COVID-19 Webinar Series Session 10 – The Science and Policy of Vaccine Development

12:00 p.m. – 12:05 p.m.     Welcome and Introductions

Sarah J. Dash, MPH

President and CEO, Alliance for Health Policy, @allhealthpolicy

12:05 p.m. – 12:15 p.m.    Opening Remarks

L.J Tan, M.S., Ph.D.

Chief Strategy Officer, Immunization Action Coalition, @ImmunizeAction

Esther Krofah, MPP

Executive Director, FasterCures, a center of the Milken Institute, @KrofahEsther

12:15 p.m. – 12:30 p.m.     Moderated Discussion

(This is an unedited transcript. For accurate quotes and presentations, please refer to the full-event video.)   0:05 Good afternoon, everybody. I am Sarah – president and CEO of the Alliance for Health policy and non-partisan resource for the policy Community dedicated to advancing knowledge and understanding of Health policy issues. Welcome to today’s webinar. We launched this webinar series to provide insight into the status of the covid-19 response and shed light on remaining gaps in the system that must be addressed to limit the severity in the United States the alliance gratefully acknowledges. 0:35 Is the National Institute for Healthcare Management foundation and the Commonwealth fund for supporting our covid-19 webinar series, you can join today’s conversation on Twitter using the hashtag. I’ll help live and follow us at all Health policy. We want you all to be active participants. So please get your questions ready. Here’s how to ask a question. You should see a dashboard on the right side of your web browser with a speech bubble icon with a question mark you can use that icon to notify us about any technical issues. 1:05 Just submit questions you have for the panelists at any time. We will collect those and address as many as possible during today’s broadcast. Check out our website. I’ll Health policy dot org for background materials and a recording of today’s webinar, which will be made available there soon as government and Healthcare leaders look for ways to ease social distancing measures and return to some semblance of normalcy. We know that a safe and effective vaccine is the most promising tool to combat this pandemic. 1:35 Currently there are dozens of candidates in developments that must undergo rigorous evaluation before they become widely available today. We will discuss the steps necessary to bring vaccines from the lab to the front lines. Now. I have the pleasure of introducing our distinguished panelists first. We have LJ 10, who is the chief strategy officer at the immunization Action Coalition before this role LJ was the director of medicine and Public Health at the American Medical Association. 2:05 And he was am a director of infectious disease immunology and molecular medicine for 10 years. Next we’re delighted to have Esther covid raining us Esther is the executive director of faster cures a center of the Milken Institute. She was previously director of public policy at GlaxoSmithKline and served as the deputy director for the HHS office of Health reform. Thank you both for joining us today. I’m now going to turn it over to LJ tan for opening remarks. 2:34 Okay, go ahead. Oh, thank you very much. Sarah really appreciate the opportunity to up to do this and I have some slides and I hope you all can screen capture this and I think we’ll try to make this available later so that you can get a lot of this information in front of you since five minutes is actually going to be very very fast. So if you can skip the first three slides of disclaimers and stop at than this one this I’ve been asked to kind of give a very high level view of vaccine development and then kind of wrap up and saying what might have to change in order for a covid-19. 3:04 Vaccine to get to Market quickly, but just to set the background to remind everybody that even in the traditional sense of the word process vaccine development is not simple it can take 10 to 15 years. Maybe sometimes as much as 20 costing at least eight hundred million dollars even more with substantial risk to the people who are developing the vaccine and if you include the cost to build manufacturing facilities Etc, the figure can rise to well over a billion dollars to bring a vaccine from initiation to tomorrow. 3:34 pocket and as you all know clinical development involves a very large number of subjects because these vaccines are held to a very high level of efficacy as well as safety and rightfully so and then obviously once the vaccine is being manufactured there very stringent quality control criteria that in place and then when someone when an organization or a car manufacturer finals a fight or find a filing to to get approval from the governmental regulatory authorities Is a very rigorous and in-depth evaluation. So in the United States, obviously, that’s the Food and Drug Administration or the FDA. So this is just to show that there’s a huge very complicated development process and the next slide. I’m hoping to kind of run you through that very quickly with the next slide, please. 