Transcript

Army Medical Experts Hold Virtual Press Briefing on Covid-19 Vaccine Efforts

June 2, 2020
Brig. Gen. Michael Talley, Commanding General, U.S. Army Medical Research And Development Command (USAMRDC) and Fort Detrick, Maryland; Col. Wendy Sammons-Jackson, Director, USAMRDC Military Infectious Disease Research Program (MIDRP); Col. Darrin Cox, Commander, USAMRDC U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID); Dr. John Dye, Chief Of Viral Immunology, USAMRIID; Dr. Nelson Michael, Director, Center For Infectious Disease Research, USAMRDC Walter Reed Army Institute of Research (WRAIR); Dr. Kayvon Modjarrad, director, Emerging Infectious Diseases, WRAIR

STAFF: Good afternoon and thank you for calling in today's update for Army Medical Research and Development Command on efforts to protect, detect, and treat COVID-19 and progress with vaccines and therapeutic developments. 

My name is Lori Salvatore.  I'm the Public Affairs Officer for the Army Medical Research and Development Command and I will moderate today's session. 

The following senior leaders are on the panel, Brigadier General Mike Talley, Commanding General of the Army Medical Research and Development Command in Fort Detrick.

We have Colonel Wendy Sammons-Jackson, the Director of the Military Infectious Disease Research Program. 

Colonel Darrin Cox, Commander of the Army Medical Research Institute of Infectious Diseases, or USAMRIID.

Dr. John Dye, Chief of Viral Immunology, at USAMRIID.

Dr. Nelson Michael, Director of the Center for Infectious Disease Research, Walter Reed Army Institute of Research, or WRAIR.

And Dr. Kayvon Modjarrad, Director of Emerging Infectious Disease, WRAIR.

Today's discussion is on the record.  After General Talley's opening remarks I will call on you by outlet.  Please state your name before asking your question.  Please limit yourself to one question until we've gotten around the line and then we'll come back and field questions until we're out of time.

We have about one hour today.  Remember to mute your phone when not speaking, and with that, I'll turn it over to you, General Talley.

BRIGADIER GENERAL MICHAEL TALLEY:  OK, hey.  Thank you Miss Salvatore, I appreciate it and thanks to all of the media outlets represented today.

Good afternoon and thank you for being part of today's media roundtable.  We're joining you remotely from United States Army Medical Research and Development Command in Fort Detrick, Maryland. 

As with the two months since we last briefed you, our team has continued to work in support of the whole-of-government response to COVID-19.  Our researchers and scientists are using all of our assets to develop countermeasures to prevent, detect, and treat the virus.

The U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID as we call it, is the only laboratory in the DOD equipped to safely study highly hazardous infectious agents requiring maximum containment at a biosafety level 4 level.

For example, USAMRIID scientists assessed the effectiveness of a new smallpox vaccine.  They're testing played a pivotal role in last year's FDA decision to approve the vaccine.  In addition, the scientists were key players in remdesivir testing for the treatment of Ebola a few years ago.

Since this pandemic began, we've heard the saying, “follow the science”, echoed over and over again, and our staff at the Walter Reed Army Institute of Research, or WRAIR, have been following the science for really 127 years.  They've investigated some of the most pressing threats to the health and readiness of the military, especially in the realm of infectious diseases. 

Their efforts have led to significant advancements in science and the development of medical countermeasures to protect and treat against infectious diseases.  Today, as we move at top speed in the fight against COVID-19, the work being done by our scientists at both laboratories are yielding promising results.

At USAMRIID, they've been safely replicating the virus to support countermeasure development.  Meanwhile, the team at WRAIR has designed a unique COVID-19 vaccine candidate. 

In addition to this, many of our other subordinate commands are using their unique assets to support the whole-of-government response in the virus – or to this virus.  For example, our lab in Natick, Massachusetts, this is the lab that focuses on environmental medicine, and it's evaluating the use of wearable technologies to detect key early symptoms of COVID-19.

In Fort Rucker, Alabama, our Aeromedical Lab is expediting the testing and approvals needed to obtain air worthiness certification to transport COVID-19 patients who require isolation on board U.S. Army rotary wing aircraft.

And the U.S. Army medical material development activity right here at Detrick, has established a working group to support DOD added manufacturers to produce, test, and obtain the necessary FDA regulatory approvals for PPE and other medical devices.

These are just a few of the many ways we are working to support force health protection and other things against COVID-19. 

MRDC has teams of incredibly competent, intelligent, and dedicated men and women supporting this effort.  And I'd like to introduce those who will be answering your questions today. 

Colonel Wendy Sammons-Jackson is the Director of MRDC Military Infectious Disease Research Program.  She's also the Chair of the joint program committee for military infectious disease research across DOD.

For the last two years, Colonel Sammons-Jackson has managed this portfolio, which has achieved significant accomplishments with MERS, Zika, and Ebola.  And I'm -- it's kind of bittersweet because Wendy is fast approaching her last day in uniform.  She's going to be retiring this month after 26 years of service. 

I want to thank her publicly for her great service to MRDC, the Army, and the nation.

Colonel Darrin Cox is the Commander of the U.S. Army Medical Research Institute of Infectious Diseases and he's been instrumental in leading the Institute's researchers and scientists as they helped defend our nation against COVID-19.  His team has been working with antibody tests, convalescent plasma, and they'll also be testing vaccines developed by outside laboratories.

Dr. John Dye is the chief of viral immunology at U.S. Army Medical Research Institute of Infectious Diseases.  He's spent much of his career at the forefront of research and development of medical countermeasures against the Ebola viruses and other viral, biological threat agents.

Dr. Nelson Michael is the director of WRAIR’s center for infectious diseases research.  And Dr. Michael brings more than 37 years of research experience to the table, including direct involvement with vaccine development for HIV, Zika, Ebola, and MERS.

You may have seen that Dr. Michael on other national media broadcasts.  And when you look at the likes of Dr. Anthony Fauci, Ambassador Birx, Dr. Michael effectively is a protégé of those two top scientists that grew up in the MRDC organization.  

