Dec 21, 2020

Defense Officials Press Conference on Operation Warp Speed Transcript December 21

Defense Officials Press Conference on Operation Warp Speed Transcript December 21
RevBlogTranscriptsPress Conference TranscriptsDefense Officials Press Conference on Operation Warp Speed Transcript December 21

Defense officials held a press conference on December 21 to provide updates on Operation Warp Speed and COVID-19 vaccine distribution. Read the transcript of the briefing here.

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Dr. Slaoui: (00:00)
… reactions happen in the population in order to improve our capacity to predict and manage any reactions if they were to happen. Broadly, that’s the update. Thank you very much, and I’ll pass on to my co-leader, General Perna.

General Perna: (00:15)
Dr. Slaoui, thanks, and Mr. Secretary, thank you as always. So team, last week, we had a strong week finishing the distribution of 2.9 million out of Pfizer and this week we’re heading into a big week at 7.9 million total Moderna and Pfizer vaccines being distributed. As the secretary highlighted, for Moderna, the 5.9 million that’s going out to over 3,400 locations and then the additional 2.1 million for Pfizer going out to another thousand locations. So over 4,000 locations will be receiving vaccines between today and tomorrow. And then we continue to order on a repetitive basis, so I see vaccines being delivered again on Wednesday and Thursday, and if needed, and if required, and if asked for by the states, industry is ready to go on delivery on Christmas day, really to lean forward and make sure that everybody has access to the vaccine accordingly. We will begin to work a cadence, which I’ll talk about in a minute with you, to aluminate the consistent delivery of vaccines on a repetitive basis to allow everybody to understand the confidence that vaccines will come when ordered.

General Perna: (01:37)
Before I do that though, I’m never going to miss an opportunity to say thanks to industry for the Herculean work that they’re doing. This weekend when most of America does try to take a couple of days off after a long week working, doing all their due diligence and working in and around COVID, these industry partners worked all weekend to make sure that vaccines are properly stored, they’re properly packed, they’re properly labeled, and that they’re moved into distribution places so that we can deliver on a regular basis, Monday through Friday, as orders occur. So hats off to Pfizer, Moderna, McKesson, UPS and FedEx, really just a remarkable job for all of them. We do still feel strongly that we will have allocated to the states by the end of the year 20 million doses of vaccine that’ll be available. I’ll allocate it and then the states will order the vaccine as they need for their locations by numbers.

General Perna: (02:49)
And we feel confident that we’ll be distributing the end part of that vaccine no later than the first week in January for everybody to have access to. The cadence that we’ve instituted now that the first push from Pfizer went out and the first push from Moderna going out today is what we want is a regular cadence of distribution. Allocations will go out every Tuesday. On Thursday, they will be for microplaning at the state level. On Thursday, they will be unlocked and releasable for ordering and so anything ordered following the release will be delivered on Monday, Tuesday, Wednesday, Thursday, Friday of the next week. Really allows the states and the governors to execute their plans in a good rhythmatic consistent basis to ensure that we get the right vaccine quantities to the right places so that it is most effectively used inside of the governors’ strategies and plans. Really, really important aspect of our delivery process. So we continue to learn. Every day we’re getting better at what we are doing. Industry and OWS, CDC collaboration is very high. We talk several times a day and we conclude with lessons learned as we go forward. Things like exact addresses for labeling, very important for final deliveries. How to schedule, how to coordinate and schedule where they want deliveries to be. So not only has the vaccine been ordered, picked to that quantity, distributed in the time that they want, but everybody’s ready to receive the vaccine so that it can be immediately accounted for and then begin shots as we’ve seen, really miraculous effort. But we want to make sure from the strategic to the operational to the tactical level, everybody is synced and nested, and we get stronger on that every day. The big lesson learned is we want to make sure that the states have good timing.

