As the race for a COVID-19 vaccine approval continues, the need for a multi-stakeholder, national vaccine deployment strategy is becoming more urgent. With ambitious dose manufacturing goals and increased pressure to make COVID-19 vaccines accessible to everyone as quickly as possible, it is crucial to identify and understand potential challenges that our health care system will need to overcome. This briefing explored the manufacturing, distribution, delivery, and coverage approaches that will enable nationwide COVID-19 vaccine uptake. Panelists discussed manufacturing and workforce infrastructure, equitable allocation strategy, and payment and coverage tactics for approved COVID-19 vaccines as well as examined facilitators and barriers to a successful nationwide immunization deployment.
This is the final event in Part I of the Alliance for Health Policy’s 2020 Signature Series focused on disruptors and transformers in health care. See previous events in this series here.
- Richard Hughes IV, JD, MPH, Managing Director and Vaccines and Preventive Services Leader, Avalere Health
- Esther Krofah, MPP, Executive Director, FasterCures, a Center of the Milken Institute
- Nicolette Louissaint, Ph.D., Executive Director, Healthcare Ready
- Reed Tuckson, M.D., Managing Director, Tuckson Health Connections; Board Chair, Alliance for Health Policy (moderator)
“COVID-19 Treatment and Vaccine Tracker.” FasterCures. September 22, 2020. Available at http://allh.us/c6wJ.
“From the Factory to the Frontlines: The Operation Warp Speed Strategy for Distributing a COVID-19 Vaccine.” U.S. Department of Health and Human Services. September 16, 2020. Available at http://allh.us/mYUu.
“Readout From the White House Coronavirus Task Force’s Governors Briefing on COVID-19 Response & Progress on Vaccine Development, Manufacturing and Distribution.” U.S. Department of Defense. September 9, 2020. Available at http://allh.us/PETj.
“Vaccines Outlook: Hesitancy, Uptake, and Infrastructure with Dr. Angela Shen.” Hughes, R. Avalere. September 1, 2020. Available at http://allh.us/dwbR.
“A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus.” Foege, W., Gayle, H., Brandau, M., et al. The National Academies of Sciences, Engineering, and Medicine. September 1, 2020. Available at: http://allh.us/JTM6.
“CMS Proposal Would Increase Provider Payment for Vaccine Administration.” Hughes, R., Jones, K., Sobel, E., et. al. Avalere. August 27, 2020. Available at http://allh.us/dFUY.
“Bringing COVID-19 Vaccines and Therapeutics to Market.” George, K., Hughes, R., Neal, J., et. al. Avalere. August 11, 2020. Available at http://allh.us/fYQp.
“COVID-19 Resource Guide: Healthcare Supply Chain Partner.” Healthcare Ready and PhRMA. 2020. Available at http://allh.us/QyjE.
“Hahn Insists FDA Will Stick to Guidelines for COVID-19 Vaccine Decisions.” Mezher, M. Regulatory Focus. September 29, 2020. Available at http://allh.us/yJdj.
“FDA Poised to Announce Tougher Standards for a COVID-19 Vaccine That Make It Unlikely One Will Be Cleared by Election Day.” McGinely, L., Johnson, C. The Washington Post. September 22, 2020. Available at http://allh.us/cqaD.
“Cutting Through the Vaccine Headlines.” Holt, C. American Action Forum. September 18, 2020. Available at http://allh.us/f7EV.
“Trump Administration Releases COVID-19 Vaccine Distribution Strategy.” U.S. Department of Health and Human Services. September 16, 2020. Available at http://allh.us/hCqu.
“COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations.” Centers for Disease Control and Prevention. September 16, 2020. Available at http://allh.us/rHPh
“Promoting Equitable Access to COVID-19 Vaccines – The Role of Medicaid.” Wallace, J., Schawartz, J., Orenstein, W. Health Affairs. September 15, 2020. Available at http://allh.us/X3K8.
“How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine.” Gottlieb, S. American Enterprise Institute. September 13, 2020. Available at http://allh.us/J6F4.
“Beyond the Case Count: The Wide-Ranging Disparities of COVID-19 in the United States.” Getachew, Y., Zephyrin, L., Abrams, M., et. al. The Commonwealth Fund. September 10, 2020. Available at http://allh.us/TWM8.
“The Biopharmaceutical Industry is Leading the Way in Developing New Vaccines and Treatments for COVID-19.” PhRMA. September 11, 2020. Available at http://allh.us/vUde.
“An Ethical Framework for Global Vaccine Allocation.” American Association for the Advancement of Science. September 11, 2020. Available at http://allh.us/uedW.
“Some Epidemiologists Say FDA Standard for Coronavirus Vaccine Not High Enough.” Hogberg, D. The Washington Examiner. September 10, 2020. Available at http://allh.us/Ajwr.
“Several COVID-19 Vaccines Could Join Winner’s Circle.” Loftus, P. The Wall Street Journal. September 10, 2020. Available at http://allh.us/MDFW.
“Public Trust in CDC, Fauci, and Other Top Health Officials is Evaporating, Poll Finds.” Florko, N. STAT. September 10, 2020. Available at http://allh.us/aUdm.
“Pharmacists Nationwide Can Vaccinate Kids Under Latest Guidance.” Lee, J. Bloomberg Law. September 9, 2020. Available at http://allh.us/6c8k.
“Health Official Tries to Reassure Public That Science Will Set Vaccine Approval.” Stolberg, S. The New York Times. September 9, 2020. Available at http://allh.us/VyYx.
“The Health 202: Most Americans Won’t Be Allowed to Get a Coronavirus Vaccine as Soon as It’s Approved.” Cunningham, P. The Washington Post. September 8, 2020. Available at http://allh.us/A7PQ.
“When Will We Have a Vaccine? – Understanding Questions and Answers about COVID-19 Vaccination.” Bloom, B., Nowak, G., Orenstein, W. The New England Journal of Medicine. September 8, 2020. Available at http://allh.us/pahm
“Trump Administration Collaborates with McKesson for COVID-19 Vaccine Distribution.” U.S. Department Health and Human Services. August 14, 2020. Available at http://allh.us/fHhr.
“The Fragile Vaccine Plan to Save The World.” Capretta, J. American Enterprise Institute. July 29, 2020. Available at http://allh.us/MgBP.
“Expand COVID-19 Testing With Real – Time Processing Through Community Pharmacies.” Kocot, S. Health Affairs. July 1, 2020. Available at http://allh.us/XHMr.
“Planning For a COVID-19 Vaccination Program.” Schaffer, S., Pudalov, N., Fu, L. The Journal of the American Medical Association. May 18, 2020. Available at http://allh.us/BGFt.
“The Equitable Distribution of COVID-19 Therapeutics and Vaccines.” Bollyky, T., Gostin, L., Hamburg, M. The Journal of the American Medical Association. May 7, 2020. Available at http://allh.us/hjWa.
“To Prepare For COVID-19 Vaccine, Let’s Ensure Manufacturing Capacity Will Meet Demand.” Haislmaier, E. The Heritage Foundation. April 28, 2020. Available at http://allh.us/DWna.
For even more resources, experts, and materials on the COVID-19 response, please see the Alliance’s COVID-19 resources page.
Good afternoon, everybody. I’m Sarah Dash, President and CEO of the Alliance for Health Policy. For those who are not familiar with the Alliance, welcome. We are a non partisan resource for the policy community, dedicated to advancing knowledge and understanding of health policy issues. We’re thrilled to be hosting this afternoon’s webinar on the covert 19 Vaccine Deployment Process. This briefing is the final event in the first name of our 2020 Signature series Disruptors and Transformers, which has explored the short and long term impact of the Ongoing coven 19 Pandemic, and its potential to significantly transform our healthcare system. And today, we will focus that on the vaccine efforts. I’d like to take a moment to thank our 2020 Signature Series Sponsors. And remind everyone that you can use today’s conversation on Twitter, using the hashtag hashtag … live, and follow us at all Health Policy.
