Health care workers and long-term care facility residents should get Covid-19 vaccine first, CDC vaccine advisers say
By Maggie Fox, CNN
Updated 0239 GMT (1039 HKT) December 2, 2020
Vaccine advisers to the US Centers for Disease Control and Prevention voted 13-1 on Tuesday to recommend that both health care workers and residents of long-term care facilities be first in line for any coronavirus vaccines that get emergency authorization from the US Food and Drug Administration.
The Advisory Committee for Immunization Practices voted to include both groups in what they're calling Phase 1a of the CDC's coronavirus vaccine distribution plan.
They are at "exceptionally high risk," Dr. Jose Romero, who chairs ACIP, said.
"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," the CDC said.
These very frail people account for 40% of coronavirus deaths in the US and the ACIP committee members felt strongly they need to be protected. So far, the CDC's Sara Oliver told the meeting, 100,000 long term care facility residents have died from Covid-19.
ACIP members also agreed it would be efficient to vaccinate the staff working in nursing homes and similar long term care facilities and the residents at the same time.
And no one had doubts about the need to protect health care workers. More than 240,000 health care workers have been infected with coronavirus and 858 have died, the CDC says.
…
The CDC and ACIP are considering a four-phase plan for allocating vaccines eventually. Phases 1b and 1c will likely include essential workers such as food production workers who are at high risk of infection, as well as emergency personnel and perhaps people at highest risk of coronavirus complications and death.
B.
https://www.webmd.com/lung/news/20200901/advisory-group-outlines-covid-19-vaccine-priority
Advisory Group Outlines COVID-19 Vaccine Priority
By Carolyn Crist
September 2, 2020 -- A preliminary report released Tuesday outlines which groups may receive priority when a coronavirus vaccine is available.
The National Academies of Sciences, Engineering and Medicine created the committee in July to create a framework for priorities. They released the “discussion draft” Tuesday and will hold a five-hour public listening session on Wednesday afternoon.
“While major efforts are being made to have a significant supply of COVID-19 vaccine as soon as possible, the committee has been tasked with considering the tough choices that will need to be made for allocating the tightly constrained initial supplies,” Helene Gayle, committee co-chair and president and CEO of the Chicago Community Trust, said in a statement.
- The first step is to distribute the vaccine to reduce severe illness and deaths. Availability will be increased as vaccine supplies increase.
- Teachers and school staff are included in Phase 2.
- Young adults and children are in Phase 3.
The committee focused on underlying causes to create priorities rather than race or ethnicity.
- Those who have frontline jobs,
- crowded living conditions,
- lack of access to personal protective equipment and
- the inability to work from home are the most at risk for contracting the coronavirus, the report said.
- Statistics show that people of color — specifically Black, Hispanic, Latinx, American Indian and Alaska Native — have been disproportionately affected by COVID-19, itself.
The public comment period is open until Friday at midnight, and people can submit comments online. The committee’s final report, which will include an updated allocation framework, is expected later this month, according to STAT.
“Input from the public on this draft framework, especially from communities disproportionately affected by COVID-19, is essential to produce a final report that is objective, balanced and inclusive,” Victor Dzau, president of the National Academy of Medicine, said in the statement.
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Nursing home residents could start receiving COVID vaccines in about 2 weeks
Nursing home residents could be just a little more than two weeks away from receiving the first doses of a COVID-19 vaccine, according to federal health officials.
The Food and Drug Administration’s vaccine advisory committee is set to discuss Pfizer’s emergency use authorization (EUA) request for its COVID-19 vaccine on Dec. 10. The federal government could be distributing a vaccine two days after that meeting “if all goes well,” Health and Human Services Secretary Alex Azar said Tuesday morning.
“As all of these pieces come together, we want to try to give Americans the best sense of when our most vulnerable will start receiving vaccines,” Azar said during a briefing. “We believe we can distribute vaccines to all 64 jurisdictions within 24 hours of FDA authorization.
HHS Assistant Secretary for Health Adm. Brett Giroir, M.D., in a media call later Tuesday stressed the need for infection control measures, such as universal mask wearing, adequate testing and good hygiene, despite potential vaccines being on the horizon.
He added that the best ways to stop outbreaks in nursing homes is through the correct usage of personal protective equipment and good hygiene by staff members, and by limiting community spread.
“We cannot shield our elderly if we don’t wear masks, avoid crowds, avoid travel if you can [and have] good hygiene,” he said.
