Evidence Table for COVID-19 Vaccines Allocation in Phase 1a of the Vaccination Program
Question:
Should healthcare personnel and long-term care facility residents be offered COVID-19 vaccine in the initial phase of the vaccination program (Phase 1a)?
Background:
Demand for COVID-19 vaccine is expected to exceed supply during the first months of the vaccination program. The ACIP COVID-19 Vaccines Work Group considered evidence related to SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles in developing the interim recommendation on allocation of the initial supply of COVID-19 vaccine (Phase 1a).
Healthcare personnel (HCP)
Healthcare personnel (HCP)
Long-term care facility (LTCF) residents
Long-term care facility (LTCF) residents
Science
What is the burden (SARS-CoV-2 epidemiology, COVID-19 incidence, morbidity, mortality) and what are the potential harms and benefits of vaccination?
Science
What is the burden (SARS-CoV-2 epidemiology, COVID-19 incidence, morbidity, mortality) and what are the potential harms and benefits of vaccination?
Healthcare settings are high risk locations for SAR-CoV-2 exposure.1
As of December 1, 2020, approximately 245,000 COVID-19 cases and 860 COVID-19-associated deaths have been reported among HCP.2
HCP are at risk for transmitting the virus to medically vulnerable patients as seen with long-term care facility (LTCF) outbreaks.3,4
From a subset of jurisdictions reporting occupation type and job setting for HCP with COVID-19, health care support workers accounted for the largest overall group of occupation types (32%) and residential care facilities were the most common job setting (67%).1
Analysis of COVID-19 hospitalization data from 13 sites through May 31 indicated that 6% of adults hospitalized with COVID-19 were HCP. Of hospitalized HCP, 52% were non-Hispanic Black. Approximately 28% of hospitalized HCP were admitted to an intensive care unit, 16% required invasive mechanical ventilation, and 4% died. 5
LTCF modeling predicted more cases and death averted at the facility by vaccinating staff compared with vaccinating residents.6
Early protection of HCP is critical to preserve healthcare capacity to care for COVID-19 patients and ensure hospitals maintain workforce to care for non-COVID-19 patients.
Healthcare settings are high risk locations for SAR-CoV-2 exposure.1
As of December 1, 2020, approximately 245,000 COVID-19 cases and 860 COVID-19-associated deaths have been reported among HCP.2
HCP are at risk for transmitting the virus to medically vulnerable patients as seen with long-term care facility (LTCF) outbreaks.3,4
From a subset of jurisdictions reporting occupation type and job setting for HCP with COVID-19, health care support workers accounted for the largest overall group of occupation types (32%) and residential care facilities were the most common job setting (67%).1
Analysis of COVID-19 hospitalization data from 13 sites through May 31 indicated that 6% of adults hospitalized with COVID-19 were HCP. Of hospitalized HCP, 52% were non-Hispanic Black. Approximately 28% of hospitalized HCP were admitted to an intensive care unit, 16% required invasive mechanical ventilation, and 4% died. 5
LTCF modeling predicted more cases and death averted at the facility by vaccinating staff compared with vaccinating residents.6
Early protection of HCP is critical to preserve healthcare capacity to care for COVID-19 patients and ensure hospitals maintain workforce to care for non-COVID-19 patients.
LTCF residents, because of their age, high rates of underlying medical conditions, and congregate living situation are at high risk for infection and severe COVID-19 disease.3,7
As of November 26, 2020, approximately 730,000 COVID-19 cases and 100,240 deaths have been reported among LTCF residents and staff; LTCF residents and staff accounted for 6% of cases and 40% of deaths in the U.S.8 Among skilled nursing facility residents approximately 500,000 COVID-19 cases and 70,000 deaths have been reported as of November 15, 2020.9
COVID-19 hospitalization rates increase with age and are highest among older adults.10,11 Risk for COVID-19-associated hospitalization increases with the number of underlying medical conditions.12
During March 1-May 31, 2020, the majority of COVID-19-associated hospitalized patients older than 75 years of age were admitted from a LTCF; 49% and 66% of COVID-19-associated hospitalized patients aged 75-84 years and 85 years and older, respectively, were from a LTCF.11
COVID-19 mortality rates are also highest among older adults. Compared with persons aged 35-54 years, those aged 65-79 years have a 10 times higher risk, and those aged 80 years and older a >40 times higher risk for COVID-19 deaths.13
Vaccinating residents could help to directly protect persons highly vulnerable to severe disease and death and may be necessary if a COVID-19 vaccine does not prevent transmission of SARS-CoV-2.
