added brick and mortar capacity.  In other words, we have built facilities from the ground up to produce and still finish vaccine.

We have garnered all the materials required to produce the six vaccines, right, not only to execute trials, but also to bring it up to scale in full manufacturing for eventual distribution to the American people.  And then we had to accumulate the right equipment from all the manufacturing that we put together.  And then the last stage of that was making sure we have the right workforce that was trained and ready to produce and actually manufacture and go finish the vaccine.  So really a remarkable task on its own.

In this effort, what we did is we did implement the Defense Production Act authorities with OWS through the Secretary of Health and Human Services and the Secretary of Defense.  To date, we've implemented 12 with industry and we're working eight more.  So it is this effort that has allowed us to prioritize contracts, prioritize materials, authorize control of scarce and critical materials, and then drive industry to expand production and supply resources, which I think will be, at the end of the day, really critical to our overall success.

We received nothing but absolute support in this light, whether it was permission from higher to do so and/or the execution by our industry partners to do day-to-day business.  So really remarkable effort collectively by again the whole-of-America highlighted particularly in this part by industry.

So let's assume that we're going to have vaccine available where science will drive the safety and efficacy of a vaccine as Dr. Hepburn talked about.  Let's assume that we have quantities of vaccines available to go upon FDA approval of an EUA.  What is next, right?  It goes without saying, but it will be the distribution of vaccine across all of America to include territories and major cities, large metropolitan areas.  And it's just a herculean task all on its own.

So, you know, what do we do?  We thought through the process there was many courses of action, but at the end of the day I made the decision that we were going to utilize the commercial industry that was most capable of implementing this task, right?  And so there was three large companies all capable.  All three of them are playing a role in vaccine distribution, as well as therapeutic distribution.  But the primary industry partner for distribution will be McKesson.  And McKesson is well-versed on how to do this.

At the end of the day, I chose it because they know how to do it.  They have experience doing it at the end of it, we want to be able to transition to them down the road for routine effort.  And then third and most importantly is that the states are very comfortable with dealing with the commercial industry as we do all sorts of vaccines and therapeutics throughout the year accordingly.

And so, in fact, I just let Dr. Slaoui and I were just visiting with McKesson yesterday down in Memphis, Tennessee, and we got to see firsthand a brand-new distribution warehouse that's included freezers that can go down to minus 80 and minus 20, and then how the facilities really distribute across America.  McKesson will partner with FedEx and with UPS for distribution, not only CONUS but around the world, as well as local pharma -- Wal-Mart, CVS, Walgreens, Kroger's, et cetera -- to ensure that distribution can reach everybody.

Four tenets of the distribution strategy that I gave the team as we are working planning was, first and foremost, we needed to understand, we need to have visibility and control of all vaccines.  We need to know where every bottle was, whether it was in the factory or it was on a truck or it had been distributed down to administration site.  We must have 100 percent accountability of all vaccines every day.

Second, we must be able to track the uptake of vaccine to persons out in America.  Two reasons for this, first and foremost, because five of the six are two-dose vaccines, we need to make sure that people are registered to the vaccine that they were administered, and that there is failsafe checks and balances to make sure when they come back 21 or 28 days later that they get the right vaccine for their second dose.

The second point is we want to manage the flow of vaccines to the American people.  Initially, we're going to have tens of millions of doses available come December.  But come January, February, March, it will quickly and exponentially increase the hundreds and millions of doses.  So it will be essential that we maintain the right flow of vaccine to the American people, so tracking the uptake.

Third, we must make sure that we have traceability of the vaccine and that we know where the vaccine is going at all times.  It will be a hot commodity, of course, and we needed to get to the places where it will be distributed based on state priorities and requirements in accordance with the safety and effectiveness of a vaccine.

And then last, we want to be able to cover all parts of America, whether you're in the Pacific in remote islands or down in the Atlantic.  We want to be able to get to those islands.  We want to be able to get to all of CONUS America whether it's in the metropolitan cities or rural America.  And we want to be able to make sure we can distribute to those American citizens who are overseas, you know, serving in the Department of Defense or State Department, et cetera.  So we had to have coverage.

Those are the four major tenets for our planning.  The last thing I'll leave you with before I turn it back over for questions, this is different as we distribute this vaccine than the normal routine execution of something like influenza vaccine.  The distribution of influenza vaccine on an annual basis is a pull method.  In other words, pharmacies, doctors' offices, hospitals will register and request certain amounts of vaccine, and it will be delivered to them directly by industry.

