Preparing for a COVID-19 Vaccine

Preparing for a COVID-19 Vaccine Podcast with
•Dr. Sree Chaguturu, SVP and Chief Medical Officer , CVS Health
•Stacey Meade, Regional President for National Accounts, Meritain Health

Transcript

Welcome to In the Booth, Meritain Health’s podcast series, touching on the most relevant information for the TPA industry.  I’m Stacey Meade, regional president for Meritain national accounts.  I’m here today with Dr. Chaguturu, chief medical officer for CVS Health, Meritain’s parent company. We're excited to be talking about the latest developments on the COVID vaccine, as well as the role plan sponsors can play in helping to protect their members. So let's get started. First. thank you Dr. Chaguturu for being here today. Can you start by telling us about what we should expect over for the vaccine over the next few weeks? 

Sure thing. It really is a pleasure to be here. And so this has been such a rapidly evolving space and I'm excited to bring you up to speed on what's been happening in terms of COVID vaccine development, as well as distribution administration. So why don't we first start with a little bit around the science and what are we actually trying to do with the COVID-19 vaccine.
We currently here at the beginning of December have nearly over 200 vaccine candidates that are in some form of investigation with respect to COVID-19. This is an unprecedented scientific achievement. We only first discovered this virus late last year. We only first genomically sequenced it in early winter-in around February of this year, and here we are now with over 200 plus candidates. So that in and of itself was a tremendous scientific feat. But in addition to that, and it's important to know that there will be multiple vaccines that comes to market and each one will have different safety and efficacy profile. And as we think about moving forward into 2021 and beyond, we'll need to make sure that we have a good sense of the science, the different soft profiles, and how do we ensure that the right patient gets the right vaccine at the right time.

If we think about what the vaccines are trying to do, that seems added to those. So trying to train the immune system to identify the Coronavirus, maybe think about those pictures of the Coronavirus. There's been these spikes that are coming off this spherical virus and Corona actually means crown. And those spikes are the spike the crown of the Coronavirus. It turns out that that spike is actually a really good way to train the immune system, to recognize the coronavirus and then kick into gear the ability to fight against coronavirus when it sees it. So our vaccines in general are trying to train the immune system around that spike protein, it’s called the S protein, and we're doing that in a lot of different ways. So in terms of the way that we're doing it, there's some traditional approaches. I won't go into much detail around the different approaches that we have but you know, we either take the whole virus and then reduce its infectivity and we see that as polio or a TB vaccine. There's not many candidates in that space, so I won’t really spend much time there, but then there's other candidates where you're taking the protein, that spike protein and showing just that protein to the immune system and training the immune system. So we see that with some manufacturers like Novavax, Sanofi and GSK with their protein vaccine, there are other candidates where we're injecting the coronavirus spike gene. The gene that actually creates an encode set spike and putting it into another virus. So these are called viral sensors. And so AstraZeneca, Johnson and Johnson, Merck, Vaxart, these are companies that are actually using a virus, genetic material and coded in a virus and training our immune system. And then there's the more new manufacturing process, which is actually incorporating that spike protein into, and we manufacture that in the lab, the DNA or the RNA inject that directly into the body using an innovative way of delivering it, what we call a lipid by layer cholesterol envelope. And so that trains the body around the spike protein, and there's two manufacturers Pfizer and Moderna where we've heard some early reports of very high safety and efficacy of these nucleic acid vaccines. So really exciting over 200 candidates and a lot of different approaches that we're taking. So I hope that's helpful in terms with the science. And so I thought, Stacey, if it makes sense, I'll just keep moving on and we'll talk a little bit about what the road to approval looks like and what we'll be seeing over the next few weeks. So that sound good? 

Perfect. Thank you.

Okay. So a lot of different scientific approaches, but then the question is how are we actually able to create a vaccine so quickly? And how did we and then what's the actual aspects of the FDA to be looking at.

So in terms of the reasons why we've had a vaccine so quickly, we have a really kind of head start scientifically by using some data and information that we had prior to the SARS epidemic so middle east respiratory syndrome, and SARS COVID-1 one really helped us build on a platform of science. So we weren't starting from ground zero. We also co-invested the federal government through operation warp speed and other vehicles have enabled us to de-risk the manufacturing process by providing a government investment. We've also been able to recruit heavily because of the pandemics, and then also show that there's impact of the vaccine because of the high rates of transmission that's happening. So you're able to show the impact of the vaccine much quicker than in the case where an infectious disease doesn't actually have as much events.

So think about Ebola, for example, it's harder to show the impact of a Ebola vaccine than it is to show a COVID vaccine. And we're also using a lot of cutting edge approaches. So like the paths at Pfizer and Moderna are taking, so really this has been unprecedented speed, but the speed is not because of any shortcuts it's because of that head start on science and government investment, our ability to show an impact, academics, these new cutting edge to purchase. What the FDA is going to be looking at is the safety and the efficacy when they meet later on in December to review the candidates that have submitted at the time that we're recording Pfizer and Moderna submitted to the FDA, they're going to be looking for at least a 50% effectiveness, which means that the people who received the vaccine were 50% less likely to get COVID than those who are in the placebo.