4:23 So as you can see here, this is how we’ve broken up back the vaccine development pathway. So the first step is the pre-ind on investigational new drug step. Then it goes into an investigational new drug application to the FDA. Then there’s a licensing process and then finally following licensing and distribution of the vaccine. There’s obviously a post approval process as well and I’ve highlighted in each of these boxes all the different things that happens at these different phases. 4:50 So for example in the investigational early Concept of conceptual phase has you’ve got discovery of the vaccine. You got test tube animal studies trying to make sure you have a viable vaccine candidate. Once you have that you didn’t move into the investigational new drug phase where you didn’t work with the FDA the regular leg Regulators essentially to create a human studies that you need to get that vaccine into a final approval filing which happens at the licensing stage. Once that happens. And you get approval for That vaccine. 5:18 The manufacturers didn’t go into post approval process which requires lots of vaccines to be Hurley tested facility inspection and so on and so forth. And what have going to Overlay here as we click through. This is the different partners that we have to engage in order to go through this development pathway. 5:32 So one click Josie that the conceptual phase and I HD LD tends to take all these basic sciences and translate them into something that can be used eventually by the industry as a vaccine industry can also do that and during this phase FDA consultation and review is also happening as we go through this process of vaccine development. You do a click please next slide next click. Thank you at this second phase you can see aspirin barter for example with public-private Partnerships, which I think will hear as to talk about will come into play. 6:04 lick And that third face it tends to move into industry at this point because some industry will Shepherd the the application to find licensing process and production of the vaccine for upscaling and then finally FDA and Industry are involved in that Final post-approval Phase. And if you go to the finals next two slides we can go ahead and skip this slide and go to the next slide. So if you take that traditional process and think what do we need to do for covid-19, these are some of the things that people are talking about with regards to excel. 6:35 Operating that process down from the 10 to 15 years to hopefully within a year year and a half right? That’s what we’re kind of looking at. It could be a little bit quicker. But this is what we’re looking at. We’re looking at instead of doing sequential clinical trials. We’re looking at simultaneous clinical trials and these simultaneous clinical trials will occur in multiple Target population. So the elderly the Pediatrics pregnant women and they will have to have they’ll have to happen in multiple countries with different socio-economic standings because you want to make sure that this is advancing global. 7:05 As well, you’ll have adaptive trial designs what not. Does that mean what that means is that as trial results come out there gathered and in consultation with pre-specified rules that you done with the FDA. For example, you’ll actually modify the trial as it goes forward so that you can continue to improve the approval process, right? So this is what we call an Adaptive trial design and you want to run those trials where results are going to be most likely so in areas where their High outbreaks and that will have to happen regardless of where those areas could be. 7:35 Are you want continuous at the only collaboration with the regulatory agencies in the US will be the FDA so that you can ensure a rapid and appropriate approval process. So in other words you want to keep that going fast and quick and then you want to have to have early discussions on how you’re going to incentivize scaling up production. If you have a candidate vaccine that’s gets approved and how we going to distribute That vaccine fairly and equitably across the globe the globe should this happen because this is a pandemic and all of this obviously will require strong Global coordination and collaboration. 8:04 So Just kind of my quick 30,000 foot level. I’m going to stop there and then turn this back to you Sarah for our next panelist. Great. Thank you so much LJ and next we’ll hear from Esther profile executive director of faster cures Esther. Go ahead. Thank you so much Sarah and the opportunity to be able to participate today and LJ. Thank you for going over that not overview over the last several weeks as many of us have been watching this pandemic unfold around. 8:35 Round the world likewise, you know, we’ve been tracking these events in the early days starting in China and then into Europe and then here as well in the United States. One of the things that we wanted to do quite early on was to track the development of treatments and vaccines in response to this coronavirus, which really speaks to our mission and our focus at faster cures consistent with how can we accelerate the development of those? 