COLONEL KATHLEEN TURNER: Good afternoon, everybody. Thanks for coming to our press briefing on the Army support to vaccine development. My name is Colonel Kathy Turner. I'm the director of the Army Media Relations Division, and I will moderate today's session.
The following senior leaders will be on -- are on today's panel. We have Brigadier General Mike Talley, commanding general of U.S. Army Medical Research and Development Command in Fort Detrick; we have Colonel Wendy Sammons Jackson, director of Military Infectious Disease Research Program, U.S. Army Medical Research and Development Command; we have Dr. Nelson Michael, director of the Center for Infectious Disease Research, Walter Reed Army Institute of Research; and we have Dr. Kayvon Modjarrad, director of emerging infectious diseases, Walter Reed Army Institute of Research.
Today's discussion is on the record. After Brigadier General Talley's opening remarks, I ask that you limit yourselves to one question and one follow-up until we have gotten around the room, and then we'll continue to field questions until we are out of time. We have about 30 minutes today.
And with that, I'll turn it over to you, sir.
BRIGADIER GENERAL MICHAEL J. TALLEY: Good afternoon, and thank you for participating in today's briefing. Our hearts go out to those that are affected or know someone who's affected by this disease.
Emerging infectious diseases like coronavirus, or COVID-19, are why a global network of military infectious disease surveillance laboratories exist around the world. Military medical research is a force multiplier designed to support the service member and the public in every conceivable circumstance. Through both emerging science and technological advances, the United States Army Medical Research and Development Command is on the forefront of delivering medical capabilities faster and more efficiently than ever before. We are supporting a whole-of-government approach to detect, prevent and treat COVID-19, and when it comes to infectious disease threats, we have extensive capabilities and an international research infrastructure already in place that allow our scientists to anticipate and develop countermeasures against emerging infectious diseases.
COVID-19 is the infection caused by the SARS-CoV-2 virus, and this is familiar territory for our team. Our labs have previously studied SARS and MERS, both of which are coronaviruses. They're in that same family. Our researchers and scientists at the Walter Reed Army Institute of Research conducted the first in-human Phase One trials of the MERS vaccine. That's the only MERS countermeasure and only the third coronavirus vaccine ever tested in humans, and we're building upon that science for COVID-19 solutions as we speak right now.
Just this week we were able to develop new versions of COVID-19 candidate, one of the first candidates that we've tried, and we initiated research to determine if there is a response to the vaccine. Again, this is just one piece of the solution. There are other vaccine candidates being developed by other organizations, but we're all working toward a solution, and we want to get it done as quickly as possible, and we're doing this in a whole-of-government fashion and certainly, a whole-of-DOD fashion.
In addition to vaccine prevention, we are also exploring treatments. Efforts are ongoing right now to identify new drug candidates to respond to the COVID-19 infection. A cooperative research and development agreement with an industry partner is under review for the DOD to gain access to an antiviral drug for treatment use in our medical centers, our military treatment facilities.
So together with our United States government partners, we are progressing at very fast rates, revolutionary rates almost, a constant effort, and this is in order to deliver effective treatment and prevention products that'll protect the citizens of the world and preserve the readiness and lethality of our DOD's service members.
I want to thank you in advance, but I'd also like to tell you a little bit about -- about my teammates here.
So Colonel Dr. Wendy Sammons Jackson is the director for our military infectious disease research portfolio. She dual-hats as the joint program committee director for the entire DOD. So when you're looking at the capabilities and capacity within the Medical Research and Development Command, the demand signal is coming from all over the joint forces. She's managed that portfolio for the last two years, and when you talk about some of the most recent accomplishments with MERS, with Zika, she has been involved in all of those things.
Dr. Nelson Michael, about 37 years of experience. We talk about some of our -- our latest successes with MERS. Both he and Dr. Kayvon Modjarrad have been at the forefront. For example with ZIKA, very proud to say that within nine months, this is the team that was able to start the first in-human clinical trials, and in December of 2019 the Ebola Zaire version vaccine was given full FDA approval. These two gentlemen played a big part in that.
