The very first doses of any approved COVID-19 vaccine should go to both front-line healthcare workers and residents of long-term care facilities, a committee of expert advisors for the Centers for Disease Control and Prevention recommended in an emergency meeting Tuesday evening.
The committee’s recommendation now moves to CDC director Robert Redfield for approval before it becomes official federal guidance. And, ultimately, states will make their own final decisions on how to distribute the first coveted shipments of vaccine vials.
Still, the committee—the Advisory Committee on Immunization Practices (ACIP)—has for decades set such vaccine policy recommendations and states are likely eager to have its guidance settled as they try to finalize their plans. States have only until this coming Friday, December 4, to place their first vaccine orders with the federal government. The orders will determine which facilities in each state will get vaccine shipments and how much vaccine each facility will receive out of their state’s limited allotment.
The hurried planning comes amid anticipation that the Food and Drug Administration is just days away from granting an Emergency Use Authorization for the frontrunner COVID-19 vaccine developed by pharmaceutical giant Pfizer and German biotech firm BioNTech. The FDA is now reviewing the companies’ EUA request and will hold an advisory committee meeting to review the request Dec. 10. If the request is granted, shipments of vaccine doses could start going out to states as early as Dec. 11 or 12. Moderna has also requested an EUA for its COVID-19 vaccine, which will be reviewed in a meeting Dec. 17. The federal government expects to have enough vaccine doses available to vaccinate around 20 million people by the end of December, with five to 10 million doses distributed weekly.
In a press briefing last week, top officials for Operation Warp Speed—the federal government’s program to swiftly develop and deliver COVID-19 vaccines and therapies—said that the first 6.4 million doses of COVID-19 vaccine will be distributed to states on a per capita basis—to “keep this simple.” The decision was a reversal for Warp Speed, which previously suggested it would allocate vaccine based on each state’s high-risk groups—matching the ACIP recommendations. Officials for the program had also previously indicated they would wait for ACIP’s final guidance before deciding how to distribute vaccines.
ACIP had planned to finalize their guidance only after the FDA authorized a vaccine. But, with Warp Speed’s abrupt distribution decision last week, the committee called an emergency meeting Tuesday to finalize their recommendation and help guide states.
In a 13-to-1 vote after a nearly four-hour meeting, the committee finalized their recommendation for the earliest stage of vaccine distribution, called Phase 1a. The final wording for the recommendation is as follows:
When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) heath care personnel and 2) residents of long-term care facilities.
The committee defined healthcare personnel as paid or unpaid people serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care facility residents were defined as adults who live in facilities that provide a variety of services, including medical and personal care, for people who are unable to live independently. The definition is meant to primarily include skilled nursing homes, but also assisted living facilities, residential care communities, and other living facilities where medical care is provided.
The committee noted that there’s an estimated 21 million or so frontline health workers and about 3 million long-term care facility residents who would be covered in the Phase 1a distribution.The total number of people covered is just over the estimated 20 million vaccine doses expected to be available this month.
With limited early vaccine access, the committee went a step further to recommend sub-group prioritization. For healthcare personnel, priority consideration should be given to those with direct contact with patients, those working in long-term care facilities, and personnel who haven’t previously been infected with the pandemic coronavirus in the prior 90 days (reinfection appears uncommon within 90 days, the committee reasoned.)
For long-term care facility residents, priority consideration should go to those in skilled nursing facilities, which tend to care for the most medically vulnerable residents. After those facilities are provided with vaccines, state officials can broaden distribution to other types of facilities, including assisted living facilities and veterans’ homes.
The decision to have frontline health workers at the front of the line for vaccines was easy. Frontline workers are putting their own health and lives at risk to treat patients amid the devastating pandemic. Additionally, their health and ability to work is critical for saving the lives of others. As of November 30, there have been at least 243,000 healthcare workers infected with the novel coronavirus and 858 have died, the committee noted.
Putting long-term care facility residents alongside health workers on the priority list was a more difficult decision. The committee overall was swayed by the oversized impact the pandemic has had on residents of these facilities. Residents and staff account for 6 percent of all US cases and a staggering 40 percent of all US deaths. Of the people aged 85 and older who were admitted to a hospital with COVID-19, nearly 66 percent were from long-term care facilities.
Still, the data wasn’t enough to sway the entire committee. The one lone committee member who voted against the Phase 1a recommendation did so out of concern for including long-term care facility residents. Helen Talbot, an infectious disease expert at Vanderbilt University, worried that the COVID-19 vaccines developed so far haven’t been tested enough in people living in these facilities specifically.
Though her fellow committee members pointed to data showing that older adults tend to have milder vaccine side-effects than younger age groups, Talbot was not convinced. Additionally, she noted that weaker side-effects could also suggest weaker immunity, raising the question of whether vaccinating these residents would maximize public health benefits. (Early vaccine data has suggested high efficacy in older age groups). The lack of certainty that the vaccine will work and be safe in this group “concerns me on many levels,” Talbot said. Instead, she advocated for only vaccinating staff of long-term care facilities.
Still, the other 13 members of the committee were unmoved by her concern, noting the enormous impact the disease has had on residents of the facilities.
Tuesday’s recommendation maximizes benefits, minimizes harms, promotes justice, and mitigates health inequalities, the committee’s chair, José Romero, emphasized in closing statements after the vote.
After Phase 1a is complete, the committee has suggested moving on to vaccinate essential workers in Phase 1b, then people over age 65 and those with high-risk medical conditions in Phase 1c.