General Perna: (05:05)
They have great plans. They’ve worked hard on their plans, but now as we allocate on a Tuesday, they really get to finalize their micro plans on Wednesday and Thursday, and then we release the doses to where they want to be. Really, really been affective as we work through this the last week. And then the last thing is the continued open communications at all level is just essential as we want to make sure we’re doing the right, getting better every day. It’s key to our success and so I applaud the states and our teams for being alert and collaborating with us. I applaud the CDC for their effort in continually getting word out to everybody as we go through it. And then our ability to adapt to those lessons is just going to be crucial. By the end of next week, we’ll be 11 million doses distributed to the American people, but we have a long way to go and we want to be better and better and better every day, every week, every month, to ensure the right vaccine gets to the right place at the right time.

General Perna: (06:11)
Mr. Secretary, that concludes my comments.

Michael: (06:14)
Great. Thank you, general. Michael, do you want to open us up for questions please?

Speaker 1: (06:18)
Yep. Thank you all. Operator will now open it up for questions. And a friendly reminder that when asking a question, please state your name and publication and keep your question as short as possible so we can get to as many as we can in the time we have. Turn it over to the operator.

Speaker 2: (06:32)
As a reminder, in order to ask a question, please press star, then one, unmute your phone and record your name and media outlet clearly when prompted. The first question is from Dan Vergano from Buzzfeed. Your line is now open.

Dan Vergano: (06:46)
Thanks very much. Dan Vergano of Buzzfeed News. I was wondering if you can say anything now that you have both vaccines going about. When do you think things will be more or less normal in the US again? This is a question we’re getting from a lot of readers. Does that hinge on the J&J vaccine coming through or the AstraZeneca one, what you would say? If you were to tell your uncle, when will things be normal again, what are you telling them now?

Michael: (07:12)
Well, I think it’s important that we be measured in our approach here. We’re going to be getting tens of millions of doses of vaccine out progressively, getting people vaccinated, this massive logistical undertaking. And as we’ve said, we believe late February into March, we could be seeing more general vaccination approaches, of course, subject to the decisions made by governors on prioritization. And of course, if we have Johnson and Johnson, Janssen, and, or AstraZeneca entering into play in the February timeframe that only accelerates these timelines. And then in that second quarter of next year, enough vaccine to vaccinate every American who wants to be vaccinated. So at some point, of course, as our vaccination campaign succeed, we get to levels of vaccine induced herd immunity and life starts looking more like normal.

Michael: (08:05)
Foundational to this will be some of the studies and work that are underway regarding the ability of individuals who have been successfully vaccinated to continue to carry and transmit the virus or not. That’s important data that we’re working to generate as we speak. That’ll help us with understanding what the behaviors are, even after a large percent of the American population has been vaccinated. That will be necessary. Thank you. Next question.

Speaker 1: (08:29)
Thank you, [crosstalk 00:08: 30]. Next question.

Speaker 2: (08:33)
The next question is from Eben Brown, Fox News. Your line is now open.

Eben Brown: (08:38)
Thank you very much. My question follows that a little bit. Do you have a good timeline as to when people might be able to… Talking about people who are not in any delineated risk groups here that the general public would be able to maybe seek vaccine for themselves. I know that there’s been talk late next year or middle of next year that there would be 300 million doses available, but would there be a time before that that people could start getting vaccinated?` And where are the prospects or the… Not prospects, but the necessity for an adolescent vaccine? Is that a risk group that needs to be focused on?

Michael: (09:21)
So I will leave the adolescent question to Dr. Slaoui. But again, just in terms of thinking about the progression, as General Perna said, we should have 20 million doses to be able to allocate for distribution by the end of this year. And of course, that also has 20 million of the second dose, the booster shot is in reserves so that that’s there and available for individuals. And then we think that by the end of January, we would have had the capacity for 50 million individuals to have been vaccinated with the first dose. And then going into February, by the end of February, we believe just with the Moderna and Pfizer vaccines that we would have enough vaccine that a hundred million shots in arms could have been delivered between first and booster shot. If you add the J&J and, or AstraZeneca vaccines in, assuming approval sometime in late January, you could significantly enhance those numbers going into February.

