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Transcription

Nick: Hello, and welcome to another episode of Avalere Health Essential Voice in our Get the Facts on COVID-19 podcast series. My name is Nick Diamond, and I’m one of the senior members of the Vaccines team here at Avalere. Today, I’m very fortunate to be joined by two of our vaccines experts, Alexa Trost and Mitchell Finkel.

On this episode, we’ll be discussing a very timely topic—COVID-19 vaccines. Specifically, we’ll be focusing on the state distribution plans which are currently underway and will continue to unfold into the new year and well into 2021.

We’ll spend a little time getting a baseline on what those state plans look like, and then talk about some of the potential challenges associated with distributing COVID-19 vaccines. We’ll also take a moment to look ahead to 2021 and get a sense from Alexa and Mitchell about what they’re focusing on going into the new year.

So with that, Mitchell, let’s start with you. What are you seeing with these COVID-19 vaccine distribution plans? I know this is something that you follow closely.

Mitchell: Absolutely. Thank you, Nick. I think a good place to start is back in September when the Centers for Disease Control and Prevention (CDC) and Operation Warp Speed (OWS) released their Vaccination Program Interim Playbook. This provided the blueprint for the 64 immunization jurisdictions, which includes 50 states, some cities, and other jurisdictions, and tells them how they should structure their own COVID-19 program. Immunization jurisdictions took that initial playbook and then created their own plans and submitted them to CDC, where they went through a refinement process. CDC then released an updated playbook, which states are going to be editing as well.

When we look at every state and immunization jurisdiction’s playbook, they all cover a variety of topics which include provider populations, priority populations, points of dispensing, data collection requirements, and immunization jurisdiction communication plans.

The topic of priority populations has been the focus of the most news reporting, and perhaps some of the most interesting reporting. Most states are going to be following the Advisory Committee on Immunization Practices’ (ACIP) recommendations for Phase 1a, which are the initial vaccines that will be distributed to healthcare personnel and long-term care residents. Many states are sub prioritizing among healthcare personnel in the event that there’s limited supply.

Looking forward, states are developing their phase 1b and phase 1c approaches for when there are more vaccines available. This can include adults 65 years or older or essential workers in phase 1b. ACIP has provided guidance that it should include essential workers, but we’ll see ACIP weigh in more in the future.

When we look at the different providers and points of dispensing in state plans, most states are going to be initially vaccinating their healthcare personnel at large medical institutions or hospital systems. As supply expands, we’re expecting vaccines to be dispensed at other locations such as pharmacies, provider sites, and mass immunization sites.

And finally, for their communication strategies, states are investing varied amounts into their plans. Some states are focusing on traditional public messaging including press conferences and traditional media, while others are expanding to non-traditional media, such as social media and targeted outreach to certain communities to focus on equity.

Nick: Excellent. Thank you, Mitchell. That’s helpful context. Obviously, this is a big undertaking for both the states and the federal government. So many stakeholders are trying to anticipate some of the potential challenges that might occur as this distribution and administration phase really ramps up in the new year. Alexa, I know this is something you’ve been focused on very intensely as well. Can you share some thoughts on the potential challenges that we could see going into the new year?

Alexa: Absolutely. One of the big things on stakeholders’ minds is cold chain and supply chain for these COVID vaccines. The Moderna vaccine, which is being reviewed this week for an Emergency Use Authorization (EUA) and an ACIP recommendation, needs to be frozen, but it is on par with existing frozen vaccines for chicken pox, shingles, and the MMR/chicken pox combination vaccine.

On the other hand, the Pfizer BioNTech vaccine is really, really cold and it has ultra-low storage requirements, which are being planned for and have been a core focus for the CDC, ACIP, and state immunization managers and COVID vaccine planning teams. Since the storage requirements will limit the types of healthcare providers who can stock vaccines, it will also limit minimum sizes of orders as well as access in rural and other hard-to-reach areas.

The federal government has been working with various stakeholders over the last months to prepare for this by procuring dry ice, including cold chain storage in distribution plans, and procuring ultra-low freezers and other packing containers, on top of some of the ancillary typical kitting supplies like syringes and vials.

One of the other things at the top of my mind, and something that stakeholders have been focusing on as well, is vaccine hesitancy and confidence. In the public’s view, the vaccine has been developed quickly, which seems to create uncertainty in the side effects and efficacy. But we know that the technology and much of the research was already there from SARS and MERS outbreaks. Since H1N1 and past pandemics like Ebola and Zika, which now have vaccines, the systems and infrastructure have been built to support more rapid development.

