The very first doses of any approved COVID-19 vaccine should go to frontline healthcare workers and residents of long-term care facilities, a Centers for Disease Control and Prevention expert committee recommended during ‘an emergency meeting on Tuesday evening.
The committee’s recommendation is now forwarded to CDC Director Robert Redfield for approval before becoming an official federal directive. And, ultimately, states will make their own final decisions on how to distribute the coveted first shipments of vaccine vials.
Yet the committee – the Advisory Committee on Immunization Practices (ACIP) – has made such recommendations for vaccine policy for decades, and states are probably eager to see their directions set as they attempt to finalize their recommendations. plans. States only have until Friday, December 4, to place their first vaccine orders with the federal government. Orders will determine which facilities in each state will receive vaccine shipments and how much vaccine each facility will receive outside of their state’s limited allocation.
The rushed planning comes as the Food and Drug Administration is reportedly just days away from granting emergency use authorization for the leading COVID-19 vaccine developed by pharmaceutical giant Pfizer and German biotech company BioNTech. The FDA is currently reviewing the companies’ EUA request and will hold an advisory committee meeting to review the request on December 10. If the request is accepted, vaccine dose shipments could begin to flow to states as early as December 11 or 12. Moderna has also requested an EUA for its COVID-19 vaccine, which will be reviewed at a meeting on December 17. The federal government expects to have enough doses of the vaccine to immunize about 20 million people by the end of December, with five to ten million doses being distributed weekly.
At a press briefing last week, senior officials in Operation Warp Speed - the federal government’s program to rapidly develop and deliver COVID-19 vaccines and therapies – said the 6, 4 million doses of COVID-19 vaccine will be distributed to states out of one per capita – to “keep it simple.” The move was a reversal for Warp Speed, which had previously suggested assigning the vaccine based on each state’s high-risk groups – matching ACIP’s recommendations. Program officials had also previously indicated that they would await final guidance from ACIP before deciding how to distribute the vaccines.
ACIP had planned to finalize its guidelines only after the FDA cleared a vaccine. But, with Warp Speed’s abrupt distribution decision last week, the committee called an emergency meeting on Tuesday to finalize its recommendation and help guide states.
In a 13-1 vote after a nearly four-hour meeting, the committee finalized its recommendation for the first stage of vaccine distribution, called Phase 1a. The final wording of the recommendation is as follows:
When a COVID-19 vaccine is cleared by the FDA and recommended by the ACIP, vaccination in the initial phase of the COVID-19 vaccination program (phase 1a) should be offered to both 1) healthcare personnel and 2 ) residents of long-term care facilities.
The committee defined health workers as paid or unpaid people working in health facilities and likely to be exposed directly or indirectly to patients or infectious materials. Residents of long-term care facilities have been defined as adults who live in facilities that provide a variety of services, including medical and personal care, to people who cannot live independently. The definition is meant to primarily include qualified nursing homes, but also assisted living residences, residential care communities, and other living facilities where medical care is provided.
The committee noted that approximately 21 million primary healthcare workers and approximately 3 million residents of long-term care facilities would be covered in the phase 1a distribution. The total number of people covered is slightly more than 20 million doses of vaccine expected. will be available this month.
With limited early access to vaccines, the committee went further by recommending prioritization of subgroups. For healthcare workers, priority attention should be given to those who have direct contact with patients, those working in long-term care facilities, and staff who have never been infected with the pandemic coronavirus in the past. over the previous 90 days (Reinfection seems rare within 90 days, the committee reasoned.)
For residents of long-term care facilities, priority should be given to those in skilled nursing facilities, which tend to care for the most medically vulnerable residents. Once these facilities have received vaccines, state officials can expand distribution to other types of facilities, including assisted living facilities and veterans’ homes.
The decision to have frontline health workers on the front line for vaccines was an easy one. Frontline workers are putting their own health and lives at risk to treat patients amid the devastating pandemic. In addition, their health and ability to work are essential in saving the lives of others. As of November 30, at least 243,000 health workers were infected with the novel coronavirus and 858 have died, the committee noted.
Putting residents of long-term care facilities alongside health workers on the priority list has been a more difficult decision. Overall, the committee was influenced by the oversized impact of the pandemic on residents of these facilities. Residents and staff account for 6% of all cases in the United States and 40% of all deaths in the United States. Among people aged 85 and over who were admitted to a hospital with COVID-19, nearly 66% were from long-term care facilities.
Yet the data was not sufficient to influence the entire committee. The only committee member who voted against the Phase 1a recommendation did so for the sake of including residents of long-term care facilities. Helen Talbot, an infectious disease expert at Vanderbilt University, was concerned that the COVID-19 vaccines developed so far have not been sufficiently tested in people living in these particular facilities.
Although 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 might also suggest weaker immunity, raising the question of whether vaccinating these residents would maximize public health benefits. (Early vaccine data suggested high efficacy in older groups) The lack of certainty that the vaccine will work and be safe in this group “concerns me on many levels,” said Talbot. Instead, she advocated vaccinating only staff in long-term care facilities.
Still, the other 13 members of the committee were not moved by his concern, noting the enormous impact the disease has had on residents of the facilities.
Tuesday’s recommendation maximizes benefits, minimizes harm, promotes justice and mitigates health inequalities, committee chairman José Romero said in closing statements after the vote.
Once phase 1a is complete, the committee suggested moving to vaccinating essential workers in phase 1b, then people over 65 and those with high-risk medical conditions in phase 1c.