9:05 And some vaccines and and like many watching the news media on a daily basis quite difficult to put your arms around. Where do we stand what’s in development how fast we expect to get to a vaccine obviously getting to a vaccine is really what’s going to allow us to get back to normal as we started to talk about. How do we come out of all of this? And what does that look like going forward into the future having a vaccine? That’s really what’s going to allow us to do that. 9:35 That I did want to set this all up in the context of what these other efforts are so that we have a good sense of how vaccines can be thought of in the context of all the different efforts out there to help us really get back to normal. We are tracking treatments where we expect that in the short-term over the next four to six months likely we will have a treatment that can help Abate the most severe illness from the Coronavirus. 10:05 Now these are not expected to be cures. These are expected to help individuals either in a preventative mode as we see data come out of early studies for those who’ve been exposed or those who are severely severely ill in ICU. These early treatments are being thought of as either antibody treatments either those that are recovered from patients who have recovered sufficiently. 10:35 Or or develop synthetic Ali and you may have heard a lot of that discussion in the news media with studies that are underway around an antibody or monoclonal antibody. We also see efforts underway with any antiviral receipt early data, that’s come out of studies. 10:54 Like them visibly are being developed by Gilead that it can again help is severely severely ill patients in ICU and we have a number of other Technologies being considered so that Dia is that as we wait for the vaccine development time frame and a candidate to emerge coming out of these clinical trials that we would have some therapies that can really help particularly those who are the frontlines and are continually exposed to the virus and the vaccine side. We’re tracking 86 vaccine candidates that fall into two broad categories DNA vaccines RNA vaccine. 11:35 The MRNA vaccines conjugate vaccines and so forth and essentially taking all the different technology capabilities that have been built up over the years and see that being rapidly deployed and we’ll talk about this later in the webinar with all these different partnership to bring their assets to Bear to help us accelerate this process. So it’s been very encouraging to see these multinational Partnerships. 12:05 Encourage acceleration in a process that as LJ mentioned would typically take a decade or more and and we can get further into that conversation Sarah great. Thank you so much Esther for that overview. That’s that’s really really helpful. Let me just start with following up on the point. You just made about public-private Partnerships, and I want to again encourage our audience to send in your questions using your question mark icon. 12:34 Can you Just give a little bit more context as to the market dynamics that surround vaccine development. And and what is the investment landscape look like and what’s the role of these public-private Partnerships in accelerating the development of a vaccine right there at so when we look at the global vaccine Market at least in 2016. It was valued at thirty 1 billion dollars. It’s expected to rise to about 58 billion dollars in 2020 for their many major companies that have invested in the development. 13:05 Vaccines for many years Pfizer as an example J&J Mark GSK Santa Fe as well as a number of the smaller biotechs that we’re seeing a lot of activity around like moderna Novak’s and novio and others the vaccine Market tends to be segmented based on technology as I indicated earlier by region. 13:30 And which part of the world is they’re attempting to address as Well as by the type of disease area that they’re they’re focused on from flew all the way to pneumococcal disease to hepatitis measles and so forth. We further see segmentation based on pediatric best vaccines versus adult vaccines and we have seen a growth of this Market over the last few years particularly given the increased incidence of infectious diseases a few years ago. We were dealing with the zika virus. 14:05 There’s the ongoing Dengue virus as well and the ongoing struggles against malaria and tuberculosis. And so the vaccine Market has grown as Ellijay indicated because it takes so long for the development of these vaccines. 14:23 They tend to be a very far and D heavy process quite an expensive process, which is due to many different reasons because of a high failure rate, which happens It’s predominantly in the early stages of this and because of all of these factors what we’re seeing right now is this unprecedented collaboration happening between the public and the private sector and these collaborations are quite unique. 