Dr. Kayvon Modjarrad, again, having been the scientist behind a patented adjuvant that's designed for this same family of diseases. It's an adjuvant that's being used right now, being shared with our -- with our whole-of-government partners. We were lucky enough to be able to recruit him from the World Health Organization.
So when you look at the scientists that -- that we recruit and train within the DOD, they are some of the top scientists in the country. We’re very proud to take part in this effort, and we look forward to your questions.
COLONEL KATHLEEN TURNER: Lita?
Q: Hi. Lolita Baldor with the Associated Press. For whoever this applies, just on the vaccine, can you talk a little bit, just more detail about the vaccine, your work that's being worked on. Is -- is it different than NIH's approach? And how soon are you to -- for, like, a phase 1 trial? And then I'll just throw the follow-up out just in case that's easier. The rapid diagnostic that is being worked on, can you talk a little bit about that, and how, sort of, where you are in the rapid diagnostic tool, and how soon that might also be available for -- for testing?
DR. NELSON MICHAEL: Yes, ma'am. Let me... let me take the first two questions quickly and turn it over to Dr. Modjarrad, who can talk about some more granular aspects of this vaccine.
First thing that I want you all to know is that the Walter Reed Army Institute of Research has been around for 127 years. A lot of people like to ask, "Well, why is the Army involved in vaccine development?" We've been doing this for an extremely long period of time.
Two is that we work very closely in the interagency space. The -- my first rater in the Army, I recently retired, was Bob Redfield, who's the CDC Director. My second rater was Debbie Birx, now the Global AIDS Coordinator and running the COVID response under the Vice President. Dr. Fauci, he retired me about 18 months ago.
We work very, very closely in the interagency space and with the vaccine that I'll let Dr. Modjarrad talk about. We worked with Dr. Fauci's team to find a vaccine candidate that was scientifically not duplicative but mutually supportive of what others were doing but also made sense. We ended up moving on two different vaccine platforms in coordination with Dr. Fauci and his team.
I’ll let Dr. Modjarrad tell you a little bit more about that.
DR. KAYVON MODJARRAD: Thanks for your question. So from the first day that the sequences of the new viruses were published, we were working on this vaccine and we were doing so in coordination with our interagency partners at the NIH, specifically the Vaccine Research Center, where the President was visiting just a couple of days ago and which is a place that I came from, where I trained under Dr. John Mascola and Dr. Barney Graham there, and I have been in constant communication, very much like we did for the Zika vaccine, where the NIH and Walter Reed Army Institute of Research had two complimentary approaches towards a vaccine candidate for Zika.
Here, again, we're taking a platform that actually has been used in clinical trials so far for influenza, a different respiratory virus, and focusing on a component of the virus that a lot of groups are working on but with a unique platform and a unique adjuvant, which is a chemical that is used in combination with vaccines all of the time to enhance their immune response. And that adjuvant is actually patented by the Army.
So we see this as a unique and complimentary approach that is non-duplicative, that is being coordinated as part of the whole of government response.
DR. NELSON MICHAEL: I know you asked a question about the point of care testing. Fortunately -- I think we have the world's leading expert in infectious disease diagnostics, who just happens to be at the Walter Reed Army Institute of Research, Dr. Sheila Peel. Sheila has been working on HIV almost her whole professional career and there isn't a single HIV rapid test that's out in the market that hasn't, at some level, passed through her hands.
She's our lead for looking at the diagnostics that are currently being used to test whether someone's infected or has been exposed and I can tell you that, for now, most of those tests are based on the detecting of the virus itself.
Developing a test like a -- pregnancy test -- that you might be familiar with is requiring a different kind of technology. Sheila is already having those discussions. I think what you're going to probably see is much more sophisticated higher throughput test that initially would be done in laboratories and then as time goes on, that technology will then roll out to established platforms to allow these tests to be used more at the point of care.
Q: Do you have a sense on when -- when you'll have a test ready to roll out? Do you have a sense of any timing on that and do you have a sense on whether this vaccine, when that would be -- have you started testing it on animals or -- or have you -- the phase one time -- trial -- do you have timing?