Dr. Kayvon Modjarrad is a director of WRAIR’s emerging infectious diseases branch, and he is leading the efforts for COVID-19 vaccine development for MRDC.  Dr. Modjarrad previously worked at the forefront of our efforts against MERS and Zika. He is the scientist behind a patented AG adjuvant that's designed for the same type of diseases.  His expertise is always important to these conversations. So we're all very proud to be part of this effort, and we look forward to your questions.  I'll open it up now.

STAFF:  Wall Street Journal, you're first.

Q:  Thank you. Michael Gordon, Wall Street Journal.

Has there been progress in the last month or so that would suggest to you, you're going to have a vaccine by the end of the year, and what progress has been made?

BRIG. GEN. TALLEY:  I really appreciate the question, and very optimistic.  And rather than me talk about what's going on, certainly at the ground level, I'm going to turn it over first to Dr. Nelson Michael and then Kayvon Modjarrad, who are leading certainly our efforts in MRDC.  I think you're going to find that they convey what we're doing, it's all part of that whole-of-government effort.  So Dr. Michael, I'm going to let you take that and talk about the specifics that are happening at WRAIR.  Over.

DR. MICHAEL:  Very good, thank you, general. Yes, this is Nelson Michael from the Walter Reed Army Institute of Research.  Let me first say, that the teams that the general just mentioned are fully engaged in the new governmental structure called Operation Warp Speed, which really covers the waterfront from therapeutics and diagnostics to vaccines.

For our specific work in vaccines, we are very heavily engaged to ensure that across all of the agencies, that the Army and the Defense Department's capabilities and competencies in vaccine development can be brought to bear.  What do I mean by that?  We don't necessarily test only those vaccines that are invented in our intramural program; we have the ability to do preclinical and phase one through phase three studies, and have done this consistently for almost 127 years.

So the first few vaccines that are being queued up for Operation Warp Speed, which would include the vaccines made by the companies Moderna and AstraZeneca and Sanofi Pasteur and Janssen, part of Johnson & Johnson.  We are heavily engaged in discussions for how at every level of testing that we could be involved in those efforts.  So I think that’s important, because I really want Dr. Modjarrad then to pick up the thread on the particular vaccine that his group has developed and why we think even though it will not be one of those first four vaccines that initially go into large-scale testing, we believe that in the long fight against coronaviruses in general, not just this particular one, I think -- I think we may be onto something very good.  Let me stop there.

DR. MODJARRAD:  I'll take it from there then.  This is Dr. Kayvon Modjarrad from WRAIR as well, and I'll just say that in addition to what Dr. Michael said, our particular vaccine takes, as he intimated, a long-term approach towards a potential new strain of COVID-19 and other coronaviruses in the future.  There's no evidence currently that there are new strains.  We actually have done a lot of work that you'll hear about in the near future on showing that all the viruses -- viruses circulating in the world can be covered by a single vaccine, but in the event that there -- these virus can mutate, our vaccine is positioned to be able to cover any new strains or species of the virus.

Since we last spoke with the press corps, actually over the past few months, several times now, we have been vaccinating hundreds and hundreds of mice with different versions of our vaccine, and we will be making a decision as to which one is the best one that we will be taking forward for manufacturing next week and then ultimately to a first in human clinical trial into the late summer.

As Dr. Michael mentioned, then depending on the human data that we obtain, that will then inform the advancement of our vaccine candidate for a much larger trial towards the end of the year in context of Operation Warp Speed.

And the other thing that I'll add is about competencies and capabilities that advance other vaccine candidates.  You only need to look -- you don't need to look very far from the current news cycle of what just was announced yesterday that there's another Ebola outbreak in the Democratic Republic of Congo – and the vaccine that’s being deployed for that new outbreak was developed by many different partners, but that vaccine for Ebola was first tested and selected -- dose selected by the Walter Reed Army Institute of Research in collaboration with industry partners.

So we have that parallel model of inventing and advancing our own products with our own scientists, but then, at the same time, collaborating with outside partners to advance and accelerate their vaccines as well.

BRIG. GEN. TALLEY:  Certainly those vaccine development efforts go across all of MRDC, which includes the laboratories at RIID.  We'll continue on with the questions.  We can get through as many as we can.  Go ahead, Lori.

STAFF:  Army Times, go ahead.  OK, Defense One?

Q:  Did you say Army Times?

STAFF:  Yes, Army Times.  Go ahead, Army Times.

Q:  I was wondering with those four civilian companies that you mentioned and the vaccines they're developing, can you go into greater detail about what you're doing to help them through trial?

BRIG. GEN. TALLEY:  Absolutely.  I’m going to let Nelson that up.  As he mentioned, we are part of the whole-of-government Operator Warp Speed efforts.  Nelson is also serving as a member of the White House Task Force.  So certainly speaking from, you know, that perspective, I'm going to let him go ahead and talk about those things.

DR. MICHAEL:  Yes, thank you, general.  You know, so we can get more granular.  I think the wonderful thing about the formation of Operator Warp Speed is that we are -- we are -- we're told quite clearly that we leave our uniforms, which means your affiliations, and you -- and hopefully your egos at the door when we sit down at the table together.

So this is truly an all-in effort to something that affects, you know, the entire United States as well as the world.  I mean, I asked my 89-year-old mother when the last time every state in the United States was under a state of emergency, and she said World War II, which she lived through.  So, you know, this is -- this is all of us.

So what specifically are we doing with Moderna?  Moderna is very, very likely to be the first major vaccine to be tested in a large scale phase three.  Almost certainly it looks like this -- and this stuff changes by the day, but almost certainly looks like this vaccine is going to be largely if not exclusively tested within the United States.  So how's that going to happen?

There are very large existing armies, if you will, of vaccine testers that are available to do this kind of testing.  They're largely funded by the National Institute of Allergy and Infectious Diseases, that’s Dr. Fauci’s institute at the NIH.  And they have formed clinical trial networks.  The Army's part of them, and they -- the bulk of those clinical trial efforts have been oriented towards the testing of vaccines for HIV.  That's why we have been involved in those studies for almost 30 years.

So I say this because, imagine this is like the beginning of the Second World War.  You have a small standing army, but you do have a standing army.  You can build bigger forces around them.  But the HIV vaccines trial network, the HIV Prevention Trial Network and the much smaller network that tests basically other infectious disease have now been all married together to perform -- to form something called the COVID Prevention Network.