14:49 I’ll mention just a few of them because what you’re seeing are either combination of Partnerships between a big manufacturing company that has the capacity and a smaller biotech or between The federal government and respective agencies and these big companies for example Pfizer and value in Tech. They have developed a partnership around an M. RN a vaccine to address the coronavirus. They’re expecting to utilize each other’s respective research and development sites and and bringing different resources and expertise to Bear. We recently saw the GSK and Santa Fe. 15:34 Collaboration where in that collaboration GSK will contribute their adjuvant technology while Santa Fe contributes the vaccine candidate itself. We also see great Partnerships between moderna who just even recently I think is so yesterday receive 483 million dollars from Florida. They are partnering with the National Institutes of Health would seppi which is a coalition that has been pulled together to develop vaccines for emerging infectious. 16:04 Diseases and I can go on and on between J and J and Barda and caravaca and stuffy. So all of these Partnerships really helped to bring either manufacturing capability to bear or funding for manufacturing capability or leverages different expertise. But each of these companies have so we’re not talking about a decades-long collaboration, but rather something that could happen and under 18 months. 16:32 Great. Thanks Esther. And I do just want to ask one that one of the quick follow-up that came in from the audience, which was could you speak a little bit to the role of the World Health Organization and accelerating vaccine testing and deployment and sort of combined with what cans are multiple governments do globally to help to accelerate and if you could just speak briefly to that that would be great. Yes, the who has established a platform study platform. 17:01 Studies are based on adaptive clinical design protocol where you can substitute in different compounds or candidates and quickly go through because you’ve already determined the clinical trial design quickly go through their study and leverage early data to inform what else comes in or what else goes out who established the solidarity clinical trial study. That is this multi-armed, you know. 17:31 Adaptive clinical trial which is quite important as we know that we need many different options. We cannot as you stay put all of our eggs in one basket. So if we can have studies like those that the who is sponsoring and the role that they have in bringing together International Partners. Those are going to be you know, quite critical and quite effective and needed going forward. We’ve also seen International or other countries rather. 18:01 To International organizations like stuffy that I mentioned earlier the UK government has contributed to seppi as well as some Scandinavian countries that have contributed to the work of Step. He’s tough. He’s working in close collaboration with the Gates Foundation having these kinds of international Cooperative agreements in place and and coalition’s in place that are funding the development of these vaccines is going to be critical we need everyone to do what they can from their respective areas to speed us. 18:31 To this hopefully what will be the most effective treatment? 18:37 Great. Thank you so much because of the fact that I think there’s going to be Global efforts and having research information shared across borders. It’s going to become very important and I think that’s what who can also have a very important role. 19:02 Thanks LJ and that’s that’s a great segue into my next question because I wanted to ask you and we’ve had several audience questions come in along these lines about you know, as you talk about accelerating that development timeline from 10 years down to 12 to 18 months. So I know some have called the the pandemic Paradigm and you talked about doing simultaneous trials instead of the sequential trials. Do those have greater material inherent risk. 19:31 As compared to sequential trials. So are they riskier? And and then can you talk a little bit about the evidence? How is the evidence going to work in terms of really when you have so many different trials in process so many different kinds of vaccine candidates how will how will researchers be able to tell the the safest and the most efficacious out of all of them? Maybe you could start there and then Esther jump in as you see fit. 20:01 Yeah, this is that’s a huge question. Obviously, I think you know, I think they’re I think when you talk about compressing the clinical trials what we are essentially doing with overlapping trials is really going into humans quickly doing a quick safety those kind of selection quickly and then moving quickly into kind of a safety efficacy trial all happening at the same time using adaptive trial design so that we can continue to adjust the clinical development as we get data out of those trials. 