Giroir also revealed that the U.S. has spent $20 billion for testing and other needs at nursing homes during the pandemic. About 15,200 facilities have received about 5.3 million point-of-care tests, he added. Additionally, 24.4 million BinaxNOW tests have been distributed to nursing homes, assisted living facilities, historically Black colleges and universities, tribes and other disaster relief efforts.
Giroir noted that the BinaxNOW tests have become a favorite among providers following a call with the major nursing home associations last week.
“Literally, the two most common words [during the call] were ‘game-changer’ and ‘godsend’ for the Binax tests that have been there because they have really revolutionized what they can do in a very quick way,” he said.
Some research has found that just 38% of nursing homes haven’t used the point-of-care antigen testing devices that were shipped to facilities starting in September.
I.
C.
Nursing homes will be first to get COVID-19 vaccine in Spain | Reuters
Nursing homes will be first to get COVID-19 vaccine in Spain
By Emma Pinedo, Ingrid Melander
II.
Obese Americans Could Receive Priority for Coronavirus Vaccine | National Review
Obese Americans Could Receive Priority for Coronavirus Vaccine
by Brittany Bernstein, Nov 30, 2020
III.
Nursing Homes’ Next Test—Vaccinating Workers Against COVID-19 | Geriatrics | JAMA | JAMA Network
October 28, 2020
Nursing Homes’ Next Test—Vaccinating Workers Against COVID-19
JAMA. 2020;324(19):1928-1930. doi:10.1001/jama.2020.21354
A key struggle in rolling out coronavirus disease 2019 (COVID-19) vaccines could be getting several million initial doses to the nation’s massive and far-flung long-term care workforce.
Early in the fall some experts in long-term care and immunization predicted significant hurdles in vaccinating long-term care workers. After all, staff turnover at nursing homes has been high for decades, and long-term care facilities typically possess fewer resources than hospitals for staff education about vaccine risks and benefits.
After months of shouldering personal protective equipment and testing shortages along with an enormous disease burden, the industry saw a ray of hope in mid-October. The Trump administration announced the new Pharmacy Partnership for Long-Term Care Program with pharmacy giants CVS and Walgreens to vaccinate long-term care facilities’ residents and staff on site at no cost.
“This is really significant…because we’ve never really had [a] coordinated partnership between pharmacies and public health across all states,” Claire Hannan, MPH, executive director of the Association of Immunization Managers, whose members lead state, local, and territorial immunization programs, said in an email.
“The only way to keep older adults healthy and safe in this pandemic is through a coordinated federal response,” Katie Smith Sloan, president and chief executive officer of LeadingAge, which represents nonprofit nursing homes and other aging services, said in a statement. “The vaccine is still months away, so there is time to get this right.”
Even with the federal effort, however, significant obstacles remain. Inadequate vaccine safety is a widespread concern, and the vaccines themselves pose some unique logistical challenges. For example, the 2 leading Even with the federal effort, however, significant obstacles remain. Inadequate vaccine safety is a widespread concern, and the vaccines themselves pose some unique logistical challenges. For example, the 2 leading candidates, both made with new gene-based messenger RNA (mRNA) technology, require ultracold storage.
Although CVS and Walgreens will maintain the cold chain for the vaccines they administer through the new partnership, long-term care facilities have to opt in to participate and choose a pharmacy to give vaccines on site. Facilities that don’t participate may not have the equipment necessary to properly store vaccines.
Moreover, the pharmacy partnership program might not help to vaccinate long-term care workers during the first phase of vaccinations, as state plans may require. Some states’ draft plans, completed around the time the program was announced, made long-term care workers a top priority and called for residents to be vaccinated later.
According to the Trump administration’s announcement, the program will offer vaccinations to staff who weren’t previously vaccinated in other settings such as satellite, temporary, or off-site clinics. A Centers for Disease Control and Prevention (CDC) document distributed to the industry acknowledged that staff might be eligible for vaccination earlier than residents and strongly encouraged that staff be vaccinated “as soon as they are eligible.”
Priority Status
In September, as states and local public health agencies crafted vaccine distribution plans based on a CDC playbook, the American Health Care Association and National Center for Assisted Living (AHCA/NCAL) issued a plea to the National Governors Association.
The group, which represents more than 14 000 nursing homes and assisted living communities, appealed to the governors to make nursing home residents and staff “the highest priority” for vaccines. Despite stringent measures that have been put in place to screen and test staff, the industry group said that “the asymptomatic and virulent nature of this virus makes it impossible to truly prevent entry into the building.” [Vaccination of the Residents and Staff will greatly facilitate promoting socialization and activities for the residents. Solitariness and loneliness can be fatal.VM]
Days later, allocation recommendations from a National Academy of Sciences, Engineering, and Medicine (NASEM) committee put long-term care workers among the 5% of the US population that’s first in line as part of a “jumpstart” phase 1a category for a vaccine because of their high-risk occupations. The recommendations cite the high potential for these workers to spread the virus.
