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February 24, 2021 2:00 - 3:00 PM ET

COVID-19: Lessons Learned and the Path Forward

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Summary

Join Avalere’s panel of policy, public health, and regulatory experts to learn about the challenges, opportunities, and key milestones to watch.

As we near the 1-year mark of the COVID-19 pandemic declaration, new issues and questions emerge for healthcare industry stakeholders. COVID-19 has significantly altered traditional approaches. It has also accelerated change and further exposed challenges within our system. During this webinar, Avalere experts will discuss how the pandemic has transformed healthcare and what these changes will mean going forward. 

Key Topics 

  • Exploring FDA pathway developments
  • Understanding COVID-19 vaccine challenges
  • Examining overall vaccine market implications  
  • Advancing evidence generation strategies 
  • Elevating the importance of health equity 

Transcription

Sarah: Hello, and welcome to our webinar, “COVID-19: Lessons Learned and the Path Forward.” My name is Sarah Butler and I’m the Head of Sales, Marketing, and Operations here at Avalere Health.

I’m thrilled today to be joined by 3 of my colleagues. First, Loren Becker, who is an Associate Principal in our Vaccine Policy and Market Access team. Second is Jasmaine McLean, who is a Consultant II in our Center for Healthcare Transformation. And finally, Gillian Woollett, who is a Principal Research Scientist on our Market Access Team. With that, let’s get started on a great conversation.

We are nearing the one-year mark of the COVID-19 pandemic. Just this week, we hit the dismal threshold of over 500,000 US deaths due to COVID. I think all of us are really feeling that COVID-19 has significantly altered the way that healthcare is delivered. It has accelerated some changes, but also further exposed some challenges within our healthcare system.

Fortunately, there’s a light at the end of this long tunnel. We now have several vaccines available. We had some good news this morning from J&J about their vaccine and 2 others are on the market. A fourth is soon to be on the market as well. So, we’ll cover all these things and more.

Gillian, I’m going to start with you. Just summarize for us where we are today in the COVID-19 pandemic.

Gillian: So, clearly those numbers of deaths are tragic, and as you said, we’ve been in it for a year. On the other hand, we’ve learned an awful lot over that year. The treatments are getting better, even if we don’t have cures, and understanding transmission and ways to mitigate it are much better than they were at the beginning. So yes, we have to deal with a very frightening virus that is continuing to spread around the world, but we each of us have better ways of handling it in our own lives.

Remarkably, particularly in the US, people have found ways to keep working, and as we’re showing here, we can be very, very productive. So, I don’t think we’re going toward, “This will disappear and there won’t be anything to worry about.,” but our ability to handle it is becoming more apparent.

Sarah: We’ve seen declining infection rates across the country for the past couple of weeks. Talk to me about how we’re doing on testing.

Gillian: Testing is a big issue and it’s obviously been a little bit of a conundrum from the beginning. How many people we test; who, when, and where; what it allows you to do; what it doesn’t allow you to do. I think the most important aspect of testing right now is tracking these variants and knowing what we’re up against in terms of whether we’ve really got new pathogens out there that are going to escape the ways of handling them that we’ve learned over the last year.

The good news is, if you remember, we were hoping for a vaccine that showed 50% efficacy. The vaccines are all way up there in the 80s and 90s, and most of them are showing a level of efficacy against the variants so far, but that is why it is so key to get those vaccines in arms. That reduces the load of virus reproducing in people, which is where the variants come from. So, all of these systems approaches complement each other.

Sarah: We’ll definitely speak more about the variants. I know that’s something we want to cover, so we will move that toward the second half of our conversation.

You mentioned the huge accomplishment of getting a vaccine out in under a year. Can you put this into context? Help us understand how significant it is that we got a vaccine available to the public in under a year via an Emergency Use Authorization (EUA). Is there anything we can compare this to?

Gillian: There is really nothing, and vaccines are notoriously difficult. If we look at the technology of the first 2 vaccines, the mRNA, that was dreamed of back in the 80s and it never quite worked. When we first heard Moderna and Pfizer were taking a risk on mRNA, I was like, “That’s a long shot.” But they’ve done it and I have to emphasize that one of the reasons that they’ve done it is the science is always the best it’s ever been. It’s cumulative. We have one international language of the science. The collaboration worldwide has been phenomenal. The data sharing on the sequences of the viruses means we know what we’re up against. So, there’s been a huge amount of absolutely critical collaboration that jumpstarted everything we were doing.

Your average medicine, let alone a vaccine, takes 12 to 15 years to be developed. Risks had to be taken here, but not risks that impact the quality of the vaccines. They were risks in terms of information sharing, just making it available everywhere. There were also investment risks in manufacturing vaccine candidates before you knew they would work. Now that is coming home to be our opportunity to have these vaccines deployed very quickly.

So on all fronts, including with our regulatory authorities and their imagination in how they’ve evaluated these products, we’ve shown just how much faster we can develop key products, and I think that’s an opportunity we can use more broadly going forward.

Sarah: That’s wonderful perspective. So, we’ve talked a little bit about what it’s taken to get vaccines developed so quickly and approved via an EUA. Soon we’ll have 4 on the market, but distribution of the vaccines has been challenging. I think it has pushed the health system’s limits. Now we hear it’s picking up. We saw the announcement earlier this week from Pfizer, Moderna, and J&J that they’re increasing manufacturing, which will increase supply. Loren, what are your thoughts on this?

