Business as Usual: Paul Mango of Operation Warp Speed

Transcription: 

Good afternoon, this is Audrey Roussel president and CEO of the Pittsburgh Technology Council. It is the week of Christmas. But we have we, the show goes on here. And today, we are pretty thrilled to have Paul mango back with us. And we're gonna introduce him appropriately in one minute, want to give a shout out to Huntington bank thanking them for all year of being their great, great partners with us on every experiment that we ran in terms of telling stories and making sure that we're highlighting all that we need to highlight it during this pandemic. And it's hard to believe that it's Christmas. But I also want to give a big shout out to the Jewish health care Foundation, they've been partners. And if you don't know anything about them, we're gonna put their website up so you can maybe navigate as we're having conversation with our guests today. And then also 40 by 80. That's the wholly owned subsidiary of the Pittsburgh tech Council, where we're working on all things entrepreneurship and workforce development in this region. So we've muted your microphone so that we can hear our guest, and we put a chat session in. And that is for you to ask our guests questions, not to sell your wares. That's not what today is about. So I'm pretty thrilled that we have an opportunity to hear from Paul mango. Again, this is the second time he's been with us. And he is with the US Department of Health and Human Services. And we are going to discuss the status of operation warp speed, we've been staying pretty close to it. And Paul serves as the Deputy Chief of Staff for the US Department of Health and Human Services. And he is no stranger to southwestern Pennsylvania. So before we just jump in and talk about the status, let's go welcome. Thank you. You know, I know this is a critical moment in history. This is second time, as I mentioned earlier that you've been with us the first time we spent much of our time discussing the timeline for a vaccine. At that time, the fastest set of vaccine had been brought to the market was about five and a half years. Today, we have two vaccines approved and I think some more in the pipeline. So let's just before we jump into the status, just talk about the original mission. So you can set the table for everyone here about operation work speed.

Sure. Thanks for having me. And Greetings to everyone in western Pennsylvania. I know there's some snow back there. So hopefully you'll have a white Christmas. I think just to go back and talk about operation warp speed from its inception, there was actually three major components to it. It was vaccines, therapeutics, and diagnostics. And there's really good news on all fronts. Obviously, you've read a lot about the Pfizer vaccine, and now the maternal vaccine. I'll come back to those in a second. But we shouldn't lose sight of the fact that there's two other vaccines that are imminent meaning in the next month, we hope to get the type of authorization to ship them and that's Johnson and Johnson and AstraZeneca. We're particularly excited about Johnson and Johnson because it's a single dose vaccine and makes things a lot easier from a logistical standpoint. But just going back to Pfizer and Madonna, we're shipping out about 8 million doses this week. We shipped out about 3 million last week. So it's ramping up. The Medina vaccine is terrific in the sense that it doesn't require ultra low cold storage, or more freezer that makes it easier and more important. The Pfizer vaccine is shipped in in batches of 975. But the Medina is shipped in batches of 100. So we can actually get it to places that may take a little bit longer, but physician's office or whatever that may not have 975 persons coming in in five days. We can get it out there and use it in rural environments more effectively. So that's where a lot of it is going this week. There's about 4000 different locations that will get vaccines this week, and that's far FedEx and UPS have done a spectacular job even last week during the snowstorms that were all over the country. They didn't miss a beat. They didn't miss miss a delivery. I think one or two were a little bit late, but they didn't miss any. So they've had a perfect record. so far. One little issue we're dealing with today is in our computer system whenever a site is authorized by the state or the jurisdiction to receive vaccines, they have to put their operating hours in and we were sending out about 1200 orders today. And 50 of them were to sites that told us they weren't going to be open today so they're not going to get their shipments because we can't waste those vaccines. Just a small on one of our sides a small communication issue either they were open and they didn't tell us or they're not open and they ordered anyway and we're not shipping But those are the types of day to day things we're dealing with relatively minor, bear to the larger mission at hand, which is to get all Americans vaccinated. Go ahead.

No, it's only been nine days.