What we've done since we have purchased these doses from industry, what we're going to do is push, right?  We are going to allocate equitably vaccine doses to all of America simultaneously, and as doses become available, we're pushing down and out through the United States of America.

Eventually this will transition to a pull, but probably not likely any earlier than March-April time frame.  And so we must ensure that we have a very intricate and integral distribution process to meet the four tenets as I described, be able to ensure the constant flow of vaccine as it's available, and then make sure that everybody gets the right vaccine at the right time.

So that concludes my comments.  And I am really grateful and welcome to any questions you might have.

MR. SPOEHR:  Great, General Perna, that was awesome.

General Hepburn, also thank you so much.

We're now going to go to some questions from Ed and I, but the questions are also rolling in from the audience so we're going to quickly cut to those and   we'll just going to ask a couple to get things warmed up.

And so my first question is to you, General Perna, and it's -- you're a humble man, I know.  You don't like talking about yourself frankly, but this is really a personal kind of question.

You were weeks away from retiring from the Army after a distinguished 39-year Army career when you got a call from the President that he wanted you to help lead Operation Warp Speed.  And, you know, I'm guessing many of the listeners on this webinar might face a similar kind of moment when they are unexpectedly hit with a new task, a new mission that they probably never in their wildest dreams expected to face and they had to pivot to a new environment, a new set of challenges.  I know they'd love to hear from you, you know, how did you get this news?  How did you get your head around this new mission, and how did you prioritize what you had to do first in this new immense mission that you were given?  Thank you.

GEN. PERNA:  Yeah, so, Sir, what a great question.  I still remember, you know, we all have those moments where you know exactly where you were when the phone rang.  I know exactly where I was.  And Susan and I were transitioning into our, what I thought at the time "retirement home." It was a weekend.  It was about a week before the announcement by the President in the Rose Garden.  And I was asked you know, if I would be interested.

Of course, immediately without hesitation, with full support by Susan who oh, by the way, was sitting right next to me when I got the call, you know, it was immediate, "Yes, I am honored and humbled to do so and, quite frankly, greatly privileged to co-lead this effort with Dr. Moncef Slaoui," who is just, as I said earlier, a remarkable leader and scientist.  You know, quickly – and people who know me and read the bio can speculate why I was picked primarily probably to enable manufacturing, distribution, but it is also about the collective leadership and experiences of all the years I have served.

And so I would tell you that my experiences have really contributed to what I have done.  My instincts that I've developed over the years have enabled and supported decision-making.  But in partnership with Dr. Slaoui, we've been able to really just put really numerous pieces together simultaneously, understanding - really teaching each other.

And as Matt Hepburn said, what I'm finding to be most rewarding, you know, I really have been proud of working for what I have always called "a team of teams", the United States Army.  But as Matt Hepburn said, I have never ever worked with a greater collective group of professionals, whether they are scientists, doctors, military persons, industry, and, really, academia.  That's why it is so exciting to do what I'm doing.

And then at the end of the day, Sir, I know you know this, but it's just a calling, right?  And, you know, this is about saving American lives.  And for me, it is a focused effort to do so.  And it is this great collaborative effort.  Egos are checked at the door.  And we are working this together to an end state that will bring America back to a healthy state.

So thanks for that question.  I probably underestimated the impact if Susan is listening, but I really appreciate her support in case she is listening.


So thanks, Sir.

MR. SPOEHR:  Ed, why don't you go ahead with a question?

MR. HAISLMAIER:  Yeah, I will, thank you.  I've been scrolling through the ones from our audience, and some folks have questions that are very similar to the ones that are on my mind.

Dr. Hepburn, I'd like to ask you a couple of things that really is very much in the forefront not only of our listeners on this but, the general public, and that is some of the safety issues around here.  I think one of the things that's gotten overlooked maybe and you sort of touched upon it in your remarks is that what most people are used to in terms of vaccines that they got as children or flu vaccines or things like that is a different -- now we have very different technologies, and some of these are new technologies that are being applied for the first time in vaccine development such as Messenger RNA.

And I would like, if possible, for you to address the concerns that people had, gee, I got an infection from a vaccine or something like that, you know, what are those concerns relative to these new vaccines?  How is the safety profile?

DR. HEPBURN:  Yeah, so, first of all, thank you for the question.  And I think I'll probably make a couple of points, I'm happy to elaborate further.

