December 2, 2020

Who's first in line for a coronavirus vaccine? Here's what a key CDC panel says.

Daily Briefing

    On Tuesday, the Advisory Committee on Immunization Practices (ACIP), which is a panel of outside experts that advises CDC on vaccines, made its first recommendations on which Americans should get the first available doses of an authorized coronavirus vaccine. However, there are still many steps in the distribution process that could determine how the vaccines, when available, are allocated.  

    Our take: How Covid-19 will impact the supply chain

    Who should be first to get a coronavirus vaccine, according to ACIP

    ACIP members on Tuesday voted 13-1 to approve a recommendation calling for health care workers and residents and staff of long-term care facilities to be the first Americans to access a vaccine against the novel coronavirus once a vaccine candidate is authorized for use in the United States by FDA.

    Those two groups of Americans, which together represent nearly 24 million people, are at high risk for contracting the novel coronavirus, Politico reports. According to Politico, CDC data presented during Tuesday's meeting showed that at least 243,000 health care workers have contracted the virus and 858 have died from Covid-19, the disease caused by the new coronavirus. In addition, CMS data shows that, as of the week ending Nov. 15, up to 500,000 residents and staff in skilled-nursing facilities had been infected with the virus and nearly 70,000 had died from Covid-19.

    Helen "Keipp" Talbot, an associate professor of medicine at Vanderbilt University and a member of ACIP, was the only panelist who voted against the recommendation. Talbot said she opposed the recommendation because she believes there isn't yet sufficient data to support the use of a coronavirus vaccine in long-term care residents.

    "I have spent my career studying vaccines in older adults. We have traditionally tried a vaccine in a young, healthy population and then hoped it worked in our frail, older adults. And so we enter this realm of 'We hope it works and we hope it's safe.' And that concerns me on many levels," said Talbot. She added, however, that she has "no reservations for health care workers taking this vaccine."

    ACIP Chair José Romero said he initially shared Talbot's concerns, especially because federal health officials have said they expect to have up to 40 million vaccine doses available by the end of this year—which will be enough to vaccinate only 20 million Americans, because the leading vaccine candidates require individuals to receive two doses. However, Romero said he changed his mind once he noticed the coronavirus's significant impact on residents of long-term care facilities.

    Many groups representing health care providers and long-term care facilities applauded the ACIP's recommendations.

    Susan Bailey, president of the American Medical Association, in a statement said, "By first vaccinating our frontline health care personnel and residents of long-term care facilities against Covid-19, we will help ensure patients continue to receive vital care during the pandemic and safeguard those who are most at risk for severe illness."

    Mark Parkinson, president of and CEO of the American Health Care Association and National Center for Assisted Living, in a statement said a coronavirus vaccine "will literally be a lifesaver for thousands of [long-term care] residents and expedite the reopening of our facilities to family members and loved ones."

    What happens next—and why ACIP's recommendation isn't set in stone

    Presenters at Tuesday's meeting said ACIP will refine and finalize its recommendations for vaccine distribution once FDA authorizes a coronavirus vaccine and more robust data from late-stage clinical trials on vaccine candidates becomes available. Those recommendations likely will include further guidance on how to prioritize vaccine access for other groups, as well, including pregnant women, essential workers, and others.

    Then, CDC Director Robert Redfield will review the recommendations and ultimately decide whether to approve them. If Redfield approves the recommendation, CDC will use the recommendation to issue guidance on who should get priority access to the vaccine. That guidance will be intended to help states determine their vaccination distribution plans, though states are not required to follow the guidance.

    However, according to STAT News, the initial recommendation that ACIP approved on Tuesday could influence states' decisions on who they should prioritize for vaccination in their early distribution plans. That's because states must submit their first orders for coronavirus vaccines to the federal government by this Friday, STAT News reports.

    According to STAT News, FDA is expected to issue an emergency use authorization (EUA) for Pfizer's coronavirus vaccine candidate within days after an FDA advisory committee meets to review the experimental vaccine and its EUA application, which is currently scheduled for Dec. 10. That same panel is also scheduled to meet on Dec. 17 to review and consider issuing an EUA for Moderna's coronavirus vaccine candidate.

    In addition, the Trump administration has invited government officials and executives from vaccine manufacturers and drug distributors to participate in a "Covid-19 Vaccine Summit" early next week. According to officials familiar with the event's plans, the summit is intended to serve as an opportunity for the White House to pressure FDA to quickly authorize a coronavirus vaccine candidate, STAT News reports.

    White House spokesperson Brian Morgenstern said President Trump "looks forward to convening leaders from the federal government, state governments, private sector, military, and scientific community for a comprehensive discussion with the American people as the administration prepares to deliver this historic, life-saving vaccine to every zip code in the United States within 24 hours of an FDA approval" (Branswell, STAT News, 12/1; Lim, Politico, 12/1; Sun/Stanley-Becker, Washington Post, 12/1; Facher, STAT News, 12/1; Owens, "Vitals," Axios, 12/2; Higgins-Dunn, CNBC, 11/16).