LTCF residents have not been systematically studied in COVID-19 vaccine trials to date; therefore, safety and efficacy data are not available to directly assess the benefits and harms of COVID-19 vaccine in this group.
LTCF residents, because of their age, high rates of underlying medical conditions, and congregate living situation are at high risk for infection and severe COVID-19 disease.3,7
As of November 26, 2020, approximately 730,000 COVID-19 cases and 100,240 deaths have been reported among LTCF residents and staff; LTCF residents and staff accounted for 6% of cases and 40% of deaths in the U.S.8 Among skilled nursing facility residents approximately 500,000 COVID-19 cases and 70,000 deaths have been reported as of November 15, 2020.9
COVID-19 hospitalization rates increase with age and are highest among older adults.10,11 Risk for COVID-19-associated hospitalization increases with the number of underlying medical conditions.12
During March 1-May 31, 2020, the majority of COVID-19-associated hospitalized patients older than 75 years of age were admitted from a LTCF; 49% and 66% of COVID-19-associated hospitalized patients aged 75-84 years and 85 years and older, respectively, were from a LTCF.11
COVID-19 mortality rates are also highest among older adults. Compared with persons aged 35-54 years, those aged 65-79 years have a 10 times higher risk, and those aged 80 years and older a >40 times higher risk for COVID-19 deaths.13
Vaccinating residents could help to directly protect persons highly vulnerable to severe disease and death and may be necessary if a COVID-19 vaccine does not prevent transmission of SARS-CoV-2.
LTCF residents have not been systematically studied in COVID-19 vaccine trials to date; therefore, safety and efficacy data are not available to directly assess the benefits and harms of COVID-19 vaccine in this group.
Implementation
What is the feasibility of vaccinating this group and how does the group value and accept COVID-19 vaccination?
Implementation
What is the feasibility of vaccinating this group and how does the group value and accept COVID-19 vaccination?
Storage and handling constraints of ultra-cold vaccines may limit early distribution efforts to centralized sites with necessary freezer equipment and high vaccine throughput. Additionally, large minimum size of vaccine orders may preclude involvement of small clinics.
Reaching workers in rural locations, shift workers, those with multiple jobs or working in small cohorts may be challenging. Personal investments in time and travel to obtain vaccine may be a barrier for some HCP groups.
In a survey of 1,399 US adults during August 14-16, 2020, 73% of respondents supported early allocation of COVID-19 vaccine supply to HCP.1
In a CDC vaccine intent survey in September 2020, 63% of HCP reported that they would be likely to get a COVID-19 vaccine (CDC unpublished data).
In a convenience sample survey of nurses (n=12,939) conducted in October 2020, 63% were confident a COVID-19 vaccine will be safe and effective, while 34% would voluntarily receive COVID-19 vaccine if not required.2 According to preliminary notes-based analysis of seven focus groups conducted with nurses by CDC between June and August 2020 (n=48 nurses), most supported prioritizing HCP for vaccine allocation; however, some were reluctant to get vaccinated, and many did not want to receive a vaccine right away (CDC unpublished data).
Storage and handling constraints of ultra-cold vaccines may limit early distribution efforts to centralized sites with necessary freezer equipment and high vaccine throughput. Additionally, large minimum size of vaccine orders may preclude involvement of small clinics.