Michael: (10:17)
So that’s why I said, it seems realistic that the end of February into the first several weeks of March, we could be seeing more generalized vaccination programs beyond a lot of prioritized groups. And what we’ve tried to do through General Perna’s great work with CDC has been to really make that mimic as much as possible, your flu vaccination experience. You’re going to start seeing that in the weeks ahead as more chain retail pharmacies are enlisted as part of our state’s distribution efforts. It will mimic the experience of flu vaccination programs for individuals. And so it’s not as if there’s a moment in time where all of a sudden they’re 330 million doses available of vaccine, it just progressively rolls off the production lines each week, we get more of it out there.

Michael: (11:01)
And so week by week, it’ll start looking more and more like general vaccination, more and more just citizens without comorbidities, et cetera, would be able to get vaccinated over the course of that. And by the end of the second quarter, we think there would have been enough vaccine for everyone who wishes to have been vaccinated to be vaccinated. But that’s not saying that that’s a moment in time, it’s just every week more people will get vaccinated, more vaccine will ship and it’ll get closer towards general vaccination. But Dr. Slaoui, could you talk about the adolescent issues please?

Dr. Slaoui: (11:31)
Yes. I think it’s an important question because if I take the population below the age of 18, is about 80 million people, eight zero. That’s a very large fraction of the population, and it’s a fraction of the population where infections even more than in the older adults’ population, the virus infection is asymptomatic, most of the cases. And therefore they will be an important vector for transmission that is a-

Dr. Slaoui: (12:03)
… vector for transmission that is a counter to the mounting herd immunity in the susceptible population. And we know very well, for instance, with the measles vaccine and the measles virus, that if you have pockets of population where there are a large number of people that are not vaccinated, the amount, the load of virus in that community gets so high that it overcomes the vaccine, particularly in terms of persistence of protection. So we know here that at the peak of the pandemic with a lot of transmission, the vaccines are super effective at 95%. Maybe a year from now, if there is a lot of virus circulating, the most susceptible people may become susceptible to an extent, maybe I would expect with less severe disease, but some people may have severe disease. While if we have true herd immunity throughout the population, even if the virus is circulating, the load is very low. And those people that may have regained some level of susceptibility to infection will actually be protected by the herd immunity. And that’s why it’s really important that a large percentage of the population as a whole be vaccinated.

Dr. Slaoui: (13:17)
And I mean, obviously all the teachers versus the students, all the first-line workers in settings where adolescents or pediatric populations are concentrated would be at risk. So it’s very important. And that’s why studies are ongoing to make sure that we have the right dose and the right safety profile for this vaccine. The expectation is they should be safe and effective. Maybe at some age bracket, those could be lower than those in the older adults. And we’re trying to do those studies as quickly as possible to have the labels. As you know, the Pfizer vaccine already has the label going down to 16 years of age.

Speaker 3: (14:00)
Thank you. Operator, next question.

Operator: (14:03)
Eric Kulisch from FreightWaves, your line is now open.

Eric Kulisch: (14:08)
Thank you. As you know, UPS and FedEx are the primary transportation providers, but they also work with partners, have some contractors. Are you able to speak to how many of those are involved or do you have visibility or have to vet those companies too?

Mr. Secretary: (14:27)
General Perna, do you want to take that please?

General Perna: (14:29)
Thank you, Mr. Secretary. So there’s numerous ones that work. We work primarily with Pfizer as the prime for distribution for their vaccine, and then FedEx and UPS. And then with Moderna, it is McKesson is the prime, and then FedEx and UPS. There is several, as you said, other capabilities that are added to enable greater extension and delivery timelines, but I’m not dealing with them. I leave that up to the primes to do that technical coordination and hold them accountable.

Speaker 3: (15:08)
Thank you, Operator. Next question.

Operator: (15:11)
The next question is from John Tozzi, Bloomberg News. Your line is now open.