NASEM’s recommendations serve as a guide; it’s the CDC’s Advisory Committee on Immunization Practices (ACIP) that traditionally recommends who should get vaccines. At a September meeting, however, ACIP members said they won’t issue final recommendations until the US Food and Drug Administration approves a vaccine and they’ve reviewed efficacy and safety data from a phase 3 trial. State and local health departments are likely to follow ACIP’s lead in finalizing their own distribution plans.
And until data are available on vaccine efficacy among different populations as well as how much vaccine will be available, it’s difficult to know how the groups most at risk should be prioritized. For example, Paul Cieslak, MD, medical director for communicable diseases and immunizations for the Oregon Health Authority, said in an interview that if a vaccine turns out to be highly protective in older people, it might make more sense to put a higher priority on vaccinating nursing home residents.
For now, however, a CDC model has indicated that vaccinating nursing home staff rather than residents would be more effective at reducing SARS-CoV-2 infections and deaths. The NASEM recommendations put older adults living in congregate settings in phase 1b, just behind long-term care workers.
Logistical Hurdles
Nursing homes and long-term care facilities can receive COVID-19 vaccines through the federal government’s public-private partnership, or they can use their current pharmacy contracts instead.
Either way, the ultracold storage requirements for the vaccines that are farthest along in clinical trials—one developed by Pfizer and BioNTech and the other by Moderna—will make them challenging to distribute. Both also require 2 doses.
Most concerning is the Pfizer-BioNTech candidate, which requires storage at −70 °C and will be shipped in containers with dry ice that hold 975 doses apiece, according to a Pfizer representative’s presentation at an ACIP meeting in September. CVS and Walgreens will maintain the cold chain for COVID-19 vaccines and distribute them to facilities in most rural areas, according to the federal government’s announcement. But what happens to rural facilities that may not be within their reach or near a pharmacy that can properly store the vaccines?
After all, Hannan said, “That’s not something you’re going to send to a long-term care facility in rural Montana because a lot of those doses would get wasted.” Some states strategized about vaccine distribution before the partnership was announced. Oregon, ninth largest in terms of land area, considered placing storage depots across the state and using emergency medical responders to conduct mobile vaccination clinics, Cieslak said.
Moderna’s mRNA vaccine doesn’t require ultracold storage, but it’s still a challenge. It must be kept at −20 °C, comes in 100-dose packs, and requires laboratory-grade freezers that log temperatures to make sure required ranges are maintained. Most commonly used vaccines require only refrigeration. Three exceptions—the combination measles-mumps-rubella-varicella, Varivax for chickenpox, and Zostavax for shingles—must be kept no warmer than −15 °C.
An extra hurdle arises for long-term care workers who aren’t vaccinated on site and must travel to a hospital or community pharmacy to get a shot. The goal is vaccinating all long-term care workers but, Hannan said, “The devil is in the details.”
Boosting Vaccine Confidence
Even if vaccines are available, their acceptance isn’t guaranteed. Among health care workers, those in long-term care have had the lowest influenza vaccination rates—69.3% during the 2019-2020 flu season, according to an opt-in internet survey conducted by the CDC. That compares with 93.2% of workers in hospitals and 78.8% of those in ambulatory care centers and physician offices.
Unlike hospitals, most nursing homes haven’t required their workers to get flu shots. But industry leaders have said more nursing homes are doing so this year because they fear simultaneous COVID-19 and influenza outbreaks.
Ideally, educating long-term care workers about a COVID-19 vaccine should be more intensive than for a flu vaccine, Christian Bergman, MD, of Virginia Commonwealth University in Richmond, said in an interview. He serves on a state COVID-19 vaccine planning task force and formed a collaboration of task force officials from various states through the Society for Post-Acute and Long-Term Care Medicine, known as AMDA.
Bergman suggested that educational programs include a live briefing in advance of vaccinations where workers can ask questions and get an information sheet with safety and efficacy data, details about adverse effects, and the populations in which the vaccine was tested.
Work has begun at the state level to develop teaching points that nursing homes can use to address vaccine hesitancy and convey data about a specific vaccine, Bergman noted. President Donald Trump’s claims that a vaccine could be ready by Election Day created widespread mistrust that politics would prevail over science. Poll results shared by the Associated Press and the NORC Center for Public Affairs Research in mid-October showed a quarter of Americans would decline a COVID-19 vaccine, up from 1 in 5 people in May.