Reaching workers in rural locations, shift workers, those with multiple jobs or working in small cohorts may be challenging. Personal investments in time and travel to obtain vaccine may be a barrier for some HCP groups.
In a survey of 1,399 US adults during August 14-16, 2020, 73% of respondents supported early allocation of COVID-19 vaccine supply to HCP.1
In a CDC vaccine intent survey in September 2020, 63% of HCP reported that they would be likely to get a COVID-19 vaccine (CDC unpublished data).
In a convenience sample survey of nurses (n=12,939) conducted in October 2020, 63% were confident a COVID-19 vaccine will be safe and effective, while 34% would voluntarily receive COVID-19 vaccine if not required.2 According to preliminary notes-based analysis of seven focus groups conducted with nurses by CDC between June and August 2020 (n=48 nurses), most supported prioritizing HCP for vaccine allocation; however, some were reluctant to get vaccinated, and many did not want to receive a vaccine right away (CDC unpublished data).
From a programmatic perspective, vaccinating residents of LTCFs at the same time as the HCP in the same facility is an efficient use of resources.
Partnership with pharmacy chains under the federal Pharmacy Partnership for Long-Term Care Program will provide on-site COVID-19 vaccination clinics for LTCF residents. This program will also cover HCP in LTCFs who have not received COVID-19 vaccine.
In a survey of 1,399 US adults during August 14-16, 2020, 71% of respondents supported early allocation of COVID-19 vaccine supply to seniors (aged 55 years and older).1
Providing information to LTCF residents and/or family members about the safety and efficacy of COVID-19 vaccines and noting that such data are not available specifically for LTCF residents promote transparency for this group. Procedures for administration of vaccines to LTCF residents (e.g., similar to obtaining consent/assent from the resident or family member for receipt of influenza vaccine) support transparency.
Turn-over is very high in the LTCF population and ensuring high 2-dose coverage will be challenging.
From a programmatic perspective, vaccinating residents of LTCFs at the same time as the HCP in the same facility is an efficient use of resources.
Partnership with pharmacy chains under the federal Pharmacy Partnership for Long-Term Care Program will provide on-site COVID-19 vaccination clinics for LTCF residents. This program will also cover HCP in LTCFs who have not received COVID-19 vaccine.
In a survey of 1,399 US adults during August 14-16, 2020, 71% of respondents supported early allocation of COVID-19 vaccine supply to seniors (aged 55 years and older).1
Providing information to LTCF residents and/or family members about the safety and efficacy of COVID-19 vaccines and noting that such data are not available specifically for LTCF residents promote transparency for this group. Procedures for administration of vaccines to LTCF residents (e.g., similar to obtaining consent/assent from the resident or family member for receipt of influenza vaccine) support transparency.
Turn-over is very high in the LTCF population and ensuring high 2-dose coverage will be challenging.
Ethics
Does vaccinating this group advance the ethical principles for COVID-19 vaccine allocation1:
- Maximize benefits and minimize harms
- Promote justice
- Mitigate health inequities
Ethics
Does vaccinating this group advance the ethical principles for COVID-19 vaccine allocation1:
- Maximize benefits and minimize harms
- Promote justice
- Mitigate health inequities
Maximize benefits and minimize harms: Vaccination maximizes benefits to both individual recipients and the population overall. These benefits include reduction of COVID-19-associated morbidity and mortality in HCP, which in turn reduces the burden on strained healthcare capacity and facilities; preservation of services essential for the COVID-19 response; and maintenance of the overall functioning of society. The ability of HCP to remain healthy helps to protect the health of others and minimize social and economic disruption.
Promote justice: Vaccination addresses the elevated occupational risk for SARS-CoV-2 exposure for HCP unable to work from home and promotes access to vaccine across a spectrum of HCP job types and settings.
Equal access to vaccine for HCP will be affected by the storage, handling, and administration requirements for some COVID-19 vaccines (e.g., need for ultra-low-temperature freezers or dry ice) which will limit the number/types of facilities that can receive and use those vaccines.