John Tozzi: (15:18)
Hi, thanks for taking the question. Can you tell us more about what we understand so far about the UK scene? And Dr. Slaoui, I think you mentioned that there’s no evidence that it’s more transmissible. Does that mean that we know it’s not transmissible or we’re still trying to kind of understand whether it is?

Mr. Secretary: (15:39)
So just to clarify, I think you made a reference to my saying that. That that was not me. I’ve not made a statement regarding that. I’ll leave that to the scientists. And on that note, let me ask Dr. Slaoui if he could comment.

Dr. Slaoui: (15:50)
And can you repeat, just can you clarify the question? What is not transmissible? The variant?

Mr. Secretary: (15:57)
The strain in the UK, yes.

Dr. Slaoui: (15:58)
Okay, sorry. Okay. So the way to demonstrate scientifically enhanced transmissibility of the virus will be, for instance, in animal studies where you infect animal and co-localize them in the same cage or in different cages within the same room, you do all these kind of studies with airflows, et cetera. And you see how many virus load in a donor animal are enough to infect a recipient animal. Those studies are very important to conduct. In order to do that, you have to isolate the virus, grow it, cultivate it. That takes several weeks. And that’s where it’s ongoing to be able to definitely conclude that the reason why there is more of this virus in a population is because it’s transmitting better than the preexisting virus.

Dr. Slaoui: (16:48)
The alternative, that would be like with, say, a causal relationship. The alternative is that this virus was in the population here and now. And in that population, that particular variant, because there was no other virus around, has grown and is going up now exactly like the virus before it has grown and is going up now. And that would be just a description of the fact. And we need to understand one way or the other. I think the key point is that there is no evidence, now it’s clear because there is a large number of people infected, there is no evidence that this virus is more pathogenic, creates more problem, more morbidity or mortality than the previous virus.

Speaker 3: (17:41)
Thank you. We’ll go to the next question.

Operator: (17:44)
The next question is from Sara Murray from CNN. Your line is now open.

Sara Murray: (17:50)
Hi. Thank you guys for doing the call. We appreciate it. I just want to know, given that the timeline seems to be shifting a little bit into the new year, do you guys have any estimate for how many doses will actually be administered to Americans by the end of the year? And when you talk about that February and March timeline as 100 million, is that 100 million of the first and second dose? Or are there 100 million Americans who could have received their first dose by February or March?

Mr. Secretary: (18:20)
Yeah. So as I said earlier, by the end of February, it would be 100 million certainly first and second doses. So that means shots in arms. That’s been a phrase that some have used publicly is just how many shots in arms? That would be first and booster. As I said, by the end of January, we believe we should have enough for 50 million first vaccinations. So you would have 50 millions first vaccinations, and then you would have been also doing your second booster shots of both Pfizer and Moderna during January for individuals who received their first dose in December. But the reference the end of February would be either a first or a second dose shot that’s gotten into the arm. General Perna, if I could ask you to discuss the other questions that were raised.

General Perna: (19:06)
So as we distribute the vaccines, as we’ve said, we’re delivering it to the states based on their plans for locations and quantities. We see a good cadence of administration occurring at all across the country. But that pace is dictated and executed by the states as they go through. Our goal is to make sure that they have the vaccine ordered to the quantities, to the right locations, so that they can administer to the priority populations as directed.

Speaker 3: (19:48)
Thank you. We’ll go to the next question.

Operator: (19:52)
The next question is from Katie Thomas from New York Times. Your line is now open.

Katie Thomas: (19:57)
Hi. On the monoclonal antibodies, I was just wondering, you mentioned and on your website it mentions numbers allocated and then numbers distributed. What’s the difference between those two numbers? And do you have any better information about how many people have actually gotten these antibodies beyond what Dr. Slaoui said last week?