20:29 So by doing that what we allow us To do is to shorten that the phase 1 2 and 3 process faster. Now this idea of 12 to 18 months is still really fast. 20:42 So this is one of the things I think we have to figure out right is this idea that the reason some of these clinical trials especially a lot of manufacturing vaccine stops at the phase 2 to phase 3 phrase because I’m going into that phase 3 clinical trial is extremely that no go/no-go decision is extremely difficult because of the cost of that Final Phase 3 and the reason why there’s a cost is there’s in that Final Phase through you’re looking for ffxv data safety data and also a substantial amount of long-term data, right? So a lot of those clinical trials go out two three four years so that we have a sense of the long-term safety of the vaccine. 21:20 The challenge we’re going to have with these new vaccines is that some of the Technologies for example, mRNA technology has not been used in vaccines before although mRNA technology has Showing itself to be extremely safe in the in the labs we and because because of the all the all the biologic because of all the biologic characteristics of mRNA. Obviously, we still are going to have to figure out you know, what do we do in the absence of that long-term data so of safety and efficacy, right and I think that’s where the you know, the use of the experimental use authorization from FDA. 22:01 Those are things that We’re going to have to look for look forward to seeing the FDA do in getting this vaccine to Market. So I think that’s an introduction. I think s do you want to jump in here with some thoughts about that? I would just add I mean, I was great out here. I would just add the manufacturing component as well an accelerating this and that compressed timeline. What we’re seeing is that companies are going ahead and developing the capability in order to quickly manufacture doses while we’re going through clinical trials. 22:31 I That is quite unprecedented. We haven’t seen that kind of activity ever before and so even the announcement with Barda and moderna the the money that Barda is investing is to develop a new factoring capabilities so that if we do get an FDA-approved vaccine, they can quickly be able to turn out potential millions of doses a month starting in 2020. 22:57 We’ve seen Jay and Jay make the same commitment as well as As you know GS can Santa Fe with their collaboration so adding that manufacturing capability in certifying those manufacturing sites early on will help to compress that time frame to actually be able to deploy it to many people and as Services, that’s a really good point because a lot of this is being done at risk to obviously the manufacturing Partners as well. So it is unprecedented to thank you for bringing that up. 23:28 Thanks, and and as a quick follow-up, I know we’ve heard that the Gates Foundation also is is investing in multiple manufacturing facilities. And as I understand it, it’s not just to ramp up the production is because different vaccines with different Technologies may require very different kinds of equipment and and so on. Is that right? 23:49 That’s right. I mean you’ve also heard Bill Gates himself say that he expects to lose billions of dollars in doing that. Right because you’re scaling all of this up while you don’t know which one will ultimately be successful. I do think what we see in some of these Partnerships as I mentioned earlier is that combination of the small biotech that has some of the capabilities with these new technologies like an mRNA platform or others part partnering up with a bigger. 24:18 Benny who has already had experience in manufacturing. For example moderna has not taken a vaccine all the way through to commercialization. So it’s important for them to develop the manufacturing capabilities of front those for partnering with with folks. Like, you know Pfizer GSK others. They have tremendous experience taking vaccines all the way through to commercialization and and Manufacturing. So being able to have that built into your early plant will be quite critical. 24:48 Great. I want to ask one more question about the science of this in the scientific development and then and then move to for what happens next. Can you talk about whether we know yet whether there’s much variance in response to any of the vaccine candidates across race and gender and what’s being done to get participation in the studies that really reflect the diversity of the population. 25:15 I’ll jump in first after that you can go ahead and continue this. I think I think this is this is what I kind of touched on it earlier in one of my slides is this idea that I think with our trials now, we’re going to have to obviously jump in where we can get results the fastest and I think by that nature we’re going to jump into places where there’s going to be a disease and I think I think that’s that’s probably the first driving point of enrollment into some of these trials is we got to go where the diseases and where we can get results fast. 25:43 And then I think as we go into that I think what we’ll do then is obviously we’ll have to be a look at what you’re enrolling who you’re rolling and then seeing whether you need to then change some of the demographics that you’re looking at to account for things like gender equality and so on and so forth, but I think first and foremost in order to get the results, you got to go in somewhere and you need to go and get disease is regardless of geography or socioeconomic status or or so on and so forth. So that’s that’s the high level thought process and then I think you adjust as we go Esther. 