This is the 3rd OWS press conference, held on June 2, 2020. The 1 min video clip above is the most pertinent info from that episode of the “War-on-Virus” Productions.
In this episode, General Talley of the DOD and the rest of the fake warriors fighting fake virus for very real mucho dinero continue their valiant, “certainly whole of government effort”. Talley repeats “whole of government” approximately a dozen times during one presser, as he does at every other OWS press conference as well. I asked Katherine Watt to opine on this curious verbal tic, and this is her response:
It has to do with preemption of state authority and state court jurisdiction.
The main SCOTUS case I'm aware of is 2005 Grable v. Darue. It uses different language, having to do with federal jurisdictional issues, and the courts' role in determining when an issue implicates "substantial" enough federal matters that state law is superseded.
HHS secretary Azar started incorporating it into PREP Act declarations from the fourth amended version, signed Dec. 3, 2020, retroactive to Feb. 4, 2020.
Cited again in the Becerra PHE determination May 11 2023.
Cited also in HHS OGC Advisory Opinion of Jan. 8, 2021, and Texas v. Pfizer Notice of Removal Dec. 28, 2023.
"Whole of government" phrase itself seems to come from the 2010 National Security Strategy document by Obama, cited in 2012-2016 FDA MCMi Strategic Plan and then a whole bunch of other plans and reports.
Also see this recent post by colleagues at
discussing the global implications of the DOD’s claim on “whole-of-government.I am continuing to review the DOD-lead Operation Warp Speed press conferences. It is a mind-numbingly-stupid-evil clown show. My brain hurts and I need a reprieve. So, I made this mixed tape for you all, enjoy:
Full auto transcript of the June 2, 2020 OWS press conference:
Speaker 1 (00:00:00):
For calling into today's update from the Army Medical Research and Development Command on efforts to protect, detect and treat COVID-19 and progress with vaccines and therapeutic development. My name's Lori Salvato. I'm the Public Affairs Officer for the Army Medical Research and Development Command on I moderate today's session. The following senior leaders are on today's panel, Brigadier General Mike Talley, commanding General of the Army Medical Research and Development Command. In Fort Dietrich, we have Colonel Wendy Salmons Jackson, the director of the Military Infectious Disease Research Program. Colonel Dearin Cox, commander of the Army Medical Research Institute of Infectious Diseases or usam, Dr. John Dye, chief of Viral Immunology at Usam. Dr. Nelson Michael, director of the Center for Infectious Disease Research. Walter Reed Army Institute of Research or Rare. And Dr. Kon, major Madrid, director of Emerging Infectious Disease Rare. Today's discussion is on the record after general Calley'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 feel 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 Telley.
Speaker 2 (00:01:24):
Okay. Hey, thank you Ms. Salvador. 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 round table. We're joining you remotely from United States Army Medical Research and Development Command in Fort Dietrich, Maryland. So in 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 US Army Medical Research Institute of Infectious Diseases for Usam R as we call it, is the only laboratory in the DOD equipped to safely study highly hazardous infectious agents requiring maximum containment at our biosafety level four level. Now, for example, srid scientists assess the effectiveness of a new smallpox vaccine. Their testing played a pivotal role in last year's FDA decision to approve the vaccine.
Speaker 2 (00:02:37):
In addition, these scientists were key players in REM DVIR 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 for Rare 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 Cassandra, they've been safely replicating the virus to support countermeasure development. Meanwhile, the team at Rare has designed a unique COVID-19 vaccine candidate.
Speaker 2 (00:03:49):
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 aero medical lab is expediting the testing and approvals needed to obtain airworthiness certification to transport COVID-19 patients who require isolation onboard US Army rotary wing aircraft, and the US Army Medical Material Development Activity right here at Dietrich has established a working group to support DOD additive manufacturers to produce tests 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.