Mitigate health inequities: Vaccination of HCP across all occupations and work settings addresses the disproportionate representation of racial and ethnic minority groups in low-wage HCP.2
Effort will need to be applied throughout the vaccination program to ensure equitable access.
Maximize benefits and minimize harms: Vaccination maximizes benefits to both individual recipients and the population overall. These benefits include reduction of COVID-19-associated morbidity and mortality in HCP, which in turn reduces the burden on strained healthcare capacity and facilities; preservation of services essential for the COVID-19 response; and maintenance of the overall functioning of society. The ability of HCP to remain healthy helps to protect the health of others and minimize social and economic disruption.
Promote justice: Vaccination addresses the elevated occupational risk for SARS-CoV-2 exposure for HCP unable to work from home and promotes access to vaccine across a spectrum of HCP job types and settings.
Equal access to vaccine for HCP will be affected by the storage, handling, and administration requirements for some COVID-19 vaccines (e.g., need for ultra-low-temperature freezers or dry ice) which will limit the number/types of facilities that can receive and use those vaccines.
Mitigate health inequities: Vaccination of HCP across all occupations and work settings addresses the disproportionate representation of racial and ethnic minority groups in low-wage HCP.2
Effort will need to be applied throughout the vaccination program to ensure equitable access.
Maximize benefits and minimize harms: The effectiveness of COVID-19 vaccines, similar to other vaccines (e.g., influenza), may be reduced in older adults. Reduced vaccine effectiveness may offer individuals in this group some protection against infection or disease; reduce the high incidence of COVID-19 disease, death, and associated hospitalizations in this group; and ease the burden on strained health care systems. Vaccine reactogenicity (e.g., fever) could lead to medical evaluation and treatment in LTCF residents and the potential for unnecessary harm.
Promote justice: The federal Pharmacy Partnership for COVID-19 Vaccination in Long-Term Care Facilities Program will facilitate equal access to vaccine in this group by providing end-to-end management of the COVID-19 vaccination process, including cold chain management, on-site vaccinations, and fulfillment of reporting requirements.3
Access to vaccine by LTCF residents in facilities not enrolled in the Program (e.g., the facility elects not to participate in the Program or a facility cannot participate because they are located in an especially remote area)4 may be affected by the storage, handling, and administration requirements for some COVID-19 vaccines.
Mitigate health inequities: Vaccination helps to address the disproportionate burden of COVID-19 morbidity and mortality in this group, as well as disparities in LTCF populations and care. Nursing homes rated 1-star (lowest rating) by the Centers for Medicare & Medicaid Services are more likely to serve patients experiencing social or economic disadvantage and are more likely to have COVID-19-associated outbreaks.5
Effort will need to be applied throughout the vaccination program to ensure equitable access.
Maximize benefits and minimize harms: The effectiveness of COVID-19 vaccines, similar to other vaccines (e.g., influenza), may be reduced in older adults. Reduced vaccine effectiveness may offer individuals in this group some protection against infection or disease; reduce the high incidence of COVID-19 disease, death, and associated hospitalizations in this group; and ease the burden on strained health care systems. Vaccine reactogenicity (e.g., fever) could lead to medical evaluation and treatment in LTCF residents and the potential for unnecessary harm.
Promote justice: The federal Pharmacy Partnership for COVID-19 Vaccination in Long-Term Care Facilities Program will facilitate equal access to vaccine in this group by providing end-to-end management of the COVID-19 vaccination process, including cold chain management, on-site vaccinations, and fulfillment of reporting requirements.3
Access to vaccine by LTCF residents in facilities not enrolled in the Program (e.g., the facility elects not to participate in the Program or a facility cannot participate because they are located in an especially remote area)4 may be affected by the storage, handling, and administration requirements for some COVID-19 vaccines.