Yeah, we've been nine days. So we'll get, we'll get 20 million doses out before the end of the year. And then we're looking at 30 million additional first doses in January, plus, we start sending out the second doses. So there'll be 50 million doses going out total in January, because we're withholding some back right now. Because we want everyone to get his or her second dose, and then come February, it's about 80 million of all the production schedules are on track. And that's even without Johnson and Johnson and without AstraZeneca. So it could be those could be real blowout months, if we get those two going by February. And if all goes well, as we've said before, April, May, all Americans who want the vaccine and are eligible to get it like kids under 16 will have an opportunity to get it. Just real quickly on therapeutics, we continue to be very excited about the monoclonal antibodies and creasing evidence that convalescent plasma when used early, is very effective. So these are, as you know, both forms of antibodies that are injected into the, into the bloodstream, when one's body is just ramping up the defense system. So, when used early, it's they're very, very effective. We've had a little bit of trouble in that we've shipped out a lot. And some places aren't using using it, we have hundreds of 1000s of doses. But the complication is there. It's it's administered in an outpatient environment, and, you know, requires the appropriate IV type of team to do it. So most of our shipments have gone to hospitals. And some hospitals just aren't finding it convenient to use. I don't want to I don't want to criticize them. But the point is, I think for everyone on the phone around the the zoom. If you're a patient, or if you know a patient, they should start asking, Hey, is there any availability of these monoclonal antibodies, if their symptoms are still relatively light, they're not an inpatient. The emergency use authorization just is just for outpatient administration. So after you're admitted, they actually can't use it. So anyway, we're very excited about those. And then I just want to say a word about lab testing, because we haven't talked too much about it. But last week, you probably heard the announcement about a technology called e loom e l l u m e, it's the first over the counter completely home administered COVID test. Francis Collins out at the NIH and his team, in the early spring, invested heavily in that technology. And again, we talked about vaccines coming to market quickly. But for an over the counter point of care tests, completely self administered above 90% sensitivity and specificity to be done this quickly is just unbelievable. So we think this will really help the American people, you know, self diagnose a bit, and make sure they feel comfortable. If they're going out to a restaurant, if they're going out to a family gathering or whatever, just give them a little bit more comfort that they're, they're doing okay. And I think it's a relatively inexpensive test similar to the by next test, which is five or six bucks a pop better than the laboratory PCR tests, which are around 100. So it's a game changer in terms of time, convenience and cost. And, again, the NIH is very proud of its ushering this technology to market. So I think that's that's the general update. I want to leave a lot of time for questions.

Yes, we haven't we have a bunch of questions before we jump in, there was $69 billion that was allocated right to for vaccine and therapeutic investments. Is there anything else that you want to talk about in there in terms of that allocation? Because I can feel it just by talking to you that we are moving at warp speed? And it is pretty exciting considering 2020?

Yeah. Is that the new? The new supplemental that was just discussed over the weekend? Are you saying, right, a lot of that was for I saw for testing so that the states can continue testing. I know, some of it was for vaccine distribution. And I think when we say vaccine distribution that is really going to be used for a lot of marketing and communications. Because the state's The only thing they really have to do is tell us where they want things shipped and everything is shipped there. The vaccines, the needles, the syringes, the swabs, the face masks, dry ice, even, we're even shipping out dry ice, and we'll ship to any corner of fifth and Vine in the country. Just tell us where to get it. So the I think they're going to be using a lot of those funds for maybe some advertising and do address vaccine hesitancy and those types of things. Although latest Reports I'm seeing is that we're up over 60% of Americans from down in the 40s, a couple weeks ago, in terms of their eagerness to get the get the vaccine.

All right, that's great. Let's just let's use this time to start to answer some of the questions that have been posed. So Jonathan, you want to start it start at the top,

right at the top. So

want to know, if companies want to assist with warp speed? What's the best way for them to communicate their capabilities with HHS or others?

