The first doses of a coronavirus vaccine should be given to an estimated 21 million health-care workers and 3 million residents and staffers of nursing homes and other long-term care facilities, a federal advisory panel recommended Tuesday afternoon.
These groups were deemed the highest priority by the Advisory Committee on Immunization Practices because the vaccine will initially be in extremely short supply after it is cleared by federal regulators. Health-care personnel are a top priority because of their exposure to the virus and their critical role in keeping the nation’s hospitals and clinics functioning.
Residents and employees of long-term care facilities were prioritized because they account for nearly 40% of deaths linked to COVID-19, the disease caused by the novel coronavirus.
The recommendations for the highest priority groups, known as phase 1a, will be sent to CDC Director Robert Redfield, who also informs Health and Human Services Secretary Alex Azar. If the recommendations are approved, they will become official CDC recommendations on immunization in the United States and provide official guidance to state officials, who are working to meet a Friday deadline for vaccine-distribution planning.
The committee voted 13 to 1 to prioritize the two groups. Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University, was the sole dissenting vote. Unease over the recommendations centered on the inclusion of long-term-care residents, with several panel members saying there was insufficient vaccine safety and efficacy data to support immunizing that population right away.
Talbot said safety monitoring of people who have gotten the shots in these settings is inadequate. “We hope it works, and we hope it’s safe,” she said of the vaccine. Other members said they were reassured by the support of the recommendation from geriatric medicine specialists.
Beth Bell, a global health expert at the University of Washington who chairs the panel’s coronavirus vaccine work group, said the vote was coming at “a particularly difficult time” in the pandemic.
“There is an average of one COVID death per minute right now,” she said. During the three-hour meeting, she said, 180 people “will have died from COVID-19, so we are acting none too soon.”
The advisory group will make recommendations at later meetings for priority groups in the next phases, which include essential workers and older adults. An ongoing debate about the ranking of priority groups probably will intensify as the Food and Drug Administration gets closer to clearing a vaccine this month.
What the independent committee will recommend may differ from what some Trump administration officials want, according to three federal health officials who spoke on the condition of anonymity to share internal deliberations.
Redfield; Deborah Birx, the coordinator of the White House coronavirus task force; and Adm. Brett Giroir, the top testing official at the Department of Health and Human Services, have recently emphasized the importance of prioritizing older Americans, whereas the committee members have held firm on giving preference to health-care workers.
Michael Pratt, an HHS spokesman, said Azar is committed to following the process and “has insisted that science and data drive the process for vaccines and therapeutic development, and will do so for vaccine allocation and distribution.” He added: “Doctors will make their recommendations, and ultimately the governors will make a determination of what works best for their communities based on input they receive and the circumstances on the ground.”
U.S. officials anticipate having about 40 million doses of vaccines from Pfizer and biotech firm Moderna by the end of the year, enough to immunize 20 million people, a fraction of the U.S. population of 330 million. Operation Warp Speed, the administration’s initiative to speed vaccine and therapeutics development, plans to send the first batch of 6.4 million doses of Pfizer’s vaccine to communities nationwide within 24 hours of FDA clearance, with the expectation that shots will be administered quickly.
But because of the limited doses, the panel’s work group suggested that health-care systems prioritize their personnel even further. They might do that by staggering vaccinations by individual units – such as emergency departments – and giving vaccine first to those with direct patient contact and those who handle infectious material, and to personnel who provide services to patients or their families.
CDC officials said they anticipate that most of the estimated 40 million doses will be distributed by the end of December. After that, 5 million to 10 million doses of vaccine are expected to be sent out each week. Nancy Messonnier, the top official overseeing distribution at CDC, said her talks with states and local officials suggest that most intend to vaccinate all their health-care workers within three weeks of getting vaccine.
The Advisory Committee on Immunization Practices, or ACIP, typically votes on who should get a vaccine after the FDA has approved it. In this case, the FDA is not expected to authorize the two leading coronavirus vaccines for emergency use until mid- to late December.