I think I want to actually go back to one of my previous comments in terms of volunteers and in terms of clinical trial.  I think maybe most people understand, but to state it clearly that with every vaccine that's been administered as part of Operation Warp Speed, it's done in the context of a clinical trial.  What that starts with is that someone makes that individual decision and says, "I'm willing to sign up."

As part of that process, we explained the risks and the potential benefits in detail, but we also acknowledged that we don't know everything there is to know about these vaccines.  It really again goes back to that spirit of volunteerism.  We appreciate people that are willing to do that as part of this -- as part of developing these vaccines.  But what we also do for their willingness to volunteer is we monitor them extremely closely to make sure that they're not having side effects and to make sure we're truly understanding the impact of these vaccines.

So when we say 30,000 patients, what we're talking about -- or 30,000 volunteers, we're saying that 15,000 of those volunteers have received a placebo, but 15,000 volunteers have already received these vaccines, and we're watching them literally on a daily basis to say how are the vaccines going okay, are we seeing side effects from them or not?  So I think that's the first point is that that safety standard and then all of the information is packaged, processed, and, ultimately, presented to the Food and Drug Administration for an independent – and I say again, independent – evaluation to make sure that these vaccines are safe.

The second point is in terms of new technologies and vaccine – sort of vaccine technologies, in general, that we have been as I previously mentioned and as you mentioned, Sir, that there are very traditional ways of making vaccines, but we've also seen a lot of progress that are accelerating, allowing us to make vaccines faster.

One of the benefits that we think we're going to see from this is that it also may make these vaccines safer as well.  And what we've seen with the products that we've chosen, not for COVID-19 but for other pathogens, that these vaccines have been tested in clinical trials and have shown us that they are effective for other pathogens, but also safe.  So essentially for each of the vaccines in our portfolio, we've said, okay, have you used this similar technology for an Ebola vaccine or something like that?  And we look at the detailed safety profile of every person that received those vaccines, and the safety profiles have looked to be safe so far.

Ultimately, though, we are not only saying we're looking at the vaccines in the short-term for clinical trials, but as part of the regulatory process.  The Food and Drug Administration is providing guidance in terms of how will we follow these people out for the longer-term.  It's called "pharmacovigilance," and that again, like any other vaccine, we are meeting that highest standard so that the long-term safety will be followed according to regulations.

MR. HAISLMAIER:  Yeah, and I think that gets some of the other concerns that we've heard expressed by people, which is that if this whole process, Operation Warp Speed, is pushing things a long in a fast pace then does that imply the corners are being cut, that it may not be safe, et cetera.  And I think what is not fully appreciated is as you mentioned, the technology is being used to allow for faster mass production than has historically been the case with vaccines, that in some cases, just because of the nature of the technology, there's a somewhat better safety profile.

And I think you addressed two things in your comments about the speed.  One is that they're taking steps in parallel instead of in sequence.  And the risk to that is, well, we may, you know, be paying money for stuff that turns out to not work, but hey, you know, better try five things and wait for one to fail and then try another.

And the other point, though, and I want to drill down on that, is the clinical trials.  It sounds like if I'm correct in hearing you that essentially to expedite the process you all are -- or the vaccine candidates and their sponsors are doing larger trials than they would normally at this stage.  Is that correct?

DR. HEPBURN:  Yes, Sir.  We agree with all of your points.  And if I can just add a couple of points, we are not cutting corners on safety.  We are not cutting corners on the quality of the manufactured product.  Those will be done to the highest standards.  And we are not cutting corners in terms of what would be expected from a regulatory authority, the Food and Drug Administration, which I think has the highest standard in the world for medical products.  We are going to meet those standards.  I think it's an important message.  And I think we are practicing what we preach.

I think one of the things that we would also highlight is that the Food and Drug Administration has published guidelines and have said here is what we are going to expect for COVID-19.  The FDA has also had a public meeting last week where they had an open dialogue about here's how we are going to evaluate these products and here’s why.

We have also, with the products in the earlier phases of clinical trials and in their pre-clinical development, the companies are publishing their results in peer-reviewed journals.  All of this is not only is showing that we don't cut corners, but I strongly feel this has been an incredibly transparent process so that people will have confidence in the vaccines that we are generating.