This is largely a collection of academic scientists, but again the military is involved and always has been in sites that we have, especially overseas.  So we can bring our clinical trial expertise, our statistical expertise, understanding community engagement, I mean, the entire lifecycle of how one has to do vaccine development.  These can all be brought to bear.

I think, again, that's important because Operation Warp Speed isn't starting from scratch.  In terms of existing competencies and capabilities and then repurpose them for a single purpose which is to test vaccines and also monoclonal antibodies and eventually drugs for the response against COVID-19. 

So the second study that's coming up not that far behind is some people have called it the Oxford Vaccine.  It's a vaccine that's based on chimp adenovirus, Oxford 1, and that vaccine has been used before for related coronavirus only in phase 1 testing.  And that has already begun to go into clinical studies in the United Kingdom, and it's looking like that the United States will add a significant number of clinical sites to that.

And when you get further out to talking about Janssen's adenovirus type 26, that's actually a vaccine many of have already had some experience with; it’s in large scale testing for HIV, so that platform purpose for HIV, you can basically slot out a portion of that vaccine and put in something COVID-19, and that's being done. 

That has -- my -- my guess is that vaccine is going to be tested more internationally because they have, their networks are more oriented in that direction and so forth.  So, I mean, I think, you know, that's the long winded answer, so I want to stop. 

But, I think it gives you the idea of how we can help.  We don't necessarily have to help with -- with the provision of brand new trial sites that the DOD will bring to bear, although those are being spun up, but we can also help immediately because we have sites available, we have expertise that runs the gamut from supporting clinical work that's being done in USAMRIID to the clinical trials that can be done through WRAIR with other networks.  So we're -- we're -- we are becoming part of a larger conversation and a larger collection of efforts to test these vaccines.  Over. 

STAFF:  OK, thank you.  How about Defense One?

Q:  Hi, thanks for doing this.  So, a quick question, you mentioned a vaccine possibly available by the end of the year and I'm trying to understand, you know, based on other vaccines candidates that have already been touted, I know this was in human test like as early as in February, when you say available by the end of the year, are you talking about available to the first responders by the end of the year? 

Are you talking about available -- and if not, when would it actually be available to not just people in the clinical trials, but by first responders and beyond that, when would it be available to the broader public in your estimation?

And I have a second question about the testing capabilities.

BRIG. GEN. TALLEY:  Go ahead Nelson, please.

MICHEAL:  All right, well -- so now you're asking a far more complex question and I think that it's important to -- to recognize that at the end of the day the lead Federal agency that is responsible for actually doing what we would call a vaccine campaign, and other words, now we're past the time when we tested the vaccine or vaccines, we have one or more that look like they are safe, effective, and we make them acceptable to the American people. 

Then the question of who gets the vaccines is a complex one.  And number one, some of these vaccines work better in certain populations than in others. 

For example, some of the vaccines are being put into clinical testing are ones that are probably aren't going to be as safe in people that are very young, very old, or have other diseases of the immune system.  For example, someone who might have lupus, or someone might have HIV infection. 

So, decisions about how these vaccines get used is really a complex question that involves safety.  This is where the U.S. FDA will have a very strong hand in deciding who gets those vaccines. 

And then, of course, the CDC is responsible at the end of the day for the deployment of vaccines.  I remember as a child getting the oral polio vaccine in the sugar cube when I was in, I think, third grade, and that was that campaign is being what it was and would be again would be overseen by the Centers for Disease Control, because they make federal policy for how vaccines are implemented.

And I think the critical point that need to keep as guide posts are, we are moving quickly and the American people need to understand that the vaccine has to really hit three different guide posts.

One, it has to be safe, first and foremost.  Two, it has to be shown to be effective.  And three, that it need to be acceptable.  I would say that from a bioethical standpoint that these studies will be done against a placebo. 

You know, I think in general, in clinical trials that people were involved in the placebo arm usually are offered to get vaccines earlier than others, but at the end of the day, there’s a complex question about who gets the vaccine and it's going be based on who needs it the most in terms of safety, and what risk they face.

Q:  Thanks.  It's going (inaudible) you mentioned the testing, so basically the same question about the testing.  In March, General Milley has said that the Army's working on a self test, to be distributed to troops.  So, the testing capability that you mentioned, when do you think that will be available to say either first responders or front line U.S. troops?  And when do you think that capability will be available to the broader public?

BRIG. GEN. TALLEY:  Yes, so I can take that one.  And certainly when you look at the testing that's in place now, using the different -- the different platforms that available -- are available, we're using a number of types of systems right now certainly in the military.  So, the availability to first responders it is ongoing certainly as we speak.

Our team at MRDC along with the whole of government is certainly taking measures and efforts to perfect the testing, if you will.  It's not 100 percent effective.  You've heard reports about a false read potentially. 

And our teams are actually heavily engaged with the best types of tests, confirmatory testing, tests that will detect antibodies right away to confirm or deny if you have the test.  And it certainly -- those tests, that’ll determine whether or not you've had the disease, and if whether or not the antibodies themselves are being produced in the body and there’s a long-term effect.  So certainly that’s ongoing, and the availability is ongoing right now throughout the country for first responders and then certainly in the military as we move forward.  I’ll stop there, but certainly our team at RIID, heavily engaged in that, and I would invite certainly follow-ups from the other reporters with some of the things we’re doing with our infected military population.  Over. 

(CROSSTALK)

Q:  Hi, so you're talking a lot about vaccines.  What work might you be doing on therapeutics for treating COVID until we get a vaccine? 

BRIG. GEN. TALLEY:  Thanks, Ellen, and I was hoping you’d ask that.  I want to turn it to Colonel Cox and John Dye over at RIID.  A lot going on, of exciting work going on and they’re moving with alacrity to develop some of those countermeasures.  So Colonel Cox and John Dye, I’m going to flip it over to you and I think that’s a great question from Ellen.

DR. JOHN DYE:  Thank you general, this is John Dye.  And, so, we have multiple lines of effort moving in parallel for the development of medical countermeasures in the therapeutic realm – so something that you could give to someone who is either suspected to be infected or potentially already infected.  There are different buckets when it comes to that; you have to think about different types of therapeutics when a person is showing signs of disease, but not in the hospital yet, and those when you move into the hospital and potentially on a ventilator. 