DR. NELSON MICHAEL: As far as the diagnostics are concerned, there are large and very confident commercial companies that are looking literally in the next month or two to be able to convert the current tests that are relatively slow to execute and you can only do a small number of samples at a time, to being able to do these on very robust machines that could execute up to 800 tests per eight hours, which is a standard work shift.
Those are the kinds of approaches that industry has already done. We do HIV testing, at our laboratory in Silver Spring and we use those kinds of instruments. They can be adapted for other technologies.
I’ll let Dr. Modjarrad talk about where we are in terms of stages of development pre-clinically then into the clinic for a vaccine.
DR. MODJARRAD: So if we think about vaccine development at different stages, the first stage is the design and the discovery to decide what is going to be your candidate. We've completed that and we have gone into small animals and we're looking at what the response is to that vaccine.
As far as a timeline to getting into humans, I wouldn't want to speculate too much on that. I think the important thing to consider also is that beyond a Phase One study, there's the second phase, which is often times looking at a larger population, at the safety and the immune response, but also then transitioning to see if it's effective in populations.
What I think the field is trying to do is position itself so that if there's a second wave during the next season in the winter, then those candidates have made it through Phase One studies to be ready to look at the effectiveness during the next season.
COL. TURNER: So let's go over to Caitlyn and then we'll come over to Tara.
Q: It's a question/request. With describing, like, the vaccines, can you be a little bit more broken down in terms of language about what you're talking about? Cause you're talking about candidates, which -- what does that mean? What does it mean for vaccine platforms? Just so that when people -- so that we can communicate best about what you're kind of really talking about.
DR. MODJARRAD: So think of the virus, as my fist, it's a sphere. And it's got little spokes coming off of it. That makes it the corona. When you look at it on cross-section, it's got that crown look to it.
So almost all of the vaccine candidates out there are focused on that little spike -- the spike protein. And there are different parts of that spike that mediate the attachment of the virus and the entry of the virus into our lungs.
So if you block that attachment, if you give a vaccine that trains and educates your immune response, your immune system to recognize that part of the virus that attaches to your cells and blocks it, that's going to be a good vaccine.
So what's a candidate, then? Candidate means that you're looking at options, you've got different options. That's your different candidates. And you look to see which of those options looks best in animals before you go into humans.
As far as a platform -- you have that little piece of the virus that is going to be the part that educates your immune response but you need to deliver it in something to the body, you need to get it expressed in your body and there are different ways to do that.
You can have it on a nanoparticle, basically another sphere that kind of looks like the virus. You can have it in DNA, that goes into our body and our cells express that.
The Moderna vaccine that you've probably heard about, in collaboration with the NIH, is mRNA. It's a different kind of thing, like DNA. That's the platform part, it's the part that expresses that candidates that we're trying to find out how good it is.
COL. TURNER: Thank you for asking that question. We are going to Tara and then we'll head back over --
Q: I'll say thank you too, I was about to ask something kind of related, but tied to that, could you talk a little bit about what your scientists are actually doing in the labs? Are they working with test tubes, are the -- did they actually get samples of coronavirus from someone who was infected. How -- how did they do this.
COLONEL WENDY SAMMONS JACKSON: Our scientists are doing a number of things right now. There has been receipt of the virus in one of our laboratories and they're currently culturing, growing that virus, so that we can have stocks available for a number of things, to test products with, they're also doing characterization of the virus to learn what we know about the virus and how the virus impacts the host and our immune response to that virus.
The scientists in our laboratories are, yes, using test tubes, pipettes, they're running cell cultures…I can let the scientist that are doing the hands-on work talk a little bit about that.
GEN. TALLEY: One of the laboratories that received the samples that Colonel Sammons Jackson mentioned, is the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick.
If you think of the movie Outbreak and the suits that they wore in that highly contagious environment, without all of the drama of the movie, certainly, but that capability exists within military medicine. And that particular laboratory is the DOD's only biosafety level four laboratory.
That type of work, and we're not there yet with coronavirus, is where we would actually bring it into containment laboratories to test it at higher levels. Not there yet, but that's what the laboratory work looks like.
COL. SAMMONS JACKSON: The Medical Research Development Command is really fortunate, because we have a very unique national assets, as the General mentioned, in the U.S. Army Medical Research Institute of Infectious Diseases, for biosafety level 3, which is what the current virus is required to be handled within, and biosafety level 4.