We want you all to be active participants, so please, do get your questions ready. And here’s how you do it. You should see a dashboard on the right-hand side of your web browser with a little speech bubble icon. And you can use that speech bubble icon with the question mark in case you have questions, as well as any technical issues. And, finally, you, if you have additional technical issues, you can use the Troubleshooting tips or technical support in the bottom left-hand corner of your screen.
Finally, please be sure to check out our website, all health policy dot org, where you will be able to find background materials, and a recording of today’s webinar, as well as materials and recordings from the rest of our Signature series. And now I am very pleased today to be introducing doctor Reed Toxin to moderate today’s discussion. Not only is he a member of the National Academies of Medicine, A Framework for Equitable Allocation of vaccines for the Novel Coronavirus Taskforce. He is also the managing director of Toxin Hough Connections and he is the chair of the Alliance for Health Policy for doctor …. And thank you so much for joining us today. And now I’ll turn it over to you to introduce the discussion and our panelists. Over to you. Thank you. Thank you very much, Sarah. We appreciate this.
As the race for a covert 19 vaccine approval continues, the need for a multi stakeholder, national vaccine deployment strategy is becoming more urgent with ambitious those manufacturing goals and increased pressure to make covert 19 vaccines accessible to everyone as quickly as safely as possible. It is crucial to identify and understand potential challenges that our healthcare system will need to overcome in these pursuits. This briefing will explore the manufacturing, distribution, delivery and coverage approaches that are so necessary to enable nationwide covert 19 vaccine uptake.
Our three, especially knowledgeable panelists, will discuss manufacturing and workforce infrastructure issues, equitable location strategies, payment and coverage tactics for approved vaccines, and examine facilitators and barriers to a successful nationwide immunization deployment.
Well, let’s get right to it, and we will begin with our great colleague, Esther …, who is the executive director of Faster Cures, the Center of the Milken Institute that focuses on building a patient centric health system where science is accelerated and barriers are overcome. Esther, what are your opening thoughts, please?
Well, thank you so much, doctor …, and thanks. So, as well to Sarah, the entire team at the Alliance for Health Policy for having me on this webinar, and very much looking forward to the conversation. Over the next 90 minutes, I wanted to provide a level set on where we are with development of covered 19 vaccines, but, importantly, we should, we should start with treatments as well. If we can get the slides up, I would like to go through a few slides to show us where we are.
If you go onto the next slide early, in, March, we at Faster Cures started to track the development of both therapeutics and vaccines for covert 19 and created what we call our cover 19 treatment and vaccine tracker. That we’ve been updating daily since March. And for those of you who can imagine, it is actually a monumental task to keep up with what’s happening globally in this really highly evolving landscape.
At the moment, we have identified our tracking 316 compounds that are either novel or repurposed compounds, as well as efforts to scan additional compounds that could be useful for this virus. And then 213 different vaccine efforts underway, if we go to the next slide.
Just to start on the treatment side, because I do think it’s important to understand that while we are in this hot pursuit for vaccine, there are a number of efforts that are underway from a therapeutic perspective, as well. For those of you who are familiar with the HIV story, you will recall that even as vaccine development and research continues, 30 years later, we were able to get to highly effective therapies for HIV, to control that virus. And, in some, in some ways, suppress even the transmission of the virus. So, it’s important to understand what’s happening with treatments, as well. And then we’ll get into the vaccine discussion on the treatment side. There are a number of compounds that have broken down into the categories that you see on your left, whether antibodies, antivirals, cell based therapies, RNA based treatments, as well as even devices.
And the use of devices in patients, particularly, to address issues in the lungs, 204 of these, are in clinical trials, or being used for compassionate use, 112, are in pre clinical trials. Many of you are familiar with what’s already been approved through emergency use authorization, including Red desert beer. Early on through an NIH study was found to be effective, moderately effective in reducing the time to recovery from patients who were in ICU, a UK study, identified dexamethasone, quote unquote Stuart Steroid, That was also found to have effect in reducing mortality for about a fifth of patients. Severely ill patients as well in ICU, Convalescent plasma very recently was provided emergency use authorization.
Again, for ill patients, 49 of the 204 compounds that we’re tracking are in phase three clinical trials, but the totality represents over 2500 clinical trial efforts that are underway globally. We should really be paying attention to what I call the master protocol, clinical trial efforts underway. These are adaptive design trials focused on therapeutics on the compounds that I have here. In the blue. The most notable ones are active, which is a public private partnership underway at NIH, established by doctor Francis Collins. That’s looking at monoclonal antibodies, Immune modulators, anticoagulants are also part of that study, recovery in the UK outside of the US. Solidarity through the WHO. So, a number of efforts are underway to get to an effective therapeutic, which I do believe plays into this entire story with regard to vaccines as well, if we go to the next slide.
I’ll spend more time here talking about where we are in terms of vaccines. As I mentioned, 213 vaccines in development for covert 19, that fall into nine different product categories. Some of these categories are well studied and understood. Others are new and novel, for example, the … RNA platform that many of the vaccines that are in later stage clinical trials do not currently have a commercialized or licensed vaccine on the market. However, because of the nature of that technology, to allow the process, to get to a viable vaccine for study, to move much more quickly so that that will be interesting to watch how the clinical trials or novel technologies like the m-r.n.a. or others, of course, have been tried and tested and used.
Many times over in the past, we knew a lot of B vaccine development efforts outside of the US are using mechanisms like an inactivated buyers or live attenuated virus that have some potential risk of carrying a live virus directly to patients. So not many here happening here in the US, but we do see some of those efforts outside of the US.
If you go onto the next slide, it’s important to understand the clinical trial process. Many, of course, are watching these efforts quite closely. There are some emerging concerns. Are we moving too fast? And in order for us to answer that question, we need to look at what the different stages of clinical trials are. All of the vaccine efforts underway will follow this stages of clinical development that are outlined here. Stage one clinical trials focuses on safety. Generally, fewer than 100 patients typically lasts 1 to 2 years. And this is being accelerated, of course, in the time of killed it, but still going through that rigorous safety assessment through phase one study.
Phase two, studies are typically and hundreds of patients continuing to monitor safety, but also testing dosage, what it’s appropriate dose to give to different patient populations in order to realize the effect that is desired in the body, in the case of the vaccine. To see the immune response, whether the immune responses at or greater than those who are convalescing patients or have a neutralizing effect on the virus.
Phase three studies where a number of the vaccine efforts are focused right now or current thousands of patients. We see a range right now, with a phase three clinical trials underway, with, with some product developers, ranging from 30,000 patients enrolled in those studies. All the way through to 60,000 anticipated patients enrolled in new studies typically takes 2 to 4 years to get through a phase three clinical trial. And the phase four is the post approval post marketing phase, where you’re continuing to monitor safety in the population based on real-world conditions. Continuing to monitor manufacturing facilities, to ensure ongoing quality and safety. At this point, we have 35 of those vaccine candidates I referenced earlier of the 213, 35 are in one of these stages of clinical trial.
Could go on to the next slide.
We’ve noted here a few of the vaccine candidates that a number of you would have heard a lot about in the media and the press. Madonna, which is a partnership with the National Institutes of Health, is in phase three clinical trial, the anticipate being fully enrolled by the end of this month. September and about 30,000 patients leveraging the NIH network. Leveraging and using an m-r.n.a. platform, the body when Tech and Pfizer collaborations, also similarly in a phase two, phase three clinical trial, anticipate enrolling 44,000 patients. And, and that studies well underway with expectations. that has been stated by the company and others that there will be read out by this fall later.
This fall astra zeneca, University of Oxford partnership. This is a global effort where, with trials that are occurring all over the world, including in Brazil, in South Africa, as well as in the UK. They are in phase three.
clinical trial, Johnson and Johnson and, and others, as you see here. So a number of these companies are very well experienced in vaccine development, have been doing it for decades and decades. If you go onto the next slide, another hot button topic that’s emerged is.
Differentiating what would be permissible: three emergency use authorization versus full licensure biologics license application.