Loren: As you mentioned, Sarah, after some early struggles, distribution is picking up speed in the US. We’re now administering upwards of 1.5 million doses a day, with some disruptions due to the inclement weather over the past couple of weeks. We have heard this week that by the end of July, Pfizer and Moderna combined will have delivered 600 million committed doses to the US government. This week, the FDA is meeting to consider the J&J candidate, so that would further increase our supply. So, if things stay on track, by mid-summer we could have enough vaccine supply to give a shot to anyone in the US who wants one.

As that supply increases, we’re rapidly approaching a point where supply could eclipse demand in the US and we really have to start to address some of the demand-side issues. According to polling in late January, about half of all Americans either had gotten or intended to get the vaccine as soon as it was available to them. That is an increase from previous polls, but it still shows a huge gap from what we need to achieve broad population-level immunity. We really do need to think about how to reach communities where there may be some hesitancy and that in particular affects specific communities, including communities of color and other communities that may be more vulnerable to COVID-19 in the first place.

Sarah: Absolutely. So Gillian, as someone who’s worked in vaccines for decades, it’s great that we’re increasing supply, the science is good, but how do we actually get these vaccines stuck in arms? If every American that wants one will be able to get one by summer, how do we make that happen?

Gillian: Well, I think part of it is it’s going to become increasingly apparent, and we’ve already seen this from Israel, that you’re seeing a decline in the number of infections, the number of hospitalizations, the number of deaths. I think those tragedies have affected pretty much every family in the United States. People are seeing it. I’m hopeful that as we see the ability of those that are vaccinated to be protected, to meet with their families, to be able to go back economically to do things that they want to do, we begin to get confidence across the system. Just as we’ve seen the deaths and the tragedies, we will see that people are going back to the gym and they’re not getting sick.

I think it’ll take a while and we need to share the stories and we’ll need to get to the communities and show how easy it is to get vaccinated and how minimal the side effects are for the vast majority of people. Personally, I can’t wait to be on the list but I’m not old enough yet and I’m not unhealthy enough, so I’m just waiting to be allowed to get the vaccine.

Sarah: You and me both, and I think everyone on this call as well.

So, you’ve touched on this a little bit and Loren mentioned some at-risk communities as well. One thing we’ve looked at quite a bit here at Avalere is the impact of COVID on vulnerable populations, including communities of color and senior citizens. What we see in the media is mainly focused on infection and death rates. Jasmaine, how are we doing in terms of vaccinating these at-risk populations?

Jasmaine: Sarah, that’s a great question. As the plans for vaccine rollout were announced at the beginning of the year, it became clear that we needed a strategy to address some of the potential disparities around vaccine distribution. If you look at the data, as of late last week, the vaccination rates among White Americans in the states where we have race and ethnicity data is about double the rate of vaccination among Black Americans and triple the rate among Hispanic and Latino populations. That’s about 34 states that are reporting that race and ethnicity data, and I think there are opportunities to continue expanding the information that we have to track that.

There are a number of reasons that we see some challenges related to vaccine distribution among communities of color. We know that there are persistent challenges in access to healthcare, there have been limitations in the locations where individuals can actually receive the vaccine, and then also there is a longstanding legacy of mistrust in the healthcare system. Those things together have really undermined the rates of vaccination for communities of color.

But what I will say is that it’s not all a bad story here. I think there are communities that are really looking for expert information. They’re looking for trusted resources where they can learn a bit more about the vaccine. One way I’ve heard this framed is, those individuals are “slow yeses.” They just need more information and learning about what the data say to make that decision.

So, we’re not going to be able to close the deal with just the data. We really need to understand what the needs and the preferences are related to opinions about the vaccine and ultimately the decision to receive one among communities of color.

Another area I’d love to share some of our information on is for seniors. We know that seniors are a population that we need to prioritize when it comes to the vaccine rollout. It’s estimated that about 8 out of 10 COVID-19 deaths were adults aged 65 and older. And while seniors were prioritized in the plans for vaccine rollout, and particularly those in nursing homes and in long-term care facilities, there were huge challenges with the actual vaccine registration and scheduling process. A lot of it was done online and there are limitations in the amount of broadband access that older adults have. Frankly, it has been a clunky process in just making sure that you’re able to navigate the waitlist and understand the options that you have for getting the vaccine.

Those are issues that we’re continuing to address and thinking about new ways to reach senior populations. It’s certainly a challenge that I think we’ll see for vaccination rates over the foreseeable period, and that’s a place where Avalere has done some work with Tivity Health.

Sarah: Thank you, Jasmaine. I think we’re all experiencing those challenges in different ways, whether it’s having a parent that’s over 65 that hasn’t been able to register or other challenges that you’ve mentioned. Some of the challenges that you highlighted appear to be on the radar of the Biden administration. Earlier this month, the administration announced the creation of an equity task force, which is something new. Can you talk about the remit of this task force and some of the key experts that have been tapped to serve on it?