Those scientists are a critical asset and those scientists are actively working to investigate the virus.
In addition, we also have the Walter Reed Army Institute of Research, who are working biosafety level 2, doing the discovery work, some of the most brilliant minds in the world in infectious disease research.
We have a very robust science and technology platform. In addition, we also have the capability to take products from the science, from the prototype level and move it into advanced development, which is required in order for us to move into manufacturing and commercial utilization.
Within MRDC as a whole, we have the entire pipeline for developing products.
Q: And just super quick follow up, where did the sample come from, the coronavirus sample you're working on.
COL. SAMMONS-JACKSON: The CDC.
Q: Ok, but it's no geographic area that can be identified of where the infection was. Was it from -- you know did it come from China or --
UNKNOWN: It came from a U.S. patient.
UNKNOWN: Yes, in Washington State.
(CROSSTALK)
COL. TURNER: So let someone get some more questions in. So let's go to Phil.
Q: So just to get a clarified (inaudible) on the rapid diagnostic that (inaudible) asked about. What -- first of all, you said -- if all (was ?) clear you said it'd be about a month or two months before you think such a diagnostic would exist.
DR. MICHAEL: No. Industry right now is taking the very robust platforms they have been using for a long time to do testing for other infectious diseases and are adapting those for testing of the -- for the coronavirus too.
The point of care test, if they're going to be actually detecting the virus itself, it's trickier to take that kind of technology and then make it really small.
We are not involved directly in those efforts. We're aware of those research projects to advance a point of care test, largely for infections like HIV. That's the sort of test you want to be able to use in the field, it’s the same mind set we have in the military to have those types of tests available in rucksacks.
I don't want to give you the impression that that's going to be available any time soon. Clearly what we're focused on is the more complex laboratory tests. So that in those situations where the patients are coming to a central place, having the high throughput test makes sense. If you're talking about people that want to go detect in less dense populations, that's where the rapid or point of care test will be important.
Q: So then are you preparing yourselves for the possibility that the military is going to have to test military patients. I mean its large-- a very large community and when you think about all the people around the world, you know, it's unlike that the civilian capacity would necessarily be there (inaudible).
COL. SAMMONS JACKSON: Absolutely.
Q: What does that look like? I mean like right now my understanding is there's only a small number of kits that have been distributed to a very specialized, about a dozen or so labs, so what is it -- what does that look like when you're talking about getting ready for testing over a million people maybe potentially in the U.S. Military.
COL. SAMMONS JACKSON: So the goal and there are multiple approaches, the goal is increased capacity. And as Dr. Michael mentioned, one way to do that is to develop these high throughput tests and place them in critically strategic regional areas so that we can increase the throughput of the diagnosis.
Another approach, as was mentioned before with the point of care, is actually reaching further out into the environment to be able to test rapidly as an initial screen.
There are multiple approaches within the Army and across the DOD and the U.S. government as well. Certainly critical in each one of those approaches is our industry partners in this to be able to take a product and develop it and commercialize it. So we are working with a number of partners and providing the support within the laboratories to help develop those capabilities.
COL. TURNER: Thanks.
Let's go to, Lucas. And then we'll hit Courtney, in the back.
Q: Lucas Tomlinson with Fox News. In your modeling, how many U.S. military service members are going to contract the coronavirus?
GEN. TALLEY: That would be speculative, sir, not -- I don't think we have done any estimates on that.
DR. MICHAEL: The General is 100 percent right. We don't have any data right now, but we're beginning to work with partners who have gotten pretty sophisticated in modeling infectious disease outbreaks.
The problem with models is that they are only as good as the data that you have, right? So we're beginning to coordinate with really good modeling groups to be able to ask questions in areas of the world where the virus is already spreading very quickly. We have good epidemiology data that will allow us to inform those models and give us some prediction.
So again I will say that we have to be careful with these models – sometimes they can look really bombastic but they're only as good as the data that goes into them.
GEN. TALLEY: The current assay, or test, I think the throughput is around 60 patients every eight hours. So when we're looking at volumes or what we are trying to get to for detection capabilities, our goal is anywhere from 275 to 500 every eight hours.