I mentioned early from a therapeutic perspective that emergency use authorization has been provided for two therapeutics … convalescent plasma. The EUA allows the FDA to allow the use of unapproved medical products in emergency situations where there are no proven products that are are are definitively identified as beneficial to patients. So if there is a signal that that product is potentially beneficial, and save the, FDA has latitude to allow its use through emergency use, authorization, and define the scope of that use. Typically.
For vaccines, they go through a full licensure process, licensure applications are submitted after a product developer, has completed pre clinical studies, animal studies, lab studies, as well as the three phased in Human clinical trial studies. And provides a full application, including details on manufacturing and quality control to the FDA. Included in that type of application are product manufacturing information, the pre-clinical studies, clinical studies, and expected labeling information. This in this process typically takes 1 to 2 years, and once the FDA approves that, they continue to monitor the vaccine development process as well as inspecting the manufacturing facilities.
Many of you will know that the FDA has has stated that they are expecting manufacturers that are developing cover 19 vaccines to be to target about 50% efficacy for either an EUA or a licensure application and, and of course, we’re hoping for something much greater than that, but that is the current target right now. If we go to the next slide, questions are going to emerge and have already around allocation, distribution, and administration of the vaccine in the US.
The National Academy of Sciences was directed by the NIH to develop an allocation framework of equitable allocation of covert 19 vaccines as an input. They provided a draft of that last, just earlier this month. In fact, just a couple of weeks ago, at provide an opportunity for public comment, And I believe the received about 1400 comments. So, it shows is a very engaged public around this process that provides an input into a US. Government approach where the Advisory Committee on Immunization Practices ASAP, Which is responsible for providing recommendations on the target patient population.
To use the input from the National Academies Report as well as working with the Centers for Disease Control and Operation Warp Speed, as there, aren’t in the midst of evidence generation toward the vaccines that are in that process. Guidelines coming out of the US government will be provided to state, local, tribal, and territorial authorities to implement at that level.
The US government has identified McKesson as a third party distributor of these vaccines there, potential for some manufacturers to distribute the vaccines directly. Particularly, in cases where there are ultra cold storage requirements. The Pfizer vaccine for example, needs to be kept frozen at very, very cold temperature.
Given the nature and the logistics behind it, it’s possible that they might distribute that themselves or go through, go through McKesson. We are going to have some challenges in distribution. Will get much more into this on the rest of the webinar. Hard to reach areas, hard to reach populations, tracking the dosage. Most of these vaccines, with the exception of the Johnson and Johnson Vaccine, are two dose regimens. You need to take a first shot. Either, 21 days, as, in the case of the Pfizer, or 28 days, is the case of the modern a vaccine, you need to get your second dose. So tracking and monitoring that two dose regimen is going to be quite important.
And alongside the vaccines are all of the equipment that are needed to administer glass vials, syringes, appropriate PPE for the healthcare workers. If you go to the final slide and then we’ll turn it back over to doctor Toxin.
We are all very mindful of the current climate that work. And in terms of vaccine hesitancy, I will say vaccine uses is actually traditionally quite high, particularly for pediatric vaccines. And, and what we tend to see are on the margins sentiments against vaccines. We are hearing more and more concern about uptake of these vaccines. I think, primarily out of concern that, there are shortcuts being taken, which, as I described earlier, all of these vaccines are going through the different stages of clinical trial. But there are some concerns that there were Some shortcuts are occurring, which might be contributing to the hesitancy.
Recent poll, as you can see here, is showing from Pew. On the far right, is showing that compared to May, earlier this year, where 72% of all adults say they will get a vaccine, Either definitely. probably. Will get a vaccine. We’re now down to 51% of adults in September that said that they’re likely to get a vaccine, and, of course, to see the differences depending on, on your politics. So that is certainly an uphill climb that we’re going to have to address a lot of that is going to be focused on education around what a vaccine is, education on the development process, and, of course, bringing in different patient populations into the clinical trial process. So I’ll just pause there and turn it back over to doctor Tungsten and look forward to the Q&A.
That was a terrific way to launch this, this presentation and conversation. Thank you very much. I’m happy now to turn to Nicole that Luis. Aunt who is the Executive Director and President of Healthcare Ready. An organization that leverages relationships with medical supply chains to enhance resiliency before, during, and after disasters. And she will help give us some insight into the building blocks of vaccine manufacturing and distribution from bench to body. And helpless also made me to level set on some important definitions and terminologies. So that will really understand some of the concepts involved. Nicola, thank you so much.
Thank you for having me, great to be with you all, doctor Toxin. I will make my remarks very quick recognizing that there are many questions and Esther did such a fantastic job covering really the breadth and the scope of this problem. I really will focus on a few points to really dig in a little bit deeper into a few of Esther’s slides, recognizing that, again, she covered much of this. in her remarks. I think it’s important that we recognize that from the vantage point of the, the entire vaccine manufacturing and distribution process that we are currently building. We are currently using the existing medical counter-measures pipeline and the established public, private partnerships that have been long in place prior to cope.
It’s important to recognize that from everything, from questions around speed and efficiency, a process, all the way to addressing some of the challenges that we will inherently face related to vaccine hesitancy. There are a lot of questions about, you know, speed of, of being able to move to development, the trial process. All the way to what it actually looks like to have an efficient distribution process.
And we should recognize that many of those processes have been in place the distribution side. You know, I think we’re gonna get into a lot of the questions related to medical distribution, but it’s important for us to think about it in a few phases, The first being on the question of, movement of product from the manufacturer to the distributor. So that third party distributor, currently the primary as McKesson, as Esther noted, that product will have to get there. And then, from that cold storage capacity, then, moving to the state. And then there is the long, long, dreaded Last mile question once that product made to the states, and then has to be distributed across that state, And that is a separate logistical undertaking, and, I know many states are working on their plans and micro plants that are in revision with the CDC now.
And a lot of the pilot work that was done, wow, just earlier this month, is going to be used to help inform those micro plans. But, that last smile is a critical component of this, and very important, because, in addition to just recognizing the logistics across various states, tribes, territories, and, and that logistics really do differ based on the population that will need to be vaccinated. The facilities that are engaged, it’s also going to be different at each of the phases.
And so, recognizing that, what distribution looks like across the state during Phase one, where there is limited, vaccine available, and that allocation and prioritization is really going to be focused on that. Whoever is ultimately deem to be that, that critical essential workforce population. I think many of us are putting in guesses, if you will, and, and can reason through who will likely be those first vaccinated. But again, the science is going to drive that, as well as the recommendations from the academies panel, that ultimately will inform ACF’s direction.
And then, you know, really thinking about those later phases, when there will be more product available. That will be the point where it’s really critical to think about what distribution looks like across those various across the states to get to those various facilities. And not just what distribution looks like for that single dose. That’s when those double, you know, the two dose complexities coming into play. So it’s not just getting people to the pharmacy the first time. How do you get them back for the second dose? You know, I also want to just note that, as we’re thinking through this, it’s important to remember that we’re not just talking about vaccination vaccination sites being hospitals. So really thinking about broadening our language, broadening our understanding at that last mile, that last mile, is going to include a number of critical healthcare facilities that will play a very important role, Especially in phases 2 and 3.
Pharmacy, federally qualified health centers, clinics are all going to be a part of that, in addition to the public health sites that are going to be set up and run by the state or the local. So this is a massive undertaking. Public health has been doing a tremendous job trying to co-ordinate all of these various pieces, but so is the healthcare sector.
And so it’s important that we are moving through this and even asking questions about distribution that we are thinking about that middle mile as well as the last mile. And with that, I’m happy to turn the floor back.
That is an excellent presentation. Nicola. Thank you so much. And it falls nicely and quite logically now to be able to turn the hand the baton to Richard Hughes, the managing director of Vaccine because then if service leaders or … this, maybe Mike, that needs to be.