Jasmaine: Absolutely. We were really excited to see the composition of the task force because it speaks to a lot of the demographics that need to be targeted when you think about COVID-19, both from a vaccine perspective, but also in generally addressing the needs of populations, from incarcerated populations, homeless populations, and Black and Brown individuals as we plan for pandemic recovery. We really saw a nice diversity in terms of the individuals that were named to that task force, and we’re looking forward to seeing how they shape the plans to come as it relates to the pandemic.

Sarah: Thank you. So, I want to switch gears back to your side of the world, Loren. We’ve talked a little bit about distribution of vaccines, but not really payment for vaccines. Right now, all vaccines are paid for at the federal level and distributed at the state level. What will this look like when we shift into a commercial market? Holding aside the variant aspect for now, what are your perspectives on what a commercial market for the vaccine could look like?

Loren: If we look at our current government purchase commitments, they’ve secured enough doses theoretically to cover demand well into 2022. It remains to be seen whether some of those doses might be donated to other countries or placed in a government stockpile, in which case that might accelerate the shift to a commercial market. In the event that they aren’t, it may be that we don’t really see a true commercial market for vaccines for COVID-19 vaccines in the US until sometime next year. In that case, manufacturers might want to consider whether there are some opportunities to sell vaccines to end users despite the existing government purchase channels. So that’s one thing we’re starting to think about within our teams.

The other piece of this is that there’s growing consensus among experts that COVID-19 will, for at least some period of time, become an endemic disease. So, it seems quite likely that some form of periodic revaccination will be required, whether to address waning immunity or virus mutations.

One scenario we’re tracking quite closely is whether the COVID-19 vaccine market might evolve to be more like the market for a flu vaccine, which requires annual reformulation of the vaccine and revaccination of the population. In that case, there will be a number of questions manufacturers will face as they have to predict demand for a given season. Since the excess doses would need to be discarded at the end of the season, there’s really some interesting thinking that needs to be done there to prepare for that market.

Sarah: If COVID becomes endemic like flu, what will happen in terms of COVID vaccine requirements? Will we see school requirements, employers making staff requirements? How do you think these will be implemented?

Loren: I think we’re already starting to see some travel-related requirements, so countries talking about requiring proof of vaccination for entry. That’s the most obvious and easy one to answer.

We’re looking at how one might then set up the system to prove that you have been vaccinated, so things like electronic vaccination passports or other mechanisms. There is legal precedent, of course, for various kinds of vaccination requirements, although some of the changes in the Supreme Court may create some challenges we haven’t seen in the past.

There’s a big open question on employers, schools, and workforces, and I’ll pass it off to Jasmaine to talk a little bit about that.

Jasmaine: This is a place where we have been tracking the information that we’re seeing very closely, especially coming from employers around the vaccine requirement. The pandemic has certainly shaped work as we know it over the past year. If you look at the data, more than half of people are saying that they would elect to work from home permanently if they were given that option. I think this is a place where employers of all sizes are really thinking about how to reengage the workforce in a way that keeps them safe and healthy, but ultimately allows us to return to some of those in-person interactions that we all enjoy so much with our colleagues.

To that end, there have been some data that we’re starting to see around incentives that employers are offering for the vaccine, things like cash-based incentives. We’re seeing grocery and retail stores offering $100 or $200 for their employees to be vaccinated. There are some who are offering additional vacation time if you’re able to document that you’ve received the vaccine once it’s more broadly available. We’re also seeing allowances to use paid time off to get the vaccine during typical work hours.

So, those are a few of the incentive structures and I think the requirements are something that are yet to be seen, depending on the industry in terms of how employers will engage with the vaccine process.

Sarah: Yeah, great points. To your point of employers allowing staff to take time off, I’ve experienced that with my daughters at school. They are reserving time for teachers to get the vaccine in DC, which is great.

So, we’ve been talking mainly about vaccines in the US, but I think we should acknowledge that we’re in a global pandemic. What happens outside of the borders of our country will certainly impact us, as we’ve learned. Loren, can you talk about how things are going on the global level and what it means in terms of getting to the end of this pandemic? Gillian, I’m sure you’ve got thoughts as well.

Loren: We definitely need to take a global perspective on this pandemic. While the US and select high-income countries have been ramping up vaccination, there’s been almost no availability to date in the rest of the world. This is starting to change. The COVAX facility started shipping doses today to 72 participating countries. COVAX expects to distribute about 100 million doses in the first half of 2021. To put that in perspective, it’s enough to vaccinate just 3% of the population in those participating countries. So that’s really just dipping their toe in the water.

Despite recent infusions of cash support, available supply for the rest of the world will remain insufficient well into 2022, as projected currently. This isn’t just a problem for the rest of the world. It’s a problem for us here in the US as well. If the virus is left to run rampant anywhere, it creates opportunity for mutation. As we’re already seeing with the South Africa variant, that has the potential to make vaccines less effective in some cases. Maybe not completely ineffective, but it lessens the efficacy. So, to make sure our tools remain effective, we really need to make sure that vaccines are widely available around the world as quickly as possible.

Gillian: To add to that, it does say that while vaccines are truly wonderful, and as an immunologist I’m a great advocate for them, we also need to remember therapies. Therapies come in 2 forms, 1 being antiviral where you’re actually zapping the virus itself and reducing the load in that person, and then treating the symptoms of an infected person to increase their chances of survival.