If we can increase the throughput, when you're talking about a large number that would be affected -- take the military, for example -- we're developing things in the event that were to happen, and that goes for any population.
COL. TURNER: So I'm going to go...
DR. MODJARRAD: I would add, General Talley is correct in that any kind of numbers are speculative.
However, we have epidemiologists at our institute working with others, modelers who do this all the time at the Defense Threat Reduction Agency, DTRA, who respond to all the requests of all the different geographic combatant commands. And we have been working with them for the past few weeks, initially based on assumptions but now, on real life data to refine those models.
So this is something that we're working on, but can’t speculate and give you any specific numbers.
Q: (OFF-MIKE) And just one small thought, what is the earliest that a vaccine would be ready for a U.S. military service member?
DR. MODJARRAD: So again, it depends on what you're talking about in terms of “ready”. When we go into Phase 1 clinical trials, the volunteers who are involved in those trials are a mix of civilian and active-duty populations. As you go further on, there is -- in discussions with our partners and our military treatment facilities -- the potential to have them involved in clinical trials.
As far as licensure, whether you're talking about Emergency Use Authorization or full licensure, Dr. Fauci's comment that he's stated over and over again is really the benchmark we should use. The earliest -- probably 12 to 18 months to get something out to the populations, that would be civilian or military populations.
DR. MICHAEL: The science can go very quickly but, first, do no harm, right?
Obviously there are vaccines that can cause harm and provide benefits. So that mixture is something you always have to look at.
And so part of the hesitation to say, oh, well we can get a vaccine quickly, is you need to make sure that it's really safe. If you test the vaccine on 1,000, but 1 in 10,000 people is going to have something terrible that happens, until you get to those numbers you may end up doing mass vaccination campaigns with a vaccine that could cause a significant amount of problems. So you -- this needs to be a constant reassessment of the risk and the benefit.
The other thing I would tell you -- and this is a really good benchmark -- we were the first people that tested the vaccine that eventually got licensed by Merck to -- for Ebola. OK? That vaccine was first tested by the Walter Reed Army Institute of Research. Five years later, it was approved by the U.S. FDA. In the meantime, a half a million souls were vaccinated with it, largely in Africa, especially during the outbreak in the Democratic Republic of Congo.
So again, that was a risk-benefit assessment. The leadership in the DRC said, OK, we know it's not approved yet by European Medicines or by the U.S. FDA, but we have a terrible outbreak of Ebola which is highly fatal. And so decisions were made to use that under emergency use authorizations. And so, you know, there's always that kind of debate but just -- I think that's a good benchmark for vaccines.
Let me also say that, we haven't really talked much about this, we are beginning to make other countermeasures, and one of those are monoclonal antibodies. So antibodies are a part of our immune response. You know, it’s part of the way the body tries to push infections back.
But we can actually make these in test tubes and these are becoming a much more common tool that are being used, especially in the fields of oncology but increasingly in infectious disease. So instead of actually waiting for a vaccine to be made, giving you that vaccine and waiting the time it takes for it to develop the immune response, you can give -- with these kinds of reagents, you can give almost immediate protection.
So we're literally in the process now of beginning to take those first baby steps, as well as looking at -- at -- we talked about one drug. The general talked about that one drug that's currently being repurposed and has been looked at for Ebola and now is being looked at for CoV-2.
But there are other small molecules that could be discovered. And one capability that we have at our institute is every malaria drug that's ever been discovered has at some level gone through the Walter Reed Army Institute of Research. So we have a really good drug discovery program.
And so, we're looking for other kinds of drugs that might be lead candidates in partnerships with the pharmaceutical industry that we could bring those to bear, so vaccines, monoclonal antibodies, and small molecules -- drugs that could be brought to bear.
So we don't have one theme in play, we have actually a number of themes in play and all of these are being coordinated very closely with our partners either in government, or in academia, or industry.
COL. TURNER: Thank you, sir. I want to try to get a little bit more questions out there. So Courtney, we'll go to you.