So the major lines that we're focusing on are – we’ve been supporting efforts, MRDC has been supporting efforts, on convalescent plasma studies in multiple sites across the United States.  What we’ve been looking at is we’ve been trying to assess the convalescent plasma itself for its ability to stop or halt the viral growth –if we take that convalescent plasma and put it into a dish and put virus in that dish.  So the idea would be that we can actually determine from donors whether their convalescent plasma would have a really good effect if we were to take that convalescent plasma and put it in to an infected person. 

That's one line that we've been moving forward on.  A second line is moving forward with high-throughput screening of existing drugs, or novel small molecules.  So we have the ability here at USAMRIID through high-throughput screening to screen tens of thousands of drugs or small molecules on a weekly basis.  So we are constantly looking for novel and repurposed drugs that are currently available.  These would include drugs like hydroxychloroquine, remdesivir -- this was actually the way remdesivir was discovered and utilized for Ebola virus infection. 

The last line of effort that I would focus on is the development of monoclonal antibodies.  So USAMRIID and MRDC and WRAIR are in collaboration with multiple companies across the United States and across the world for the development of novel monoclonal antibodies whether that would be a human monoclonal from a human convalescent survivor, or an artificially generated monoclonal.  And those monoclonal antibodies can be given in cocktails of two or three monoclonals that act in different ways and that would also halt the spread of virus.

So these are the three lines that USAMRIID has been focusing on and we've been not only using our in-the-dish approach with virus, but we've also been developing animal models to allow the testing of that product in animals as we move forward those emergency-use therapeutics in humans into Phase One and Phase Two clinical trials. 

STAFF:  Okay, thank you.  Army Magazine?

Q:  If they’re not on, this is Tara from McClatchey, I would love to ask a question.

STAFF:  Okay, go ahead.

Q:  Sorry, I’m sorry, I was on mute.  I’m sorry, I forgot to take it off mute. I have a quick question.  This is Gina from Army Magazine. 

STAFF:  Go ahead.  We’ll get to you next, Tara.  Go ahead, Gina.

Q:  Okay.  How many Army labs are there?  How many of those labs are working on this vaccine?  And what is their level of effort -- around the clock, in shifts?  Could you describe kind of the level of activity at the Army Lab?  Thank you.

BRIG. GEN. TALLEY:  I certainly can.  So as it pertains to vaccines specifically, the two labs represented today are doing the bulk of the work.  At US Army Medical Institute of Infectious Diseases and certainly Walter Reed Army Institute of Research, it’s 24/7.  And there are various aspects of the lab work – we’ve mentioned some of the animal research that is ongoing.  The different types of vaccine development.  At WRAIR, certainly using the patented adjuvant that Kayvon Modjarrad is working on.  So the work is continuous.  The other effort is certainly our advanced development efforts with convalescent plasma – not vaccine related, necessarily – and the therapeutics and that involves our U.S. Army Medical Material Development Activity.  And then certainly the supporting agencies that conduct the contracting, the programmatics, they're hard at work as well.  Probably not the same 24 hour cycle, but certainly the efforts here with USAMRIID and WRAIR – when we talk about Warp Speed and making that our number one priority.  That's been ongoing for quite a few weeks now. 

Q:  How long does it normally take to develop a vaccine like this? 

BRIG. GEN. TALLEY:  That's an even better question, and we get asked that one often.  I'm going to turn that back over to our team at WRAIR and I appreciate the question because it’s going to show the comparison of what I’ll say “normal” is, perhaps what the fastest effort we’ve done to date is, and then when you talk about the goals of Warp Speed, it truly is.  So I’m going to turn that over to Team WRAIR, either Kayvon or Nelson, if you could answer this one.  That’s a great question and we’re pretty seasoned at answering this one.  Go ahead.

DR. MICHAEL:  Okay, I’ll give the 35,000 answer, and let Kayvon come in on the treetops.  So, let me start by saying that I've been trying to make an effective vaccine for HIV for 30 years.  We've had some success, you know, some glimmers of hope, but we're still putting significant amounts of effort against that disease.  That is an incredibly difficult problem.  Historically, those timelines have gone 60 or 70 years in some cases.  You might hear those numbers quoted sometimes.

We're getting better and better and better at making vaccines quickly for lots of reasons.  Some of it is technology, some of it's the ability to mobilize communities and to bring to bear these scientific advances, working better with public-private partnerships.  In other words, it isn't just all the government, or all pharmaceutical companies, it's a mixture of both.  So lots of reasons why we’re getting faster.

But typically getting from concept into a Phase One Study is usually two to four years, and then getting to the time in which you're beginning to look at Phase Three Studies can be up to 10 years, even in the modern era. 

But Kayvon, I think, has some important anecdotes from Ebola and from Zika, and our own experiences in the MRDC family that I think are relevant to this situation.  Kayvon?

DR. MODJARRAD:  Thank you.  So one of the slides that I typically present when I'm talking about vaccine development is one in which I show timelines for, from the time that a new virus or new pathogen is discovered until a vaccine is developed over the past 100, 150 years.  And that timeline hasn't changed all that much.  But what has changed is when there is a concerted and intentional effort to develop a vaccine – when that vaccine program begins to when we get the vaccine – that timeline has compressed considerably from years, maybe decades, to years, and now potentially to months. 

The example that Dr. Michael alluded to with regard to Zika, our group at WRAIR, others at the NIH, and industry, went from the initial sequences of the new strain of Zika circulating in the Western Hemisphere to a vaccine in humans in clinical trial in about eight to nine months.  For Ebola, going from the first in human clinical trials to getting the vaccine licensed was about five years, so that was before Zika.

It can go even faster, and there are really two – there are two things that limit how fast something can go.  I've said this before and I'm sure my colleagues are tired for this phrase that I say, but there are laws of man, laws of humans, and laws of nature.  Laws of man we can compress quite a bit, but the laws of nature we don't have as much control over.  What I mean by that is sometimes the science dictates how fast we can go.  In the case of HIV it's been very much that way.  Much political will and funding has been put towards developing an HIV vaccine and it has been a very difficult enterprise to get one that's effective.