We’ve seen a lot of research into secondary uses of current medicines that manage the immune system. We’ve seen much less in terms of effective antivirals. We’ve got remdesivir, which helps to some degree, but we cannot afford complacency on vaccines if we don’t have good therapies because as we’ve seen with some of these new variants, with high infection rates, you’re going to see very rapid pop-ups of populations that are infected and the associated hospitalizations. All of these things run in parallel.

Interestingly, the UK is now considering challenge studies because the ability to challenge a patient to check out a vaccine and conceivably also to check out drugs down the road allows you to readily compare different treatments. That means comparing different vaccines head-to-head, and also comparing different drugs. The importance of that is, even though we have some inordinately effective vaccines, perhaps we can do better.

The J&J vaccine single shot, that matters. How we make the vaccine, what the supply chain requires by way of temperature management, that’s going to be critical in some of these emerging countries that don’t have the ability to distribute at very cold temperatures. All of these tools of how you develop the product, how you know what is a good vaccine, a good therapy, are moving by leaps and bounds. I do think we should give credit to our regulators—FDA here in the US, but also elsewhere in the world, for being very creative on how they are going to reach their metrics of “safe and effective if used as indicated,” in a manner that gives us multiple options.

This pandemic has taught us one is not enough. Future pandemics, whether they’re coronaviruses or something else, will need this sort of expeditious efficient development too.

Sarah: Loren, I want to go back to something that you said earlier about the impact of COVID on other areas and other disease states. What impact has the pandemic had on other routine immunizations?

Loren: COVID has been the top public health news story, and really the top news story, around the world for the past year. But that doesn’t crowd out all the other diseases that affect us, many vaccine-preventable diseases among them. There have been a number of analyses on the impact of COVID on pediatric vaccination rates. Just this past month, we published our own analysis here at Avalere looking at the impact of COVID-19 on adult and adolescent vaccination rates.

What we and others have found is that, particularly early in the pandemic, there was an incredibly steep drop in vaccination rates across age ranges for existing ACIP (Advisory Committee on Immunization Practices)-recommended vaccines. That has rebounded in certain markets. Children have returned close to normal levels as things have reopened and people are going in to see their doctors for their routine well care visits, but it has not come back to the same degree in adolescent and adult populations. We’ve seen some rebounding, but not nearly enough to cover the gap that was lost in the very early months of the pandemic.

We did see a bright spot in that the early data from the flu vaccine season showed flu vaccination going up quite a bit this year over last year. That likely reflects a lot of messaging about the intersection of COVID and flu, and really trying to keep people out of the health system if they didn’t need to be there. Lots of people rushed to get their flu shots early.

We are looking forward to digging into this data a little bit more and being able to look at things like the equity implications of this story and how it cuts across different communities, so stay tuned for more on that.

Sarah: Gillian, I’m going to put you on the spot a little bit. From your perspective, do you think that our experience with COVID-19 will lead to more people getting vaccinated in the future, not just for COVID but for other diseases?

Gillian: I would hope so because even flu was killing 30,000 to 40,000 people a year in the US on a comparatively not-so-bad year, and up to 80,000 on a really bad year. But people don’t like needle sticks. I think we need to understand whether there are better ways of delivery, how people are thinking about vaccines, and why they do what they do.

My mother had diphtheria as a child. Her generation saw the horrors of these diseases, and that was an isolation hospital for 6 weeks at the age of 6. If you haven’t seen the diseases, you don’t understand just how very real they are. I think we’ve got to be very careful, very responsible, about how we tell that story, not to terrify or intimidate people, but to help them understand that this helps them. It helps their families. A lot of the other adult vaccines are a really good idea, too.

I’ve realized it’s been 30 years since I had a tetanus vaccine. Maybe it’s time to update it. So, I think there’s an opportunity created here that we can take, but public health has to matter.

That gets into perhaps some of the broader approaches taken and one thing that’s come through loud and clear to me is, this has been like 50 different countries when we look at the distribution system in the United States. Who is responsible? Who decides? A lot of the issues on distribution have been bad coordination. A lot of the countries with National Health Systems, like Israel as we cited earlier—small country, small population, more homogenous society, but with a very tight system—have a much easier means of getting a public health message out. So, I think the opportunity is there for us, we just have to use it.

Sarah: Jasmaine, I want to circle back to some of your earlier comments about the effects of COVID-19 on communities of color over the past year. You spoke about hesitancy around getting vaccinated and what it would take to impact some of those communities. Can you level-set with us, talk more about the impact of COVID-19 on communities of color and what we are seeing in the data right now?

Jasmaine: Yeah, that’s a great question, Sarah. I think what we’re seeing in terms of the impact of COVID-19 when it comes to hospitalizations and deaths among communities of color has been particularly stark. I don’t know that it is a surprise to anybody on the phone, but just to give more context there, Black and African American populations are nearly 3 times as likely to be hospitalized from COVID-19, and nearly twice as likely to die as a result of COVID-19. Those numbers are even worse in Hispanic and Latino populations, unfortunately.

That’s devastating to people’s personal lives, but also in thinking about how we have established our healthcare infrastructure around meeting the needs of these populations. That’s one category of the impact that has been particularly devastating to communities of color.