And my second point is yes, to answer your question, these are large clinical trials.  These are clinical trials that are enrolling a lot of volunteers in a short period of time.  These are clinical trials where our experts and our professionals are working nights and weekends.  And as you would expect, we're doing that, too.  But our partners in the private sector that are running these clinical trials are working around-the-clock to get these clinical trials up and running.  But it's ultimately driven by again those people who have said, you know, again literally, thousands of people who are lining up at the door of the clinical trial site saying, "Please, I want to do my part and volunteer."

MR. HAISLMAIER:  And if I can just as one very interesting question that came up from one of our viewers here, Tom, that follows on this line, and that is that there is the probability that there will be, or the possibility, that there will be more than one vaccine available at the same time for COVID.  And the obvious question is, well, will people have a choice?  And if so, how would they choose which one to take?

And I thought that was interesting question.  Have you all given some thought to that?

DR. HEPBURN:  We have.  Not coincidentally, we are actually in a meeting talking about this right before.  So -- and I will say it there will be some complexity.  But God, I hope we have that problem.

We went into this process, again doing the impossible with the thought of that we were going to invest in six vaccines with the hopes that we would have one vaccine that makes it through all of those typical challenges of medical product development.

We still have six that are on track.  We're thrilled that we've made this much progress so far.  And, but we are working through I think, our Department of Defense colleagues understand this very well, it's contingency planning.  So we have, in all aspects of Operation Warp Speed, have thought about all of the different scenarios and contingency plans.

So there are scenarios where we might have more than one vaccine that could be useful.  Now the simple answer to your question is that we're going to let the science drive that process in terms of which vaccines work best for which people, meaning that it is possible that we may have equivalent efficacy and equivalent safety across the board.

We could also be in a scenario where one of our vaccines preferentially works very well in elderly populations that are most vulnerable, so we would then pivot our program so that the vaccine that works best in elderly are given to elderly volunteers.

A final point that I'll make is that all of our vaccines in our portfolio are two-dose vaccines which, as everyone can appreciate, adds a lot of complexity.  The Janssen vaccine for which we are enrolling, as I mentioned previously in the clinical trial now, is a one-dose vaccine.  And so we're again thinking through contingency plans as well in situations where if we have a one-dose vaccine, what would be the optimal use of that?

MR. HAISLMAIER:  Right.  And presumably, the large studies doing 30,000 in the Phase 3 trial, 30,000 of patients as opposed to say 5,000 as you mentioned earlier, that enables the companies, the sponsors, and the FDA to get a better handle on some of these issues like differences in age and race and other demographic issues.

DR. HEPBURN:  Yes, Sir.


DR. HEPBURN:  Yes, that's precisely it.

MR. SPOEHR:  So I think this question, and I’m going to try and bundle a couple of questions together because we're getting a lot of good ones here.  And this --


MR. SPOEHR:  -- this is for General Perna.  I was hoping a lot of people have asked about the military's role, you know, in terms of distribution of the vaccine.  And they've also asked should -- you know, I've heard we have an election coming up, would a change in administration, how would that affect Operation Warp Speed?

GEN. PERNA:  Hey, Sir, thanks.  So really quickly, to answer your first question directly, the military is providing planning, right?  We're helping with, you know, things with logistics, augmentation, program support, LOGCAP (Ed.:  Logistics Civil Augmentation Program) support.  We're running program management for them, for the team.

What we're doing is enabling capability and capacity to the fight.  There will not be this vision that some people have it where there'll be Army trucks driving to the streets delivering vaccines.  That's not one, feasible, or the right way to do it.  You know, this is the greatest country in the world.  We know how to do this, right?  Commercial industry knows how to do it, and that's how were going to do it.

The second point to your question, no, you know -- we got our heads down and we are driving the sled.  And we are going to execute our mission as directed.  And so I see nothing that would cause us to stop doing what we're doing no matter the results of the election.  Break.

I would like to highlight though, again, we talked briefly about the whole-of-America approach.  I want everybody to visualize really the brilliance of what we're doing here.  And this is not my vision or Dr. Slaoui's vision, but really of others who had the foresight and vision to bring the collective team together.  This team is partnered at the highest level by the Secretary of Health and Human Services and the Secretary of Defense.

We are a direct report to them.  We don't have to go through staffs.  We don't have to coordinate time.  We are “pick up the phone” and we have direct and immediate access to these senior secretaries.

Two, everything we are doing, right, is from scratch, right?  This whole process is built from the ground up scratch.  There was no structure in execution.  There was no strategy in execution.  There was no training guidance or budget in execution.  And all of it had to be brought together simultaneously as we've started our effort collectively.  So we built the team across – as I talked about HHS, Department of Defense, industry, academia, by those who we thought could contribute, and those who would help us really make the strides necessary to achieve our goal by the end of the year.

