This interview was originally published as a podcast. The audio is no longer available, but you can read the transcript below. For updates on our newly released content, visit our Insight Subscription page.

Transcription

Richard: Hello, and welcome to another episode of Avalere Health Essential Voice in our Start Your Day with Avalere podcast series. I’m Richard Hughes, a Managing Director at Avalere, and leader of our vaccines team. I am joined by my vaccines team members, Marissa Shaw and Alexa Trost. Today we will dive into the 2020 vaccines marketplace. We recently released a vaccines outlook that provides information on the vaccines pipeline and marketplace, as well as interesting policies in the space. We are excited to release this outlook at a time when the COVID-19 pandemic has generated so much focus on vaccines. We began working on this document long before the pandemic, but have updated it to reflect issues that have arisen. With that, I would like to turn to Marissa and Alexa so they can tell us about the document.

Alexa: Thank you, Richard. For this outlook, we spent a lot of time diving into an exciting and diverse pipeline full of traditional vaccine candidates, such as Tdap, pneumococcal, and meningococcal, as well as novel candidates for diseases such as respiratory syncytial virus (RSV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), and C. diff. These vaccines are being developed and coming to market at a time when the national focus is on childhood vaccinations as well as adult vaccinations, which have historically lagged behind childhood rates and Healthy People 2020 goals, but will be vital in preventing COVID-19 once a vaccine is available.

Within the outlook, we looked at both the pipeline and the vaccine landscape. We examined different opportunities within the market through the Advisory Committee on Immunization Practices (ACIP), non-vaccine immunizations and prevention, different implications of United States (US) vaccine coverage, and the emergence of new immunizers. We also looked at the impact that vaccine hesitancy has on uptake of various other vaccines.

Marissa: We also looked into new delivery mechanisms being used, such as needle-free options for those who are afraid of them. Vaccine delivery technology continues to improve. We also took a look at exciting new combination vaccines, such as an RSV and influenza vaccine, which is especially important in relation to COVID, should it become an endemic disease, as well as coverage barriers that exist for access to existing and future market vaccines.

Richard: So, Alexa, you mentioned some novel vaccines that I am interested in. You mentioned cytomegalovirus. Tell us about some of these interesting vaccines in the pipeline for diseases that nobody has heard about but are significant in terms of public health.

Alexa: Yes, absolutely. Our team has focused on several of these key novel vaccines that are being developed. These would alter how we approach and prevent diseases that are well known, as well as those that are underdiagnosed and unknown, especially in the adult population. In the next few years, we could see vaccines for HIV, C. diff, which is a bacterial infection primarily impacting older and more vulnerable adults, as well as a variety of respiratory diseases. This is especially important in the context of the COVID-19 pandemic. Prevention of other respiratory diseases such as pneumococcal disease, influenza and RSV will be vital in reducing the burden on the healthcare system, as well as numerous comorbidities and coinfection. RSV is underdiagnosed in adults, with no vaccine or treatment on the market. As we are approaching the upcoming flu and RSV season amid the pandemic, the industry has been working toward expanding the flu platform to include novel technologies, like influenza vaccines that would protect against more strains than existing seasonal products.

Richard: That is exciting! Marissa, you mentioned COVID. We are in the middle of a global pandemic, and there has been a lot of discussion about a vaccine, its importance, and when it might be available. Could you talk us through what the COVID vaccine pipeline looks like?

Marissa: Yes, absolutely. The COVID vaccine pipeline is extraordinarily robust, and the industry has come forward and put a lot of hard work into developing a candidate that could be approved as early as this fall. There are over 180 candidates that are in pre-clinical studies, and over 20 that have reached the clinical trials stage, with some entering phase 3 earlier this summer. So, it is interesting to see. The US and world governments committed to investing heavily in vaccines right away so that we could do as much as we can in the vaccine space. I think it will be interesting to see how vaccines come to market and what technologies there are this fall and early in 2021. Some of the technologies are based on RNA and DNA platforms that have not been approved prior to the pandemic, so it is an exciting time in the COVID vaccines pipeline.

