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      The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020

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          Abstract

          The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic that has disrupted all sectors of society. Less than 1 year after the SARS-CoV-2 genome was first sequenced, an application* for Emergency Use Authorization for a candidate vaccine has been filed with the Food and Drug Administration (FDA). However, even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program. The Advisory Committee on Immunization Practices (ACIP) advises CDC on population groups and circumstances for vaccine use. † ACIP convened on December 1, 2020, in advance of the completion of FDA’s review of the Emergency Use Authorization application, to provide interim guidance to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both 1) health care personnel § and 2) residents of long-term care facilities (LTCFs) ¶ be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a**). †† In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles. §§ The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization. Evidence-based information addressing COVID-19 vaccine topics including early allocation has been explicitly and transparently reviewed during seven public ACIP meetings ( 1 ). To inform policy options for ACIP, the COVID-19 Vaccines Work Group, comprising experts in vaccines and ethics, held more than 25 meetings to review data regarding vaccine candidates, COVID-19 surveillance, and modeling, as well as the vaccine allocation literature from published and external expert committee reports. Health care settings in general, and long-term care settings in particular, can be high-risk locations for SARS-CoV-2 exposure and transmission ( 2 – 4 ). Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. As of December 1, 2020, approximately 245,000 COVID-19 cases and 858 COVID-19-associated deaths had been reported among U.S. health care personnel ( 5 ). Early protection of health care personnel is critical to preserve capacity to care for patients with COVID-19 or other illnesses. LTCF residents are defined as adults who reside in facilities that provide a range of services, including medical and personal care, to persons who are unable to live independently. LTCF residents, because of their age, high rates of underlying medical conditions, and congregate living situation, are at high risk for infection and severe illness from COVID-19. As of November 15, 2020, approximately 500,000 COVID-19 cases and 70,000 associated deaths had been reported among residents of skilled nursing facilities, a subset of LTCFs serving residents with more complex medical needs ( 6 ). With respect to vaccination program implementation, vaccines that require cold and ultracold storage, specialized handling, and large minimum order requirements are most feasibly maintained in centralized vaccination clinics, such as acute health care settings, or through the federal Pharmacy Partnership for Long-term Care Program. ¶¶ ACIP’s ethical principles for allocating initial supplies of COVID-19 vaccine, namely to maximize benefits and minimize harms, promote justice, and mitigate health inequities ( 7 ), support the early vaccination of health care personnel and LTCF residents. Approximately 21 million U.S. health care personnel work in settings such as hospitals, LTCFs, outpatient clinics, home health care, public health clinical services, emergency medical services, and pharmacies. Health care personnel comprise clinical staff members, including nursing or medical assistants and support staff members (e.g., those who work in food, environmental, and administrative services) ( 8 ). Jurisdictions might consider first offering vaccine to health care personnel whose duties require proximity (within 6 feet) to other persons. If vaccine supply remains constrained, additional factors might be considered for subprioritization.*** Public health authorities and health care systems should work together to ensure COVID-19 vaccine access to health care personnel who are not affiliated with hospitals. Approximately 3 million adults reside in LTCFs, which include skilled nursing facilities, nursing homes, and assisted living facilities. Depending upon the number of initial vaccine doses available, jurisdictions might consider first offering vaccination to residents and health care personnel in skilled nursing facilities because of high medical acuity and COVID-19–associated mortality ( 6 ) among residents in these settings. Monitoring vaccine safety in all populations receiving COVID-19 vaccine is required under an Emergency Use Authorization. Vaccines are being studied in older adults with underlying health conditions; however, LTCF residents have not been specifically studied. ACIP members called for additional active safety monitoring in LTCFs to ensure timely reporting and evaluation of adverse events after immunization. ACIP will consider vaccine-specific recommendations and additional populations for vaccine allocation beyond Phase 1a when an FDA-authorized vaccine is available. Summary What is already known about this topic? Demand is expected to exceed supply during the first months of the national COVID-19 vaccination program. What is added by this report? The Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) health care personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program. What are the implications for public health practice? Federal, state, and local jurisdictions should use this guidance for COVID-19 vaccination program planning and implementation. ACIP will consider vaccine-specific recommendations and additional populations when a Food and Drug Administration–authorized vaccine is available.