They want to see that there's a very large population that are in these trials. They also want to look at the safety data and they want to see at least two months of safety data in the submission. There's other aspects around adverse events and manufacturing processes that the FDA will also be reviewing. The key points here is that did you reduce COVID by 50% and did you have two months of safety data? And so we have a number of manufacturers who are working I’ve mentioned them already the course of this conversation with Pfizer and Moderna having submitted data showing 90 to 95% effectiveness in their early release information as well as very safe profiles. You know, the most common safety event was fatigue, some headaches and fevers, but in general, we await the full release of the information, but the information that we've seen at the time that reporting shows a highly efficacious and very safe vaccine. They do have very particular storage requirements being frozen or ultra-frozen, but the health system has been gearing up really to be able to manage the distribution and administration of these vaccines.

We have another set that will be are in trial or about to start- AstraZeneca with Oxford Johnson and Johnson, Novavax are in trials right now. And we will see those likely in early 2021 submitting for review by the FDA as well. And you know, in terms of the distribution and handling, what we do know is that these will require various levels of cold chain, so of dry ice, ultra-cold freezers and optimize logistics. Many of these will be coming in multidose vials requiring five to 15 doses per vial. And once a vial is opened up, there'll be a limited time to use all of those doses before there's any wastage or spoilage. And we know that these vaccines, all the leading candidates look to be two dose vaccines. So initial dose, and then the second dose at 21 to 28 days after the first vaccination.

And so it's going to be really important for those providers of the vaccination to have that logistics capabilities to be able to manage cold chain multidose vials and follow up in terms of dosing scheduling and tracking. And the CDC is meeting and a subcommittee called the ACIT will be voting as actually today on December 1st, the day that we're recording this to create a plan for and guidance for the country on the phases to release the COVID vaccine and who should be vaccinated when, and so there's an emerging consensus that in this phase one who will be high-risk health workers and first respondents, as well as those who are most vulnerable. And that definition will likely be long-term therapy facilities and skilled nursing facilities, elderly individuals living in these congregate facilities. And so as we move on from phase one high-risk health workers, respondents, skilled nursing facility, long-term care facilities there will be a phased approach that the CDC will provide that will help us work through from there to the general population.

This guidance will be then given to States and States will adapt and modify it to ensure that the local needs of the state are met using the providers of that area. So they'll, this will be evolving in terms of a roll out plan over the next couple of weeks. And, and or so but there, with this emerging consensus around what phase one looks like. In terms of availability about 20 million doses will be available for each of the leading manufacturers. So for Pfizer and Moderna over the first couple of months, and then each of the other manufacturers have similar amounts of capability to produce the vaccine. And so if you have 40 million doses that are produced every month, you know, 20 from each of the two leading manufacturers then that would allow you knowing that there's two doses per person, about 20 million people can be vaccinated for a month.

So when we talk about, when will the general population have an opportunity to be vaccinated, that likely will be in Q2 of 2021 depending on how manufacturing plays out. And then what we have also noticed is that there's a variable interest in terms of the COVID vaccine in terms of acceptability. And so there's a lot of survey data most recently at CVS Health has performed a large review a survey of over 5,000 individuals across the country and found variable interest. And so overall there's approximately anywhere between you know, 10 to 20% are interested in getting the vaccine as soon as it's available. And then another 20 to 40% would be interested, but will want to wait and see how it plays out in those early days. And then up to 20 to 40% where there's a hesitancy when I say that range, that range varies based on community white, black, or brown. So we see overwhelming interests and hesitancy across all communities, as well as variable interest by communities color. And so, as we think about how we can increase awareness and education, we need to have general population messages, as well as tailoring communications to address the unique concerns of each community. 

So what can we do now? And I'll, I'll wrap up here is that this is really an exciting time for our country. 2020 has been incredibly difficult for all of us, with the unimaginable toll that we've all taken as a country. And we are now entering the next phase where we can now add another tool of vaccinations to our armamentarium of fighting the pandemic. But as employers, we still need to continue to encourage our employees to get their preventative services, to get their flu vaccine pneumococcal vaccines, to follow the CDC guidelines around wearing a mask hand-washing social distancing and consider thoughtful use of testing and contact tracing.

So we are now entering this next phase.  This next phase is quite frankly our generations’ Manhattan Project, in terms of being able to vaccinate a large population of America. And so very excited about that. And so with that, I will pause there and Stacy, I really want to thank you for the opportunity to talk about the science, the road to approval and what the next couple of months will look like.

Yes, this is great information, thanks so much for sharing. So if I were to summarize for our listeners, you know, it's exciting, we've got multiple pathways to effective and safe vaccines safe, we'll be setting individual priorities. That will be based on CDC guidance combined with their individual leads and Q2 ‘21 is the most likely timeline for mass vaccination, but it's going to be critical that the public be comfortable with those vaccinations.

So employers, some actions that employers can take is making sure they're educating their employees on the safety and efficacy of the vaccine, making sure they're educating their general population, as well as addressing specific communities, individual concerns. And finally, employers, I think you've mentioned can make sure that they're encouraging their employees to continue getting preventive care, their regular flu vaccine and reminding them of CDC protocols around hand-washing social distancing and masks wearing. Is that a pretty good summary of where we stand? 

You got it, Stacy? Awesome. 

Well, thank you so much for joining us today. We hope our listeners found this helpful the pandemic is continuing on and we've got a pathway forward that might get us back to some sense of normalcy. So appreciate you sharing this information with us. 

Thank you. And please be safe. Yes, same to you. Thank you. Take care.