Mr. Secretary: (20:20)
Yeah. So as with vaccine, allocated means it’s been made available to the governors to tell us to ship. And then distributed is it’s actually been shipped. We have parts of the country where the monoclonal antibodies are being used very effectively. We have parts of the country and hospitals where the monoclonal antibody is not being used effectively to be able to help get to people early in the disease course who are at risk of severe complications or hospitalization. And we simply can’t have this very valuable tool, this therapeutic sitting on the shelves. And so we’re going to make sure that we’re getting product out there where it can be used most and most effectively. But that’s the difference. Allocation means the product has been produced and we’ve allocated it according to the methodologies among the states. The governors have been told they have it, they can draw it down and tell us to ship to certain places. Let me ask Dr. Slauoi or General Perna on the rest of the question regarding antibodies.

Dr. Slaoui: (21:23)
No, I think you addressed the whole thing. So Secretary’s very clear. I mean, again, as for vaccines, the monoclonals are produced and then there’s quality control, testing, et cetera. And then there is a release. And allocation happens after quality control has been completed successfully. We have, maybe just an addition, we have and are continuing to have negotiations with the two companies that have developed these monoclonal antibodies to enhance our sourcing of monoclonals into the first half of 2021 to continue covering the gap between where we are now and the time where the full population has been immunized. We’re also working on what could be a more practical alternative, which is an oral, small molecule antiviral. But the data with that program will only become available maybe late in January. And that could help us address the issue of intravenous inoculation of the monoclonals in patients that are not hospitalized and infected, which is really where the challenge is in for the system.

Mr. Secretary: (22:38)
And also, this is one reason why we’ve been strongly encouraging our nation’s governors on the monoclonal antibodies to not only have us ship to hospitals, but also ship to retail pharmacies that have infusion centers, home health that can do home infusion, offsite outpatient infusion centers, and skilled nursing facilities. Again, get the drug as close to people where they may be diagnosed as positive and willing to take an infusion product in order to prevent hospitalization or severe complications as early in their disease progression as possible. So not just seeing them when they present at the emergency room at the hospital, but having the governors forward deploy this product to those who can deliver it really much earlier in the stage of disease.

Speaker 3: (23:26)
Thank you. We’ll go to the next question.

Operator: (23:30)
The next question is from Mike Erman from Reuters. Your line is now open.

Mike Erman: (23:35)
Hi, I’m wondering about only about a fifth of the doses have been used through today. Is there any thought on how to speed that up? And are there any plans for federally backed mass vaccination sites in order to speed distribution of the shots?

Mr. Secretary: (23:55)
General, do you want to take that?

General Perna: (23:57)
So as I said, we distribute what is releasable and available for distribution and we’re-

General Perna: (24:03)
… what is releasable and available for distribution, and we’re getting it out to countless locations to spread the requirement or to enable quick administration throughout the country. I talked earlier, over 4,000 administration sites will receive vaccine this week. So the ability to get up and administer the vaccines, I think we’ve demonstrated that the states really have some good plans and they’re administering them literally into execution. Watching the numbers grow every day in administration, we do know the CDC is going to post numbers. You’ve seen it on their website. We do know that there is a lag to those numbers based on the data that is provided by the states to us. They’re providing great data, but it’s a time period in execution depending on the way the data is provided. So it’ll catch up and I think execution will catch up.

General Perna: (25:12)
At the end of the day, we want to make sure that the states have vaccine where they want it, at the right quantities, dispersed throughout their states, but fair and equitably across the country simultaneously. And it is just so important that the correct due diligence in final administration is applied. Every dose is so important. We want to make sure that it is cared for that way, administered that way, to the right people at the right time. So my thing is steady as we go. And I think you’ll see good progress as we get better and better every day.

Speaker 4: (25:58)
Thank you. We’ll go to the next question.

Operator: (26:01)
The next question is from Candice Choi, AP. Your line is now open.

Candice Choi: (26:07)
Hi. When [inaudible 00:26:08] expect vaccinations in nursing homes to be complete? I think the majority of states have said they’re not going to be starting and ramping up until next week. And then also, was there any explanation on the Pfizer doses that got colder than they were supposed to in California and Alabama?