Speaker 2 (00:05:04):
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 Sams Jackson is the director of MRCs Military Infectious Disease Research Program. She's also the chair of the joint program Committee coordinating infectious disease research across DOD For the last two years, Colonel Salmons Jackson has managed this portfolio which has achieved significant accomplishments with mers, Zika and Ebola and 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. So I want to thank her publicly for her great service to MRDC, the Army and the nation Colonel Darren Cox is the commander of the US Army Medical Research Institute of Infectious Diseases and he's been instrumental in leading the institute's researchers and scientists as they help defend our nation against COVID-19.
Speaker 2 (00:06:20):
His team has been working with antibody tests, convalescent, plasma, and they'll also be testing vaccine candidates developed by outside laboratories. Dr. John died is the chief of viral immunology at the US Army Medical Research Institute of Infectious Diseases. He spent much of his career leading the research and development of medical countermeasures against Filoviruses and other viral biological threat agents. Dr. Nelson Michael is the director of Rare Center for Infectious Disease 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 Dr. Michael on other national media broadcasts and when you look at the likes of Dr. Anthony Fauci, ambassador Burkes, Dr. Michael effectively is a protege of those two top scientists that grew up in the MRDC organization. Dr. Kon Maja is the director of Rares emerging Infectious Diseases branch and he is leading the efforts for COVID-19 vaccine development for MRDC. Dr. Maja previously worked at the forefront of our efforts against Mers and Zika. He is the scientist behind a patented adjuvant that's designed for the same family 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. So I'll open it up now.
Speaker 3 (00:08:09):
Wall
Speaker 2 (00:08:10):
Street Journal, your first
Speaker 3 (00:08:14):
Thank you for Gordon Wall Street Journal. Has there been any 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?
Speaker 2 (00:08:28):
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 Ben Chavon Maja who are leading certainly our efforts in Mr DC, but I think you're going to find as they convey what we're doing, it is 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 going on at rear over.
Speaker 4 (00:09:05):
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 to diagnostics to vaccines for our specific work in vaccines. We are very heavily engaged to ensure that across all 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 I've 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 company's Moderna and AstraZeneca and Sano Fe and part of Johnson and 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. Maja 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 we may be onto something very good. Let me stop there.
Speaker 5 (00:10:55):
I'll take it from there then. This is Dr. Cavan, Jared from Rare as well, and I'll just state that in addition to what Dr. Michael said our particular vaccine takes as he intimated a long-term approach towards potential new strains 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 currently circulating in the world can be covered by a single vaccine, but in the event that the virus mutates, 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 in the late summer, as Dr. Michael mentioned.
Speaker 5 (00:12:27):
Then depending on the human data that we obtain, that will then inform the advancement of our vaccine candidate towards much larger trials towards the end of the year in the context of operation warp speed. And the other thing that I'll add is about our competencies and capabilities that advance other vaccine candidates. 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. 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 those selected by the Wall Street Army to the 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.
Speaker 6 (00:13:43):
I
Speaker 2 (00:13:45):
Gave the question and certainly those vaccine development efforts go across all of MRDC, which includes the laboratories at rid. We'll continue on with the questions so we can get through as many as we can. Go ahead, Lori, army Times.
Speaker 6 (00:14:02):
Go ahead. Did you say Army Times? Yeah, army Times. Go ahead. Army Times. 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 trials?
Speaker 2 (00:14:28):
Absolutely, and I'm going to let Nelson pick that up as he mentioned that we are part of the whole of government's operation warp speed efforts. Nelson is also serving as a member of the White House Task Force. So certainly speaking from that perspective, I'm going to let him go ahead and talk about those things.
Speaker 4 (00:14:50):
Thank you General so we can get more granular. I think the wonderful thing about the formation of Operation Warp speed is that we are told quite clearly that you leave our uniforms, which means you're affiliations and hopefully your ego is at the door when we sit down at the table together. So this is truly an all-in effort. This is something that affects the entire United States as well as the world. I mean, I asked my 89-year-old mother when the last time that every state in the United States was under a state of emergency and she said World War ii, I mean she lived through. So 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 it looks like this vaccine is going to be largely, if not exclusively tested within the United States.