And so to that end, we really had to, as I said earlier, check egos at the door.  You had to come in, and no matter what you were a part of before, you had to, one, shoulder the burden of responsibility of execution, not just of sitting at the end of the table.  Two, you had to have the right relationships to garner support in all that we were doing.  And then three, you know, at the end of the day, we're all being held accountable, you know, to help how we're moving the ball.  We're mildly interested in the theory or pontification of what could be.

We are, every single day, all of us, Dr. Slaoui, myself, Matt Hepburn, other members of the team, we receive hundreds of e-mails from people with recommendations.  And I got to tell you that some of them are very illuminating and very helpful.  And they're welcomed and we're really appreciative that we receive them.

On the other side of that spectrum, though, we get a lot of conversation about everything we're doing and how it's not going to work, and how it's not the right way to do it.  You know, quite frankly, not very helpful.

You know, so my thing is being a part of the team, help us become successful.  Understand that this has never ever been done before and we have successfully, so far, take any process that normally takes between five and 10 years, built an extraordinary team, put it all together and we are successfully driving down the field.  So at the end of the day, come be a part of what we're doing.  Come help us do it better, but sitting on the sidelines just poking away is not helpful to what we're doing.  Over.

MR. SPOEHR:  Great.  Thank you very much.  Again, I have a lot of questions that I want to get to as many as possible.

Dr. Hepburn, maybe this is for you.  A couple of people have asked, does this effort that you're in now change fundamentally how vaccines are developed in this country?  Have we moved the goalpost permanently or is this just a thing?  Are we going to go back to eight to 10-year vaccine development cycles?

And then if I could piggyback on that, a couple of people asked about the really cold temperatures that some of these vaccines may have to be stored at.  Could one of you talk to what kind of challenges and solutions we have for that situation?

DR. HEPBURN:  Sure, so, happy to start.  Yeah, frankly, I find it profoundly exciting to say imagine a world post-pandemic where we can rapidly develop treatments, where we can rapidly develop vaccines, not only for the new threats that come up that we weren't expecting, but for all of those infections that plague us as a global community.  So I do hope we can revolutionize vaccine development.  I hope we can show people what is possible in terms of how we can achieve accelerated product development without compromising, making sure that the vaccines are safe and effective.  And I'm glad you brought it up.

MR. HAISLMAIER:  Yeah.  Tom, I saw an interesting question here if I can jump in from one of our listeners.  And it's asking about the estimated duration of protection that these vaccine candidates will give.  That's one of the open questions is, okay, if it generates a response, how long does that response last?  Do you have anything you can share with us on that, Dr. Hepburn, or is that just something we have to wait --


MR. HAISLMAIER:  -- when we get the clinical trial results?

DR. HEPBURN:  Well, we are going to have to wait – we are going to have to wait until the clinical trial results.  And -- but the intention is, this is why the people that are vaccinated in the clinical trial now, our intention is to follow for up to two years so that we can get a better idea on that critically important question of duration of protection.

What we are also doing, though, and again we are informed by great scientists and the National Institutes of Health and in academic collaborations that we're watching -- we don't understand the duration of protection from coronavirus infection itself, so can you get coronavirus again?  And there's a lot of recent publications that are coming out, getting a better characterization of the immune response to coronavirus infection.  All of that scientific knowledge is just feeding into our vaccine programs, so we are understanding that duration of protection and, ultimately, that we will design the trials and the medical research to answer it.

MR. SPOEHR:  Great.  Let me pick up on a question that a public a couple of people have asked, and that's -- and I'm sure you probably have a word for it, Operation Warp Speed, but it's vaccine hesitancy.  And so some people reluctant in the best of times to get a vaccine, and -- and this might be a bit more than that.  What are your plans, I guess, going forward to kind of attack this problem that this fear or this reluctance people might have to get these vaccines?

DR. HEPBURN:  Yeah, we acknowledge, acknowledge, appreciate, and we have been very kind of thoughtful about this that is a much bigger issue than just Operation Warp Speed, but it will certainly impact what we do.