But most viruses aren't like HIV.  They don't mutate like HIV.  And so, we can actually develop – the science is not so much of a hindrance.  So what you're seeing now from us being able to compress the timeline is overcoming some of the prior issues that we've had with other vaccine development with funding and coordination and making sure everything is streamlined so that the only thing that stands in our way is the science.  And we're learning about the science of this new virus faster than we have about any other virus before.

So going to a vaccine in a matter of months from concept all the way to Phase Three Clinical Trial and potentially licensure is unprecedented, but in this case I think very much it's possible.  Over.

STAFF:  Okay, thank you.  Go ahead Tara and McClatchey.

Q:  Thanks to all for doing this.  So, just to follow on to those last remarks, given the speed that all of this is moving forward and based on where the tests are now, choosing the mice, would you say access to a reliable vaccine is more likely in 2021 or by the end of calendar 2020?

BRIG. GEN. TALLEY:  Wendy, I'm going to let you take that one.  Because certainly as we continue to work whole-of-government and within DOD, we have projections.  You know, absolutely, but I think it's important to weave in some of the aspects that have been named already with respect to risk and certainly Kayvon's analogy with man, human, and nature competing with all of those things.  So Wendy, I’m going to let you give perspective on that one, please.

COL. SAMMONS-JACKSON:  Okay, thank you, sir, I appreciate it.  Colonel Wendy Sammons-Jackson.  So Dr. Michael's already alluded to sort of the complexity behind the term access and what do we really mean by that because that could mean a number of things.

And so I think what we can at least confidently say is that we have goals in place from a whole-of-government approach to make a vaccine available, and we can talk a little bit more about what available means, in some, some scale by the end of the year and certainly increasing the scale of that, which would increase the availability by the first of the year.

And so while those goals are in place, I think that we are confident that there can be progress towards those goals and exactly taking into account exactly what that means in terms of availability, as Dr. Michael has already mentioned, that has to be done under consideration in coordination with the CDC from a policy perspective, with the FDA from a safety perspective.

And so certainly that would be the goal.  I think it is reasonable to expect that there will be some form of a vaccine that could be available at some level to a certain population by the end of the year, the first of the year, and that is based on the goals that are presented from the efforts that we're engaged in, Operation Warp Speed being one of them.  And certainly that would be the intent to do that.

I know it's kind of a convoluted answer, but it's a very complicated question to answer because there are so many factors that come into play, but I can just tell you from that, that is the goal.  That's the target that we're shooting for, and of course to echo Dr. Modjarrad's comment, science is controlling this at this point.  And so, as long as we're able to continue to progress and learn and understand and adapt, I think we have all of the resources available and pointed in the direction that can make that possible.

BRIG. GEN. TALLEY:  Thank you, Colonel Sammons-Jackson, I just want to reiterate with those goals, everyone who is part of this effort within the whole-of-government – Warp Speed, the various efforts – safety will not be compromised.  Certainly getting the most efficacious vaccine candidate to the front of the line or across the line is incredibly important, but what we don't want to do is jeopardize safety for the sake of speed.  Everyone's committed to that.  Thanks.

STAFF:  Go ahead, Bloomberg.

Q:  I have one follow up, if that’s alright.  So just more science-based, not timeline-based.  Based on what you have learned so far, where are the blind spots?  What do we not know about this virus at this point that might concern you?  And given that there may still be unknowns at this point, do you recommend antibody tests?

BRIG. GEN. TALLEY:  John Dye, please take that one on, and then if we need to further expand we can go from there, but that's a great question.  Go ahead.

DR. DYE:  Yes, sir.  We were sitting here with the phone muted saying that is a fantastic question.  So. let’s take the first part first, the what do we or do we not know about this virus.  And I can also have our friends at WRAIR comment as well.  So at this point in time we are still in the learning phase of this virus.  Every time we think we have it cornered and we know exactly what the clinical signs of the disease are, how it replicates, how it moves through populations, it does something different and we learn something new.  And that's what viruses do.  They're able to modify and adapt and change, and we have to modify and adapt and change with those viruses.

So we're still in a learning phase, in every aspect of this, whether it's the development of treatments, the development of vaccines, and it’s going to be a constant learn.  So scientists around the world, including at Army and other Armed Forces laboratories, are doing their best to keep up.

Regarding the antibody tests, there are multiple antibody tests that are currently available out there.  Right now, there are multiple tests that have been validated.  And I would say that moving forward there will continue to be advances that are made in those antibody tests.  The big question is, we don't really know what those antibody levels mean.  We don’t – we cannot relate those antibody levels to some level of protection.

Everybody wants to know if I have an antibody or an antibody level of ‘X’, if I come into contact with the virus, will I be infected, and right now we don't have those answers.  So I think epidemiology and looking at serology over large cohorts of people, both in the United States and worldwide, we’ll start to understand what those antibody levels mean.  And when we get a vaccine on board, we can look at the antibody levels that are generated in those vaccines.  But right now, we are still in the learning phase.  And that’s probably not a great answer but that’s where we are.

STAFF:  Okay, go ahead, Bloomberg.

Alright, how about CNN?

Q:  Hi there, this is Michael from CNN.  I was hoping – I think it was Dr. Modjarrad that mentioned that the candidates that they're working on is sort of hoping to have some sort of lasting protection against coronaviruses.  And I'm curious maybe to get into the weeds just a little bit about what specifically about that vaccine candidate is hoping to confer that lasting protection.  I believe the target is a spike protein versus some of the other vaccine candidates and platform that are being used.

DR. MODJARRAD:  Thanks for that question.

BRIG. GEN. TALLEY:  Kayvon, go right ahead.

DR. MODJARRAD:  Okay, thanks.  Thanks for that question.  A great question.  So let me just deconvolute that a little bit, that what is unique about our candidate is not necessarily the durability.  So, durability is. how long does the immunity last from the time that you’re vaccinated, and that gets to a little bit about the question that Dr. Dye was addressing, we don't even know how long the durability is from just getting naturally infected.  With our vaccine candidate, there's not necessarily an expectation that it will provide longer term immunity.

What is unique about it is that it's a platform; it's a base that can be used for targeting multiple strains and multiple species of a coronavirus in one vaccine.  So most of the vaccines out there, you have to keep changing the insert.  But most of what you see out there in the landscape, whether it be the top four that Operation Warp Speed is prioritizing, or the second tier candidates, they all have some insert, and in almost all of them a spike; the difference is the vehicle in which they're delivering that spike.