Q: Courtney Kube, of NBC. I want to ask a couple of clarifications, so when you're saying that there's testing going on in mice, you mean -- you're not saying that they're being injected with the coronavirus and that -- right? OK, I just wanted to be sure of that.
DR. MODJARRAD: That's just injected with the vaccine, candidates -- those options.
Q: They -- the body...
DR. MODJARRAD: To see how the immune response -- yeah, to see how it responds to the vaccine, not the virus.
Q: OK good, I just wanted to be sure of that. And then, I was a little unclear, Dr. Michael when you were talking about -- you were talking about potentially rolling something out the next time that -- the next season, which I assume would be fall-winter, or maybe it was you Dr. Modjarrad, forgive me -- of the next season, but I don't quite understand what that was you were hoping of rolling out.
DR. MICHAEL: So that's a really important question too -- was there a third?
Q: The third one was just about the production...
COL. TURNER: Let's keep it at two.
DR. MICHAEL: OK.
Q: Yeah, I think you kind of answered the other ones so if you could do those two that'd be great.
DR. MICHAEL: So this is a respiratory virus and they always give us trouble, you know, during cold weather. For obvious reasons we're all inside, and windows are closed et cetera. So we typically call that the influenza, or flu season.
So our expectation is that this virus, like every respiratory virus, is going to be less troublesome for us as the weather warms up, and that's going to be true across the globe. But our experience -- and most of our experience comes from influenza which is sort of the -- you know, the enforcer, the king of respiratory viruses.
But we know a lot about that, and our experience there is that every flu season equals -- you know, when the weather gets cold again this is when these viruses tend to come back. So this is why it's really important to understand that a lot of what we're doing now is really getting ourselves ready for what we're calling the second wave of this.
We hope that that doesn't happen. If you remember SARS -- SARS came and went very quickly. And you know, I really hope that happens again, but we can't count on that -- we have to be ready even if this epidemic begins to wane, we have to be ready for next winter when it may come back again.
Q: I'm sorry, I still don't understand what it was that you were hoping to roll out with the next wave...
DR. MICHAEL: Well -- so we're saying that as we begin to develop any of these countermeasures we're talking about: monoclonal antibodies, drugs, vaccines that even if this disease abates over the next few months, we're very concerned that it will come back -- and may come back again in the next flu season. If that's the case then in the meantime we've been working steadily on these countermeasures so that they'll be ready if there's a next time.
COL. TURNER: Thank you. So let's do...
Q: Thank you. I also just have a couple of clarifications, so hopefully this will go quick. But following up with her, just to reiterate -- so you're testing in small animals -- mice now, you're testing the candidate.
And then you had said something about the second phase was looking at large populations of mice, would that be -- I mean, large populations of mice, or would that be of something else that you said that -- thinking about this next phase in the winter -- I'm not quite sure what's going on.
DR. MODJARRAD: Ok, so I'm just going to break it down again in terms of what are the general phases of vaccine development. First you decide down at the atomic level what your vaccine is going to be. And then you have your best guess, and you have a few different options as to what that will be.
Then you test all those different options in mice, meaning testing -- give them the vaccine and see what kind of immune response they have. Then, typically you go in to larger animals like monkeys, that's typically the case.
This is a new virus, we don't know which one of these animals is the most relevant one to humans. You know mice are mice, mice are not humans, right? Monkeys may be a little closer to humans.
And then you go in to humans, and when you go in to humans in that first phase you're just, again, looking at the safety of your vaccine and the immune response -- you're not looking at if it's effective against -- to protect you from the virus.
The next phase is where you look at larger numbers of people for safety and immune response again, because the first phase in humans is just a few dozen people -- now we're talking hundreds to thousands. And you start looking at is it protecting against infection? And you need to have large numbers of infections going on to be able to know whether or not it's protecting against that.
So that's why we anticipate, potentially if there is a second wave we've got to be ready -- make it all the way through those first studies on the animals, and the safety, and the immune response so we're ready in position and ready to go if this comes back and there are a bunch of infections so we can know is it protecting.
Q: Ok, so you're planning to be at that second phase of humans by next winter, just -- that's where you are -- Ok, just wanted to clarify that. And then the other thing I wanted to clarify is that you said you had a candidate that was complimentary but not duplicative. What exactly is the candidate? I know you talked about spokes -- are you too focusing on the spoke of the virus?