Speaker 4 (00:15:57):
Now how's that going to happen? There are very large existing armies, if you will, of vaccine testing that are available to do this kind of testing. They're largely funded by the National Institutes of Allergy Infectious Diseases, that's Dr. Fauci Institute at the NIH. And they have formed clinical trial networks. The Army is part of them, and the bulk of those clinical trial efforts have been oriented toward the testing of vaccines for HIV. 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 outstanding army. You can build bigger forces around them. So the HIV Vaccines Trial Network, the HIV Prevention Trial Network and another much smaller network that tests basically other infectious diseases, have now been all married together to form something called the Covid Prevention Network.
Speaker 4 (00:16:56):
This is largely a collection of academic scientists, but again, the military is involved in 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 life cycle 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. It can turn to these 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 C CVID 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 one, and that vaccine has been used before for related coronavirus only in phase one 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.
Speaker 4 (00:18:11):
And when you get further out to talking about janssen's, adenovirus type 26, that's actually a vaccine many of us 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 for COVID-19. And that's being done that has, my guess is that vaccine is going to be tested more internationally because they have a bit more time and their networks are more oriented in that direction and so forth. So I think that's a 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 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 free clinical work that's being done at usam to the clinical trials that can be done through rare with other networks. So we are becoming part of a larger conversation in a larger collection of efforts to test these vaccines over.
Speaker 1 (00:19:25):
Hey, thank you. How about Defense one?
Speaker 7 (00:19:30):
Hi, thanks for doing this. So a quick question. You've mentioned a vaccine possibly available by the end of the year, and I'm trying to understand, based on other vaccine candidates that have already been touted, I know that one was in human tests as early as in February. When you say available by the end of the year, are you talking about available to first responders by the end of the year? Are you talking about if not, when would it actually be available to not just people in the clinical trials but 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 capability.
Speaker 8 (00:20:14):
Go ahead Nelson, please continue.
Speaker 4 (00:20:17):
Alright, so now you're asking a far more complex question, and I think that it's important 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. In other words, now we're past the time when we tested the vaccines or vaccines. We have one or more that look like that they are safe, effective, and we can make them accessible to the American people. Then the question of who gets that vaccine is a complex one. Number one, some of these vaccines are probably going to work better in certain populations than in others.
Speaker 4 (00:20:55):
For example, some of the vaccines that are being put into clinical testing are ones that probably aren't going to be as safe and people that are very young, very old or have other diseases of the immune system. I mean, for example, someone who might have lupus or someone who might have HIV infection. So decisions about how these vaccines get used is really a complex question that involves safety. This is where the US 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 vaccine. I remember as a child getting the oral polio vaccine on the sugar cube when I was in I think third grade, and that that campaign is being was and would be again, would be overseen by the Centers for Disease Control because they make federal policy for how vaccines are implemented.
Speaker 4 (00:21:51):
And I think the critical points that we need to keep as guideposts are we are moving quickly and the American people need to understand that the vaccine has to really hit three different guideposts. One, it has to be safe first and foremost. Two, it has to be shown to be effective and three that need to be acceptable. I would say that from a bioethical standpoint, if these studies will be done against a placebo, I think in general in clinical trials, the people that were involved in the placebo arm usually are offered to get vaccine earlier than others. But at the end of the day's, a complex question about who gets the vaccine and it's going to be based on who needs it the most in terms of safety and in terms of what risk they face.
Speaker 7 (00:22:45):
You mentioned the testing. So basically same question about the testing, mark. General Mille has said that the Army was 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 frontline US troops, and when do you think that capability will be available to the broader public?
Speaker 2 (00:23:14):
Yeah, so I can take that one and certainly when you look at the testing that's in place now using the different platforms that 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 a hundred percent effective. You've heard reports about false reads 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 then 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 go forward. I'll stop there, but certainly our team at R 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.
Speaker 2 (00:25:06):
Great question
Speaker 9 (00:25:07):
Synopsis. Thank you. 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?
Speaker 2 (00:25:23):
Hey, thanks Ellen. And I was hoping you'd ask that and I want to turn it to Colonel Cox and John Dye over at RA lot going on a lot of exciting work 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.