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          Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility

          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can spread rapidly within skilled nursing facilities. After identification of a case of Covid-19 in a skilled nursing facility, we assessed transmission and evaluated the adequacy of symptom-based screening to identify infections in residents. Methods We conducted two serial point-prevalence surveys, 1 week apart, in which assenting residents of the facility underwent nasopharyngeal and oropharyngeal testing for SARS-CoV-2, including real-time reverse-transcriptase polymerase chain reaction (rRT-PCR), viral culture, and sequencing. Symptoms that had been present during the preceding 14 days were recorded. Asymptomatic residents who tested positive were reassessed 7 days later. Residents with SARS-CoV-2 infection were categorized as symptomatic with typical symptoms (fever, cough, or shortness of breath), symptomatic with only atypical symptoms, presymptomatic, or asymptomatic. Results Twenty-three days after the first positive test result in a resident at this skilled nursing facility, 57 of 89 residents (64%) tested positive for SARS-CoV-2. Among 76 residents who participated in point-prevalence surveys, 48 (63%) tested positive. Of these 48 residents, 27 (56%) were asymptomatic at the time of testing; 24 subsequently developed symptoms (median time to onset, 4 days). Samples from these 24 presymptomatic residents had a median rRT-PCR cycle threshold value of 23.1, and viable virus was recovered from 17 residents. As of April 3, of the 57 residents with SARS-CoV-2 infection, 11 had been hospitalized (3 in the intensive care unit) and 15 had died (mortality, 26%). Of the 34 residents whose specimens were sequenced, 27 (79%) had sequences that fit into two clusters with a difference of one nucleotide. Conclusions Rapid and widespread transmission of SARS-CoV-2 was demonstrated in this skilled nursing facility. More than half of residents with positive test results were asymptomatic at the time of testing and most likely contributed to transmission. Infection-control strategies focused solely on symptomatic residents were not sufficient to prevent transmission after SARS-CoV-2 introduction into this facility.
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            Update: Characteristics of Health Care Personnel with COVID-19 — United States, February 12–July 16, 2020

