Frontline healthcare workers and elderly residents of long-term care facilities will receive the very first COVID-19 vaccinations, a Centers for Disease Control and Prevention (CDC) advisory board recommended Tuesday.
These groups will make up Phase 1A of U.S. vaccine recipients who will receive the first 40 million or so doses that could be available by the end of the year. The Food and Drug Administration (FDA) is currently reviewing two vaccines, from Pfizer-BioNTech and Moderna, for emergency use authorization.
According to the CDC, there are about 21 million healthcare workers, including people who work in hospitals, long term care facilities, home healthcare, pharmacies, emergency medical services as well as in public health, and about 3 million older Americans living in skilled nursing or long term care facilities.
The 13 to 1 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP) was the first official step toward prioritizing who will get the scarce first doses of any COVID-19 vaccine. Over the nearly four hour meeting, the committee discussed in detail who within these two priority groups would get access first when doses are limited early on. For example, the committee wanted to ensure that people who work directly in providing patient care will be first in line.
The reasons for focusing on healthcare workers and long term care residents include both the potential for magnifying the impact of vaccination: If healthcare workers are protected, they will be able to continue working and caring for more people with COVID-19 as cases continue to spread across the country. The board also focused on the groups most impacted by the disease. While only 1% of the US population lives in long term care, the residents and the staff who work there account for 6% of COVID-19 cases and 40% of the deaths.
“I believe my vote [in favor of the recommendation] reflects maximizing benefit, minimizing harm, promoting justice and mitigating health inequities,” Dr. Jose Romero, the committee chair, said in explaining his support of the priority groups.
The recommendation now go to the director of the CDC, Dr. Robert Redfield, who does not have to accept it but likely will. If he accepts the recommendation, state health departments can start making decisions about how to allocate the anticipated 6.4 million doses that will be the first batch released within days of the FDA authorizing a vaccine. They will probably go to hospitals where healthcare workers are most concentrated, as well as to pharmacies that have contracted with long term care facilities to administer shots to residents and staff.
The committee also discussed at length the systems in place for collecting and monitoring reports of side-effects and adverse events from the vaccine. Participants in large-scale trials for both the Pfizer-BioNTech and Moderna vaccines have reported no major adverse effects, however the CDC closely monitors the safety of all vaccination programs. The CDC is planning several levels of check ins, beginning with a smartphone-based texting system that vaccinated people can register for in order to report side effects. The agency will also utilize existing national systems that doctors and healthcare providers routinely use to track vaccine side effects, as well as institutional systems for reporting adverse events by hospitals and other facilities.
Dr. Helen Talbot, associate professor of medicine at Vanderbilt University, was the only member to vote against the recommendation, based solely on her misgivings about the lack of safety data on vaccinating residents of long term care facilities. “I’ve spent my career studying vaccines in older adults, and traditionally we’ve tried vaccines in young, healthy populations and hoped it worked in frail, older adults,” she said during the meeting. “We have now entered the realm of ‘We hope it works, we hope it’s safe,’ and that concerns me on many levels.”
She noted that while studies so far show that the elderly who are vaccinated don’t experience significantly higher adverse events, that could also mean that the vaccine isn’t as effective, either. (So far, both Pfizer-BioNTech and Moderna report that their shots are around 95% effective in protecting against disease in all age groups.)
Second, Talbot said she worried that long term care facilities aren’t equipped to properly monitor potential adverse effects from vaccinations. “I’m still struggling with that since we don’t have a good safety surveillance network in place yet,” she said. It will likely fall to the healthcare professionals at these facilities to take on reporting of any unusual symptoms after residents are vaccinated, but that could place an additional burden on already taxed teams—not to mention that the symptoms of fever, fatigue and coughing are often common among frailer people in this age group so it will be harder to determine which symptoms need to be reported.
CDC board members also discussed practical issues such as whether healthcare workers in a particular facility should be vaccinated in a staggered fashion to avoid personnel shortages in case people develop side effects severe enough to keep them from working.
Ultimately, based on the growing number of cases and the urgent need to corral the spreading virus, the committee members felt that, at least to begin with, vaccinating healthcare workers and those living in long term care facilities made the most sense. The recommendation, said Dr. Peter Szilagyi, professor pediatrics at University of California, Los Angeles, “helps to maintain our healthcare system and protect a very fragile population.”
The committee’s recommendation is focused only on who should receive the first doses of vaccine once a shot is authorized by the FDA, and doesn’t represent a recommendation that people should get vaccinated against COVID-19 — yet. That will come after an advisory committee for the FDA meets in mid-December and makes a decision about whether COVID-19 vaccines are safe and effective enough to distribute. Then, the ACIP committee will meet again to make recommendations about specific vaccines.
While most of the American public won’t be eligible to receive the first doses of vaccine that might be available this year, Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the CDC, said the end is in sight. “For all the people who are anxiously awaiting [a COVID-19] vaccine,” she said, “we hope this vote gets us one step closer to the day when we can all feel safe again, when this pandemic is over.”
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Contributor: Alice Park