And we will hope that that Mike would get muted. And so as I was saying, Richard is the managing director and back for Vaccines and Preventive Services leader of wherever they are health, which is a community of innovative thinkers dedicated to solving health care system challenges. And he is going to focus in actually on that last mile helping us to understand insights into the general mechanics of how Kobi … vaccines can be priced and covered by insurance during. And after the pandemic how these policies may vary from payer to payer and the role of initiatives such as operation warp speed on market lunch for one or more of these vaccines, Richard, thanks for joining us.
And you might be able to unmute now.
Yeah, there you go. Wonderful, thank you so much. So, we can go onto the next slide.
And happy to talk about how vaccines will be covered and pay for over the coming months and years for covert. So, you know, this question is persistent question of being on everybody’s mind is When will we be able to get a vaccine and as was described nicely by Esther. There are discussions going on with ACIP with the National Academies around who should receive the vaccine first. So we have this this layer of allocation and prioritization that you see here. We have this question around EUA and then ultimately licensure and timing there and the availability of this, so as doses are rolled out and administered to these various populations, you can see that there are these ups and downs of supply. And, demand.
Know, my best sort of guesstimate here as to when people will be able to the general population will be able to receive a vaccine is really toward the end of 2021.
And related to this question about, you know, who pays for the vaccine?
We’re in this period initially, at least up until that point where we reached the general population of responding to a pandemic. And so what you see is the government is in a procurement role, purchasing the doses. Additionally, it has the option to purchase additional doses in the future. So the government is going to continue. The US government is going to continue to play that role for some time. There will be an ultimate question about, you know, when does that procurement role ramp down? When, when does the US Government turn the responsibility purchasing doses over to, say, private payers? But perhaps continuing to purchase doses for a safety net population to ensure that everyone has access? So that’s a that’s a future question.
Both for the conceivable future, you know, we can all anticipate that the Federal government is due to play a strong role in purchasing doses to to provide initial doses in this public health response phase. Now ultimately, as everyone knows, there are lingering questions about whether this will be a pandemic vaccine or an endemic vaccine, so this is going to become endemic in the US. Is this something that we’re going to continue to have to fight on a regular basis, like, like flu or RSV?
Will it will it be seasonal? And that really comes down to, you know, we need to know more about the duration of immunity of all of the vaccines that are in the pipeline. And, that will help us understand both of those factors that … and the duration of immunity will help us understand whether we need to know, give this vaccine on a seasonal basis. And, you don’t really that. That is going to make a difference in the future, in terms of whether the government needs to continue to procure vaccines, whether we need sort of the same seasonal infrastructure and approach to vaccine distribution that kept for flu.
Or, does it look something more like a one and done pneumococcal vaccine?
I’m happy to answer additional questions about some of these tipping points later in the Q&A, but I think we can move on to the discussion around coverage. So, you know, there is, I find a lot of confusion and lack of clarity about, you know, initially, there was discussion about whether the vaccine would be affordable.
I think that is a little bit of a misguided question.
There are mechanisms in place to ensure access.
And today, except that, there is fragmentation and resulting disparities, those issues existed prior to two coven, and we can talk about how they affect access to code Vaccine.
There is a separate question about affordability the US government and how the vaccine will be price that, you know, initially there was a lot of discussion about about pricing. We’ve seen a number of price announcements so far. So so pricing is starting to become more of a known is a little bit of a different situation because companies are setting a price in a pandemic environment.
It’s really sort of know, we’re coming at this sort of backwards from a pricing standpoint. So I think we can anticipate that pricing will continue to evolve as we see which candidates make it to market, which ones are more or less effective.
And just how things really play out as we looked at that tipping point slide. We can expect that pricing will evolve in the future, but I view that as a very separate question from affordability to the patient, And I’ll explain why. So, prior to the Affordable Care Act, payers were able to set their own coverage policies with respect to vaccines and other preventive services. When Congress passed, the Affordable Care Act added, Section 27 13, to the Public Health Service Act, that’s what we all commonly know as the first dollar coverage provision. It requires that all ACIP recommended vaccines must be covered by commercial payers. So that includes self insured, non self insured. That includes the exchange market. All of those plans must cover vaccines without cost sharing. Now, under ordinary circumstances, a plan has a very long runway to implement a coverage policy following an ACIP recommendation.
So essentially, the ACIP makes it a recommendation and one calendar year, elapses and the plan has until the following plan year after that to implement the coverage. That could mean up to two years before a plan is required to cover a vaccine first dollar.
Now, Congress and the Cures Act took care to, know, speed that timeline up, So essentially, payers will have 15 days from an ACIP recommendation to, to cover the vaccine. So we can anticipate that payers, As I said, the government will play this role of procurer. Payers will still be responsible for reimbursing the administration DESE, where they would otherwise be required to cover the back seats, the government purchasing those. Hey, you’re paying the administration fee.
The best analog that we have for this today is the Vaccines for Children Program. So, today, the government CDC purchases through federal contracts with, with manufacturers, and with CMS financial backing. They purchased vaccines, provide those to the states for the eligible population, And then Medicaid program, the payers and the Medicaid market, they reimburse for the administration fee for the dose. That was, that was given by the federal government to the state, so, that is, essentially the scenario we’re looking at in this, in this space of government vaccine procurement for coping with payers, pay administration. So the coverage requirements that I just articulated for the commercial market that also applies to Medicaid Expansion programs.
I don’t have the account in front of me, but we know that a number of states, of course, have not expanded Medicaid, And in those days, in traditional Medicaid, the ACA did not apply here. So, states still have the ability to determine whether or not they will cover a vaccine traditional Medicaid. And we have historically since the ACA seem quite a bit of variability in vaccine coverage there, that is a notably vulnerable population to have a lot of low in pregnant women in this population. And, so, that’s something that, of course, will want to to address what the states.
Now, if you, if you know how vaccine coverage works, you know that Medicare is different. Because the Affordable Care Act did not address vaccine coverage in Medicare like it did for the commercial market.
What we’ve seen since the 19 eighties, pneumococcal, flu vaccines, recovered and Part B, and all other vaccines are covered in Part D, following the Medicare Modernization Act, which created Part D.
This is really meant that the vaccines have more access barriers. They are subject to out of pocket, unlike commercial health insurance vaccines are our subject out of pocket and Part D that is a notable access barrier for Part B vaccines. Whereas, in Part B, pneumococcal flu vaccines are covered without cost sharing, just like the commercial market.
Congress also had the wisdom and the cares Act to place the coves indexing in Medicare Part B. So, essentially, seniors will have access to the vaccine under Medicare Part B, which is, you know, traditionally a physician benefit. So, what CMS will need to do to sort of effectuate access to the indexing, similar to pneumococcal influenza is they’ll need to set up a roster billing process so that pharmacists, other non traditional health care providers, public health clinics, outpatient facilities. So, that they can go to the vaccine as it is covered under Part B.
And then, you know, I would just note here, there is an ongoing discussion. This is sort of in the background about the adequacy of Administration Fees for vaccines, the Medicare Physician Fee Schedule for a long while, has linked vaccine administration, sees two codes for other administrations. So injectable drugs.
And now, CMS is proposing to link to catheterization, which is a step in the right direction because that will result in higher reimbursement for administration. But there’s a strong feeling among immunization stakeholders that administration fees are not reflective of what it really takes, the practice to vaccinate the page, the cost of storing, and handling by going vaccines counseling patients. It’s just not all adequately accounted for, in their view through administration fees, as they are today. And we know that the Medicare physician fee schedule dictates you, know, indirectly fees across other markets, payers, rely on, in reference to the Medicare physician Fee schedule. So, it really has a very broad effect.
And, then, as we look ahead, we can anticipate, as I mentioned, you know, once the government stepped back and its role as procurer of the …
vaccine during this epidemic phase, we can anticipate doubt, you know, the government will then, one and the future to, to consider safety net populations and providing access through safety net approaches, such as the Receptor: T. Section 3, 17 Program, which is a program that allows the federal government to purchase vaccines for adults, and states, have access to that program. And so, that’s a mechanism by which we can make sure the uninsured individuals in the future have access to the vaccine. Some states do purchase vaccines, either through the federal contract, or there has been some discussion of states wanting to buy their own vaccines, So that that’s something that we could potentially see play out in the future. As, I think, everybody knows, children are going to essentially be one of the last populations recommended to receive the kogod vaccine.