26:14 Any thoughts there well in there and the early study that moderna started in mid-march, they needed to enroll 45 healthy patients largely in the in the Seattle region Washington region, and I believe the first dose was been someone who that’s you know, Kaiser permanente’s health systems. So again, you’re going to go to where you have those Partners who are working with you either academic research. 26:44 Action what NIH is bringing to bear or they’re already developed clinical trial networks. And so activating those quickly will be the key and then of course reaching out to the respective patient populations that are part of you either, you know, those networks or can be quickly and rolled. I do think you’re raising important points there around how do we ensure the right demographic distribution and and in that reflects and their data of the early studies? 27:14 But I think right now seed is the first factor and in having some of these other other considerations will be important going forward great. Thanks. So I want to ask a question related to the speed of getting of getting a vaccine and we’ve had a couple questions come in around this which is are there trade-offs with regard to speed and safety. 27:38 And of course, we inhabit a world in which we’re all anxiously awaiting this vaccine, but not everybody sort of trust that Seems necessarily so so how what’s that interplay? What are the key messages that need to be gotten up to the public and what do we need to do to make sure that the vaccine is is safe as well as efficacious. 28:01 I mean I can start on the speed versus safety component and have a no LJ’s thoughts which is it everything that I have seen and all of our discussions and interactions with a lot of these companies. They are not compromising safety. 28:14 So safety is not being you know subverted for the sake of speed what we’re seeing in the pin the amazing Partnerships underway is bringing different expertise to Bear to speed up the time frame where you traditionally Not have had the incentives to do that. And so that will help us to go faster. We we obviously have regulatory bodies who are prepared and ready to be able to review these trial designs and and to activate networks and to bring their own expertise to Bear to make sure that things are going through the appropriate protocol, but safety is still the first and critical factor and then of course efficacy, which is really what we need. The last thing I will say is that in order for us. 28:59 To go back to life as normal. We do need a vaccine and so with vaccine hesitancy issues and so forth. We need to communicate and I’m sure the public will understand that for us to go back to you know, going to our social lives as we had it. We ultimately need a vaccine in order to do that. 29:19 That’s the thank you that was actually really well said son that the part about I think you know, obviously the way you get through a pandemic is to get through it and one of the big factors of helping us get through that obviously is Just the treatments a Tesla was talking about but ultimately this vaccine I do think it’s going to be interesting as the Saxon gets rolled out, you know, a lot of the partners rolling these facts the things out the public and private sector are taking enormous risks on themselves to do this because it is a public health good here. And I think the big picture we want a message to everybody is is vaccinations and vaccines are a public health good and it’s a social Norm for protecting our populations against not just, you know outbreak diseases but existing vaccines. 29:59 Preventable diseases as well. And so now I think I think we want to remember that. We have a incredible track record in the u.s. Of an around the world of safe and effective vaccines and that I do not expect and I don’t anticipate that at that that’s going to be at all compromised in the development of a covid-19 vaccine even as quickly as these incredible Partnerships and bringing the vaccine to Market. 30:20 So I think that’s a really important message that we want to keep emphasizing to the public about the safety and efficacy of not just the covid-19 vaccines that are being developed but also vaccines that are currently approved by the FDA Well, thank you so much, LJ and Esther, and unfortunately, we are already out of time time flies and there have been some great questions coming in from the audience. Unfortunately, we couldn’t get to all of them, but we encourage you to continue to reach out to us and we’ll try to get back to you one-on-one with with some responses. I want to thank LJ tan and Esther cofa for joining us today on the science and policy of vaccine development. We really appreciate your time. 31:03 Expertise, and I want to remind the audience that a recording of This webinar will be available on our website. I’ll Health policy dot-org later today Esther and LJ. Thanks again for joining us. Thank you for the opportunity. 31:18 Thanks.