Bergman said the goal for educational programs will be to “confidently say to staff members that this vaccine has gone through the appropriate channels and it is safe and effective based on the following data.”
To support such efforts, the US Department of Health and Human Services and CDC officials have told state and local officials that they plan to produce educational materials including a website, but details have yet to be disclosed, Hannan said. Neither agency responded to requests for comment.
Nursing homes also say they will step up. In an email, the AHCA/NCAL said the importance of vaccines “has never been more prominent” and its members “are sharing information and education on the importance of vaccines with their staff, including that [vaccines] help protect the person vaccinated as well as the residents, staff, visitors, and community.”
One nursing home chain, ProMedica Senior Care, formerly HCR ManorCare, plans to educate workers at its senior care facilities in 26 states with strategies such as virtual town halls where workers can ask questions of medical leaders, Chief Medical Officer Mark Gloth, DO, said in an interview. He added that employees who are offered a vaccine and refuse will be required to sign a form acknowledging that they’ve been counseled on risks and benefits.
“We need to be actively engaged,” Gloth said.
But without more specific information about potential vaccines, nursing homes are limited in what they can do to prepare, said Barbara Resnick, PhD, RN, a geriatric nurse practitioner and professor at the University of Maryland School of Nursing. Resnick would like to address COVID-19 vaccine hesitancy with the staff she works with at Roland Park Place senior living facility in Baltimore. For now, however, she said it’s not possible without specific safety and efficacy data.
The Question of Mandates
Even a strong educational push might need reinforcement. CDC data show that flu vaccination rates are highest among health care workers in settings where it’s required. During the 2019-2020 season, the vaccination rate for those workers was 94.4% vs 80.6% for health care workers overall.
In an article published in May, Dorit Reiss, PhD, of the University of California Hastings College of the Law in San Francisco, and bioethicist Arthur Caplan, PhD, of the New York University Langone Medical Center, predicted that a COVID-19 vaccine mandate for health care workers “will surely be imposed with almost no if any exceptions.” They cited the risk of exposure to nonclinical staff, vulnerable patients, and others, as well as the need to keep the health system functioning.
However, it’s unclear where a mandate might come from or when.
Resnick predicted that states would mandate health care worker vaccinations, as they have with flu. “If we want to move quickly into some type of herd immunity, there’s going to have to be a state push,” she said. But state flu vaccination policies for long-term care workers vary widely. Some require nursing homes to vaccinate their workers, with only narrow exceptions. Others require employers only to offer vaccines or to document how many workers get them. A similar hodgepodge could occur with a COVID-19 vaccine, resulting in confusion for workers and uneven protections for residents and workers. [This can cause local surges and disastrous results.VM]
Bergman suggested it would be faster and more effective for a federal agency such as the Centers for Medicare & Medicaid Services (CMS) to step in with a regulation. The agency has compelled hospitals to increase worker flu vaccination rates by adding those data to the Inpatient Quality Reporting Program, and it required nursing homes to offer influenza and pneumococcal vaccines to residents. CMS did not respond to a request for comment.
Caplan said once vaccine supplies are robust, which could take months after approval, nursing homes themselves might move to mandate COVID-19 vaccination for workers to reduce their liability and demonstrate to residents’ families that they are taking necessary precautions to protect their loved ones.
Gloth said he doesn’t expect his company to mandate vaccination, at least not initially. Although many staff members are enthusiastic about a vaccine, Gloth said that with any new biological product, “people have concerns. We want to be respectful of that.”
Despite the enthusiasm, a vaccine probably won’t eliminate the need for strict nursing home protocols such as universal testing, wearing personal protective equipment, restrictions on visitors, and isolating residents who test positive for COVID-19. CDC and state guidance that prescribes those measures is unlikely to change until data are available on the duration of immunity from a vaccine, Renee Beniak, PhD, RN, executive director of the Michigan County Medical Care Facilities Council, which represents county-owned nursing homes, said in an interview.
Initial vaccines will likely reduce the risk of becoming infected or lessen the severity of illness, but they’re unlikely to eliminate all risk, Gloth noted. Rather, he said, a vaccine will provide “another layer of infection prevention and control.”
IV.
https://vitals.lifehacker.com/who-will-get-the-vaccine-first-1845750249
Who will get the Vaccine First
One COVID-19 vaccine is already under review for possible emergency authorization in December; its competitors are close behind. Once we have a vaccine—or maybe several—it will be a while until there are enough doses for everybody. The CDC is working on a plan to prioritize certain groups of people to get it first.