Ultimately, the Vaccines for Children Program, as I described it earlier, would instantly, again, to provide that access to the vaccine.
So that is essentially the, you know, the coverage framework for the vaccine and how it will be access by Asians. And, yeah, I’m happy to answer any questions in the Q&A.
Thank you so much, Richard.
And so, what we will start to do now is I’ll remind our audience to submit questions using the question button on your attendee interface. And as you start to do that, let me have the enjoyment of the moderator to ask our panelists a few quick questions, and start with Esther. Esther, two quick things, number one. You describe the number of clinical trials that are going on with treatment initiatives as well as vaccine initiatives that around the world.
What if any impact does our leaving the United States leaving the World Health Organization and the fractured or challenging geopolitical realities that are confronting the world today? What if any, in the implications, do that, does that have for the ability to provide the American people with access to what’s going on with developments in around the world?
That’s an excellent question and I think it’s it’s quite important question, particularly in the context of addressing this as a pandemic, right? It’s not happening just here in the US, it’s happening all over the world. And we just hit that grim milestone right of a million deaths globally as a result of … 19. So for us to contain this virus globally, we need to have access to vaccines for the global population. And right now the implications of the US. Leaving the WHO are the efforts like the Covax facility, which is a collaboration between GAVI, the vaccine alliance, as well as the WHO, to ensure that countries have access to the vaccine, Notably. The US Is not included in that.
They’ve made the decision to not participate in the … facility, which essentially allows companies to, our countries rather to pool their resources or advance purchase of vaccines as they’re coming from these different did these different companies and what the US has said, is there going to pursue this in a bilateral way. They’ll negotiate with individual companies, just secure access to the vaccine. We do, of course, have other global actors, including efforts.
through the Gates Foundation, the Welcome Trust, set B the Coalition for Epidemic Preparedness, Innovation, WHO, and others that are quite focused on how do we ensure that low to middle-income countries or any country that participates in the Covax facility does get access to the vaccine. But we absolutely need to look at this as a global issue. We need to solve for this as a global issue. If we can ever think about re-opening, not just our country, but all Global boarders.
Great. Thank you so much. And by the way, related to that, we are getting a question that deals with the notion of a trade implications for the distribution of the vaccine. If it’s coming from abroad, Could the United States impose export restrictions similar to PPE Limits do sort of see any of that. Do you any of you see that as an issue?
I will let maybe Nicola. If you’re focused on that last mile, I’m not sure what the trade implications specifically would be in terms of how the US. Will inhibit the The distribution and Allocation conversations globally. There are some countries that are following the steps of the US. And saying you know what, I’ll go at it alone and and try to secure our own supplies alone. Rather than this pooling strategy that I just talked about which of course does not bode well in locking up supply by companies and not necessarily having sufficient supply available for distribution, for broader economies and other countries. So, again, that bilateral single country securing advanced purchase of the vaccine directly does not help to solve this from a global allocation perspective. But I’ll let others comment.
I would say that the for the first, if we look at this in phases, what Esther has highlighted in terms of the Covax facility. And the co-operation happening there we we really have to think about it. from the vantage point of Wisconsin, we have invested in with products.
And based on the products that eventually get E ways or approval, whether in our regulatory system or others, the countries that have invested in those particular products will have also purchased product from, from those manufacturers. I think, as we think about later, phases, specifically face phase three and on, that’s where we may begin to see questions of, in the open market, what products are being manufactured in the US, but being procured by other countries.
But I think for this immediate phase, more of the questions are going to pertain to for the products that are currently in development. Whichever products end up being successful in moving to an approval, it’s going to be the countries that have invested in that development that will have access to that product, which could potentially put the US. Had a disadvantage.
If there are other products that are being invested in within that Kovacs facility for example, that reach approval first or see, you know, demonstrated success first, but that’s not really a trade or distribution problem that that’s just about investment in the counter-measure pipeline.
Thank you so much. As to let me come back to you for a minute. You mentioned the percentages of Americans who are not willing to or indicating they’re not willing to accept even a free vaccine, at this point. And 35% of the American people across the board, but for intend minorities for well known reasons of, of past misadventures between the black community and scientific establishment. That leads to a certain level of distrust and current political environment adding to it. My question to you, is, enrollment in clinical trials, which you really laid out quite wonderfully. What happens if there are not adequate numbers of minorities who decide to participate in clinical trials?
Will the vaccines still be? Vaccines still be approved and put out into the open market, and, if so, what do we say to minority Americans of the, of the safety of that vaccine for their particular population?
No, such an important question. I think, really, based on the experience to date, the disproportionate numbers of minority populations have suffered from, from kogod relative to others, whether morbidity or, or in mortality. And it’s extremely important that we ensure that population is included in clinical trials, not just on the vaccine side. I would also say, on the therapeutic side as well. But with regard to vaccines, the FDA has made it clear to product sponsors at the expectation is that minority populations be included in these clinical trials. In phase three, all of these companies, a number of them have made very specific efforts to enroll minority populations in their clinical trials.
For example, modernity has been fairly successful at enrolling Latino population in their clinical trials to a percentage that it’s Reno, slightly less than what’s reflected in the population writ large.
There are some challenges and enrolling the african American population, but it’s important that, that those efforts continue, The FDA is encouraging, but not requiring, and I think that’s where it gets to that second part of your question, doctor Tucks, in, which is, that will a vaccine receive emergency use authorization or licensure?
If insufficient numbers of the minority population are not enrolled And there is not a specific regulatory requirement, So, there, there is no legal stance, I think, for FDA to decline an Emergency Use Authorization or our Biola. However, there are going to, of course, be implications for how those populations perceive recommendations in terms of, of, of uptake. I think what we all can do is to be that voice, talking about the science, Encouraging enrollment in these trials, Maybe doing better than encouraging and, and, and ensuring the FDA has steps in place to monitor and to do their part right into in terms of making sure that the product sponsors are being robust in their enrollment practices. But, but right now, it’s, it’s really, it’s a recommendation, but not a requirement. So very likely that we will see a vaccine on the market, or unlimited use, that might have insufficient numbers.
And certainly, hope that we do get the numbers up across the board with all of these vaccine candidates and phase three clinical trials.
Well, I hope we do, as well, Esther, and I hope that some of the prodigious, amounts of money that is being allocated and spent from for manufacturing through distribution, that some of that, with a lot more of it, will find its way into financing. The kinds of engagement with minority communities, african americans, latin X, Asian Pacific Islanders and Native Americans who really are going to need it. And I’m terrified, quite frankly, it’s one observer that all this money on the front end will be to no avail when you don’t have people willing to, to deal with that. Nicollet, I want to turn to you on this issue, and you gave us great insight on the issue of dissemination and the pathway down to the local level.
I wonder if we know, and I will be cautious as a member of the National Academy Committee on dissemination, but it has been alluded to that. there was a public release of the report. And in that released, in the public release of the draft, there was some focus on people with multiple chronic illnesses who ought to be certainly considered as a very critical element.
I’m wondering how you sort of see the capacity of the delivery system at the local level to be able to identify who these high risk people are and then be able to co-ordinate them being able to have access to two proven efficacious vaccine?
Absolutely. Thank you. And I think that’s a part of this ongoing conversation about diversity in, in the, in clinical trials and extends all the way to understanding the diversity of the populations that we’re going to need to prioritize and serve. What I think is a really critical part of understanding those high risk populations. And being able to reach them, it’s understanding where they routinely access healthcare. And so, you know, one thing that healthcare ready has done quite a bit, is to really work through the mapping and understanding of what high risk actually means, what chronic diseases are, greatest concern, depending on the hazard. In this case, with cope in 19. We understand that there are certain populations of chronic disease populations are comorbid populations that we need to be especially concerned about. But, understanding where they routinely access, health care, is going to be critical, especially when you’re talking about cold chain product.