From my standpoint, and I'll turn it over to General Perna for further comment.  From my standpoint, what we've said is it's the product development, this is why we don't cut corners, this is why we make sure we maintain the highest ethical quality and regulatory standards, and that we're transparent throughout the process so that we can create a sense of confidence that what we know is being communicated publicly so that people can make the decision about these vaccines.  But that again where you can help us today, everybody on the phone, conveying that message that we're doing everything we can to assess these vaccines for their safety as well as their efficacy.  Hopefully, that will inspire confidence that once we show that these vaccines meet the regulatory standards, that people will be willing to get the shot.

General Perna?

GEN. PERNA:  Yeah.  I just would add to that; I have 100 percent confidence that we have executed to make sure that the vaccines are safe.  And in the development, I feel confident that they'll demonstrate efficacy against the virus.

In that light, I also have 100 percent confidence, as Dr. Hepburn alluded to, in what I think is the gold standard for the world, and that's our FDA and their approach to determining whether or not the vaccine is safe and effective.  And we will make sure that we will follow the science to that end.  We will not distribute vaccines that are not determined safe and effective.  And you can take my personal word for that, as well as -- you know, well, just my word.  I don't want to speak for others.

What I think about every day when I come into work, quite frankly, and just to personalize it for me, right, I think about my 84-year-old mother and her husband, right?  I think about my three granddaughters, right?  And then, of course, extend it all the way through all my family and friends and everybody I've ever served with over the last 39 years, right?  That's how I extend myself personally to this effort.

And, you know, nobody in this organization, this task force is going to allow a vaccine to go out to the American people that is not safe and effective.  And it would just be shameful if we get a vaccine out to the American people and people don't take it because there's doubt or concern.  So we're working hard, diligently, to increase confidence in the vaccine.  It will be everybody's individual right to determine whether or not they want the vaccine.  But what we stand behind is the safety and the efficacy of a vaccine that will be delivered to the American people.  Over.

MR. SPOEHR:  Great.  One last question and we may go over a bit over the hour, so I'll understand if people have to leave.  It's got to do with the actual -- I would call it the tactical distribution of the vaccine, the -- who decides between the elderly, the first responders, all those type of things?  Where does those lines between the federal government, Operation Warp Speed, and the states and the territories and that -- can you talk about that briefly?

DR. HEPBURN:  Yeah, I think I'll make some initial comments on the product development and scientific side and then hand it over for General Perna in terms of the distribution.

I think, you know, we have designed our clinical trials to really assess if this vaccine will protect those that are most vulnerable.  Those broad categories are people -- the elderly or people over 65, and also people with other types of medical conditions.  We're ensuring that a large percentage of our clinical trials are enrolling those volunteers so that we can understand how effective it is.  And I hope it will be.

So the answer to your question, ultimately, is that the first step is to really understand how these vaccines perform.  Again, we emphasize the science drives the process.  Once we understand that, it will go into a prioritization process.

And I'll let General Perna comment a little bit more on that.

GEN. PERNA:  So as Dr. Hepburn really did a great job talking, the science will drive it.  It will be determined, the safety and efficacy by the FDA.  The CDC will play a role in helping to define based on the FDA findings, the priority, and recommendation of how the vaccines will be distributed, and then, of course, approved by the Health and Human Services Secretary accordingly.

At that time, we'll distribute vaccines accordingly to all of America simultaneously.  We will make sure that there is equitable distribution in accordance with that priority.  And then the states will -- you know, they own the actual final distribution and administration down to individual arms.  And so really a collective team approach to that effort. 

MR. HAISLMAIER:  Yeah.  And, General, my understanding is states have submitted plans to HHS and CDC on the local distribution.  Is that correct?

GEN. PERNA:  Yes, they did a remarkable job, and they've all submitted plans.  We've spent about five to seven days reviewing them, provided synopses, and we returned them yesterday.  All weekend, teams were working on them and returned them yesterday so that we continually improve, you know, our effort to make sure it's done the right way.  Over.

MR. HAISLMAIER:  Right.  It gets Secretary Azar to disseminate those more broadly.  Yeah, that would be helpful.

MR. SPOEHR:  Well, teammates, we have run to the end of our time, although I personally could go another hour still listening to this great discussion.  I want to thank General Perna, Dr. Hepburn, one, for participating today, but in more general terms, for your great work on this.  I know you're working really long hours and it's not going unnoticed by Americans, so thank you so much for joining us today.

And I want to on behalf of Ed and I, thank you for your time today.  And I wish everybody on this call a great day.

General Perna, Dr. Hepburn, thank you.

GEN. PERNA:  Thank you.

DR. HEPBURN:  Thank you.