TALLAHASSEE — The process of rationing the first doses of the coronavirus vaccines is underway as a federal advisory group recommended Tuesday that when Florida and other states receive their first shipment it “should be offered to both healthcare personnel and residents of long-term care facilities.”
The guidelines were approved by the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices as the federal government prepares to distribute the first of an estimated 20 million doses of the Pfizer and Moderna vaccines. The vaccines will be allocated based on state population and it is up to state officials to decide how to prioritize who gets vaccinated in the first round.
Gov. Ron DeSantis said Monday he expects the state to receive between 1 million and 2 million doses sometime in the middle of December. There are 497,000 licensed healthcare professionals in Florida and at least 368,000 residents of nursing homes and other long-term care facilities.
But as more information emerges, the federal vaccine advisory group made it clear that it will take weeks to get all healthcare providers vaccinated and questions remain about how efficiently they can move to vaccinate the elderly.
With two doses needed per person, the first doses the state receives “will not be enough” to cover all of those people, said Mary Mayhew, chief executive officer of the Florida Hospital Association and former secretary of the state Agency for Health Care Administration.
“We are not going to have enough to vaccinate the vulnerable population, so the hospitals are prioritizing within their workforce,’' she said. “Those who are more at risk in terms of their location within the hospital, the emergency departments, intensive care units and their age — if they’re over the age of 55 — will be given priority in this initial round, given the limited allocation.”
Moderna and Pfizer have submitted data from their vaccine clinical trials to the Food and Drug Administration for review. The FDA will meet on Dec. 10 to consider approval of the Pfizer vaccine for emergency use. Later in the month, it is expected to review Moderna’s submission.
States are in charge of distributing the vaccines and have asked for guidance from he CDC advisory committee, made up of scientists and public health experts who review and make recommendations for all vaccines, on how to prioritize the limited doses. They have until Friday to report their vaccine distribution plan to the federal government.
After a four-hour meeting, the CDC committee voted 13-1 in favor of the guidelines.
“We are using the principles of maximum benefit and minimizing harm and promoting justice and mitigating the health inequalities with the distribution of this vaccine,’' said Dr. Jose Romero, chair of the Advisory Committee on Immunization Practices who is medical director for the Arkansas Department of Health.
Florida’s vaccine chief said that FDA authorization will provide crucial details that will help inform the plan from the state Division of Emergency Management, tasked with distributing the vaccine.
Jared Moskowitz, the division’s director, said the emergency authorization would come with guidance on vaccine priorities and delivery schedules from vaccine manufacturers and federal officials.
A pilot program to start
Officials at Memorial Healthcare System, South Broward County’s public hospitals, said they anticipate vaccine doses arriving as part of a state pilot program as early as Dec. 11.
Last week, the CDC advisory group recommended that seniors in long-term care facilities should be given the same priority as healthare providers because they make up 6% of the COVID cases in the U.S. but 40% of the deaths from the disease in the United States.
But questions have emerged.
While there is wide agreement that the first recipients of the vaccine should be healthcare workers who are at the highest risk of exposure to the disease, the debate was over whether to extend the vaccine to residents in long-term care facilities.
Debating vaccine efficacy
Members of the working group noted that there is little data to determine if the vaccines work as well among older people as younger people, and questioned how effective the system is to track patients who are in facilities temporarily.
Helen Talbot, associate professor of medicine at Vanderbilt University and a member of the advisory group, said she has spent her career studying vaccinations in the elderly population and, because she does not think there is enough data to prove it safe, she was the lone vote against the guidelines.
“We hope it works and we hope it’s safe, and that concerns me on many levels,’' she said.
Although the CDC has developed an elaborate reporting system for any adverse impact of the vaccine, she said she was not confident that the “safety network was strong enough for long-term care facilities.”
Peter Szilagyi, a professor of pediatrics at the University of California, Los Angeles, endorsed giving a priority to the elderly.
“To me, this has been a Solomon’s choice, and we all feel that all U.S. residents should eventually have faith, have access to safe and effective vaccines, but will all have access, very soon, ’' he said. “...A nation’s greatness is measured by how it treats its weakest members, and I feel prioritizing healthcare providers and prioritizing residents of long-term care facilities represents the right decision at this time.”
Katherine Poehling, director of Pediatric Population Health at the Wake Forest School of Medicine, said the group had little choice but to give priority to the elderly.
“While it would be nice to have additional data on the population, that is not feasible,’' she said. “During this pandemic and with the disproportionate share of deaths belonging to residents in long-term care facilities, I believe it is important that they be included as well.”
Under the recommendation, healthcare personnel “are defined as paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.”
The definition of long-term care facility residents “are defined as adults who reside in facilities that provide a variety of services including medical and personal care, to persons who are unable to live independently.”
CVS and Walgreens
The federal government has arranged for long-term care facilities to register to partner with CVS and Walgreens to run on-site clinics to administer the vaccines. Neither the Florida Department of Health nor the Agency for Health Care Administration responded to questions about the number of long-term care facilities in Florida that have registered to take part in the program.
Mayhew said Tuesday there are about 50 hospitals that are equipped with the cold storage facilities that will be able to handle the super cold conditions needed to to distribute the Pfizer vaccine, but the federal government asked the state to identify five hospitals “to be beta tests sites to just evaluate the logistics distribution and then quickly begin to distribute it to the next round.”
Mayhew said that she was optimistic that by the end of December both vaccines will be widely distributed.
“Ideally we’re talking about over the course of several weeks we’re able to increase the number of healthcare staff who are vaccinated,’' she said. At the same time, she said, “significant priority remains for elderly living in congregate settings and individuals with underlying medical conditions.”
But not everyone was happy with the proposal to single out large hospitals and healthcare systems.
Representing the American College of Physicians at the meeting was Dr. Jason Goldman, a professor of biomedical science at Florida Atlantic University who practices medicine in Coral Springs.
He urged the group to give additional priority for vaccines to personnel at doctors’ offices where staff is “not employed by hospitals and not associated with large healthcare systems to make sure we are truly getting the vaccine to the people on the front lines who need it the most — the small, private, independent and primary care physicians.”
Moskowitz, the state’s emergency director, said that front line doctors and nurses, nursing home residents and people with underlying conditions are the “three legs of the stool as far as the first tranche.”
“There’s no doubt that we need to take care of our most vulnerable, people who are most susceptible from the most serious impacts of this first, which is why we’re talking about our nursing home residents,” he said.
But it’s still unclear when a high-risk individual outside of a nursing home setting could have access to a vaccine, he added.
“We’ve got to be focused on the now versus in the future because we’ve got to make sure that the division is poised and ready to help distribute first deliveries of this vaccine,” Moskowitz said.
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