Because, in reality, in that Phase two process, Richard described, you know, we’re going to be really around this time next year, seeing a Phase two process rollout, likely that would allow for healthcare facilities to really engage those high risk populations in vaccination. And, again, that repeated vaccination. Those two visits are probably going to be done at a pharmacy or a clinic, and it’s going to be those facilities that would routinely engage those patients. So, if you’re thinking about a comorbid patient that has multiple prescriptions, that are, the chances are, that they’re going to be at a pharmacy more frequently than any other form of health care of sort of maybe a dialysis center, and so understanding the role of those ancillary care facilities. And their ability to be able to engage with distributors.
Work with them to understand since being able to schedule and plan. And then receiving a delivery, such that they’re able to vaccinate when that person comes in for a routine script, For example, is the opportunity that we have to make sure we’re co-ordinating and taking advantage of. Because the reality for a lot of those individuals is that a hospital visit may not be feasible, but it also could put them at greater risk. So, if we’re thinking about keeping people out of health care systems that are not necessary for their treatment, and making sure that they’re getting that the interface with the healthcare facility that’s most appropriate for their care, that does mean that that dissemination has to go to multiple facilities. And it also means that our best approach is going to be making sure that we’re using the facilities that they routinely engage.
So, I wanted to sort of follows on there. The notion of, are you confident that our data systems are integrated enough to be able to handle all of that? Particularly when you’ve got to have those vaccines that will require more than one dose?
So, I, So, the existence of our data systems, and the integration, are two different questions. I think we have, you know, if you really look at the, though, the robust capacity of medical distribution in this country, and the data systems that medical distributors use on a daily basis to move product across the country, It is it a state-of-the-art. If you also look at the public health systems that are being used and even the systems that are being upgraded right now, to be able to accomplish this mission that we are seeing that there are investments in IT infrastructure.
My question is, around the integration, I think there’s still a lot that needs to be done, and also needs to be tested, because we’re talking about integrating systems or pieces of systems that normally do not have to speak to each other, but also have to speak to each other with a cadence and frequency that may not have to be real time but probably have to be near real time. So I think there is a lot to be done. But I also recognize that a big part of the investments that are being made right now by HHS and operation warp speed and the CDC, are around IT infrastructure, as well as data in integration, specifically for public health departments, to be able to integrate better with the federal government, and with their distributors that they’ll be working with on on routine ordering.
I think this is an area that everybody needs to really focus on. I think this is going to be critical, particularly for people who are poor, who are so much of the population of people with multiple chronic illnesses, and how those individuals become identified, how did they get into the vaccine dissemination system and so forth. Richard, I haven’t forgotten you, but I’m gonna go one more for you. Nicola is a lot of people get confused about this, the meaning of this whole change storage and how cold is cold and does that mean that for those vaccines that require that that would rule out physician offices or small clinics from being able to to to handle this?
Absolutely, I can’t tell you the number of times I’ve, I’ve been asked. How cold it’s called Exactly. So why? my best rule of thumb is, if you are in your refrigerator, we’re talking about 4 to 8 degrees Celsius, your freezer is about and liquid nitrogen is around between and minus ADC I think most scientists remember that rule of thumb. So when we’re talking about cold storage where normally talking about the refrigeration or or or freezer storage and in this case, mainly so that freezer capacity is important.
The ultra cold as my understanding right now is that the Pfizer product would need the ultra cold but would need to be reconstituted prior to delivery. And so, a lot of the guidance that we’ve seen, and including, I think some of the public guidance at the CDC, has shared, has advised public health departments and facilities to not focus on just buying freezer space, not focused on buying freezers, but really work with local logistics networks to understand what’s in their state and can be leveraged. My, my initial answer to whether or not, you know, PCPs would need to purchase reserves, is: no, I think not at this point, is probably a clear answer. I think there are a few reasons for that.
one is, realistically, when we’re thinking about the amount of product that, especially in that first phase, maybe the first two phases will remain on hand, it’s going to be very little. So, what I am expecting, and I think, what many people are expecting is that a pharmacy or a clinic or a doctor’s office will, at some point, placed the order knowing that they would need to vaccinate the next day. So what they’d receive at the top of the day would be what they use. And so they would just have to have limited capacity to be able to hold that products safely and and be able to vaccinate throughout the day and do the same thing. So we’re talking about more frequent deliveries rather than a longer hold of inventory for those types of facilities, but also recognizing that while we are talking about delivery to specific facilities.
A big part of what I understand the CDC’s pushed to not encourage just purchasing of freezers or other space is in part because there’s recognition that there is local logistics capacity. Many of the healthcare distributors and cold chain logistics companies have geographical presence across the United States and are prepared to be able to support this movement. So, it may not be that the delivery just needs to go to the pharmacy or just need to go to the doctor’s office. There are local third party logistics partners that are prepared to support this, and they do have cold chain capacity. So, they can hold maybe, for, you know, a day, or two inventory, for those facilities, and I think that type of co-ordinated approach, especially until we understand, you know, we’re trying to do this. You know, Richard pointed out once and done, or we weren’t going to see this being endemic and needing to continue to sustain this year after year.
I think the strategy is, let’s determine how we actually co-ordinate these types of approaches where we’re using existing capacity. Recognizing that, again, there is a lot of cold chain capacity, but it is about making sure that we’re using the breadth of the full system. And that those of states are recognizing all of the local resources that are available to be able to support those facilities.
But, again, not thinking about long term inventory.
And my expectation is that most facilities will not be housing 4 to seven days a vaccine at a time, but rather 1 maximum 2 days, that they would be able to safely vaccinate, recognizing that there is a 10% sensitivity to that inventory.
Richard, if I play that out and I started thinking about reimbursement. My goodness, what, how do we speculate what the insurers are on the hook for and self insured employers?
On the hook For, there are a lot of people who, it would seem, get to have a bite out of the apple of the administrative costs. You’re going to have some people that will, will get it from McKesson. Have to store it, frees it, somehow, have to reconstituted. Some are going to have to deliver it from point A, then back to the doctor’s office at zero point B is am I? Am I right to be worried about the, the, the economic bill that insurers and self insured employers will have to pay? And then of course, how much of that gets passed off to it higher premiums?
Richard, you may be on mute, was thank you. That’s a very, it’s a very complex question and a good one. So as I mentioned, you know there is this sentiment today that administration the did not adequately compensate providers for the cost of storing and handling vaccines.
It’s very, very challenging for many practices to maintain the storage and the refrigeration equipment, to deal with issues of wastage it, you know, to ensure the product, to do all of that, the handling. And then in some markets, as I described, this sort of very fragmented coverage market, and that are fragmented coverage scenarios in the US. It can be very difficult for a provider to bill and get reimbursed for, for a vaccine or for administration fee. So it’s very costly for practices. You know, payers will, as I describe, be responsible for the administration fee, which as I’m saying may not, may or may not go to the practices cause.
They ultimately will be responsible for paying for doses when when the government backs out of that role, but but not until that point as long as the government is saying, we’re going to purchase doses for every American, then yours can anticipate that they will not need to bear that cost.
So the cost of getting everything from point A to point B no really is going to depend on adequate public health funding.
And you know congress really writing whether it’s outreach and warp speed or CDC with the adequate resources, so that they can either deploy those resources at the federal level, or for you to provide those resources to the states, to, to really co-ordinate all of this, and to ensure that that happens.
So, whether that’s, you know, special refrigeration equipment or ensuring that, right, kids get to the right place at the right time that the building up of all of the data systems that we’re talking about, it will require substantial public resources, and I wouldn’t anticipate that, that’s going to be passed on to payers.
It’s really going to be public resources that are needed and will be reliant on Congress to ensure that that funding is there and the Federal Government, to, to, to really provide these resources, because this is a, after all, a public health, a public health is demands of public health response.