Speaker 10 (00:25:49):
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. And 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've been 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.
Speaker 10 (00:26:46):
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 into a infected person. So 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 usam 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 things like hydroxychloroquine, rem, desi, this was actually the way REM DESI severe 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 USAM and MRDC and rare 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 Usam has been focusing on. And we've been not only using our in the dish approach with virus, but also we've been developing animal models to allow the testing of the product in animals as we move forward. Those emergency use therapeutics in humans into phase one and phase two clinical trials.
Speaker 1 (00:28:37):
Okay, thank you. Army Magazine,
Speaker 11 (00:28:44):
If they're not on, this is Tara from McClatchy. I would love to ask a question.
Speaker 12 (00:28:49):
Okay, go ahead Tara. I'm sorry. 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.
Speaker 1 (00:28:56):
Go ahead. We'll get to you next Tara. Go ahead Dina.
Speaker 12 (00:28:59):
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 and shift? Could you describe the level of activity at the Army lab?
Speaker 2 (00:29:22):
Thank you. I certainly can. So as it pertains to vaccine specifically, the two labs represented the day are doing the bulk of the work. Yes, army Medical Institute of Infectious Diseases and certainly our Walter Reed Army Institute of Research. It is 24 7 and there are various aspects of the lab work. We mentioned some of the animal research that's ongoing, the different types of vaccine development at rare, certainly using the patented adjuvant that Kon Magrid 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 US 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 rare, we talk about warp speed and making that our number one priority. That's been ongoing for quite a few weeks now. Thanks for the question.
Speaker 12 (00:30:56):
How long does it normally take to develop a vaccine like this?
Speaker 2 (00:31:01):
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 Rare, 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 that 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 Rare and 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.
Speaker 4 (00:31:46):
Okay, I'll give the 35,000 answer then let Kayvon come in on the treetops. But so let me start by saying that I've been trying to make an effective vaccine against HIV for 30 years and we've had some success in getting some glimmers of hope, but we are still putting significant amounts of efforts against that disease. That is an incredibly difficult problem. Historically, those timelines have gone 60, 70 years in some cases, but I think that 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's 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 there are 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 the modern era. But Kayvon I think has got some important anecdotes from Ebola and from Zika in our own experience within the MRDC family that I think are relevant to this situation. Kayvon,
Speaker 5 (00:33:16):
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 from the time that a new virus or new pathogen is discovered until a vaccine is developed over the past a hundred, 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 to decades to years and now potentially to months. The examples that Dr. Michael just alluded to with regard to Zika, our group at rare others of the NIH and industry went from the initial sequences of the new strain of Zika that was circulating in the Western hemisphere to a vaccine in humans in clinical trials in about eight to nine months.
Speaker 5 (00:34:34):
For Ebola, going from the first inhuman clinical trials to getting the vaccine license was about five years. So that was before Zika. It can go even faster. And there really are two things that limit how fast something can go. And I've said this before and I'm sure my colleagues are tired of this phrase that I say, but they're 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. And 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. As much political will and funding there has been towards developing an HIV vaccine has been a very difficult enterprise to get one that's effective.
Speaker 5 (00:35:34):
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 in terms of us being able to compress the timelines is overcoming some of the fire issues that we've had with other vaccine development with funding and coordination and making sure everything is streamlined. So 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 trials and potentially licensure is unprecedented. But in this case I think very much is possible over.
Speaker 1 (00:36:35):
Okay. Thank you. Go ahead, Tara from McCloskey.
Speaker 11 (00:36:39):
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?
Speaker 2 (00:37:03):
Hey Wendy, I'm going to let you take that one because certainly as we continue to work with whole of government and within DOD, we have projections absolutely. But I think it is important to weave in some of the aspects that have been named already with respect to risk and certainly K Vons analogy with man human in nature competing with all of those things. So Wendy, I'm going to let you give perspective on that one please.