And so, you have to keep changing it in and out.  Ours right now is presenting the spike protein, but it's presenting it multiple times, about 24 times around the particles; it's like a soccer ball in terms of its symmetry.  It has got all these different faces and on each face is a spike protein that's pointing out. 

What we can do, if there is new strains of the virus that emerge, or if we want to try and cover all coronaviruses in one particle, we can mix and match spike proteins from the different coronaviruses and put them on the same particle so that you have one vaccine that is universally effective against all coronaviruses.

STAFF:  Okay, go ahead, Task and Purpose.

Breaking Defense?  

We lost a couple.  Hurra Television?

Q:  Hello, Mark Abbot here, thanks so much for doing this call.  If we could just stay on that – that sort of universal or global vaccine candidate that you were just mentioning; two questions – well, one question and a comment.  As you look to begin the first human trials on that late summer.  Just an observation, would love for you folks to consider the visuals on that and how we can visually tell that story.  So as you decide how you're going to ramp that up, if there were some sort of pool options option for still images and video, that would really help us to tell that story.

And then I'm curious, on that development, what does that human trial that's in late summer or so look like.  Is that using, as you sort of referred to, that standing army of vaccine testers that NIH has or are you going to be assembling a new sort of army for that?

BRIG. GEN. TALLEY:  Yeah, so a lot of efforts going on, certainly, as we begin planning for first human trials.  Certainly, some are beginning now.  Essentially when you're looking at the different types of trials, so, Phase One certainly representing a smaller population and when you jump to Phase Two, which it could potentially be 1,000 and then up to as many as 30,000 for Phase Three.  Certainly the planning efforts are going in to that are going to take, certainly, a whole-of-government approach and a solicitation for volunteers.  Colonel Sammons-Jackson, if you can comment a little bit more about what that'll look like as we go forward.  I think that’ll be helpful.

COL. SAMMONS-JACKSON:  Can you elaborate a little bit more on the second part of your question?

Q:  Sure.  I was curious if you could provide more detail on what steps will be taken in late summer.  You mentioned the first human trials.  I'm curious, are you going to have to assemble a new army of, you know, these vaccine testers, you know, the humans that are going to be taking this, or are you using that existing army of folks that you were talking about earlier with the clinical trial networks.  I’m just kind of curious for more specifics on what your standing up this human trial this late summer will look like, please.

COL. SAMMONS-JACKSON:  Oh, okay, great, thank you, I appreciate that clarification.  So I can just tee it up but that's really a question I think Dr. Michael can answer, but certainly, he's already mentioned the network that we have in place that can be leveraged and certainly that would be part of the strategy for executing the trials.  The capacity depends on the stage of the – the capacity of the requirements of at which we're testing.  So you’re answering different questions at different phases of the development of the vaccine.

And so certainly the earlier stage is going to be a limited – limited capacity requirement for testing initial safety and then expanding upon that.  So it’s more of a kind of a sequential process in terms of ramping up for that, but we do have existing platforms in place that will be leveraged.  We're also exploring – and Nelson can certainly give you a lot more detail on this – exploring opportunities where we can send potentially trained personnel to sites to facilitate execution of those trials as well.  And I’ll hand it off to Nelson to expand on that.

DR. MICHAEL:  Alright, thanks, Wendy.  No, I think we handle it very very well.  The Moderna trial, which is first out of the gate, is definitely going to be handled by this new entity called the COVID Prevention Network or C-O-V-P-N.  That's important because we're talking about a trial of probably 30,000 people.  They're enrolling 250 to 500 people per site; you can do the math.  This is a large exercise.  We famously did the only vaccine trial for HIV that showed a glimmer of efficacy in Thailand.

That was a heavy lift.  It was 16,000 people and we had years to get ready to do it.  So I think you can see the enormity of the logistical efforts before us.  But the good news is that there are few organizations in the world that logistics doesn't make nervous and one of them is the United States Army.

So I think the good news here is that yes, the existing field armies that now are called the COVID Prevention Network are going to be marshaled to jump on the Moderna and probably the ChAdOx1. 

But then as -- as these trials begin to execute as the summer roles on and we're getting into the third study that will likely start in September with Janssen, I think the critical point is that all of these networks right now, all of these organizations to include ours are very busy, going from, let's say a clinical trial site that might exist in Washington D.C. and seeing how we can leverage and develop new capacities in Prince Georgia's County if you want to keep in local here in the United States and the Washington D.C. area.

So, at the same time we are staring at real-time analytics.  Literally looking at zip code level data about new cases of where COVID's popping up because what you don't want to do is put all your troops where there is no virus to fight.

So if you're going to do these efficacy studies, it is important to be able to capture new infections, or otherwise you're going to be testing a vaccine and thousands and thousands of people are not getting any signal.  So we need to figure out where really to put these new resources, and we’re meeting literally every day.

I include Saturday and Sunday.  There's no such thing as a weekend anymore in this efforts.  We are looking at how we can leverage the existing resources we have, in some cases do the not-so heavy lift of saying well, the Walter Reed Army Institute of Research, or RIDD, with clinical trial research capabilities can reach out within 30 to 50 miles and develop some new ones with academic groups that are good, that maybe haven’t been doing that sort of thing before, we can get them trained up.

And those sorts of discussions are very active.  The networks are doing exactly the same thing.  We're talking within the entire defense agency structure so that it serves the department as well as DOD for how this could look as we just use our military treatment facilities, hospitals and clinics across the United States and elsewhere. 

So you can think of the method we are beginning to operationalize it to the point where some elements of the Army are coming through our Clinical Trials Center at Walter Reed Army Institute of Research on Wednesday, and we're going to walk them through what it takes to do -- the actual mechanics for vaccinations, and a Phase Three trial, what's required for follow-up.  Because we're also interested in developing mobile clinics.  This has been done before, this is not a novel concept. 

But again, logistics does not frighten the United States Army.  Our General who is always on these calls, is actually a medical logistician.  So, you know, we're comforted in the fact that we have some very, very senior people that this is in their blood.