Another place that I think we have to highlight is the economic impact of the pandemic. If you think about jobs where we were able to transition to a remote platform, women of color were particularly impacted by job loss when you compare them to other types of populations. So Black women and Hispanic women in particular had a significantly higher likelihood of losing their jobs as a result of the pandemic. That impacts not only individual ability to care for your family and provide food and the resources that you need during this pandemic, but it also impacts your health insurance status. I think that’s something that we really have to put a close eye on.

An Avalere analysis that came out in September of 2020 showed that Asian, Black, and Hispanic populations were nearly twice as likely to lose their health insurance coverage as a result of losing their employment. We have to be mindful of that as we think about pandemic recovery.

The last thing I would say in terms of the impact, and I could go on and on about this, is the mental health impact of the pandemic. There have been increased reports of anxiety and stress and depression and those have been fairly similar across racial and ethnic populations. But where we have seen differences is in the access to treatment for those issues. So, when you think about mental health treatment or substance use treatment, that is something that has been particularly difficult for African American populations and Hispanic and Latino populations to navigate during a pandemic.

Unfortunately, there are several ways that communities of color have been hardest hit when it comes to the pandemic, but I think that presents an opportunity for creativity in thinking about how we address those needs moving forward.

Sarah: Absolutely. You’ve talked about some of these disparities that have been exacerbated by COVID, but can you get back to basics for us for a minute and talk about what some of the root causes of these disparities are? Many of these issues are not new to COVID, but they have been exacerbated by the experiences of the past year.

Jasmaine: I’ve highlighted a couple there. More broadly are the challenges related to the social determinants of health, which I think have come to the forefront as we have navigated our way through this pandemic. We know that communities of color are more likely to live in multigenerational households, they’re more likely to work in congregate settings, and so the risk of COVID-19 exposure tends to be higher in those communities. That’s something to consider.

The second is, they’re less likely to have access to paid sick leave. So if you are exposed to COVID-19 or if you ultimately test positive, the ability to stay home and not have that put your financial stability at risk is something that tends to be a challenge.

And then, of course, what I just mentioned about the rates of unemployment. So, you may seek out jobs where your level of exposure is increased relative to a job that you may have had prior to the pandemic. That’s one place where we’ve seen a lot of challenges when it comes to the disparities that have become more and more clear over the course of the past year.

Another thing I’d highlight is the lack of access to healthcare services broadly. So, think about something like the COVID-19 testing that Gillian was just mentioning. The number of testing sites per zip code in communities predominantly of color are much lower than communities that are predominantly White. So that can be a challenge just in terms of being able to assess your risk in order to get information that you need to make a decision about your level of daily activity and being able to quarantine effectively.

And then, of course, preventive care is huge. We know that comorbidities related to cardiovascular diseases, respiratory conditions, the ability to seek out those preventive healthcare services so that if you are diagnosed with COVID-19, you can manage the prognosis, that’s a place where there have been challenges among communities of color.

Those are a few of the root causes in things that we’re looking to address in our work at Avalere.

Sarah: I want to take you back to your forward-looking lens. You ended on a positive note with the prior question, but how can we learn from this to directly tackle these disparities, both in the context of the pandemic, but also at a systemic level in the US?

Jasmaine: I think that’s a place where we’re all solution oriented. It’s a place that we really are excited to think about how we can be creative moving forward beyond the pandemic. One thing that we have done here at Avalere is put together a framework around responding to and investing in health disparities in a way that can help us make true change. There are 3 elements of that framework that I’ll talk through.

The first is our infrastructure, who we have running these clinical trials, the physicians that are at the frontline—really investing in the individuals and the systems that we have in place that can help to operationalize health equity, which I think is a goal of everyone’s. I think a great example of that is what we saw with the clinical trials around COVID-19 vaccines. Communities of color had some reservations and having people like Dr. Corbett and NIAID (National Institute of Allergy and Infectious Disease) and others who were able to step forward and highlight the importance of being involved in those clinical trials was hugely impactful. I think that’s a place where we want to continue to make investments over the coming years.

The second is thinking about analytics and in particular, equity-driven analytics. So, how are you assessing the current state for your organization, for your beneficiaries, when it comes to health disparities? And then how are you defining your benchmarks over time to hold yourself accountable? That’s something that we continue to push our clients in thinking about, and also ultimately developing very detailed plans around.

And then third would be the partnerships that you have. In 2021, if you haven’t brought new people to the table when it comes to your planning process, you are missing out on really important insights. To that end, engaging with community-based organizations, looking for those trusted messengers in communities is really important. It’s a place where we’ve seen a lot of exciting innovation over the past year because we’ve all been realizing how interdependent we are during this pandemic.

Sarah: Are you able to give a more specific example of one of those partnerships that you’ve seen come to fruition over the past year?

Jasmaine: Yeah, I’ll share one that I personally thought was remarkable in terms of the approach. There was a group of entities in Philadelphia. Penn Medicine, an academic medical center; Mercy Philadelphia, a safety net hospital; and faith-based leaders in South and West Philadelphia where there are large communities of color all came together to host a vaccination clinic. It was pushed by the faith-based leaders in organizing their congregations to bring them in and talk about the needs related to the pandemic and the vaccine.