I know that, you know, very complex time. But I just sort of wonder whether you’ve had enough humility to have any insight as to whether or not our Government agencies co-ordinating with State agencies, actually have the ability to implement something as complex as this. And be able to parse out, again, the economic chain. So that there won’t be a huge fistfights in, a couple of months regarding who pays. You know, Will we see, is it conceivable that? We will see a slowing down of the ability to get a vaccine into someone’s are simply because the, the, the economic supply line change?
Is, is, it’s going to be challenged because there’s so many different steps, so many different permutations. And not clarity as to who, who gets paid, what and how much. Yeah. Again, a very complex, multi-layered question in a very, very good one. I know, as I said, I don’t know if I mentioned today, but I’ve worked on the H 1 N 1 response. I was at the Association of State and Territorial Health Officials in 2009. You know, worked with the states, and worked with other NGOs, and the CDC, and co-ordinate the response. And I saw the tremendous co-ordination across levels of government that occurred or uncle every single day with the health officers, the epidemiologists.
The immunization programs, all, talking with the CDC all, planning and co-ordinating and preparing to ramp up for that seasonal flu season to administer the H 1 N 1 vaccine in addition to the regular flu vaccine. And it worked really well and, you know, I think in this in this pandemic, what we saw was, you know, an April, the CDC came out and said, we will do what we did during H 1 N 1 and everybody’s. Yeah. That’s, that’s familiar, we know how that works. There’s good co-ordination. There’s infrastructure there are hiccups and our immunization information systems lagging as we all were discussing earlier, of course. But there’s a tried and true infrastructure and collaboration between states and the federal government through CDC, where states can place their orders, state plan, and that they have people with the CDC that they work very closely with, to do all that planning.
And so, you know, we anticipate that that will be the case here, shortly after that, operation warp speed when it was announced and stood up. The focus became, you know, DOD is in charge, and DOD will deploy this vaccine and then distribute the product. And there were a few questions about whether DOD would administer the products and people, you know, we were talking up against the backdrop of everything that’s going on with Black Lives Matter. Is the army going to come out and vaccinate people? Gosh, what would that be letting you know? Sort of scary, scary thought.
Ultimately, they said, you know, this will be the responsibility of the CDC after all. So we tilted back in a direction where we’re saying OK we’ll rely on traditional public health actors in the federal government.
So, I think we might have lost some time. There. There has been a significant amount of confusion and a lot of focus on standing up new systems. And it remains to be seen how well it will all play out. I think we’re going to experience some challenges that do. I think that there sometimes is an inherent disconnect between public health and healthcare. Our healthcare system has evolved significantly over the last decades. If you look at adult immunization prior to …, we have not overcome the challenges that we, that we, the baseline challenges that we haven’t vaccinating adults, anybody over the age of 18, there are unique challenges, especially between 18 and 64 and vaccinating adults. And so, we’ve not done very well as a country with with routine vaccines for these populations.
So, can we do it now? You know, I think that we can anticipate that. There will be no system breakdowns. But, I also think, we can anticipate that. It’ll just, it’ll just be hard to get patients to, show up and get the vaccine.
Yeah, please. Yeah, that’s great, great, great, response. Or in a second, but let me just ask you, just make one observation. I think you’re right on. In one experience, and I think a lot of things did well, but, because of our audience, and we have so many people, who are, focusing on details. There was a great deal of confusion, particularly at the, at the 11th hour, between whether or not employers and insurers, what would be there, what would they be on the hook on, and whether or not the administration fees. By pediatricians in particular, we’re going to be waived or, or, or, or paid. And it was an issue that cost several millions of dollars to the people who pay for health care. So, there is some need to be very focused on this chain of events.
Who gets paid for what, and this is going to be much more complicated, an H 1 N 1, so I think it’s very important. I’m glad you, I appreciate your answer, Esther. Let me, since Richard just mentioned about the experience that so many have had in our country of not using vaccines and we’ve got enormous campaigns by by I won’t try to categorize the people. But people who are deliberately trying to sow distrust and confusion about vaccines. What do you sort of see? What happened here? And what, if anything, can be done, to try to overcome the anxiety, that so much of the population has, and is increasingly having, about whether or not they are willing to accept a vaccine, even, when approved? Safe and efficacious by the FDA?
Yeah, Thank you so much for that question. I think it’s a very important question, because what we really need to, to come back to and emphasize to the general public is the important role of science.
Now, more than ever, we’re relying on science and scientists to not only identify what, potentially, we already have that’s been approved, that could have an effect on mitigating this virus, from a therapeutic perspective, but also, vaccine that hopefully can get us all out of this as as we increase that uptake. And so, going back to the important role that science has maintaining the independence of the scientific and medical community, and being able to go through this very well defined scientific process of clinical trials and evaluation of drugs and products is going to be very important. I think it’s important that we communicate the independence of the FDA in making decisions around that, The data, and what the data show, and that we make those decisions accordingly for the right populations and not make any pre judgements on what the data show.
If we can continue to demonstrate this to the public, I think it will address those issues of of trust, which is really where all of this is based. Even when we talked about the poll earlier, we did see high, You know, in the pull, at least reflections, that individuals, they want to get a vaccine.
They want to get back to normal, I think, over the course of the last several months, and unfortunately, you know, some attacks on public health agencies and maybe some missteps, we’ve seen some of that you road, as I described, these products, these vaccine candidates, are going through a clinical trial process. They’re going through safety and going through efficacy. We certainly need to continue to monitor safety over a period of time, as well, any adverse events that do show up in the population and continue to ensure that we are providing high efficacy across different populations. Including the elderly were who are immune comp or those who are immune compromised that might have a harder time getting to the kind of, of immune response that we’re looking at another population. So I just think the basis of this is going to be a science. I think it’s communicating the scientific process. I think it’s letting the medical experts and researchers do that communication and maintaining the independence of our public health agencies, our regulators, and our providers.
I will make a moderators comment and just say Esther, in addition to your excellent point, know, it really pains me to see the level of distrust that that is being built for the extraordinary public servants who work in our health agencies. And I will say to you that the FDA in particular, I know some of these people who are the ones on the point, we have to make the decision for safety and efficacy. And these are really good people. They’re smart. They’re dedicated, and they’re not going to be easily manipulated. I hope that we can elevate their profile, but in addition to that, if there are FDA people who are listening in on the call, I’m urging you and begging you to do more information about the external advisory committees. one of the great things about the American health and medical care system are the number of external citizens who devote countless hours in support of our federal agencies, NIH, CDC, FDA.
And one thing for sure, is these people will be knowledgeable about what’s going on, they will see the data prior to any decision. And I think we need to elevate those external voices a lot higher so that people understand the process is very publicly transparent. And this is not being done in the black box, but that was just a moderators comment. Let me turn to Nicole Lead and Richard and sort of ask you a little bit. Some of our attendees are curious about the notion of who actually purchases the vaccine at the federal level. Is this being, you know, sort of purchase by HHS, DOD, VA, sort of how is it working that this gets purchased?
And then related to that, there is a, another kind of question, We’ll, employers, and, or wealthy people, be able to, in run the system and be able to buy their own vaccines outside of the process. Even when there is a Prioritization that recommendations that are being made by the National Academy of Medicine. By the, by the ACIP and others that are making these decisions about prioritization, will rich folks and and employers self insured employers Will they be able to end, run, whatever agency that is buying these on behalf of the United States. I open that through either you Nicolette and or Richard.
And don’t be shy.
Richard, I’m happy to go after. Yeah. OK. Yeah, I’d be happy to address that. So, you know, you’re standing today is that the Assistant Secretary for Preparedness and response entered into contracts with all of the contracts that are publicly known today, that those were entered into through that part of HHS. With a substantial amount of financial backing from DOD. That is different than you know that their stockpile and purchase A typically occurs through asked for, but that is different than what we see the Federal Government typically do in contracting to purchase vaccine. So, traditionally, the CDC does negotiate with manufacturers to purchase vaccine, and there are federal contracts for remote government, Doesn’t versions, but, for the most part, CDC purchases vaccines.