Richard: Great! Alexa, the outlook provides a nice overview of vaccine coverage and access in the US. As we know, the Affordable Care Act (ACA) did a lot to improve access to vaccines with the preventive services coverage requirement, which requires first dollar coverage of all ACA recommended vaccines. Through an act of Congress, Medicare requires first dollar coverage of pneumococcal and influenza vaccines. Other vaccines are covered under Medicare Part D, but we see some out-of-pocket barriers for seniors. Medicaid expansion programs must cover vaccines with zero out of pocket. With traditional Medicaid, we have seen coverage variability. It is a very fragmented system of access and coverage. Can you both talk about what this will mean for a COVID vaccine?

Marissa: Absolutely, Richard. I think the biggest consideration in relationship to COVID is that Congress has declared that future COVID vaccines will be covered under Medicare Part B, rather than Part D, which will remove cost-sharing barriers. This is wonderful for COVID but creates coverage variations for other vaccines. As you and Alexa have discussed, both the uninsured and the traditional Medicaid population have gaps in coverage that need to be addressed through legislation. It will be important to see how the US government absorbs the cost of COVID-19 vaccines for the public.

Richard: Marissa, we have heard commitments from the Trump Administration that the vaccine will be available to all Americans. With such fragmented coverage, how will the uninsured access this vaccine? How will we ultimately see everyone have access to this vaccine?

Marissa: That is a great question, Richard. I think this is where local health departments and the existing public health infrastructure, as well as expanding the immunizer pool, will be critical in reaching the uninsured and other underserved communities. I think additional work needs to be done to ensure that an immunizing structure is in place when a vaccine is ready to be deployed to all those who need it immediately, as well as for those who need it gradually when additional ones come to market, so that everyone has access.

Richard: You guys have covered a lot of ground in this outlook. You have talked about vaccine innovation in the pipeline, novel delivery mechanisms, and existing policy coverage and access issues that will impact coverage for future vaccines. As you think of the challenges that lie ahead, what are some of the strategies that will be needed?

Alexa: We have talked a lot about the different products in the pipeline, as well as various access barriers that we might be seeing with these future products. Something that is important is the issue of who will be administering these vaccines when they come to market. After the 2009 H1N1 pandemic, there was a big move to expand scope of practice laws, which allow pharmacists to administer vaccines. However, there are many state laws that put limitations on immunization by pharmacists and other non-physician immunizers. As the role of pharmacists and other non-physicians expands, this issue will be important for a lot of pipeline adult vaccines, including HIV, C. diff, RSV, and future vaccinations for COVID-19. Marissa, do you have anything to add?

Marissa: Absolutely. Another thing I think will be critical is the immunization information systems and the infrastructure we use to record and report immunization activities. I think they continually need to be improved. Interoperability and communication between states also need to be improved and will be important for all of the adult vaccines you mentioned, Alexa, in addition to the typical childhood vaccines that Immunization Information Systems rely on. It’s also important for recording and reporting COVID-19 vaccination activities, especially since many of them are likely to be a 2-dose series. Richard, what are your thoughts?

Richard: I think you both have hit the nail on the head. I think coverage across markets is still very fragmented, and I think we have a lot of opportunity to improve vaccine access across markets regardless of someone’s source of coverage. This is particularly important as we look at some of the coverage shifts that are occurring because of the economic impact of COVID. We saw Congress act very quickly early in the pandemic because they recognized that this was a huge public health threat. There are a lot of opportunities to think about access to vaccines and preventing diseases besides COVID. I think it is important that we remember the lessons learned from COVID and apply them to future vaccines. We often see the urgency around a public health emergency inspire people to action, but it’s important to make those lessons create lasting change.

Thank you both for your work on the outlook. I hope our listeners will take a look at it. I think it is a very informative and insightful document. I appreciate the hard work and thank you for talking about it with me. Thank you all for joining me today on Avalere Health Essential Voice. If you would like to learn more, please stay tuned for more episodes, download a copy of our 2020 Vaccines Outlook Report or visit our COVID-19 intel center on our website www.avalere.com/covid-19