The ACIP recommendations are the culmination of months of work by national experts who carefully studied and considered the impacts of the pandemic.

The afternoon of December 1, 2020, marked an important milestone in the fight against the coronavirus pandemic. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) voted 13-1 to approve recommendations to prioritize distribution of the initial doses of COVID-19 vaccines. ACIP took an unusual step, issuing the recommendations before the FDA issues emergency use approval (EUA) of any COVID-19 vaccines so that the recommendations could assist states in developing their own vaccine distribution plans.

The ACIP recommendations are the culmination of months of work by national experts who carefully studied and considered the impacts of the pandemic as well as the pros and cons of various options for prioritizing how initial doses of vaccines should be distributed. With emergency use authorizations expected from the FDA for the first two COVID-19 vaccines—novel mRNA vaccines developed by Pfizer-BioNTech SE and Moderna—within a matter of days, the push to finalize vaccine distribution plans has taken on even greater urgency. Only 40 million doses of the vaccines will likely be available for distribution by the end of the year, which, with two doses needed per person, is enough to vaccinate only 20 million of the more than 330 million people living in the United States. States must submit their plans for distribution of the Pfizer-BioNTech vaccine by December 4, 2020, and for distribution of the Moderna vaccine by December 11, 2020.

In its newly issued recommendations, ACIP concluded that healthcare workers and residents of long-term care communities should be prioritized to receive COVID-19 vaccines as part of the initial “phase 1a” rollout of the vaccines. Individuals working in the healthcare industry are among the most heavily exposed to the SARS-CoV-2 virus and are crucial for providing treatment to those affected by the virus. Residents of long-term care communities, in turn, are highly susceptible to both exposure to and severe outcomes from COVID-19 infections. They have accounted for nearly 6 percent of diagnosed COVID-19 cases since the start of the pandemic and nearly 40 percent of the more than 274,000 U.S. deaths attributed to the virus to date. ACIP is hopeful that reducing the rate of infection among the long-term care population will not only save lives, but will also alleviate some of the current major stresses on the hospitals that care for gravely ill COVID-19 patients.

ACIP’s recommendations were designed to promote four primary goals:

• Decrease death and serious disease as much as possible
• Preserve functioning of society
• Reduce the extra burden the disease is having on people already facing disparities
• Increase the chance for everyone to enjoy health and well-being

ACIP’s recommendations were further guided by four ethical principles including:

1. Maximizing benefits and minimizing harms;
2. Mitigating health inequities;
3. Promoting justice; and
4. Promoting transparency.

The newly issued recommendations must now be approved by the director of the CDC; states will still be able to make their own prioritization decisions. While the recommendations provide a framework to help states determine how to distribute initial batches of COVID-19 vaccines, they do not provide all of the details necessary for disseminating vaccines. In particular, even if states adopt the ACIP recommendations, they will still need to determine which healthcare workers and long-term care communities will get top priority, since the initial availability of vaccines will be insufficient to allow for everyone in these two groups to be vaccinated immediately. Furthermore, ACIP’s recommendations currently address only the first phase of the nationwide vaccination efforts, and states will need to submit their distribution plans before ACIP can develop further recommendations for later phases of vaccine distribution. States and providers should nonetheless be on the lookout for additional guidance as ACIP continues to develop its recommendations.

In the meantime, with the initial distributions of COVID-19 vaccines on the very near horizon, healthcare providers—and most immediately, hospitals and long-term care providers—need to consider several important issues, if they have not already done so. They should be sure to ask themselves the following questions, among others:

1. For hospitals, who within the workforce should receive the first vaccines available, assuming there are not enough vaccines available for all workers to be vaccinated quickly?
2. For long-term care providers, how will the community obtain vaccines for its residents? (Requests to participate in the federal government’s Pharmacy Partnership for Long-term Care Program were due November 6, but long-term care providers have the option of obtaining vaccines outside the program.)
3. For all providers, should the vaccination of workforce members be staggered to ensure full staffing in the event of potential short-term side effects of the vaccines? If so, how?
4. Will the provider require all members of its workforce to receive COVID-19 vaccinations and how will it handle workers who refuse to be vaccinated and seek a medical or religious exemption?
5. For healthcare providers vaccinating their workforce and/or residents on site, how should they organize and structure their vaccination clinics and where should those clinics be held?
6. Which workforce members can assist with vaccination efforts in accordance with their scopes of practice, provider policies and modifications made to any limitations developed to ease responses to the COVID-19 pandemic?
7. What can providers do to ensure they are eligible for liability waivers under the federal Public Readiness and Preparedness (PREP) Act and any similar state legislation in connection with their provision of COVID-19 vaccines?

These are just a few of the many considerations for healthcare providers in the days and weeks to come. Providers should also continue to monitor developments on COVID-19 vaccine-related recommendations, approvals, and federal and state distribution plans.

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Duane Morris has created a COVID-19 Strategy Team to help organizations plan, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.

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If you have any questions about this Alert, please contact Erin M. Duffy, Sharon L. Caffrey, Linda B. Hollinshead, Alison T. Rosenblum, any of the attorneys in our Health Law Practice Group, any member of the COVID-19 Strategy Team or the attorney in the firm with whom you are regularly in contact.

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