Mitigate health inequities: Vaccination helps to address the disproportionate burden of COVID-19 morbidity and mortality in this group, as well as disparities in LTCF populations and care. Nursing homes rated 1-star (lowest rating) by the Centers for Medicare & Medicaid Services are more likely to serve patients experiencing social or economic disadvantage and are more likely to have COVID-19-associated outbreaks.5
Effort will need to be applied throughout the vaccination program to ensure equitable access.
References
Science:
- Hughes MM, GroenewoldMR, Lessem SE, et al. Update: Characteristics of health care personnel with COVID-19 — United States, February 12–July 16, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1364–1368. DOI: https://dx.doi.org/10.15585/mmwr.mm6938a3.
- CDC COVID Data Tracker. Accessed November 29, 2020.
- McMichael TM, Clark S, Pogosjans S, et al. COVID-19 in a Long-Term Care Facility — King County, Washington, February 27–March 9, 2020. MMWR Morb Mortal Wkly Rep 2020;69:339-342. DOI: https://dx.doi.org/10.15585/mmwr.mm6912e1.
- Dora AV, Winnett A, Jatt LP, et al. Universal and serial laboratory testing for SARS-CoV-2 at a long-term care skilled nursing facility for veterans—Los Angeles, California, 2020. MMWR Morb Mortal Wkly Rep 2020;69:651–5. DOI: https://dx.doi.org/10.15585/mmwr.mm6921e1.
- Kambhampati AK, O’Halloran AC, Whitaker M, et al. COVID-19–Associated hospitalizations among health care personnel — COVID-NET, 13 States, March 1–May 31, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1576–1583. DOI: https://dx.doi.org/10.15585/mmwr.mm6943e3.
- Slayton R. Modeling allocation strategies for the initial SARS-CoV-2 vaccine supply. Presentation to ACIP. August 21, 2020.
- Yi SH, See I, Kent AG, et al. Characterization of COVID-19 in Assisted Living Facilities — 39 States, October 2020. MMWR MorbMortal Wkly Rep 2020;69:1730–1735. DOI: https://wwwdx.doi.org/10.15585/mmwr.mm6946a3.
- The Long-Term care COVID Tracker. The COVID Tracking Project. Accessed November 30, 2020.
- CMS COVID-19 data. Accessed November 29, 2020.
- Garg S, Kim L, Whitaker M, et al. Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019—COVID-NET, 14 states, March 1–30, 2020. MMWR Morb Mortal Wkly Rep 2020; 69:458-64. DOI: https://dx.doi.org/10.15585/mmwr.mm6915e3.
- Dooling, K. Phased allocation of COVID-19 vaccines. Presentation to ACIP. November 23, 2020.
- Ko JY, Danielson ML, Town M, et al. Risk Factors for COVID-19-associated hospitalization: COVID-19-Associated Hospitalization Surveillance Network and Behavioral Risk Factor Surveillance System. Clin Infect Dis. Published online September 18, 2020.
- Source of data: CDC COVID-19 case reports from jurisdictions. Data as of November 13, 2020.
Implementation:
- The Harris Poll.
- American Nurses Foundation. Nov 16, 2020. American Nurses Foundation Pulse on the Nation’s Nurses COVID-19 Survey Series.
Ethics:
- McClung N, Chamberland M, Kinlaw K, et al. The Advisory Committee on Immunization Practices’ ethical principles for allocating initial supplies of COVID-19 vaccine — United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1782-6. DOI: https://dx.doi.org/10.15585/mmwr.mm6947e3.
- Health Resources and Services Administration. Sex, race, and ethnic diversity of U.S. health occupations (2011-2015): Technical documentation. August 2017. Rockville, MD:US Department of Health and Human Services, Health Resources and Services Administration; 2017.
- CDC. Understanding the Pharmacy Partnership for Long-Term Care Program. Atlanta, GA: US Department of Health and Human Services, CDC; 2020.
- Bui DP, See I, Hesse EM, et al. Association between CMS quality ratings and COVID-19 outbreaks in nursing homes — West Virginia, March 17–June 11, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1300–4. DOI: https://dx.doi.org/10.15585/mmwmm6937a5.