Speaker 13 (00:37:36):
Okay, thank you sir. Appreciate it. Colonel Wendy Sims Jackson. So Dr. Michael has already alluded to the complexity behind the term access and what do we really mean by that? That can mean a number of things. And so I think what we can at least competently 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 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 under consideration in coordination with the CDC from a policy perspective, from the FDA, from safety perspective.
Speaker 13 (00:38:54):
And 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. And I know it's kind of a convoluted answer, but it's a very complicated question to answer because there's so many factors that come into play. But I can just tell you from that, that is a goal. That's the target that we're shooting for. And of course, back to Dr. Maja comments, science is kind of 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 pointed in the same direction that can make that possible.
Speaker 11 (00:40:08):
Thank you so much.
Speaker 2 (00:40:08):
Thank you, Carlos faus Jackson. And just want to reiterate with those goals, everyone who is part of this effort, within the whole of government warp speed and the various efforts, safety will not be compromised. So certainly getting the most efficacious vaccine candidate to the front of the line or across the line, incredibly important. But what we don't want to do is jeopardize safety for the sake of speed. Everyone's committed to that. Thanks.
Speaker 13 (00:40:44):
Okay, go ahead, Bloomberg.
Speaker 11 (00:40:45):
Oh wait, I had one follow up if that's all right. Okay. So just more science based, not timeline based, but 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?
Speaker 2 (00:41:09):
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.
Speaker 10 (00:41:22):
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 rare comment as well. At this point in time, we are still in the learning phases of this virus. Every time we think we have it cornered and we know exactly what the clinical signs of 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.
Speaker 10 (00:42:18):
So scientists around the world, including at Army and other armed forces laboratories are doing their best to keep up regarding the antibody test. 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 cannot relate back those antibody levels to some level of protection. Everybody wants to know if I have an antibody titer or an antibody level of X, if I come into contact with a 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, will 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 a learning phase and that's probably not a great answer, but that's where we are.
Speaker 1 (00:43:33):
Okay, go ahead, Bloomberg. Alright, how about CNN?
Speaker 14 (00:43:43):
Hi there, this is Michael from CNNI was hoping, I think it was Dr. Maja that mentioned that the candidate 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 weed a little bit about what specifically about that vaccine candidate is hoping to confer that lasting protection. I believe the target is the spike protein versus some of the other vaccine candidates and platforms that are being used.
Speaker 5 (00:44:19):
Yeah, thanks for that question, Yvonne. Go right ahead. Okay, thanks. Thanks for that question. A great question. So let me just, you convolute that a little bit that
Speaker 5 (00:44:35):
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 a little bit about the question that Dr. Dai 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. So most of what you see out there in the landscape, whether it be the top four that operation warp speed prioritizing, or the second tier candidates, they're all have some insert and insert, almost all of them is spike. The difference is the vehicle in which they're delivering that spike.
Speaker 5 (00:45:55):
And for those you have to keep changing it in and out. For ours right now, our particle is just presenting the spike protein, but it's presenting it multiple times about 24 times around the particle. It's like a soccer ball in terms of its imagery. It's 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 the 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.
Speaker 1 (00:46:52):
Okay, go breaking defense.
Speaker 15 (00:47:08):
Lost
Speaker 1 (00:47:08):
A couple Hertz Television.
Speaker 16 (00:47:12):
Hi there. Mark Albert here. Thanks very much for doing this call. If we could just stay on that, that's 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 option for still images video that would really help us to tell that story. And then I'm curious on that development, what does that human trial this in late summer or so look like? Is that using, as you sort of refer to that standing army of vaccine testers that NIH has? Or are you going to be assembling a new sort of army for that?
Speaker 2 (00:48:12):
Yeah, so a lot of efforts going on, certainly as we begin planning for first in human trials and certainly some are beginning now. And essentially when you're looking at the different types of trials, so phase one, certainly representing a smaller population and when you jump all the way phase two, which potentially could be a thousand, and then up to as many as 30,000 for a phase three, certainly the planning efforts that are going into that are going to take certainly a whole of government approach and the solicitation for volunteers. Colonel Salmons 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.
Speaker 13 (00:49:10):
Could you just elaborate a little bit more on the second part of your question?