The Advisory Committee on Immunization Practices, or ACIP, is a part of the CDC that makes vaccine recommendations. In normal times, their job is invisible to most of us, but they’re the people who say we should get a flu shot every year, that babies should get their measles immunization at age one, and so on. The FDA decides whether a vaccine should be approved at all, and then ACIP makes a ruling on who should get it. (Under the Affordable Care Act, your insurance must cover the cost of a vaccine if you are in a group for which ACIP recommends that vaccine.)
With COVID-19 vaccine development proceeding at a record-setting pace, ACIP has been discussing the vaccines over the past several months, aiming to be ready to make recommendations as soon as possible once a vaccine is approved or authorized. One of the key decisions the committee will have to make: who should get the vaccine first?
Yesterday the committee published their ethical framework for making these decisions, and at a meeting the same day they publicly mulled over the possible priority groups. (ACIP meeting webcasts are available to the public, and you can see agendas and slides from the meetings here.)
The priority groups have not been finalized, and states may have some leeway to make their own decisions on top of these, but here is what the committee is considering:
1.Healthcare workers will probably be top priority: [21 million]
There seems to be agreement that “healthcare personnel” should be first in line to receive the vaccine. These people include not just doctors and nurses, but also people like pharmacists, emergency responders, and staff at hospitals and nursing homes. ACIP estimates there are about 21 million Americans in this group.
By helping these workers first, we’re enabling them to stay healthy enough to treat others. This not only keeps COVID treatment available, but also enables those workers and their employers to provide care for people with other health issues. Healthcare personnel are also close contacts of the residents or patients they work with, so protecting them protects those other people.
There are also practical reasons why it makes sense to vaccinate these workers first. Many hospitals and healthcare facilities already have the equipment (like ultra-cold freezers) to store and administer vaccines, and healthcare workers are already used to getting vaccines; more healthcare workers get flu vaccines than people in the general population.
Healthcare workers are also racially and ethnically diverse, which fits one of the main ethical considerations: to avoid exacerbating existing injustice, and to make things as fair and just as possible.
2.Nursing home residents are also high priority [3 million]
In the timeline set out in the most recent ACIP meeting, residents of “long-term care facilities” including nursing homes and inpatient rehab centers will be in the first group, along with healthcare personnel. There are about three million people in this group.
These residents are often elderly and with high-risk medical conditions, and they bear the brunt of outbreaks. Staff and residents of these facilities account for 6% of COVID-19 cases and a whopping 39% of all COVID-19 deaths, a presentation said.
3.Essential workers will likely be next [87 Million]
As the first group of healthcare personnel and long-term care facility residents’ winds down, “phase 1b” of vaccination will begin. According to the committee’s current thinking, these will be essential workers from industries other than healthcare. There are about 87 million people in this group.
The definition of “essential workers” is up to a government agency called CISA, which has a report on them here. Examples include people who work in the food, agriculture, and transportation industries, people who work in manufacturing, people who operate water and wastewater treatment plants, police, firefighters and teachers, to name a few.
Protecting these people protects the rest of us, in much the same way as healthcare workers, while still allowing essential functions of society to operate as much as possible.
About a quarter of these workers are low income, and this group is more diverse than the country as a whole. Ethically, this helps to right some of the injustice that they face in being more at risk for the coronavirus in the first place.
There are over 100 million adults with high-risk medical conditions, and some will have been vaccinated as part of the earlier phases. There are also about 53 million adults who are age 65 and older, or 50 million once you subtract those in care facilities. (Again, there will be some overlap with healthcare workers and essential workers, so these numbers may be smaller by the time this group is able to be vaccinated.)
These populations are important because they have a high risk of complications and death. They fall lower on the priority list than the groups above, in part because it will be harder to get the vaccine to everybody in these groups. (They are also a less equitable cross section of Americans, in the sense that the more privileged you are, the more likely you are to have access to healthcare to be diagnosed with a high-risk condition, and the more likely you are to live to old age.)
The Overall plan
With these considerations, the tentative plan—which, again, could change—looks something like this:
- Group 1a: healthcare personnel and long-term care facility residents.
- Group 1b (overlapping with 1a): other essential workers.
- Group 1c (overlapping with 1b): older adults and adults with high risk medical conditions.
Children aren’t in any of these groups, in part because they weren’t included in vaccine trials. (Some companies enrolled teenagers in their trials; none are testing the vaccine on young children.) Younger and middle-aged adults who work from home and don’t have serious medical conditions (this includes me) probably won’t be able to get the vaccine in the first few months it’s available.