So I can tell you that as time goes on, we are going to overwhelm the networks with the first two trials.  But by the time we get to the third and fourth, the networks and working with us and other groups are already building that capacity to be able to absorb these additional trials.

And the good news about that is that this is going to be able to work into areas where we haven't traditionally worked before.  And that's important because if you look at trial networks that are used to working in populations at risk for HIV, that's a different part of our national dialogue than individuals that are at risk for COVID.

And so therefore, getting out to these communities and doing what we call community engagement -- that's not something that, you know, scientists sometimes talk about first, but we really should -- how do you convince communities that this is an important thing for them to get involved in?  How can you convince them, at the same time we're talking about speed, that we're also talking about safety?

And so doing this in an iterative fashion gives us time to develop those important community engagements, and to get the right kind of community advocates on board and to make sure that we don't just say we're doing the right thing, but the communities believe that we're doing the right thing.

So again, it's a long answer but I'll tell you that we're going to start -- just like World War II, we'll start with a small number of people in our standing armies, and we will grow them as suits the mission.  Over.

Q:  Thank you.

STAFF:  OK, we're at Defense Media Activity?

OK, anyone I missed?  I went through the list, so we might have some late...

(CROSSTALK)

Q:  Hi, this is John Harper with National Defense Magazine.  

(CROSSTALK)

Q:  Hi, sorry, I missed your roll call earlier, Amanda Macias at CNBC.  Sorry.

STAFF:  That's OK.  OK, go ahead, CNBC, your turn.

Q:  Hi, I was just wondering if you guys could give me a little bit of -- what kind of piggybank you're sort of working with in terms of finances.  If you have all the financial resources that you need right now for your research, do you envision potentially needing more as your work continues?

And as a secondary follow-up question, I'm wondering if at all you feel that your work is in any way in jeopardy from intellectual property theft, as, you know, nations are rushing to develop a vaccine, since this is a global pandemic?

BRIG. GEN. TALLEY:  I can take that one.  This is General Talley.

So with respect to resources, we are in good shape for resources.  And certainly we have been able to benefit from supplemental funding, CARES Act, along with money, certainly, that was apportioned through the DOD to our laboratories. 

And we've been very careful with the spend plans,  I can tell you Colonel Sammons-Jackson, going back to January with the first apportionment of funding, worked some pretty long hours early on to make sure that we'd be able to track and trace it and show deliverables for each dollar.

But we're asked that question often, we brief our secretary of the Army and chief of staff of the Army.  And that's typically the first question asked.  So right now, absolutely in great shape.  And with this whole-of-government effort, it's not only shared intellectual capacity and expertise, but it is -- it is shared resources.  So we're -- we're in good shape for this whole of government effort.

With respect to intellectual property, again, not concerned about that.  We have an embedded, certainly, directorate within MRDC that ensures that intellectual property is protected.  Dr. Kayvon Modjarrad mentioned that patented adjuvant developed a few years back, which is being applied toward this particular vaccine.

So right now, no concerns with either one of those.  As we go forward, certainly, we'll continue to watch it and keep you all updated.  Thank you for the question.

Q:  And would that be in the millions or the billions, would you say, just in terms of financing that you guys have available to you?

GEN. TALLEY:  Well, I'll speak for what's been publicized for the whole Warp Speed effort.  And well-publicized, is what’s been funded, and what hasn't.  And we're sharing, certainly, with the entire resource portfolio, which is certainly well into the billions for the entire Operation Warp Speed and whole-of-government effort.

Q:  Thank you.

BRIG. GEN. TALLEY:  Thanks for the question.

STAFF:  Who else did I miss?

Q:  John Harper with National Defense Magazine.

STAFF:  OK, go ahead.

Q:  I was wondering, you know, what lessons have you learned from this current crisis that you think you might apply, you know, to future pandemics, you know, or future outbreaks?  And, you know, is there anything that you don't have currently that you would like to have to deal with viruses in the future?

BRIG. GEN. TALLEY:  General Talley.  I’m going to start off and then pass it around to these great scientists on the line who -- for them it's not their first rodeo, pardon the pun.

But what I see, the way the whole of government effort spun up, we've been battling the coronavirus since January.  And really, we're beginning to organize ourselves in a fashion that truly is going to expedite and leverage all the resources that we can bring to bear.

So I think we have to ask ourselves, how do you sustain this?  I don't think this is going to be the last pandemic, and certainly as you look at the way this type of pandemic has come into play.

I think as Dr. Modjarrad who made reference to the fact that, we went years without a pandemic.  This one's being compared to the Spanish Flu of 1918.  Yet in the last ten, twenty years, this is not our first coronavirus or type of disease outbreak we've had to deal with.

So I think the lesson that we have to take on is, how do we mobilize this quickly?  How do we maintain and sustain the type of apparatus that could respond to this quickly?  So I don't think this will be the last time, but I do believe that we're going to have to be just as effective and efficient to be able to spin up and mobilize as quickly as we can.  That has to be sustained.

So I'm going to go to Team WRAIR and let you hear from the folks that have been doing this for a long time.

DR. MICHAEL:  Alright, this is Nelson Michael.  I really want to set up Kayvon for this and I think you'll see why.  When we did our response to Zika, we went literally from conception to making a vaccine to first injection in humans with two papers -- one in science, one in nature -- describing how the vaccine worked in mice and then in non-human primates.  We did this in nine months.  It was a land speed record.

My commander at that time -- I was still wearing a uniform -- she asked me, how did you do that because you're an HIV researcher and most of the folks you worked with were HIV people?  So how'd you do that?  Did you do it based on structure or did you do it based on bluster?

I said, well, I'll be honest with you.  I did it a lot on bluster, and we didn't really -- we weren't set up for that.  And she said, you know, that's not the Army way, Nelson.  You're going to have to rethink this.  And so, under her direction she's now General Talley's Chief of Staff, Colonel Whitmer. 

We set up the Emerging Infectious Disease branch.  We set up a brand new unit within the Walter Reed Army Institute of Research that was going to be designed to do just this.  And I had at least the foresight of recruiting a brilliant MD-PhD researcher named Kayvon Modjarrad from the National Institute of Allergy and Infectious Disease, Dr. Fauci's team.  And unlike me, Kayvon is actually an expert in respiratory viruses, especially coronaviruses. 