Speaker 16 (00:49:16):
Sure. I was just curious if you could provide more detail on what steps will be taken here late summer. You mentioned the first human trials and I am just curious, are you going to have to assemble a new army of these vaccine testers, the humans that are going to be taking this or are you using that existing army of folks that you were talking about earlier, the clinical trial networks? I'm just kind of curious in more specifics on what you're standing up. This human trial this late summer will look like. Please.
Speaker 13 (00:49:46):
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. And certainly the capacity depends on the stage of capacity requirements, depends on the stage at which we are 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 capacity requirement for testing initial safety and then expanding upon that. It's more 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 this is where 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 then I'll hand it off to Nelson to expand on that.
Speaker 4 (00:51:09):
Alright, thanks Wendy. Yeah, no, I think you said that 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. If you'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 a 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 ChatOps.
Speaker 4 (00:52:15):
But then as these trials begin to execute as the summer rolls 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 DC and seeing how we can leverage and develop new capacities in Prince George's County if you want to keep it local here in the United States and in the Washington DC area. So at the same time, we are staring at real time analytics, literally looking at zip code and level data about new cases of where covid is 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 the vaccine in thousands and thousands of people and not getting any signal.
Speaker 4 (00:53:18):
So we need to figure out where really to put these new resources and we're meeting literally every day, and I include Saturday and Sunday, there's no such thing as a weekend anymore. In these 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 Reader Army Institute of Research or rid, which have clinical trial capabilities can reach out within 30 to 50 miles and develop some new ones with academic groups that are good but maybe haven't been doing this 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 the service departments as well as DOD for how this could look as we use our military treatment facilities, Reed hospitals and clinics across the United States and elsewhere.
Speaker 4 (00:54:12):
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 trial center at Walter Re Army Institute of Research on Wednesday. And we're going to walk them through what it takes to do the actual mechanics of vaccination in 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. And our general is who on this call is actually a medical logistician. So we're comforted in the fact that we have some very, very senior people. 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 few trials, but by the time we get into 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.
Speaker 4 (00:55:12):
And the good news is 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 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 that 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 it's, 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.
Speaker 17 (00:56:20):
Thank you.
Speaker 1 (00:56:23):
Okay, we're at defense media activity. Okay. Anyone I missed? I went through the list so we might've had some late
Speaker 18 (00:56:37):
Sorry. Sorry, I missed your roll call earlier, Amanda at TMBC. Oops, sorry.
Speaker 1 (00:56:43):
It's okay. Okay, go ahead. CN BBC your turn.
Speaker 18 (00:56:47):
Hi. I was just wondering if you guys could give me a little bit of what kind of piggy bank you're sort of working with in terms of finances. Do 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 nations are rushing to develop a vaccine since this is a global pandemic.
Speaker 2 (00:57:19):
I can take that one. It's 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 Sams Jackson going back to January with the first bolus if you will, or apportionment of funding work 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 shared resources. So we are in good shape for this whole of government effort with respect to intellectual property. Again, not concerned about that. And we have an embedded, certainly directorate within MRDC that ensures that intellectual property is protected. Dr. K 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 and as we go forward, certainly we'll continue to watch it and keep all updated. Thank you for the question.
Speaker 18 (00:59:09):
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?
Speaker 2 (00:59:16):
Well, I'll speak for what's been publicized for the whole warp speed effort and well-publicized as to what's been funded, 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. Thank
Speaker 4 (00:59:42):
You. Thanks for the question.
Speaker 2 (00:59:44):
Who else did I miss?
Speaker 19 (00:59:46):
John Harper with National Defense Magazine.
Speaker 2 (00:59:49):
Okay, go ahead.
Speaker 19 (00:59:51):
I was wondering what lessons have you learned from this current crisis that you think you might apply to future pandemics or future outbreaks? And is there anything that you don't have currently that you would like to have to deal with viruses in the future?
Speaker 2 (01:00:15):
General tally, I'm going to start off and then pass it around to these great scientists on the line who for them it is not their first rodeo part of the fund. But what I see the way the whole of government efforts 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 it was Dr. Maja 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 10, 20 years, this is not our first coronavirus or type of vaccine or type of disease outbreak we've had to deal with.