DR. MODJARRAD: Yes we are.
Q: But that's just what NIH is also working on -- so everybody's working on the spoke right now, just different...
DR. MODJARRAD: Different ways, different parts of the spoke, or different versions of it -- and then different ways to express it. So as I said, there is different ways -- so there is a DNA platform we can express, there is the MRNA that (inaudible) is doing with the NIH.
They are just using the protein itself, it's using it -- putting it on a nanoparticle protein. So there's different versions of the vaccine, and different ways to present it to the immune system.
COL. TURNER: So I know we're at 10 after right now, so we'll hit (Inaudible) and we're probably going to wrap it up, sir, if you (inaudible).
Q: Thank you -- and thank you all for doing this. One question for you, General Talley, last year in the fall Fort Detrick, the Research Institute had to pause testing for some safety concerns -- can you go in to what has been done since then to sort of make that a nonissue? And then, also I know that (inaudible) has gone over, you said different SARS and -- different strains of this, what makes this different from the previous strains that you've been looking at? And how have you kind of noticed such (differences ?) in how that will effect the vaccine that you're developing?
GEN. TALLEY: Yes, absolutely, I appreciate the question. Yes, so United States Army, Medical Research Institute of Infectious Diseases -- and that's the BSL4, biosafety level 4 lab that I mentioned.
But on the 18th of July of 2019 they were issued a cease and desist order by the CDC, violations because of improper practices -- all resulting from a number of structural defects -- they developed work-arounds that just were not safe. There was never any danger of risk to the community, or breaking the containment which is what the labs are for.
Since then, I am proud to say we worked very hard to come back and meet CDC regulatory standards. The CDC came back for a re-inspection after about a 90 day plan of action and milestones -- very aggressively went after that. And the CDC restored the laboratory to a limited operational capability, limited in that the same volume that the laboratory had been become accustomed to, through-putting much -- much smaller levels, and then certain types of testing.
As I mentioned, BSL4 being the highest type of Biosafety Laboratory 4 -- being the highest level. Not to that level, but probably a smaller level or a level just shy of that, where the most dangerous procedures weren't being done. This was in an effort to begin a gradual stand up of capabilities after being down for so long.
The CDC came back two weeks ago. First, two weeks -- actually, three weeks ago now, in February -- came back for a second inspection. This inspection was to allow even more capabilities, more capacity to be performed.
Again, proud to say a night and day difference according to the CDC and we were issued a letter to restore even higher level capabilities. That letter was issued to us just this past Friday. And so with respect to coronavirus -- and coronavirus is not considered a safety level type of virus that falls into the same category as some of the other higher types.
So we have full authorization to perform at the highest levels of scientific capacity at the laboratory for coronavirus. Other types of diseases that might meet some of the CDC's criteria, still having a gradual return to full operations, but with coronavirus we are going to be able to conduct laboratory research at the highest levels that the laboratory can perform.
So that's kind of where we are. Real proud, it's been a work in progress. We took the advantage of the operational pause, if you will, to really refine our standard operating procedures and frankly the complete culture has changed at that institution.
And they're back and certainly with coronavirus, it's amazing to watch the entire enterprise mobilize the way they have. Thank you.
Q: ... last quick one?
(CROSSTALK)
DR. MODJARRAD: So regarding your second question about how this virus differs from others and what we've learned, probably everybody's familiar now of some of the -- that there are seven human coronaviruses that we know of and that the highly pathogenic ones, the ones that tend to kill are SARS 1, Middle East Respiratory Syndrome coronavirus, and then the current coronavirus.
And so we have been working on those other more dangerous and deadly viruses, like MERS and the first SARS. What we've learned is really at the very basic atomic level -- when I mentioned that we first look at the atomic level of these spokes, these spikes, that's where we've been focusing on because that's the kind -- that's where the differences matter the most in terms of what kind of immune response you get to it, how efficiently it attaches to the cells in your lung, and one of our chief scientists, Dr. Gordon Joyce, has been doing a lot of the work on that and determining the structures, in collaboration again with our partners at the NIH, National Institutes of Health, the Vaccine Research Center.