So we did predict this was going to happen.  Kayvon let me use a slide of his in Korea in September of last year which basically showed SARS and then MERS and then showed a next question mark of when the next one was going to come.  I don't think that we knew it was going to be just a few months later.

So as a consequence of this, we really began to reposition ourselves to be able to absorb these new realities, and let me let Kayvon describe what I think his vantage would be for what we do from now on.  Over.

DR. MODJARRAD:  Thanks, Dr. Michael, and for the kind words as well.  So those of us in this space in infectious diseases, emerging infectious diseases, we're not oracles.  We just know that what we've seen before we're likely to see again. And that's been the case not just for coronaviruses.  You know, this is the fifth coronavirus in the past two decades that has been identified in human populations whereas since coronaviruses or human coronaviruses were discovered in the mid-60s, there were only two coronaviruses in that period of time.

There have been several -- close to half a dozen public health emergencies declared since that mechanism was established after SARS, and it just shows that we are accelerating in terms of coming in contact with these pathogens, and there are a lot of hypotheses as to why that is.  We're much more hyper-connected than we were before.  We have greater interface with animal populations than we had before, so there's a lot of spillover from animal populations into humans of pathogens that we may not have encountered previously.

But if you look at the example of what Dr. Michael gave about the Zika virus and the Zika vaccine, he went on an unprecedented timeline then as did others at the NIH and some other companies in terms of getting from a concept to a clinical trial for a Zika vaccine, which we're beating those records now.  But even with that pace, we all started our vaccine program in February of 2016.

When we looked back at the epidemic curve of Zika a year later, two years later, the peak occurred in February of 2016, so we were literally behind the curve even when we were going as fast as possible.  So the only way to really respond to these outbreaks is to be in a posture where we don’t have to respond, we’ve already prepared for, anticipated, and developed the countermeasures for that pathogen beforehand.

And you might think that's impossible to do.  It's not.  We actually have the technologies and tools now where we can do those sorts of things.  The universal vaccine approach that I described for our vaccine candidate is just one example in a whole array of technologies that we have in terms of diagnostics, therapeutics, and vaccines to be able to anticipate what is essentially just a handful of families of viruses, coronaviruses, flaviviruses -- if we know generally what's coming in terms of the family of viruses.  We have the tools to be able to anticipate it.  It's just a matter of changing our posture from one of prev—response towards one of prevention.  Over.

BRIG. GEN. TALLEY:  OK, thanks Kayvon.  General Talley, and this is a great question to conclude with.  I'd like to go to Dr. John Dye, and again I think the question was really centered on lessons learned certainly as we go forward, and then we'll close finally with Colonel Wendy Sammons-Jackson, and this will be her last time in uniform in this particular forum.  So Dr. Dye, over to you, and then we'll close with Colonel Wendy Sammons-Jackson.

DR. DYE:  Thank you, sir.  So I'd like to follow along with the last few items that Kayvon mentioned, which is that the only way that the world is going to be prepared for the next coming outbreak is going to be global communication as well as the global response network.  And I think if you institute those capabilities that allow the rapid response and scale up of medical countermeasure – whether it's vaccine or therapeutic – and Kayvon is 100 percent correct.  There is a handful of viruses that were identified by the WHO in 2014 after the Ebola virus outbreak, basically a top ten list of the most likely to develop pandemics.  And there's really only five or six viral families.  And if you start to develop capabilities against those viral families that can then be juxtaposed against those new variants that come out, you then have that capability.

So it's a matter of global communications and global rapid response.  And I think that's what I hope we learn as a country and as a world that we all need to work together to try to come up with a plan so we'll be better prepared in the future.  Over.

STAFF:  Go ahead, Colonel Sammons-Jackson.

COL. SAMMONS-JACKSON:  Okay, thanks.  Hi.  This is Colonel Sammons-Jackson.  So I appreciate it, and this is something that certainly we've been thinking about for some time, certainly since the West Africa Ebola outbreak, and a number of us on the line were engaged in working together during that.  So there's lots of lessons learned as we have progressed through each of these different scenarios over time.

And two points I wanted to make that we have made deliberate attempts to try to better prepare and reduce our response times in these types of situations, and one is what we certainly recognize, is that we desperately needed a structure in place to coordinate, communicate across DOD and across U.S. government. 

And that's probably easier said than done, and – but it's critically important to increase the efficiency of efforts if we're able to share information, develop a common strategy, and coordinate the efforts along a safe lines of efforts along, along a strategic plan perspective, that would be really beneficial to the response.  And we've learned each time from that.  You're seeing that in action right now with Operation Warp Speed, for example.

The second point is from a programmatics perspective, which is the space that I operate in.  We recognize we had some of our own challenges with our ability to rapidly respond in terms of shifting our investments and resources. 

And so we did along the same lines of what WRAIR did, is we created from a program perspective an emerging infectious diseases program area that would enable us to have the ability to rapidly shift resources towards that priority effort at -- where we've had historically our program has been very pathogen-specific-focused and that does not leave a lot of flexibility when you need to pivot and change direction quickly.  And so, we've created that, which has really paid dividends, certainly, with this outbreak. 

In addition, we've also have taken a deliberate approach to invest in technologies that are more broadly applicable either across a family of viruses, broad – for example, broad antivirals, and certainly along the same lines of Dr. Modjarrad's point to a pan-coronavirus vaccine. 

And so, our portfolio has been increasing in that space, and so we're looking at technologies that we can invest in that can be rapidly applied to whatever emerging pathogen that we need to address.

And so that is from a program perspective, from a coordination perspective across the U.S. government, those are the two areas that I – definitely we've learned lessons, we have shifted, and I think we – we definitely are better prepared and will continue to follow along that line to ensure that we are prepared for the next outbreak that we may be facing. 

STAFF:  OK, thank you.  Thank you for everyone for calling in.  We really appreciate it.  We're out of time.  We know you have additional questions, so feel free to e-mail me.  I'm Lori Salvatore, I was on the email that Will Stark sent out to invite everyone.

We also have b-roll and photos available at dvidshub.net/unit/MRDC.  Feel free to e-mail me and we'll get you everything you need for today.  Thank, you so much.  Have a great day.