August 25, 2020

The 4 surprising roadblocks in the way of a Covid-19 vaccine

Daily Briefing

    I joined Rachel (Rae) Woods in a conversation with Ezekiel Emanuel —senior fellow at the left-leaning Center for American Progress (CAP), vice provost for global initiatives and chair of the department of medical ethics and health policy at the University of Pennsylvania, and former advisor to President Barack Obama—for our podcast, Radio Advisory.

    Q&A: Ezekiel Emanuel on the path to a coronavirus vaccine

    Together, we unpacked the complexities of vaccine production, distribution, and delivery. Zeke shared a range of challenges (and some opportunities) presented by the potential approval of a Covid-19 vaccine. These are the four key points that stood out to us—especially because they hit on issues I hadn't seen covered much elsewhere.

    1. Not all manufacturing capacity is equal—or equally available.

      Despite recent news of many multi-million-dollar production commitments between pharma and manufacturing companies, Zeke flagged an important question about how manufacturers plan to allocate their capacity.

      He noted that in some cases, manufacturers have committed their capacity to more than one vaccine developer, an approach that  raises questions not only about how those manufacturers are hedging their bets (i.e.: they're assuming not all vaccines will pan out), but also about how different each vaccine's manufacturing process is likely to be. As Zeke noted, "some [vaccines] are fermented, some are based on producing the RNA," so it’s not clear that any one plant could easily flex if vaccine candidate B gets approved before vaccine candidate C or vise-versa, as they  rely on very different technologies.  

      Zeke also talked a lot about a potential rate-limiting step that I didn't know much about before our interview: fill-finish. This step involves filling glass vials with precise doses of vaccine in extremely sterile conditions—100 times more sterile than a hospital operating room. In fact, excess fill-finish capacity is so limited, Zeke strongly recommended that governments commission additional factories right now. "The buffer would be very good for the world," he explained, not only to ensure we can produce enough of the vaccine in the first wave, but to continue producing the vaccine in the years to come. Who knew that this specialized, highly sterile type of factory could be as coveted as the vaccine itself?

      We also talked about the potential ripple effects of manufacturers' choices to reallocate some production capacity, fill-finish capacity, or critical supplies (such as glass vials) to the Covid-19 vaccine instead of other vaccines or therapies. Some reallocation is inevitable, but too much could trigger downstream shortages in other essential medicines.

    2. Provider organizations can (and should) start modeling anticipated vaccine demand in their communities—today.

      Assuming vaccines start to make their way into distributors' warehouses and vehicles within a few months after FDA approval, health system and medical group leaders will need to know how many injections they really need—and it's not enough to know how many people reside in your market or service community. Leaders will need reliable estimates of people at each priority level that Zeke suggests: How many health care workers? How many essential workers (and definitions may vary)? How many seniors and high-risk patients (considering not only health but also race)?

      To do this well, provider organizations need to start demand planning now. And they need to work with community organizations, local governments, and the other providers in the area to minimize duplicates or omissions in those projections. As Zeke explained, this approach will help stave off two worst-case scenarios: an environment where so much competition has been created around accessing the vaccine that people begin hoarding it, "even if it exists and even if it can be distributed," or a situation in which leaders run out of the vaccine because they "haven't accurately accounted for demand." 

    3. Provider organizations can play a huge rule in countering medical misinformation and fears of vaccination—especially in marginalized communities.

      During our conversation, we talked about a concerning statistic: 35% of Americans say that they would not get a coronavirus vaccine even if it becomes available. To combat this fear and hesitation and ensure patients who need a vaccine actually receive one, Zeke talked about the importance of public figures—politicians, athletes, celebrities—sharing their stories of getting the vaccine. But he also noted the critical role that doctors and nurses can play by going out into their communities, answering questions, and providing relevant information to encourage vaccination.

      Clinicians' role in fostering public trust will be particularly important in marginalized communities, where's there's often a legacy of mistrust of the medical establishment. Individuals in these communities may be more likely to trust a pro-vaccine narrative from a clinician who looks like them or lives where they live.

      When discussing access, Zeke also talked a lot about the importance of "bringing  [the vaccine] to people where they spend their time." The same can be said of credible, pro-vaccine information. Clinical leaders can start developing strategies today for ways to reach and reassure those who may be on the fence—ideally by bringing a diverse group of clinicians and materials to community centers, schools, Boys and Girls Clubs, churches, etc.

    4. Absent a transparent tracking system, leaders will need to build track and trace capabilities themselves.

    5. Zeke was adamant that local hospital and health system leaders should assume they'll need to create their own tracking systems to monitor not only who gets each shot, but also how those shots affect each individual patient. This is important for two reasons.

      The first, which is near and dear to my team's ongoing research about expanding uses of real-world evidence, is because we unequivocally need more data than we'll have at the time of an approval about potential safety risks or population-specific variations in efficacy. As Zeke explained, Phase III clinical trials typically involve about 30,000 people—but to fully understand the effects of a vaccine, we'll need data on up to three million people.

      Provider organizations, alone or in partnership with industry, are well positioned to gather and analyze this data, especially if they serve diverse populations not well-represented in the original Phase III clinical trials. In fact, because of their positioning in this process, health care organizations are the catalyst to finding and sharing this data—data that's essential to ensuring a safe and effective long-term solution. But to do this well, they'll need to start planning now for the kinds of information they want to gather and the analytics platforms they'll need.

      The second reason for sophisticated "track and trace" capabilities literally blew my mind. Several of the leading vaccine programs are testing two-dose solutions. If one or more of those prove to be safe and effective, our U.S. health system will have to collectively manage one of the most logistically complex care coordination endeavors ever. Each dispensing site—whether that's a hospital system, pharmacy, clinic, or other location—will need a simple way to note when and where Mrs. Johnson received her first shot, and which manufacturer's vaccine she received. They'll also need a simple way to communicate with Mrs. Johnson so they can ensure she receives her second dose (of the right vaccine) within the allowable time frame. And if she doesn't show up as scheduled, they'll need a way to track her down.

      Despite all the efforts organizations have put into improving care coordination, most systems still struggle to minimize leakage. Yet the path to herd immunity depends on providers' ability to reengage their patients and confirm that they have received their second dose.—even if that dose comes from another provider or health system.

    A time for unprecedented trust and collaboration

    One thread that ran throughout the interview was the importance of cross-stakeholder collaboration. No manufacturer, local/state government, or provider organization can do this alone. Whether we're talking about forecasting demand accurately, educating diverse communities, ensuring complete two-shot delivery, or tracking safety and effectiveness over time—all will require organizations used to competing or negotiating to step out of their silos in service to this larger cause. Just as we saw regional rivals put away their differences to reallocate ventilators and share data on ICU bed capacity during the spring surge, this next challenge will require similar kinds of creativity, data sharing, and collaboration.

    Despite all the challenges ahead, Zeke closed our conversation on an optimistic note. The process of manufacturing, distributing, and delivering a safe, effective vaccine as equitably and efficiently as possible "is a big, complicated endeavor. Can we do those big complicated endeavors? Absolutely. That’s what gives me faith that it could happen."

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