Gosh, Well, it depends on what those capabilities are. But right now, I think the most important thing they can do is, is again, it's what we just talked about is help us deal with whatever vaccine hesitancy obviously, the other thing that we're exploring every day depends on again, it depends on what type of company is. But for the vaccines that are proven to be very effective. We are desperately looking for additional manufacturing capacity. Why wait, and it depends on which vaccine it is some have their bottleneck at the bulk production summit, Phil finishing, that's highly specific assets that are able to do that. So we've pretty much scrounged around the whole country. And we're trying to get some pharmaceutical companies to work with others to give up some of their own capacity. But if any of that's lying around, we certainly would be happy to use that. A little bit aside from warp speed. But the only other thing we're really feel that we're a little bit exposed on is nitrile gloves. So if anyone again, that's not easy to stand up. The factories that do that have equipment that's about as long as a football field. So it's not like you can do it in your basement. But with that, that if you said what are the things that we're struggling with a little bit, I would say? We'd love to have more clubs that are FDA, you know, FDA approved.

Absolutely. So Tracy lawless in the private chat sent me one here. Really good question. She wants to know, is there a plan once vaccines are available in greater quantity to have a tiered vaccination program so people don't have to congregate in line and wait for a vaccine?

Yeah, so Tracy and I go to the same hairdresser. But for some reason her hair looks a lot better than mine does. out there listening. I see you're up in Wexford, every now and then. But the Well, let me tell you what, CVS and Walgreens and there's actually 19 chain pharmacies, I think Geneva was in that group in western Pennsylvania. And those stores are all going to be turned on for vaccines in the next few weeks. And the way they're doing it, and the way we've been working with them is by appointment only. So let's just call it every 15 minutes. So what you'll be able to do is make your appointment and make sure you're not in line with a bunch of other folks. I think as important I know CBS is doing this, I'm not 100% sure Giant Eagle is when you make your appointment, they also force you to make your second appointment, that there's a much higher probability you'll come back for your second dose, we are a little bit worried about this. So shingrix, for instance, the shingles vaccine, there's about 80% of Americans who get the first dose and get the second dose but 20% don't get the second dose. We're we don't want that to happen with COVID. So I think the you know, from a behavioral scientist standpoint, making the second appointment when you make the first one, it's harder to opt out than opt in. So I think that's a good policy, hopefully, Giant Eagle will be doing the same thing. But but we're very conscious of this. And we you know, we saw this with the laboratory testing in the spring, and there were long lines. And we want to avoid not only for, you know, contagious purposes, but we want to avoid lines, because that's not that's not the right thing to ask Americans to do.

For sure. So Matthew lattic wants to know, he mentions the President mentioned use of the military and planning and executing operation warp speed. Can you speak to how our domestic forces have served or will serve in that regard and the impact in Pennsylvania?

Yeah, so you won't see unless the governor calls out the National Guard, you won't see the US military administering any vaccines. I think I said this when we talked last but it's highly unlikely that any federal employee will touch a dose of vaccine before it goes into Americans arms. We are relying very, very heavily on the private sector to do this. So it's McKesson as a distributor. It is as I said, UPS and FedEx as the you know, shippers, if you will, it's our chain pharmacies and our hospitals and then eventually physician offices as the vaccinators themselves. So you won't see any federal military forces out there. Again, each each jurisdiction if they if he wants to call out Their National Guard, they can do it. We don't think that's necessary. But that's the decision of the the governor what what the military has done is an extraordinary job in all of the planning, in the establishment of all the partnerships, and the contracting, the Department of Defense has a huge contracting capability that we just didn't have at HHS. And, you know, we've probably spent close to $30 billion on you know, many hundreds of different vendors, needles, syringes, files, as we've said, raw materials, equipment, they've also, using the defense production act of acquired those things from all over the world and flown them in and cut, you know, months off of normal shipping times that type of thing. So they are our primary point of interaction with all of our partners, they are in partnership with the Centers for Disease Control, and collectively dealing with all the jurisdictions there's 64 jurisdictions, and right down to exactly how many doses every day, and how we keep track of that, from an IT perspective, we have a highly sophisticated IT system that can tell us where every dose is from factory to receipt. Just you know, FedEx and UPS have lent us their systems, we can track everything. And then we have our own systems that once it gets there, we can track whether it's been used or not. So the military is running all that there's a vaccine Operation Center here in the building on the second floor, there's probably 25 or 30, military personnel down there. And they are 24 by seven, watching everything and making sure we intervene when there's any types of issues. So she Three cheers for the Department of Defense and particularly, Pika the army Logistics Command, I have to put in just a little plug for the army team, the army football team, they now beat Navy and Air Force two consecutive weeks in a row. So it's good. You're all around for the army.