Another thing that was really powerful was an emergency medicine physician who happened to be a woman of color who shared her own experiences with the vaccine. She had questions about whether or not she would get it individually and just thinking about both what the data say, but also personally what some of her beliefs and preferences were, as it related to the vaccine.

What I appreciate about that example is just the authenticity that we saw in that interaction, that we had faith-based leaders who were able to engage with people that they have longstanding relationships with, where they built a lot of trust, matching that with some of the data that’s available from the medical side to really make sure that we are engaging populations in a way that addresses their needs, but also helps to bring this pandemic to an end.

Sarah: Absolutely, thank you. That is very powerful. Switching gears a bit, I’m going to open up the conversation to talk a little bit about the variants that have been so top of mind. Gillian, I’m curious on your take. We’re hearing a lot of threats of an explosion of new cases, yet cases are decreasing as we mentioned earlier. What’s your take on how things are going to play out in the US?

Gillian: Well, there seem to be a limited number of variants, but this is where the testing is so key as to how much we know what the variants are and how uncommon the mutations are when they appear spontaneously in different places. So far, there seem to be a limited number of variants, but it’s a lesson to us that these variants can occur and that they can have different levels of transmissibility and probably symptomology. Also, that some of them would likely have greater viral burdens.

I think the urgency that I hear from the very fact that the variants can even exist says, collectively in the global population, we have to get the number of viral divisions down because that is what is leading to the probability of these variants emerging. It’s a great intellectual exercise to understand how they’re happening and everything else, but they are a huge threat. So this is where the collective 7 billion people needing to be protected comes in. But the monitoring is key and then looking at the different vaccines.

Now, it may be that some of the vaccines are better against some of the variants than others, but I don’t think that changes the priority of getting every vaccine shot we’ve got into somebody to protect them as quickly as possible. FDA just came out with some forward-looking guidance as to how they are going to adapt, not entirely like they have for flu, but essentially allow for the vaccines to be made to match the variants as they emerge. The advantage of some of these new technologies that are based on the old history of attenuated viral strains, these are based on sequences and vaccine technologies that are very adaptable to creating vaccines to the new variants, but clearly, you don’t want to have to run clinical trials on some 40,000 people to do that.

Sarah: You mentioned one of the vaccines being reformulated for a variant, but could we be in a situation where we get the US population vaccinated for anyone that wants a vaccine, a new variant emerges, and we have to revaccinate everyone? How do you think this could actually play out?

Gillian: Well, so far, and we should monitor to know what we’re up against in terms of these new variants, it’s not that the vaccines don’t work. In fact, they stay at least as effective as our 50% cut off objective for any vaccine at the beginning of the year. So you wouldn’t expect the entire population to be as vulnerable as we are right now. But yes, there should be the opportunity to have updated vaccines available that are more expeditiously approved so they’re available ahead of a true surge in infections.

Loren: There are a couple of points I would make here and Gillian’s covered quite a bit. If we do end up needing to revaccinate everyone, which could be likely at some level, I think it will normalize to a more traditional process, like a flu vaccine, or another regular booster shot. So, we won’t see mass vaccination campaigns necessarily the way we’re seeing them right now.

The other thing I want to highlight here is just that we also still have manufacturers working on a number of next-generation COVID-19 vaccines and in that pipeline are things that could tackle variants by triggering the immune system differently or might make revaccination easier because they’re easier to store, distribute, or administer. There are lots of things that can change as we progress into a more normal market.

Sarah: Great. So, I’m going to ask one more question of the panel, and then move to addressing some of the Q&A. We’ve mentioned a few of the actions that the Biden administration has taken related to the pandemic. What else can we expect Biden to take on in terms of the pandemic? What are the next action steps?

Loren: So, we’ve already seen a huge amount done in the first month of the Biden administration. It will take a while for the full impact of those efforts to be felt. Right now, I think all eyes are on Congress as it works to pass the $1.9 trillion COVID-19 package that the administration has proposed. Additionally, I think a lot of focus is on the economic relief and stimulus in that piece of legislation, but it also includes $46 billion to bolster testing and tracing, $10 billion for defense production act spending to offset shortages and supplies, $7.5 billion for vaccine distribution, and some other pots of money, including $50 billion for state, local, and tribal and territorial governments to help support their efforts. So, there’s quite a bit of potential opportunity to advance in those packages.

Sarah: Great. Now, I’m going to pose this first question from our audience to you, Gillian.

What do you see as the differences between the Pfizer and Moderna vaccine and the J&J vaccine in potential interest from the community? We know that one is a single dose and the other 2 are two-dose, but anything else to add there?

Gillian: I think single dose is going to have a lot of appeal. In all probability, a single dose of even Moderna, Pfizer, and any of the other vaccines gets you a long way toward having a level of protection, but I think single dose will appeal because people don’t like needle sticks.

I think we have to be very careful about how we look at the numbers. The numbers are often expressed in who gets infected, but the mild disease probably doesn’t matter that much compared to the reduction in hospitalizations, and certainly the reduction in deaths. So I think, while there may be preferences between the vaccines by some people, the vast majority of people will appropriately see it as, “When can I get my vaccine?” That may change over time, but I think right now, it’s about how many doses we can get out quickly. And there again, the scale-up of Moderna and Pfizer may be easier, but we’re seeing a lot of companies working together to hopefully get the manufacturing up collectively around the world.