What’s really been missing to support this development for other vaccines is the amount of federal funding and involvement and the administrative flexibility that we’ve seen with COVID vaccine development that has now led to potentially multiple safe and effective vaccines. FDA and CDC aren’t cutting corners or doing this too quickly. Our team has listened in on several hours of public meetings from FDA and CDC advisory committees, and that’s just the tip of the iceberg for what the government’s been up to.

We also have an analysis coming out soon that supports previous analyses that show significant drops in routine immunization rates across all ages throughout the course of the pandemic, particularly as states have implemented stay-at-home orders and people have been hesitant to enter healthcare settings for face-to-face interactions. This is a big concern for public health stakeholders since lower vaccination rates mean fewer people are protected from diseases like measles, whooping cough, and shingles, which not only impact the individual, but also herd immunity and public health in general. Reemergence of some of the previously controlled vaccine-preventable diseases in unvaccinated populations could increase disease burden and patient volume in a healthcare system that’s already stretched beyond its capacity.

CDC has released guidance for providers to take advantage of any face-to-face interactions to do catch-up vaccines. However, there’s not enough data that supports coadministration of COVID vaccines with other vaccines, so ACIP has recommended against administration of COVID vaccines at the same time as other routine vaccines, which isn’t unique to COVID vaccines. We have the same guidance for a few other vaccines, but this could be an issue as states and CDC begin to roll out COVID vaccine distribution.

Nick: Thanks, Alexa. I appreciate the commentary there on routine immunizations, which of course are rather significant in and amongst all this focus on COVID-19 vaccines.

As we all know, the environment has been changing so quickly around COVID-19 vaccination. It’s been a rather busy few months here collectively for all stakeholders. At the recording of this podcast, the FDA just issued an EUA for Pfizer’s COVID-19 vaccine. This weekend, FDA will be weighing whether to issue a similar authorization for Moderna’s vaccine, so things are moving rather quickly.

With that in mind, I would be very interested to hear from both of you on what you are most closely watching as we look ahead to 2021, particularly in those first crucial months of the year. Mitchell, let’s start with you.

Mitchell: There’s a lot to be watching next year. The thing I’m most focused on is this next round of prioritization and sub prioritization. The vaccine supply is expected to grow exponentially in 2021, allowing for additional populations to be vaccinated. However, the supply is expected to remain relatively small in comparison to the entire country, so states are going to need to focus on vaccinating their phase 1b and phase 1c populations.

Currently, the ACIP workgroup has provided initial guidance that phase 1b should be essential workers and phase 1c should be adults 65 plus and those who have high-risk medical conditions. However, many states and stakeholders have wanted to focus on vaccinating older populations in phase 1b, so we may see a divergence between ACIP and some of the states on who they vaccinate next.

For phase 1c, we really must start focusing on which essential workers to vaccinate, whether it be teachers, farm workers, or whoever that next priority population might be.

I’m also watching the new vaccines that will be coming out. The 2 current vaccines are mRNA vaccines, but we expect additional technologies to come to market and get an EUA so we can possibly have a single-dose vaccine or one with better cold chain storage. There may also be different efficacies with these vaccines, which are all going to play an interesting role in our vaccination plans across the country.

And finally, I’m looking forward to the first biological license application (BLA) and commercially marketed COVID-19 vaccine. Currently, all the vaccines are going to be EUAs until manufacturers can collect more data and submit it to FDA. However, for the time being, it will all be EUA. We expect a BLA vaccine will eventually come to market and this is when manufacturers can really start marketing their vaccines and ensure it gets to different priority populations. It will go through a traditional reimbursement channel and will look more like a market for a flu vaccine or something similar.

Nick: Thanks, Mitchell. That’s an important comment on when we might see a commercially licensed COVID-19 vaccine. Alexa, I’m curious about your thoughts here as well. What are you watching going into the new year?

Alexa: We’ve seen a lot of progress and planning under the current administration through the Interim Playbook and OWS, but we could see some of the plans shift with the new administration. The Trump administration is beginning to roll out its public education campaign to get the vaccine out, and President-elect Biden has also begun messaging how his COVID transition team may operate distribution as well.

Additionally, to quell some of the various vaccine hesitancy concerns, CDC and various stakeholders have begun releasing info sheets and educational materials that can support providers in not only understanding the vaccine themselves, but also communicating with patients and having these important conversations with people who may be hesitant or may not know a lot about the vaccine.

Nick: Thanks, Alexa, and those hesitancy considerations are likely to be so important as we advance further into the vaccination phase in the new year.

Alexa, Mitchell, thank you both for sharing your thoughts on this very important topic here today. I really appreciate your time. And thank you to everyone who tuned into our discussion today on Avalere Health Essential Voice. We have a wonderful online repository of podcasts and are constantly releasing new ones, so do stay tuned. If you want to check us out online, visit avalere.com/COVID-19. Thanks, and take care.