So I can keep going. There's a bunch of questions as they keep coming here. It's

so good to see this conversation going on. So from Wendy Parkin, she says I read Pfizer's clinical trial. And states the vaccine is 95% effective as measured over seven days. How long is the efficacy expected to last with this?

Yeah, no one knows that yet. We just those studies are going on. And obviously only time can resolve that. We hope it's yours. You know, like a tetanus shot. We hope it's seven years or so. We just don't know. We just don't know. So it'll be a while before we like I said only time can resolve that. Absolutely. At least a few months, because there's been 10s of 1000s of folks who were vaccinated starting in August, and none of them has. Well, I shouldn't say none. The efficacy was 95% 5% of the vaccinated group, actually, of those who, who acquired the virus 5% were in the vaccinated group and 95% were in the placebo group. So for whatever reason, a few folks have gotten it was it was 11 out of 196. Got it in the vaccinated group for Madonna, for instance. But we don't know the persistence. And hopefully, hopefully we don't have to do this every year. Absolutely. So Scott banyak missed DLC wants to know, are there other therapeutics in the pipeline that

can be approved and released sometime soon?

Yeah, so that the three or four, five big ones, obviously remdesivir is a very big one. And that is an anti viral. It's not an antibody, it's an anti viral. And then we have the three antibody which is less than plasma. And the monoclonal is from regeneron. And from Lilly, there are a couple of others. And then there's the the corticosteroids, which have been proven to be very effective late stage, to therapy in the hospital, those aren't new, they've been around and they're plentiful. There's a couple of others, in fact, we're likely I can't really talk about are likely to make an announcement this week on one that is extremely exciting, and it's impatient based. So it's after you are in a pretty, pretty severe condition, it seems to dramatically reduce mortality. So that standby for that one, probably later this week. There are about 400 other clinical trials underway for different therapeutics. So we'll have to see and we'll continue to make investments as necessary. And then you know, the requirement there is that they do prove to be effective in the early stage trials. But I think just one note to our care providers around the country they've done regardless of the therapeutics, they've evolved so effectively, in terms of how to care for these patients when to use a ventilator testing folks earlier diagnosing earlier that the case fatality rate is dropped by 85% since March and April. So I think it's again, you know, Three cheers for the army, but also our frontline care providers are incredibly adaptive. And the odds of surviving this are so much greater than they were in the early spring.

It seems like that, Jonathan,

keep on going. I don't think we have enough time to get to these questions today. It's amazing how many we have. So is there reporting on vaccine supply and demand quantities vaccinated? And who's next in the phased approach?

I'm sorry. So the question is what Jonathan said,

See is there reporting on vaccine supply and demand wants to know if the quantity so

our best guesses right now will be supply constrained into February, meaning there'll be more demand than supply. supply will roughly be the equivalent of demand in March and April and by May, we think supply will far exceed demand. And you know, we'll be in a position to help some other countries out with exports and that type of thing. So we do have options to procure a couple billion doses of vaccines should we need them? And one of the questions is the one that the listeners, one of the listeners posed a little while ago, which is, if this thing isn't persistent, more than six or nine months, we need to begin thinking about next season already. So we don't want to give up all of our options if we going to need them ourselves. But that's the general scenario. And it all depends on you know, uptake and how many folks are interested. But if you think about it, there's 70 or 80 million Americans under age 16. They're not eligible for this vaccine yet. So you take that away, and we're down to, you know, 260 million, maybe there's if we're really, really lucky, 80% will choose to get the vaccine. In fact, I think most of the scientists have said 70% will confer immunity on our population. So you could, you know, think about that, as you know, roughly, I don't know, 170 or 180 million persons vaccinated. That would be you know, we'll hit that in the spring for sure. So we're pretty optimistic. It should be a great summer to going back to the shore and back in restaurants and hopefully even traveling overseas, if that's what you want to do.