Sarah: Loren, I’m going to ask you to take on this next question.

Do you think that Pfizer’s plan to raise its vaccine price will impact how payers will cover this from a patient out-of-pocket perspective, and how biotechs are currently developing vaccines? What are your thoughts?

Loren: With the way payment and coverage decisions about vaccines in the US are made, it’s not entirely the payers who are making that position. It really is quite dependent on the recommendations that will come out of the Advisory Committee on Immunization Practices (ACIP) moving forward. If it has a routine recommendation from the ACIP, it’ll be required to be covered by payers, whereas if there is a differential recommendation or shared decision making, there would be a different story there.

Sarah:  Good context on ACIP. So, we’ve gotten a few questions about monoclonal antibodies and their effectiveness, and also questions about the EUA early rollout of the Lilly and Regeneron monoclonal antibody. What are your thoughts on the future of monoclonal antibody treatments and even using them prophylactically? Gillian, can you take this one?

Gillian: Sure. I love monoclonals, having worked in them since the 70s. They are very powerful, very specific tools. The candidates we’ve had so far are, as I said, antiviral. Essentially, they bind to the virus. They reduce its infectivity. One of the challenges associated with them is they have to be infused, so you’ve got a patient sitting there in a center having the product infused and it takes a fair bit of time. I think there are ways that they could be administered more readily sub-Q, but this association with how they’re administered is an issue.

Also, people just haven’t really been thinking about their availability as much and they have to be given fairly early in the disease to make a difference. The challenge is not knowing who’s going to benefit most. So, do you try and administer them to everybody early stage? I think the opportunities will expand as we get a better understanding of exactly how they work and for whom. But as in that limited portfolio of therapeutic approaches, I think they are important.

Sarah: We’ve got a question on home testing. We’ve touched on testing writ large, but not home testing. How likely is it that we’ll see more tests approved for home use by the FDA? Do you think that will be the testing trend of the future?

Gillian: There’s a lot of value to home testing if it’s convenient, easy, and accurate. You’re not sending people all to one center. You’re not having people congregating. I think different people have different preferences.

We saw a whole evolution in home testing when HIV home testing came out and how you understand the test. How reliable is it in the hands of an average person? How quick is the result? Is it like a pregnancy test? Do you get an immediate result on a plastic thing? Or do you have to mail it back and get information?

I think this is the great thing about the US. We have all sorts of proposals out there and they will use varying technologies. Some will be for the antibodies, telling you if you’ve been exposed, and some will be based on the virus to tell you if you’ve got active virus in you. But I think the opportunity is there. To the extent we can make testing easy, we will get more test results, but we want to have a means of collecting those results as well so we can pool the data, interpret them, and understand what’s happening across populations, so that’s going to be important too.

Sarah: Another follow-up question. I think this one will be in your area as well, Gillian. Do you think that the low rates of influenza this year were driven more by the improved rate of flu vaccination or social distance/masking practices currently in place due to COVID?

Gillian: I think it was probably that we’ve all been so distanced. It’s great that people got their flu shots. I got my flu shot and I’m not entirely 100% reliable on getting them. But, we weren’t traveling on the Metro, we weren’t congregating, we weren’t hanging out in places where you get very ready propagation of flu. That’s a lesson to us all about personal hygiene and washing your hands. I’m not sure how long we will wear masks for, but I would suspect a lot of it was social distancing.

Sarah:  Great. Here’s a question for everyone. What are your biggest learnings from the pandemic over the past year?

Jasmaine: I’ve definitely learned a lot more about the supply chain. That was a new area for me and I think a concept that comes from supply change management is this concept of the last mile. So how do you actually get goods and products, in this case vaccine, to people? That has been a long-standing concept. I recently heard on another webinar the description of community-based organizations and these trusted messengers as that last mile in care delivery. I think that’s going to be especially true for the vaccine of how we reach communities of color and how we reach seniors. I hope it’s something that continues as we think about care delivery more broadly, bringing those types of organizations to the table early and often and getting that feedback in streamlining care delivery. That’s been a big learning for me, just understanding more about the supply chain and how we can engage community-based organizations in a new way.

Loren: One of the things that I’ve reflected on is that the investments we make in between these pandemic or epidemic outbreaks matter. If there hadn’t already been investment in the technology that Moderna and Pfizer and other partners have been developing, we wouldn’t have been able to turn around vaccines so quickly. It really is important that we continue to talk about and think about these issues, even when they’re not affecting us on the day to day.

Gillian: Well, there’s so many, but the first one I would put right up there is that the science has delivered. We have collectively achieved marvelous things, and that goes way beyond COVID. That applies to every single disease that’s out there. When the incentives are aligned, we allow our scientists to talk to each other. The advantage of the science being a global language already builds that bedrock and has facilitated it. All of the different scientific communities, whether it’s the regulators, the epidemiologists, the people in labs, the new technology, have been able to perform together and come up with some fantastic ideas really quickly.