To be clear, these priority groups are still tentative, and they are only for the initial rollout while vaccine availability is limited. Once there is enough vaccine to give to everyone who wants it, the priority groups will not be used anymore. Vaccine distribution will be up to 64 jurisdictions, representing states, territories, and tribal authorities who will have some leeway in how they organize the vaccine rollout.
If the Pfizer vaccine is approved in December, the company plans to ship out enough vaccine immediately to immunize three million people. More doses will follow, with Pfizer estimating they can provide 50 million doses worldwide by the end of 2020 and growing from there. Moderna’s vaccine may not be far behind, and the AstraZeneca/Oxford vaccine could be available not long after that. Experts seem to expect that people in priority groups will be able to receive their vaccines in the first few months of 2021, with doses becoming available to the rest of us by spring or summer.
All this depends on trial data and post-authorization studies confirming that the vaccine works and is safe. But it’s good to know that there is a plan, and that it’s being developed with public health and ethics in mind.
Beth Skwarecki is Lifehacker's Senior Health Editor. She has written about health and science for over a decade, including two books: Outbreak! and Genetics 101. Her Wilks score is 302.
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The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020
Weekly / November 27, 2020 / 69(47);1782-1786
On November 23, 2020, this report was posted online as an MMWR Early Release.
Nancy McClung, PhD1; Mary Chamberland, MD1,2; Kathy Kinlaw, MDiv3; Dayna Bowen Matthew, JD, PhD4; Megan Wallace, DrPH1,5; Beth P. Bell, MD6; Grace M. Lee, MD7; H. Keipp Talbot, MD8; José R. Romero, MD9; Sara E. Oliver, MD1; Kathleen Dooling, MD1
What is already known about this topic?
During the period when the U.S. supply of COVID-19 vaccines is limited, the Advisory Committee on Immunization Practices (ACIP) will make vaccine allocation recommendations.
What is added by this report?
In addition to scientific data and implementation feasibility, four ethical principles will assist ACIP in formulating recommendations for the initial allocation of COVID-19 vaccine: 1) maximizing benefits and minimizing harms; 2) promoting justice; 3) mitigating health inequities; and 4) promoting transparency.
What are the implications for public health practice?
Ethical principles will aid ACIP in making vaccine allocation recommendations and state, tribal, local, and territorial public health authorities in developing vaccine implementation strategies based on ACIP’s recommendations.
Key Groups to be Vaccinated:
- Health care personnel: paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials;
- other essential workers: person who conduct operations vital for continuing critical infrastructure, such as food, agriculture, transportation, education, and law enforcement; Essential workers during the COVID-19 response have been defined by the U.S. Department of Homeland Security Cybersecurity and Infrastructure Security Agency.
- adults with high risk medical conditions: adults who have one or more high-risk medical conditions, such as obesity, diabetes, and cardiovascular disease; adults aged ≥65 years: includes
- adults living at home and approximately 3 million living in long-term care facilities. There is considerable overlap between groups, for example, many adults aged ≥65 years also have high-risk medical conditions.
TABLE 1. Essential questions for COVID-19 vaccine allocation planning related to ethical principles — United States, 2020 |
|
---|---|
Ethical principle |
Essential question |
Maximize benefits and minimize harms |
What groups are at highest risk for SARS-CoV-2 infection, COVID-19 disease, hospitalization, and death? |
What groups are essential to the COVID-19 response? |
|
What groups are essential to maintaining critical functions of society? |
|
What are the important characteristics of these groups (e.g., size or geographic distribution) that might inform the magnitude of benefit based on the amount of vaccine available or its characteristics? |
|
Promote justice |
Does the allocation plan result in fair and equitable access of the vaccine for all groups? |
How do characteristics of the vaccine and logistical considerations affect fair access for all persons? |
|
Does allocation planning include input from groups who are disproportionately affected by COVID-19 or face health inequities resulting from social determinants of health, such as income and health care access? |
|
Mitigate health inequities |
Does the plan identify and address barriers to vaccination among any groups who are disproportionately affected by COVID-19 or who face health inequities resulting from social determinants of health, such as income and health care access? |
Does the allocation plan contribute to a reduction in health disparities in COVID-19 disease and death? |
|
What health inequities might inadvertently result from the allocation plan, and what interventions could remove or reduce them? |
|
Is there a mechanism for timely assessment of vaccination coverage among groups experiencing disadvantage and the possibility for course correction if inequities are identified? |
|
Promote transparency |
How does development of the allocation plan include diverse input, and if possible, public engagement? |
Are the allocation plan and evidence-based methods publicly available? |
|
Is the allocation plan clear about what is known and unknown and about the quality of available evidence? |
|
What is the process for revision of allocation plans based on new information? |
|
Is there a mechanism to report demographic data elements for vaccine recipients (e.g., age, race/ethnicity, and occupation) to support equitable vaccination coverage? |
Abbreviation: COVID-19 = coronavirus disease 2019.