     

    Advisory Board's take 

    4 steps to take now to prepare for a coronavirus vaccine 

    By Erin Lane and Pamela Divack

    In addition to the ongoing challenges of shipment and storage, cold-chain conditions, and IT infrastructure to track dosing schedules, yesterday's CDC Vaccine Advisory Committee recommendations, while not (yet) formal CDC guidance, creates four additional considerations for health care leaders who are actively preparing their organizations for the vaccine rollout (in accordance with state guidelines).

    #1: Plan for nuances of administration and prioritization

    Health care leaders must determine how to prioritize and allocate the vaccine amongst health care workers and residents of long-term care facilities. In absence of explicit guidance from the CDC, hospital and health system leaders must make decisions for their individual organization and facilities based on capacity, risk levels, and resource allocation. For example, some systems will want to prioritize vaccinating patient-facing health care workers first, allocate vaccines to sites of care based on their risk level (e.g., ICU clinicians), or stagger distribution across different units, to prepare for the potential absence of workers due to a vaccine's associated side effects (e.g. fatigue, muscle pain, joint pain, or headache). Similarly, long-term care facilities may want to prioritize vaccinating the most high-risk patients or staff of skilled nursing facilities, followed by those of assisted living homes. Both types of organizations must consider how to staff vaccination programs appropriately, without significantly impacting existing workflows.

    Health care leaders must continue to meet regularly with their leadership teams to discuss ongoing vaccination plans and manage risk as the pandemic continues, and continue to monitor vaccine shipping, storage, and dosing appropriately.

    #2: Start education efforts now—beginning with your clinical workforce

    CDC, as well as vaccine manufacturers, have already signaled that they will put out data, toolkits, fact sheets, and support materials to educate the general public about the vaccine. However, research shows that only 60% of doctors and 40% of nurses intend to take a Covid-19 vaccine. Similarly, many older adults may not fully understand the vaccine, how it works, and its potential impacts. Both may lead to delayed uptake.

    Health care leaders must continue to educate and encourage health care workers and long-term care residents to take the vaccine, be prepared to communicate data about the vaccine and its efficacy/side effects, and explain the importance of vaccination to build herd immunity. They must also anticipate and proactively combat misinformation that will inevitably emerge about the vaccine. This will not only accelerate pandemic recovery, but also have a significant, tangible impact on patient uptake in the future—especially since most patients trust their doctor as their #1 source of medical information.

    #3: Prepare for the ripple effects that vaccine distribution may have on your system and the larger community.

    While hard to anticipate every challenge (and opportunity) that vaccine distribution will create, there are a few key ripple effects worth keeping top-of-mind:

    1. How to allocate PPE and supplies across sites of care, according to who hasand hasn'treceived the vaccine. As the pandemic continues to surge, hospitals and supply chains may once again be constrained for access to testing, masks, and PPE. Health care leaders can mitigate risk by allocating extra resources to workers who have not yet received their vaccine.

    2. How to support smaller organizations and rural health facilities who have limited access to vaccines and supplies. Larger health systems with storage and distribution capacity may have the opportunity to partner with local and regional providers to help vaccinate their staff. This could improve access and health equity, and accelerate immunity-building within local populations.

    3. How to communicate about the vaccine to healthy patients, who will likely receive the vaccine later next year. Following the news of any approval, it's likely that many patients will have questions about when they will be able to receive the vaccine. Some may try to seek early access to the vaccine or shortcut the prioritization schedule entirely. Health care leaders must prepare to share predicted timelines and vaccination schedules with patient population at large and answer questions about long-term outlook—even in absence of explicit CDC guidelines about prioritization after Phase 1a. They should encourage patients to continue to follow social distancing, mask-wearing, and other Covid-19 prevention measures in the meantime.

    4. How to anticipate workforce behavior after they are vaccinated. Despite the predicted high efficacy of the vaccine, it will be essential that health care workers maintain proper risk mitigation measures until herd immunity is achieved—both to protect themselves and their community, and to set a good example to the general public until the vaccine is widely available.

    #4: Participate in CMS/FDA data-sharing programs to aggregate data that will build future confidence in the safety and efficacy of vaccines.

    Although Moderna and Pfizer have already committed to following patients through the clinical trial for two years, health system leaders must be sure to share data about vaccination schedules and side effects once they vaccinate their populations. To do so, CDC encourages provider organizations to participate in vSAFE, a vaccine monitoring system run by the CDC, to share data. This real-world data will be essential in building public confidence and trust in the long-term safety, efficacy, and durability of vaccines, and will provide insight and evidence beyond what was collected during the clinical trial.

    It's possible that our understanding of who is most at risk and vulnerable to Covid-19 disease, and who should get vaccinated first, will change as we continue to gather data about safety, efficacy and effectiveness in different populations. In the meantime, health care leaders must prepare today for the vaccine, keep track of local state regulations, and continue to educate the public about the vaccine.

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