Mr. Secretary: (26:30)
General Perna.

General Perna: (26:32)
So, first of all, I think you’re going to see many long-term health care facilities and nursing homes administering vaccines accordingly. Several States have already started last week, as we talked about and they utilized capability and capacity to go right in and begin. At the end of the day, though, we’re supporting the state plans and execution. We developed a very, very good partnership with CVS, Walgreens and over 70,000 long-term health care facilities. But as the vaccine gets prioritized between first-line medical persons and long-term healthcare facilities, there’ll be sharing, to the governor’s priorities, in execution. We know for example, that over 1300 facilities are enacted today for execution. And I think that’s really pretty powerful. And I just see that number going up every day as we go forward.

General Perna: (27:38)
To the point reference the Pfizer vaccine last week, I thought I was clear, but just to reinforce, we sent out forecasted numbers that we thought to the best of our plan and ability, in collaboration with Pfizer was a good number to plan against. At the end of the day, between Pfizer and I, I felt there was only X number to be released, and that’s what we allocated to the states for planning. So the forecast number was one, the actual allocation was another. At the end of the day, it was fair and equitable distribution across the whole country. It is a mathematical problem in execution. Once I defined the releasable doses, then we put it through the gonculator and doses are distributed in that algorithm. Everybody is receiving fair and equitable distribution of the vaccine.

Mr. Secretary: (28:42)
General, I think on Pfizer, if I heard correctly, she might’ve also been asking about the two temperature excursions that were reported last week. The one in California and the one in Alabama, if we’ve learned anything more about those.

General Perna: (28:55)
I apologize, Mr. Secretary. I was probably pre-hearing a question. So sorry. No, what we’ve heard is that Pfizer has checked it and the vaccine, those four, they’ve arrived at colder temperature than minus 80. So they arrived at minus 92. We’re still working through how that occurred, but we do know that the vaccine was approved for safe use by everybody.

Speaker 4: (29:26)
Thank you. Operator go to the next question.

Operator: (29:29)
The next question is Tom Howell, Washington Times. Your line is now open.

Tom Howell: (29:35)
Hi. Is there any reasons to believe this variance in UK will have implications for the efficacy of the available vaccines? I’m just wondering if the spike protein is stable enough that it doesn’t matter scientifically, or if it might be a bit of a worry. Thanks.

Mr. Secretary: (29:50)
Dr. Slaoui.

Dr. Slaoui: (29:52)
So I think the good thing with the vaccine is it induces an immune response against several epitopes that have been mapped around the spike protein and the three-dimensional structure of the spike protein. The chances that one set of mutations would alter all those epitopes, I think are extremely low. And the good thing with this virus is that the neutralizing immune response seems to be directed against different areas around in the spike, rather than, for instance, in HIV, there’s a little loop and all the business is down on that loop. So if you change it, you can escape significantly. So expectation scientifically is that this kind of variation are unlikely to escape fully the protective response by the vaccine. But remember, this is an RNA virus. RNA viruses are more prone to, in effect, mistakes in the way they duplicate themselves.

Dr. Slaoui: (30:57)
And that’s how those mutations happen and are selected. Whether someday somewhere a virus may turn out to escape the protective response induced by the vaccine is impossible to exclude. So we have to remain absolutely vigilant in sequencing the viruses around. For this particular one, we are running the experiment to be able to do it, but it takes a few weeks to engineer what’s called a pseudo virus that has the spike from the COVID-19 and the rest from another virus that we can cultivate it and then neutralize it with the antibodies made with the vaccine against the vaccine and test. But my expectation is this will not be a problem.

Speaker 4: (31:47)
Thank you. Operator, we have time for three more questions.

Operator: (31:51)
The next question is from Karen Weintraub, USA Today. Your line is now open.