That's what we want to hear.

A couple of more questions, Jonathan. I just want to hit before I surely Yeah.

So here's a really good technical question from Sam Brower. So hang with us here, Paul. He says, um, I don't understand why the mRNA products are considered vaccines, since they don't have adjuvants. And they use a delivery system that's similar to other biologic drugs. Would it be more accurate to call these products prophylactic drugs instead of vaccines? Also, what's the residence time of these products in the body?

Gosh, that's that. That's a great question for one of our physicians here, the answer is they're not qualified to answer it. But I do know that one of the things two things actually, one is we're thinking about using and there's studies going on the monoclonal antibodies prophylactically. So the antibodies could almost in some ways we considered temporary vaccines. And what we're also studying for the mRNA is whether and we don't know the answer to this yet, whether it what we know for sure, is that it precludes you from getting very sick, what we don't know about this vaccine, or whatever Sam would like to call it, I just, I'm just not familiar with all those scientific terms. What we don't know is whether you can still transmit it. Even though you're not getting sick, it could be in your nasal passage, you might be able to actually transmit it. Again, those studies are going on. And we hope to learn more from that. But if Sam wants to send me via email his questions, right. What I can do is I'll send it up to Tony Fauci or someone and ask them the answer. It's not pretty good.

That's great. Thank you. Jonathan, do we get to we ask about the the new strains in Europe or in the US?

I think we got to bring that up.

That's really about that whole thing about, you know,

what's had we've had meetings all weekend about that. And again, I don't want to myself as the scientist, but I'll tell you what I've heard from our scientists, including Dr. Collins at the NIH who's looking at this very closely, and that is, they believe this variant has been around for a long time, not just you know, like the last couple of weeks, probably October. It's been a it's not 100% clear whether it is more transmissible what happened in the UK is they identified it recently and associated that with a recent spike and they said, Oh, it must be more transmissible, but what our physicians are saying is, maybe not. They know for sure it's not more lethal. So Even if it is more transmissible, it's not more lethal. They feel that regardless, there's actually several 100 variants out there for COVID-19. Already. They believe that the vaccines will be robust across all of those variants that are identified thus far. So they feel very confident up to this point, that there won't be the variant won't be able to evade the vaccine. And the only small consideration is some of the monoclonal antibodies are aimed at a single spike protein, almost by definition, monoclonal antibody, and they'd not 100% sure whether the variance might cause that to be less effective, those to be less effective. So that's kind of where we are. I think it's a again, I've just listened to these conversations. I'm not the subject matter expert, but I would say the initial reports coming out of the UK, bit hyperbolic.

So one of the things I think it's Ron Rosenfeld is asking, what's the latest estimate of the current IFR? You know, IFRS?

Yeah, sure. I know what an IFR is. depends on which one he's talking about. There is certainly one that CMS is contemplating. But can you say a little bit more?

He's calling the infection fatality rate?

Oh, I'm sorry. Yeah. IFRS. Another?

Yeah, there's another Navy.

We have a term called interim final rule. Right.

There's also a Navy aviation term, that the

incident, the incident section, right? Yeah, I have all the infection, I have all the infection rates from this morning here, hold on a second,

right, as opposed to the case,

here, after Burke send them to us every morning, they are extraordinarily low. I'm giving you the lat I'll give you roughly the last year, that's great. The last full months. If you're over 70, they're in the six to 7%. range, okay? If you're kind of 49 to 70, they go down into the to two point something. If you're in the you know, I'm just giving you a rough numbers 30 to 49. There may be point 08. And then they go way down if you're, you know, in your 20s or under 18. It's like point 01. Now, remember, for over 70, we started at again, in April, it was 29%. Wow. Or that was we weren't doing as much testing and so forth. But case fatality rates have dropped, as I said, in every age group, every age cohort, and in total by about 85%. Very similar across age groups, how much they've dropped.