Abbreviations: COVID-19 = coronavirus disease 2019; HCP = health care personnel.
To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure (1). ACIP’s recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine’s safety and efficacy as well as consideration of other factors, including implementation (2). Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility:
Ethical Principles:
1) maximize benefits and minimize harms;
2) promote justice;
3) mitigate health inequities; and
4) promote transparency.
These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.
The ACIP COVID-19 Vaccines Work Group has met several times per month (approximately 25 meetings) since its establishment in April 2020. Work Group discussions included review of the epidemiology of COVID-19 and consultation with experts in ethics and health equity to inform the development of an ethically principled decision-making process. The Work Group reviewed the relevant literature, including frameworks for pandemic influenza planning and COVID-19 vaccine allocation (3–8); summarized this information; and presented it to ACIP. ACIP supported four fundamental ethical principles to guide COVID-19 vaccine allocation decisions in the setting of a constrained supply. Essential questions that derive from these principles can assist in vaccine allocation planning (Table 1).
Key Ethical Principles:
Maximize benefits and minimize harms. Allocation of COVID-19 vaccine should maximize the benefits of vaccination to both individual recipients and the population overall. These benefits include the reduction of SARS-CoV-2 infections and COVID-19–associated morbidity and mortality, which in turn reduces the burden on strained health care capacity and facilities; preservation of services essential to the COVID-19 response; and maintenance of overall societal functioning. Identification of groups whose receipt of the vaccine would lead to the greatest benefit should be based on scientific evidence, accounting for those at highest risk for SARS-CoV-2 infection or severe COVID-19–related disease or death, and the essential role of certain workers.
The ability of essential workers, including health care workers and non–health care workers, to remain healthy has a multiplier effect (i.e., their ability to remain healthy helps to protect the health of others or to minimize societal and economic disruption). Some of these workers are at increased risk for SARS-CoV-2 infection because of their limited ability to maintain physical distance in the workplace or because they do not have consistent access to recommended personal protective equipment.
Promote justice. Inherent in the principle of justice is an obligation to protect and advance equal opportunity for all persons to enjoy the maximal health and well-being possible. Justice rests on the belief in the fundamental value and dignity of all persons. Allocation of COVID-19 vaccine should promote justice by intentionally ensuring that all persons have equal opportunity to be vaccinated, both within the groups recommended for initial vaccination, and as vaccine becomes more widely available. This includes a commitment to removing unfair, unjust, and avoidable barriers to vaccination that disproportionately affect groups that have been economically or socially marginalized, as well as a fair and consistent implementation process. Input from a range of external entities, partners, and community representatives is particularly important in developing and accessing allocation plans.
Mitigate health inequities. Health equity is achieved when every person has the opportunity to attain his or her full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances.† Disparities in the severity of COVID-19 and COVID-19–related death, as well as inequities in social determinants of health that are linked to COVID-19 risk, such as income or health care access and utilization, are well documented among certain racial and ethnic minority groups (9). Vaccine allocation strategies should aim to both reduce existing disparities and to not create new disparities. Efforts should be made to identify and remove obstacles and barriers to receiving COVID-19 vaccine, including limited access to health care or residence in rural, hard-to-reach areas.
Promote transparency. Transparency relates to the decision-making process and is essential to building and maintaining public trust during vaccine program planning and implementation. The underlying principles, decision-making processes, and plans for COVID-19 vaccine allocation must be evidence-based, clear, understandable, and publicly available. To the extent possible, considering the urgency of the COVID-19 response, public participation in the creation and review of the decision-making process should be facilitated. In addition, when feasible, tracking administration of vaccine to the groups recommended for initial vaccine allocation can contribute to transparency and trust in the process. In an ongoing public health response, the situation continually evolves as new information becomes available. Transparency includes being clear about the level of certainty in the available evidence and communicating new information that might change recommendations in a timely fashion.
For the period when the supply of COVID-19 vaccine will be limited, ACIP has considered four groups for initial vaccine allocation.
These include
- health care personnel,
- other essential workers,
- adults with high-risk medical conditions, and
- adults aged ≥65 years (including residents of long-term care facilities) (Table 2).