Karen Weintraub: (31:57)
Hi. Thanks so much for doing this. I was wondering if you could talk a little bit more about monoclonal antibodies. And we’re hearing that the Infectious Disease Society of America and NIH have both not recommended monoclonals for use in at-risk people. And just trying to understand the efficacy. I know you say they’re wonderful, but the data doesn’t… I’m just trying to understand the data and how that [inaudible 00:32:18]

Mr. Secretary: (32:20)
And I’ll ask Dr. Slaoui if he could also clarify. Because unfortunately the NIH guidelines are sort of a standard of care treatment guidelines. What they say is of course this is still preliminary data that supported emergency use authorization by the FDA, as opposed to definitive phase three conclusive clinical trials that establish a firm standard of care. These monoclonal antibodies, however, are approved by the FDA under emergency use authorization for the treatment of anyone who is at risk of hospitalization from COVID. Tested positive, that includes anyone over age 65, as well as any other individuals at risk of severe complications leading to hospitalizations. The NIH guidelines simply say that it hasn’t yet achieved standard of care status but in no way recommend against the use of something that FDA has actually authorized for that purpose.

Mr. Secretary: (33:16)
I can’t speak to the Infectious Disease Society except to say we’ve been very disappointed that this incredibly important tool that should be getting used more frequently, that should be getting used to help keep people out of the hospital at the same time that we have so many individuals getting hospitalized from COVID, from the increase of cases that we’ve had, that professional societies would not be more supportive of using a very important tool that also was demonstrated in trials, according to the FDA’s approval process, to have indications towards efficacy for the benefit to outweigh the risk and for it to have a relatively safe profile. I don’t know if Dr. Slaoui, could you add or contribute on that from your perspective please?

Dr. Slaoui: (34:03)
Yes. I think it’s the issue of the strictness of total completion of an efficacy trial and the concept of emergency use authorization. Which is you’re going to save people’s life on the basis that you have 99% or 98% certainty. What you have is effectively an effective treatment. And the two monoclonals that are approved, both had observations in their trials that ask a question and that needs to be addressed and it’s being addressed. I think the confusion is coming from that. Which is while that question is being addressed, I do believe as Mr. Secretary said, these two monoclonal antibodies can be life-saving and prevent hospitalization in subjects that are at higher risk of hospitalization and high morbidity from the virus.

Dr. Slaoui: (34:58)
What are these issues? In the case of the leading monoclonal as a monotherapy, a single monoclonal, an observation was made during the trial that while in the high-risk population there was a clear decrease in hospitalization rates for subjects at high-risk, there was also an observation that they start, in the population, when they receive the monoclonal, their titers of virus go down, but then a mutant escape virus in three subjects, I believe in the trial if my memory serves me right, appears, goes up a little bit, not as high as the original virus was in that subject. But then within two days, the immune response of the subject, him or herself, gets rid of that virus and the virus goes. This raises the question that potentially in some individuals that may not be able to mount a big immune response or things like that, that, that mutant virus may take over and would not be susceptible to the monotherapy treatment. Up to now-

Speaker 5: (36:03)
To the monotherapy treatment. Up to now, such observation has not been made. The subjects that had mutant virus dealt with it. And in the real life use and in a clinical trial, that’s ongoing, the NIH platform, clinical trial, we are testing, virologically, all viruses that appear in the subjects after treatment, to further document whether those escaped mutants are relevant or not. That’s one reason why there’s a question mark on that treatment that needs to be addressed.

Speaker 5: (36:34)
In the case of the Regeneron treatment, which is two monoclonals, the issue of escaped mutants is not an issue with all the data we have today. The issue there has been that the population tested did not have hospitalizations in the placebo. So there was clear observation that the population treated compared to the placebo population had lower virus [inaudible 00:36:57], but because there were no hospitalization, one cannot conclude that this will translate into actual clinical benefit and hospitalization. And that is again, being tested in a bigger, larger trial or a longer period of time, and enriched in populations that are at high risk of hospitalization.