So Dr. Joyce, myself, we both came from the Vaccine Research Center, working with Dr. Graham and Dr. (inaudible), under Dr. John Mascola, and then one of the other structures that came out is Dr. Jason Mccloud at the University of Texas at Austin.
We've all -- this should give you an idea also how this is a very tight knit family. We're kind of spread across different centers but we talk to each other all of the time because we have that very close public health and scientific community.
So there are similarities between this virus and some of these other viruses but there are obviously very key differences between MERS and this CoV-2. There's about 50 percent difference in the sequence. With SARS 1, there's about 20 percent difference but that -- that 20 percent matters obviously quite a bit.
And so that's the kind of studying that we've been doing. When we first got those sequences and the world got those sequences back on January 10th, we started looking down at the atomic level as to how they differ.
COL. TURNER: And so ladies and gentlemen, I know we've been going for a little bit so I want to be able to wrap this up. So we're going to have folks standing by to do the follow on questions, but sir, if you want to do closing remarks?
(UNKNOWN): Well ...
Q: ... one last before -- since there won't be a vaccine ready in time for this cycle of coronavirus, could you please give your best advice to the -- the force and the public in general about how to kind of ride this out for now?
DR. MICHAEL: Well I mean, we are literally living in influenza season. People are getting infected and dying of this disease. I like to remind people that during the Ebola outbreak, both the one that just happened in the Democratic Republic of Congo and in West Africa, you know, somewhere between 16 to 19,000 people were still dying every week of HIV infection.
So, you know, the public, the medical communities, governments, we've really gotten very good at managing how we deal with the scourges of infectious disease. So like any respiratory virus, you know, we're going to be getting ourselves into the habit of washing our hands much more frequently.
If you could -- if there's one thing that you can do, it's wash your hands much more frequently. I -- so I mean we're both clinicians, as well, and we go into the hospital, a nurse will wrap you on the knuckles if you don't wash your hands coming into the room or coming out, even if you don't touch anything. So that's critical.
The things that we already know how to do -- we do social distancing. You know, we're not going to be doing a lot of hugging and kissing. If people are sick, they should stay home. If they're -- you know, if they really are very, very ill, then they can go into the hospital.
So -- but hospitals now are getting very good about -- about, you know, how they would approach making sure that they could protect their staff as well as protecting other patients from someone who might be at risk.
So, you know, I think people should recognize that at the end of the day, this still remains a low risk infection to not just our service members but to the American public, and that we are really good as a hospital system, as a medical care system, from both the EMT up to intensive care units, that taking care of these -- I'm not minimizing it, I'm just saying that even in the absence of a vaccine -- we still don't have a vaccine for HIV infection but we have very good drugs and we're beginning to develop monoclonal antibodies.
So, you know, we will continue to campaign against these infectious disease threats, as we would against enemies against the homeland. We're good at doing those sorts of things but the American public should be reassured that this is a threat that we're used to from the standpoint of influenza. We are working on developing measures but everyone can assist just by washing their hands.
GEN. TALLEY: Well hopefully you've been able to hear that, you know, when you're talking to the different agencies that are out there and you're getting different responses to what they're doing individually, this is truly a whole of government approach.
So certainly if one agency, one organization, if it's an industry partner, if it's academia, I think we're well nested and we're sharing information and collaborating so that we're able to leverage the right resources to bring a vaccination or a vaccine candidate, as -- as we've learned about today, across the finish line.
So we're going to continue to collaborate in the fashion that we have and we're going to work as hard as we can to find the right treatments, the right preventative measures and certainly the right detection capabilities that are out there. Those are our three focus areas within the DOD.
We really appreciate your time today and again, thank you very much. It's been a pleasure. Thank you.
COL. TURNER: So everybody, thanks for coming today. So we have some folks who are going to stand by in this room to do follow up questions for you. Lori Salvatore from the lab is here with her team and then we've also got my team here from here that can help facilitate follow on questions that we didn't get to that you want for your reports.
And then I just want to thank General Talley and his team for their time today. So thanks everybody.
GEN. TALLEY: Ok, thank you very much, appreciate it.