Speaker 2 (01:01:30):
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 can 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 Rare and let you hear from the folks that have been doing this for a long time.
Speaker 4 (01:02:06):
Alright, yeah, Jim, this is Nelson Michael. I really want to set up Cavon for this and I think you'll see why. When we did our response to Zika, we went literally from conception of 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 that 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 people you worked with were HIV people said, how'd you do that? Did you do it based on structure or did you do it based on bluster? And I said, well, I'll be honest with you, a lot on bluster. And we didn't really weren't set up for that.
Speaker 4 (01:02:54):
And she said, that's not the Army way, Nelson. You're going to have to rethink this. And so under her direction, she's now General's chief of Staff, Colonel Whitmer. We set up the emerging Infectious Disease branch. We set up a brand new unit within the Wall three 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 major from the national Dr. Fauci team. And unlike me, Kayvon is actually an expert in respiratory viruses, especially Coronaviruses. So we did predict that this was going to happen. Kayvon, let me use a slide that is in Korea in September of last year, which basically showed SARS and then Mers and then showed a next question of when the next one's 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 lemme let Kayvon describe what I think his vantage would be, what we do from now on over.
Speaker 5 (01:04:04):
Thanks Dr. Michael and for the kind words as well. So those of us in this space in infectious diseases, emerging infectious diseases, were 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. 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 sixties, 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 high policies as to why that is. We're much more hyperconnected than we were before. We have a lot greater interface with animal populations than we had before.
Speaker 5 (01:05:21):
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, we 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 Zika vaccine, which we're beating those records now. But even with that pace, we all started our vaccine programs 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.
Speaker 5 (01:06:28):
We've already prepared for anticipate and develop 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, flavia viruses that we know generally what's coming in terms of the family of viruses. And we have the tools to be able to anticipate though it's just a matter of changing our posture from one of response towards prevention over,
Speaker 2 (01:07:30):
Hey, thanks Daveon. Jim Tally, 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 Sams Jackson, and this will be her last time in uniform in this particular form. So Dr. Dye over to you. And then we'll close with Colonel Wendy Sams Jackson.
Speaker 10 (01:08:04):
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 K von is a hundred percent correct, there's a handful of viruses that were identified by the WHO in 2014 after the Ebola virus outbreak. Basically a top 10 list of the most likely to develop pandemics and there's really only five or six viral families. And if you start to capabilities against those viral families that can then be juxtaposed against those new variants that come out, you then have that capability. So it is 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.
Speaker 13 (01:09:35):
Go ahead, Colonel Jackson. Okay, thanks. Hi, Colonel Simmons 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 and working together during that. And 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 time in these types of situations. And one is what we certainly recognized is that we desperately needed a structure in place to coordinate communicate across DOD and across US government. And that's probably easier said than done, but it's critically important to increase the efficiency of effort. If we are able to share information, develop a common strategy, and coordinate the efforts along the lines of efforts along a strategic plan perspective, that would be really beneficial to the response that we've learned each time.
Speaker 13 (01:10:57):
From that, you're seeing that in action right now with operation warp speed, for example. The second point is from a programmatic perspective, which is the space that I operate in, we recognize we had 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 rare did is we created from a program perspective, an emerging and infectious diseases program area that would enable us to have the ability to rapidly shift resources towards that priority effort where we've had, historically our program has been very pathogen specific focus 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.
Speaker 13 (01:12:28):
Maja, it'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 US government, those are the two areas that I definitely, we've learned lessons, we have shifted and I think 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.
Speaker 1 (01:13:17):
Okay. 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 email me. I'm Laurie Salvatore. I was on the email that Will Sharp sent out to invite everyone. We also have B-roll and photos available at divid hub.net/unit/rdc. Feel free to email me and we'll get you everything you need for today. Thank you so much. Have a great day. Thank you.
Art for today: Sedona on a cloudy day, watercolor from my travel book.
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