And that’s typically for the Vaccines for Children Program, for the section versus teen program that I mentioned in the CDC, contracts are not being used at this time, I would imagine, in the future. As a workspace winds down, as we go forward, you know, into different phases of this, that, ultimately, this will transition to a place where CDC, is the primary procure of vaccine. To answer the question around, you know, the ability to sort of purchase outside the system. It’s a couple of thoughts there, I think.
The recommendations of the ACIP for informed by the National Academies. I was asked last week, the states have to follow. And I really don’t. And I think it, you know, on the one hand, the recommendations are very important to follow, and that they’re evidence based, and they should be followed. However, you know, I said last week, I think, to the extent that a state has the insight into, you know, particular situations in its own borders, where a particular area is effective or a particular population is affected in any to tweet recommendations. So that they can overcome access disparities, are really target the response that it’s appropriate. That’s appropriate for states to do, and they have the authority to do that.
So really the same manager applies to you who is allowed to buy that product. There really aren’t any restrictions on that. I think I will say I think there is an outstanding question about whether you can sell commercially during an EUA period. I actually don’t know the answer to that but if you’re taking that off the table and we’re talking about licensed products there would be no restriction of the ability for manufacturers to sell products to.
You had to states directly to payers, directly, to your group purchasing organizations directly to a large employer. So, that would be something that they would be allowed to do. And so, I think to answer your question, doctor talks of the answer is probably yes.
But I would like to think that, you know, most of the system will try to follow the framework and emphasize the populations.
Nitrogen, because. Yeah. I do, so. I, I think.
There’s a slight echo. I just want to make sure.
We’re OK. OK, so I think there are a few things to unpack in this. And I agree with most of what Richard said. I, my understanding is that the procurement and, this is, again, why phases are so important, but the procurement of the first 660 million doses has been made by the, by the US. Government.
And, so, I think, based on my understanding, you know, probably, assets, right, but, also, understanding that what’s already been procured are secured by the US. Government cannot be appended, but I think as we’re thinking about later phases, that there are other questions that remain. Which, again, that plays out into the questions of, is this, you know, a repeated vaccine or not?
Also, on the earlier question related to kind of who, who is purchasing what?
I, I want to put some context and my understanding of which agencies are involved and what procurement recognizing That this is a part of the Medical counter-measures Enterprise, which has historically involved BARDA as the, you know, the Research and Development Facility, as? well as the Strategic National Stockpile and their capacity to be able to not just hold onto products, but to issue those contracts with the movement of the S and S two Asper. Um, I think a lot of those contracts are now coming out of HHS, or HHS asper, recognizing that that procurement capacity is, now just still within the SMS, but now within a different part of the HHS. Family That the Vaccines for Children Program is actually the program that holds the contract from McKesson which has been leverage for this.
And so I think what we’re seeing is, across the HHS family, there are different programs that might be housed within asper within the CDC, that are being leveraged. What I do know, and I think, was actually publicly shared on an article earlier this week, is, that, Ask for, Is, It’s making sure that there is a sign off from asper and CDC Leadership on all of these contracts. So, whether the actual money is coming from the DOD, or not, Or if it’s being issued by the SNS or by the CDC. There is collective input. And so I think that’s important to recognize because where the money is coming from versus who was making the final sign off, maybe two different questions. So, I hope that’s helpful.
I think yeah, I do think it’s important to recognize that the OWS contract’s seem to be a hybrid of HHS and DOD, but the sign offs are the same.
But as we start to close out, I want to ask the staff if they will put up the slide that Richard showed that had a long time line with the with the bell shaped curves, and while you do that, let me come back to you neglected and just ask you one thing as a supply chain expert.
Are you happy nicollette, or are you concerned that the entire dissemination process is in the hands of one vendor?
Is that good for efficiency, or does that open us up for, for, for risks without having redundancy?
So or I think the, for the breadth of this problem, you’re going to need the entire system.
I think what McKesson has been able to invest in is definitely going to, especially in phase one, is definitely going to help us meet the need. But I think we’re really thinking about vaccinating all of America. We are going to need that, that single system, And so when you look at the capacity of medical distribution in this country, we have tremendous capabilities, and I think our best approach is to use all of those capabilities. There are not just logistics questions and capacities. There’s also the ability to integrate with those last mile recipients, their security capacities, and there’s just a tremendous capacity that we have across the entire system. And so, it’s my hope that, as we continue that, we’ll be able to learn from those earlier phases, and that, my expectation is that the full system will be engaged in different components of the mass vaccination campaign.
Great. All right. Well, let’s put that slide up. And as we close out, I want to ask each one of you as we go around.
It is, as I look at this slide, I’m trying to understand, what does this mean, or predictions about. When does this society re-open?
When do we become back to sort of something around normal?
And so, I’m, I’m just curious, as you all look at what’s there, what are your predictions? And we’ll we’ll take you in the order in which we we began. So, we’ll start with with faster than nicolette. And then Richard, what does it mean to you about re-opening the, the destination.
Yeah. I mean, this is a very, you know, important slide, interesting slide to see the numbers here, particularly the amount of doses. I mean, one thing that it’s signals right off the bat is, is how vast this problem is, and how much we’re going to need to stay co-ordinated in order to solve for that. This timeline assumes that everything will go perfectly. It assumes that we will get the readout of the phase three studies that show high levels of efficacy and safety against populations, assumes that we’ll have people who trust that vaccine at the end of the day and the the uptake is high.
So that at each point in this, whether we’re talking about healthcare personnel, essential workers, high risk individuals, and the general population, that in some ways, we have close to high compliance, what’s needed, essentially to get us toward a herd immunity where we don’t have the virus circulating, as much, as we currently have it, circulating across the country, and across the world. I think it’s a limited view, because it’s just of the US. We need to talk about this, as I mentioned earlier, from a global perspective, because it’s really about solving a pandemic, which is borderless. And we needed. We need to include that picture into this as well.
I will say, in terms of, you know, when could we re-open again, It’s going to be a story of vaccines and therapeutics. And if we get to a highly effective therapeutic, that reduces mortality rates, that needs to be coupled with vaccinations, that may take more time. When I heard nicolette speak in terms of the complexity of the distribution, all of that will add to this timeline optimistic that we will start to see access broadly to a vaccine at the end of next calendar year. I would be a little bit more cautious in terms of when we get up to 70 or 80% of the population that has taken it, particularly because we have yet to see the data being read out of these clinical trials.
Great, neglect, I would first ask for us to really think about what normal looks like and what normal means.
If we’re thinking about some level of resumption of the economy, I think that’s going to be different than people being you know in close proximity. And going to concerts, and being able to, you know, be in tight office spaces again. And I say that because I think the timeline of when that diversion of normal versus having some kind of revised version of, you know, quote unquote, normal, but being able to rhythm commerce, resume activity are going to be different. My expectation is that for a phone normal, we are talking about years from now on, I’m expecting 22,022, 2023 to be feasible for that. But I think when we get to the point where we are at that 70 or 80% vaccination, I think will will begin to see parts of life resume and really critical ways, and then it’s going to be that slow.
That slow resumption. I also think of these questions about coping 19, becoming endemic, versus, you know, whether or not, you know, too well to vaccination will be sufficient for vaccination, rather, are going to determine what normalcy or return to normalcy look like. So in some ways, and we still don’t have enough to know, what are, you know, future altered state? Our long term altered state will look like. But, I think, as we get towards, an approval, we are starting to see, that. We’re really looking at, this time next year for some altered state and then, really, 2022. NaN left for you, Richard, and we’ll close it out.
Richard do there.
Right, Richard. I think we may have lost by the hour. But if you have a couple of you have a 32nd but let’s get it. Yeah, absolutely. Yeah, I agree with everything that Esther Nicolet said. I do think that, you know, depending on that, you know, the, the geographic region of the country areas, some areas are attempting far too early to return to, quote, and quote, unquote, normal. But I do think it will be a number of years before we get back to what we perceive this as fully normal, and I think it will depend a great deal on those levels of herd immunity. I think we’re going to have to overcome potential hesitancy and lagging rates. Just like we do with routine vaccines today. So I think it’s, I think it’s going to be quite awhile.
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