So what so what about the focus on you know, getting fighting disinformation and getting the information out? What What about that? I mean, that's something that I feel that we have to have just such a monocular focus on in terms of communication. And I know the leadership of your organization is certainly you know, preoccupied with that.

Yeah, well, I mean, we're at the Secretary's orders, we're being as transparent as we can. They're holding back I just came up from a news conference, they're, they hold them three times a week, General, permanent secretaries are Monsef slouchy. If you watching the airwaves, they're on TV all weekend and the Sunday shows trying to convey information we've seen, you know, I mean, I need to put it this way. But since November 3, we've seen a little bit of a shift in the media toward celebrating operation warp speed, and therefore much more receptive to the information, you know, and conveying information that's coming out. So that's working in our favor a bit more now. There's a tons of stuff being published on CDC website MW RS every day. I think it's actually a little bit of information overload if anything we might be suffering from. And so you know, we work very hard to try to limit our messaging going out so the American people can digest it. And right now it is, I think our major messages Help is on the way, please be patient over the holidays, don't do something rash. Because we want you here next year at this time, and if we can just get through the next couple months, there are really, really bright days ahead.

It seems like it really does seem like that I mean, the amount of progress that has been made the dissemination and obviously the term warp speed really has occurred. I'm very good Excited about the next few months. And you think that we'll all have to show evidence of having the vaccine do you think will go towards that kind of model? Not just with the airlines and travel, but do you think we'll go to that?

Yeah, there's I don't know the answer. But I can tell you there's a lot of reluctance here. To do that. It sounds a little bit like 1984. sounds a little bit like, you know, government invasiveness. And that's not the that's not the philosophy of the folks here today. I'm not saying that might not change. That's right. We can tell you were very reluctant to do something like that. I mean, you know, the public health folks understand it from a public health perspective, and they think it could positive and I'm not criticizing them, but it's not their job to think about the broader implications of, and we're thinking about the broader implications. And

yeah, I mean, I just imagine when it comes to air travel, and you've seen what just happened over the weekend with the UK, yeah. And airlines across the EU.

Yeah, look, I'm cutting down just a plug for the airlines, they've done a spectacular job. And all the evidence we have, including the CDC is that when you're in that aluminum tube, it's actually a very safe place to be the problem is what people do when they get to their desk. But actually, the airlines and I flown a couple times myself secretary is flown several times he makes a point of saying he fly Southwest. The point is that we found it to be statistically extremely safe. So people shouldn't worry about flying, they should just not let their guard down in the airport, by the way, which is less space and at the destination if they're celebrating holidays with their families.

Right, right. It's a Yeah, so there's a whole bunch of comments that are still here. If you have other questions, send them to B. Kennedy at PGH tech.org. And we will get them to Paul and his team. Paul, you have taken more time, then, you know, we've asked to view and I just can't thank you enough for your leadership for representing us. And just getting through what is an historical time.

I have a great Well, thanks. Thanks for having me. I won't be in western pa for the holidays. So I want to extend my best wishes to all my friends and and colleagues back there. Hope you have a great safe holiday and hopefully a little bit of snow will still be on the ground on December 25. Yeah.

All right. Well, stay safe. Thanks, everyone. I think you have a business as usual tomorrow. Right, Jonathan?

Absolutely. We have earned stopping by which is Jessica Brooks and Zig Marton to talk about how they're helping folks. find jobs that are having a hard time finding jobs. So should be a great session.

Oh, okay. Great. Okay. Well, thanks, everyone. Really appreciate Paul. Joining us today couldn't be more timely. And we'll see you tomorrow. If we don't see you tomorrow. Have a great holiday. Thanks, guys.

Transcribed by https://otter.ai