The advisory group met Tuesday because states want priority group guidance before Friday, when they must submit final details to the federal government on where they want vaccine to be delivered once one is authorized.
“We’re doing this because things are moving very quickly with what we think will be approval of one of the vaccines,” Jose Romero, the advisory group’s chairman and the Arkansas secretary of health, said in an interview during the weekend.
The 14 members of the panel have spent the past several months grappling with questions about balancing fairness and expediency. They have scrutinized data and modeled scenarios to address how best to balance saving the lives of the most vulnerable against stopping the spread of the virus, and doing so in a way that will lessen health inequities.
“If we had vaccine for every person in the United States, it would be an easy decision,” Romero said. “But we don’t, and that’s why we have to make a prioritization scheme for the initial set of vaccines.”
“We want to give vaccine to those who need it most in our society,” he said. “I can tell you, in my opinion, this is the most weighty vote we have given in my seven years on the committee.”
The deliberative work of the committee represents a reassertion of scientific expertise and welcome federal guidance, said David Kimberlin, the American Academy of Pediatrics’ liaison to the advisory group.
The recommendation to prioritize health-care workers and residents of long-term-care facilities in the first phase of immunization leaves states and local jurisdictions – even individual medical providers – with considerable leeway to define that category and create priorities within it.
Many state officials have said they plan to follow the federal recommendations. They may be adapted differently by states, but they have the benefit of emerging from a “well-developed process that states will not need to re-create wholesale,” Kimberlin said.
“It gives states confidence to say the CDC is in charge, that public health people are making decisions,” said Kimberlin, a pediatric infectious-disease specialist at the University of Alabama at Birmingham. “I think science reasserted itself this fall, shaking off the political cloud that had begun to gather over everyone’s heads.”
David Aronoff, director of the division of infectious diseases at Vanderbilt University Medical Center, said hospital officials need guidance to help identify who among the health-care workforce should have priority.
“Let’s say before Christmas we get 500 doses,” he said. “How do we deploy that in a way that is congruent with national guidelines and is equitable, and it’s not just the squeakiest wheels getting it first, or the ones who jump into the lines?”
The advisory group is prioritizing health-care personnel because they are the people who keep the “machinery” of hospitals and the rest of the health-care system running, Romero said. Residents and staff members of long-term care facilities, including nursing homes, have been hit hardest by the pandemic. Residents and employees at long-term care facilities accounted for 6% of coronavirus cases and 39% of deaths in the United States, according to the advisory group.
The advisory committee has expressed support for, but not yet voted on, the likely order for three groups who should get the shots next: essential workers (about 87 million people, not including health-care personnel) in phase 1b; people 65 and older (about 53 million) and adults with underlying medical conditions that put them at higher risk of getting very sick with COVID-19 (about 100 million) in phase 1c. The groups overlap. Many health-care and essential workers also have underlying conditions, and some are over 65.
That discussion probably will be the focus of the advisory group’s next meeting, after the expected authorization of the vaccine developed by pharmaceutical giant Pfizer and its German partner, BioNTech.
Under the current advisory group definition, essential workers include people who work in meatpacking plants and other food-processing facilities, police and firefighters, teachers, and the transportation industry.
Data from the advisory group suggest vaccinating essential workers maximizes the overall functioning of society and promotes access to vaccine for communities of color, which have been most affected by the pandemic.
At the advisory group’s meeting last week, Beth Bell, a global health expert at the University of Washington and committee member who chairs its coronavirus vaccine work group, said essential workers “are out there putting themselves at risk to allow the rest of us to socially distance.”
She added: “They come from disadvantaged situations, they come from disadvantaged communities.”
Scott Gottlieb, a former FDA commissioner who has been warning about surging case numbers, said if the goal is to reduce the rate of infection, “you would prioritize essential workers.” But “if your goal is to maximize the preservation of human life with a vaccine, then you would bias the vaccine toward older Americans,” he said Sunday on CBS’s “Face the Nation.”
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