These groups were selected based on:
- available scientific data,
- vaccine implementation considerations, and
- ethical principles. The principle of transparency is applied across the entirety of the vaccine allocation decision-making process. ACIP’s meetings are open to the public, meeting minutes and archived webcasts are available online, and data (including data from vaccine clinical trials) and analytic methods used in developing ACIP recommendations are publicly available.§ Members of the public are invited to submit written comments to the Federal Register or provide oral comment during ACIP meetings. ACIP’s 30 nonvoting representatives from liaison organizations facilitate engagement with professional medical and public health organizations and other stakeholders and partners.
All four groups proposed for initial allocation of COVID-19 vaccine merit strong consideration from an ethical perspective. Current planning scenarios estimate, however, that the expected number of doses during the first weeks of vaccine distribution might only be sufficient to vaccinate approximately 20 million persons.¶ Although there is considerable overlap between groups** (10), the initial supply will not be adequate to vaccinate the entirety of all four groups; for example, there are approximately 100 million health care personnel and essential workers (Table 2). Published frameworks for COVID-19 allocation and ACIP discussions indicate a clear consensus that the first allocation of COVID-19 vaccine supplies should be directed to health care personnel (1,5–8); discussion of allocation to the other three groups is ongoing. As additional vaccine supplies become available, other groups may be vaccinated concurrent with health care personnel.
Discussion
During a pandemic, ethical guidelines can help steer and support decisions around prioritization of limited resources (3,4). Consideration of ethical values and principles has featured prominently in discussions about allocation of COVID-19 vaccines. This consideration is particularly relevant because the COVID-19 pandemic has highlighted long-standing, systemic health and social inequities.
Although various frameworks for COVID-19 vaccine allocation demonstrate differences in their structure (e.g., based on varying combinations of different goals, objectives, criteria, and other structural elements) and emphasis (e.g., inclusion of global and national considerations), nearly all reference values and principles similar to those which ACIP considers fundamental (5–8). ACIP viewed the following characteristics as critical for its ethical approach to COVID-19 vaccine allocation when supply is limited: [Buy in of the Vaccination rests on these principle.VM]
- simplicity in structure and definitions;
- acceptability to stakeholders; and
- ease of application, both at the national and state, tribal, local, and territorial levels.
Allocation of limited vaccine supplies is complicated by efforts to address the multiple goals of a vaccine program, most notably those related to the reduction of morbidity and mortality and the minimization of disruption to society and the economy.
If the goals of a pandemic vaccination program are not clearly articulated and prioritized, drawing distinctions between groups that merit consideration for allocation of vaccine when supply is constrained can become difficult. The unanimity in opinion for early vaccination of health care personnel indicates that maintenance of health care capacity has emerged as a high priority in the context of a severe pandemic. This perspective aligns with ethical considerations for pandemic influenza planning (3,4). If vaccine supply remains constrained, it might be necessary to identify subsets of other groups for subsequent early allocation of COVID-19 vaccine.
At the national, state, tribal, local, and territorial levels, such decisions should be guided, in part, by ethical principles and consideration of essential questions, with particular consideration of mitigation of health inequities in persons experiencing disproportionate COVID-19 morbidity and mortality. In the setting of a constrained supply, the benefits of vaccination will be delayed for some persons; however, as supply increases, there will eventually be enough vaccine for everyone.
In addition to ethical considerations, ACIP’s recommendations regarding receipt of the initial allocations of COVID-19 vaccine during the period of constrained supply will be based on:
- science (e.g., available information about the vaccine’s characteristics such as safety and efficacy in older adults and epidemiologic risk) and
- feasibility of implementation (e.g., storage and handling requirements).
Thus, ACIP’s allocation recommendations will be made in conjunction with specific recommendations for the use of each FDA-authorized or licensed COVID-19 vaccine. Although the ethical principles in this report are fundamental for stewardship of limited vaccine supply, they can also be applied when COVID-19 vaccines are widely available, to ensure equitable and just access for all persons.
Acknowledgments
Members of the Advisory Committee on Immunization Practices COVID-19 Vaccines Work Group.
Corresponding author: Nancy McClung, [email protected].
The ACIP includes 15 voting members responsible for making vaccine recommendations. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination. In addition to the 15 voting members, ACIP includes eight ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 nonvoting representatives of liaison organizations that bring related immunization expertise. https://www.cdc.gov/vaccines/acip/members/index.html.
† https://www.cdc.gov/chronicdisease/healthequity/index.htm.
§ https://www.cdc.gov/vaccines/acip/index.html.
** There is overlap among these four groups. For example, in one analysis, among the 3.8% of U.S. adults who work directly with patients as health care workers, 38.6% have high-risk medical conditions or are aged >65 years.