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The very first doses of any approved COVID-19 vaccine should go to both front-line health care workers and residents of long-term care facilities, a panel of expert advisors for the Centers for Disease Control and Prevention recommended at a meeting emergency on Tuesday evening.
The committee’s recommendation now goes to CDC Director Robert Redfield for approval before he becomes an official federal guide. And, eventually, the states will make their own final decisions on how to distribute the first coveted shipments of vaccine vials.
However, the committee – the Advisory Committee on Immunization Practices (ACIP) – has been setting out such vaccine policy recommendations for decades, and states are likely looking forward to its leadership as they try to finalize their plans. The states have only until next Friday, December 4, to place their first vaccine orders to the federal government. The orders will determine which facilities in each state will receive vaccine shipments and the amount of vaccine each facility will receive outside their state’s limited allocation.
Dizzying distribution
Hasty planning comes as we wait for the Food and Drug Administration to be within days of granting emergency use authorization for the cutting-edge COVID-19 vaccine developed by pharmaceutical giant Pfizer and German biotechnology company BioNTech. The FDA is now reviewing the companies’ EUA request and will hold an advisory committee meeting to review the request on December 10. If the request is granted, shipments of vaccine doses could start shipping to states as early as December 11 or 12. Moderna has also requested a UEA for its COVID-19 vaccine, which will be reviewed at a meeting on December 17. The federal government expects to have enough vaccine doses available to vaccinate approximately 20 million people by the end of December, with five out of 10 million doses being distributed weekly.
In a press briefing last week, top officials from Operation Warp Speed, the federal government’s program to rapidly develop and deliver COVID-19 vaccines and therapies, said the first 6.4 million doses of COVID vaccine -19 will be distributed to basic states understood – to “keep it simple”. The decision was a reversal for Warp Speed, which previously suggested allocating the vaccine according to each state’s high-risk groups, in line with ACIP’s recommendations. Program officials had also previously indicated that they would wait for ACIP’s final guidance before deciding how to distribute the vaccines.
ACIP had planned to finalize their guide only after the FDA had cleared a vaccine. But, with Warp Speed’s sudden distribution decision last week, the committee called an emergency meeting on Tuesday to finalize their recommendation and help states lead.
Recommendations
In a vote of 13 to 1 after a nearly four-hour meeting, the committee finalized its recommendation for the first phase of vaccine distribution, called Phase 1a. The final wording of the recommendation is as follows:
When a COVID-19 vaccine is authorized by the FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination schedule (Phase 1a) must be offered to both 1) healthcare personnel and 2) residents of long-term care facilities. .
The committee defined healthcare personnel as paid or unpaid individuals serving in healthcare facilities that have the potential for direct or indirect exposure to patients or infectious materials. Residents of long-term care facilities were defined as adults living in facilities that provide a variety of services, including medical and personal care, to people who are unable to live independently. The definition is intended to include mainly specialized nursing homes, but also assisted living facilities, residential care communities and other housing facilities where medical care is provided.
The committee noted that there are approximately 21 million frontline health workers and approximately 3 million long-term care facility residents who would be covered by the Phase 1a deployment. The total number of people covered is just over the 20 million vaccine doses expected. to be available this month.
With limited early access to the vaccine, the committee went a step further to recommend subgroup priority. For healthcare professionals, priority consideration should be given to those who have direct contact with patients, those who work in long-term care facilities, and staff who have not previously been infected with the pandemic coronavirus in the previous 90 days. reinfection appears rare within 90 days, the committee reasoned.)
For residents in long-term care facilities, priority consideration should go to those in qualified nursing facilities, who tend to care for the most medically vulnerable residents. Once these facilities are provided with vaccines, state officials can expand distribution to other types of facilities, including assisted living facilities and veterans’ homes.
Reasoning
The decision to have health professionals on the forefront of vaccines was an easy one. Frontline workers are putting their health and their lives at risk to treat patients amid the devastating pandemic. Additionally, their health and ability to work are critical to 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 residents of long-term care facilities alongside health care workers on the priority list was a more difficult decision. The committee as a whole was influenced by the excessive impact the pandemic had on the residents of these facilities. Residents and staff account for 6% of all cases in the United States and a staggering 40% of all deaths in the United States. Of people aged 85 and over who were admitted to a hospital with COVID-19, nearly 66 percent were from long-term care facilities.
However, the data were not sufficient to influence the whole committee. The one committee member who voted against the Phase 1a recommendation did so out of concern to include residents of long-term care facilities. Helen Talbot, an infectious disease expert at Vanderbilt University, feared that the COVID-19 vaccines developed so far had not been tested sufficiently in people living in these particular facilities.
Although his 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. Furthermore, he 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 suggested high efficacy in older age groups.) The lack of certainty that the vaccine will work and be safe in this group “worries me on many levels,” Talbot said. Instead, it only advocated vaccinating staff at long-term care facilities.
However, the other 13 committee members remained indifferent to her concern, noting the enormous impact the disease had on the facility’s residents.
Tuesday’s recommendation maximizes benefits, minimizes harm, promotes justice and mitigates health inequalities, committee chairman José Romero stressed in concluding statements after the vote.
After phase 1a was completed, the committee suggested moving on to vaccinating essential workers in phase 1b, then people over the age of 65 and those with high-risk medical conditions in phase 1c.
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