Speaker 5: (37:18)
And I think this is what people need to understand; first, these monoclonals are safe, and secondly, they are effective at either eliminating the virus and giving time to the patient’s own immune response to eliminate whatever else come up, if it comes up, on the one hand. And on the other hand are very good at eliminating the virus, decreasing the virus load, which is very likely expected to translate into a clinical benefit, but that clinical benefit has to be demonstrated. I hope this clarifies. Thank you.

Speaker 6: (37:48)
Thank you. Operator, two more questions.

Operator: (37:52)
The next question is from [Arista 00:37:54] Fernandez from Axios. Your line is now open.

Arista Fernandez: (37:58)
Hi, thanks for taking my question. This question is for General Perna on logistics. Are there any lessons learned or adjustments you’ve made between OWS and the shipping companies when it comes to the distribution of the vaccine for this week or any future modes beyond?

General Perna: (38:18)
Yes. So I wouldn’t say lessons learned, but I talked about some lessons learned earlier, but the cadence and how we’re going to allocate and then work through the ordering, and how we pick, and pack, and distributed is getting stronger every day, quite frankly. Albeit we’re only into this, day nine or 10 from the initial effort, it’s just been powerful to see the collaboration with Pfizer, and Moderna, and McKesson, UPS and FedEx. Really spectacular to watch the senior leaders of these personally be involved in this effort. And so, what I have a lot of confidence on after a short period of time is the quality control that’s being executed by these companies to ensure that the vaccine arrives safely and completely, and ready to administer when it gets to the final sites.

Speaker 6: (39:26)
Thank you operator. We have time for one last question.

Operator: (39:28)
The last question is from Derek [Gingery 00:39:32] from the Pink Sheet, your line is now open.

Derek Gingery: (39:36)
Hi, thanks for getting my question here at the last second. Dr. [Slawey 00:39:41], you mentioned that when the J&J vaccine comes up, that you want to try and get that in as many arms as possible. Can you talk about it; at that point when it’s available, will you be adjusting distribution of the Moderna and Pfizer vaccines at that point? Or has that been thought about yet?

Dr. Slaoui: (39:59)
If I understand your question, it’s about the J&J vaccine. Listen, all these vaccines are important and those are cumulative, so there will not be any interference of one vaccine versus the other. I think we will, all the time, as in General Perna, does maximize and optimize the number of those is that we can ship. We will make sure that there is no confusion and that the vaccine that should be given as a one-shot vaccine is clearly identified as the [inaudible 00:40:30] Johnson and Johnson vaccine, and the others are to those vaccines. So it should be literally a way to accelerate immunization in the population with no other form of interference whatsoever.

Speaker 6: (40:45)
Thank you, Dr. Slowey. That’s all the time we have for questions today, Mr. Secretary, I don’t know if you had any final words?

Mr. Secretary: (40:52)
Just thanks to all the members of the media for your continued attention. We’ll continue to do these. We want to make sure we’re answering your questions; you’re very helpful in getting information out there regarding the vaccines, regarding the distribution process. So we’ll be continuing that, but also if you can help us with continuing to get the word out about those three W’s; wash your hands, watch your distance, wear your face coverings when you can’t watch your distance. And especially is as we’re in the holiday season, and as we approach Christmas, please be reminding your listeners, your viewers, to be very mindful of indoor gatherings, where they’re going to let their guard down, where they’re going to take their masks off, they’re not going to maintain social distance. It’s really critical. Again, we have these monoclonal antibodies, we have these vaccines, so many new tools. We want to make sure that everybody’s here for this holiday season is going to be here for next holiday season, when we’d expect it to be more the way we’re all used to. So a bit of sacrifice now will pay back dividends for all of us in our mutual health and safety. Thank you.

Speaker 6: (41:56)
Thank you, Mr. Secretary. Again, you can please send any followup questions to our press office at mediaathhs.gov, and I’ll turn it over to the moderator to close out the call. Thank you all.

Moderator: (42:10)
This concludes today’s conference. All participants may disconnect at this time.