But it’s in the context of us having been very complacent about public health. Infectious diseases are not behind us. This is the first really bad one in 100 years, although I’d put HIV in the middle and say that was pretty bad, too. In terms of pandemics and the level of infection and how quickly this got around the world, we should be learning a lesson about our ongoing surveillance, empowering some of our existing authorities such as CDC to be monitoring much more carefully, because this was the cat that got out of the bag. It shouldn’t have gotten this bad if we’d been monitoring appropriately. We were more worried about malicious threats or bioweapons than we were about natural events. I don’t think we reacted quickly enough. So, it’s a good bad story. Look at what we can do when we concentrate, but look at how careful we need to be when we don’t.

Sarah: Yeah, great. Next question, Gillian, I’m going to direct to you as well. Do you think there’s a difference between natural antibodies and the antibodies produced by the vaccine?

Gillian: Yes, there probably are. The question is, how important is that? When you have a natural infection, you get a whole slew of antibodies and you get what’s known as polyvalent antisera. In the beginning, we were thinking that convalescent sera might be good enough to protect people. We learned that there weren’t enough specific antibodies that were going to zap the virus within that morass, that spectrum, and that we were far better off if we could target monoclonal antibodies or do a cocktail in the case of Regeneron that would go for the particular spike protein that was so important.

I think the interesting thing that we don’t know yet goes to monitoring the longevity of any of these responses. When you have a measles jab as a kid, or like I actually had measles, you have an immune response that essentially protects you for the rest of your life. We don’t know, even if this virus wasn’t to change at all, how long that immunity is going to last.

Now, I would hope that there’s sufficient so-called memory cells of both B and T that are going to be there to respond that say, even if you get it again, it’s not going to be as bad, but this issue of how long that immune response lasts is going to be very important. I would agree with the premise that these coronaviruses are going to be endemic and even if you don’t need a new version every year, are you going to need a new version every 10 years? So, the issue of boosters and understanding the disease is going to continue to be important, even when we’ve got the pandemic putatively under control.

Sarah: Great. Last question from the audience. Jasmaine, how are you feeling about the clarity of who should be up for vaccination when, and where is productivity highest? What are we learning from other countries? Where is the environment accelerating the progress and where is it impeding it?

Jasmaine: I think for people who work in healthcare, who work in public health, the decisions around the tiers or phases that you’re seeing at a state level seem fairly clear, but if you ask those consumers who those tiers or phases apply to, there is a lack of communication. One of the things I mentioned earlier was some of the work that we had done with Tivity Health around surveying seniors about their opinions on the vaccine. That’s data that we’re continuing to track with them and their SilverSneakers membership over the next few months. I think there we see a lot of questions around, “Should I be first even if I am up for vaccination? I can stay home.” So, making sure that we are really tailoring our public health messaging to address the urgency and the need for populations who are being prioritized today to get vaccinated, if that is the informed choice that they’re making. I think that’s really important. I would say we’ve done a good job in making those decisions, but ultimately need to think a little bit more about how that communication is trickling down to local communities.

Sarah: Great, thank you. One final question to close us out. Imagine that each of you are tapped by Biden to lead HHS. What would be the top item on your wish list to end the pandemic?

Loren: I’m going to be even more forward-thinking than ending this pandemic and say my top priority would be in addition to what’s already been done, thinking about the next pandemic and how we build stronger infrastructure to be able to detect and respond.

Gillian: I would put a great deal of emphasis on the lessons learned from the expedited development of these vaccines to say, “How can we be improving and speeding up the development of every single therapeutic in the pipeline?” I think we’ve gotten overly careful because we’ve forgotten how important it is to treat those people that are waiting, not in a malicious way, but we evaluate the safety and effectiveness of that particular product in the context of that particular use. So we’re saying, “What’s the adverse event for that patient?” We’re not saying, “We’ve got hundreds of millions of people that are dying daily if we don’t get this out there.” I think the opportunity to revisit and only ask for actionable data and be very candid and focused in what we expect sponsors of products to produce could vastly alleviate FDA’s burden and get medicines to patients more quickly in COVID and well beyond.

Jasmaine: A couple of wishes on my list. One is to have comprehensive statewide data by race and ethnicity for the vaccine. I think that’s something that we need to be able to allocate resources appropriately. If we’re really being optimistic, I’d love to see a secretary of equity position created.

Sarah: I love that. Well, thank you so much, Jasmaine, Loren, and Gillian. Thank you all for tuning in to today’s webinar. If you would like to learn more, please feel to reach out to us at Avalere.com. We’re also on LinkedIn and Twitter. Thank you so much for your time today. Have a great day, everyone.

Panelists

Moderator
Sarah Butler , Head, Client Solutions, Marketing & Operations

Sarah Butler specializes in evidence-based medicine, value-based contracting, and strategy development.

Speaker
Loren Becker , Associate Principal, Policy

Loren Becker supports clients in navigating US and global policy and market access issues, with a focus on vaccines and emerging infectious threats.

Speaker
Jasmaine McClain , Consultant

Jasmaine McClain advises clients on quality landscape developments and quality improvement implementation.

Speaker
Gillian Woollett , Principal Research Scientist, Commercialization & Regulatory Strategy

Gillian Woollett leads our FDA practice.

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