            As of September 21, 2020, the coronavirus disease 2019 (COVID-19) pandemic had resulted in 6,786,352 cases and 199,024 deaths in the United States.* Health care personnel (HCP) are essential workers at risk for exposure to patients or infectious materials ( 1 ). The impact of COVID-19 on U.S. HCP was first described using national case surveillance data in April 2020 ( 2 ). Since then, the number of reported HCP with COVID-19 has increased tenfold. This update describes demographic characteristics, underlying medical conditions, hospitalizations, and intensive care unit (ICU) admissions, stratified by vital status, among 100,570 HCP with COVID-19 reported to CDC during February 12–July 16, 2020. HCP occupation type and job setting are newly reported. HCP status was available for 571,708 (22%) of 2,633,585 cases reported to CDC. Most HCP with COVID-19 were female (79%), aged 16–44 years (57%), not hospitalized (92%), and lacked all 10 underlying medical conditions specified on the case report form † (56%). Of HCP with COVID-19, 641 died. Compared with nonfatal COVID-19 HCP cases, a higher percentage of fatal cases occurred in males (38% versus 22%), persons aged ≥65 years (44% versus 4%), non-Hispanic Asians (Asians) (20% versus 9%), non-Hispanic Blacks (Blacks) (32% versus 25%), and persons with any of the 10 underlying medical conditions specified on the case report form (92% versus 41%). From a subset of jurisdictions reporting occupation type or job setting for HCP with COVID-19, nurses were the most frequently identified single occupation type (30%), and nursing and residential care facilities were the most common job setting (67%). Ensuring access to personal protective equipment (PPE) and training, and practices such as universal use of face masks at work, wearing masks in the community, and observing social distancing remain critical strategies to protect HCP and those they serve. Data from laboratory-confirmed and probable COVID-19 cases, voluntarily reported to CDC from state, local, and territorial health departments during February 12–July 16, 2020, were analyzed. COVID-19 cases are reported using a standardized case report form, which collects information on demographic characteristics, whether the case occurred in a U.S. health care worker (HCP status), symptom onset date, underlying medical conditions, hospitalization, ICU admission, and death. HCP occupation type and job setting were added to the case report form in May, enabling prospective and retrospective entry of these elements. Case surveillance data were enriched with additional cases from a COVID-19 mortality-focused supplementary surveillance effort in three jurisdictions § ( 3 ). Descriptive analyses were used to examine characteristics by vital status. HCP occupation type and job setting were reported by a subset of jurisdictions with at least five HCP cases for each variable. Analyses were conducted using Stata (version 15.1; StataCorp) and SAS (version 9.4; SAS Institute). Among 2,633,585 U.S. COVID-19 cases reported individually to CDC during February 12–July 16, HCP status was available for 571,708 (22%) persons, among whom 100,481 (18%) were identified as HCP. Data completeness for HCP status varied by jurisdiction; among jurisdictions that included HCP status on ≥70% of cases and reported at least one HCP case (11), HCP accounted for 14% (14,938 of 109,293) of cases with HCP status available and 11% (14,938 of 132,340) of all reported cases. Case report form data were enriched with 89 additional HCP cases using supplementary mortality data; thus, the final HCP case total for analysis was 100,570 (Table 1). TABLE 1 Demographics, underlying medical conditions, hospitalization status, and intensive care unit (ICU) status among health care personnel (HCP) with COVID-19, by vital status — United States, February 12–July 16, 2020 Characteristic* No. (%) Case fatality ratio,§ no./total no. Total Alive Deceased† Unknown Total 100,570 67,105 641 32,824 0.95 (641/67,746) Age group (yrs) N = 100,432 N = 67,023 N = 641 N = 32,768 — 16–44 57,742 (57) 39,018 (58) 57 (9) 18,667 (57) 0.15 (57/39,075) 45–54 20,981 (21) 13,836 (21) 99 (15) 7,046 (22) 0.71 (99/13,935) 55–64 17,052 (17) 11,264 (17) 205 (32) 5,583 (17) 1.79 (205/11,469) ≥65 4,657 (5) 2,905 (4) 280 (44) 1,472 (4) 8.79 (280/3,185) Sex N = 99,741 N = 66,796 N = 639 N = 32,306 — Female 78,328 (79) 52,366 (78) 395 (62) 25,567 (79) 0.75 (395/52,761) Male 21,413 (21) 14,430 (22) 244 (38) 6,739 (21) 1.66 (244/14,674) Race/Ethnicity N = 69,678 N = 45,104 N = 552 N = 24,022 — American Indian/Alaska Native, non-Hispanic 253 (0) 186 (0) 0 (0) 67 (0) — Asian, non-Hispanic 6,010 (9) 4,083 (9) 111 (20) 1,816 (8) 2.65 (111/4,194) Black, non-Hispanic 18,117 (26) 11,172 (25) 177 (32) 6,768 (28) 1.56 (177/11,349) Hispanic/Latino¶ 8,030 (12) 4,262 (9) 49 (9) 3,719 (15) 1.14 (49/4,311) Multiple/Other, non-Hispanic 4,195 (6) 2,662 (6) 13 (2) 1,520 (6) 0.49 (13/2,675) Native Hawaiian/Other Pacific Islander, non-Hispanic 422 (1) 314 (1) 4 (1) 104 (0) 1.26 (4/318) White, non-Hispanic 32,651 (47) 22,425 (50) 198 (36) 10,028 (42) 0.88 (198/22,623) Underlying medical conditions** N = 40,582 N = 26,868 N = 378 N = 13,336 — Any underlying medical condition 17,838 (44) 11,012 (41) 348 (92) 6,478 (49) 3.06 (348/11,360) Any chronic lung disease 6,422 (16) 4,064 (15) 89 (24) 2,269 (17) 2.14 (89/4,153) Any cardiovascular disease 7,348 (18) 4,331 (16) 229 (61) 2,788 (21) 5.02 (229/4,560) Diabetes mellitus 5,466 (13) 3,314 (12) 198 (52) 1,954 (15) 5.64 (198/3,512) Immunosuppressing condition 1,504 (4) 1,070 (4) 24 (6) 410 (3) 2.19 (24/1,094) Severe obesity 1,101 (3) 453 (2) 27 (7) 621 (5) 5.63 (27/480) Chronic renal disease 503 (1) 279 (1) 45 (12) 179 (1) 13.89 (45/324) Neurologic/Neurodevelopmental disability 528 (1) 333 (1) 34 (9) 161 (1) 9.26 (34/367) Chronic liver disease 242 (1) 148 (1) 10 (3) 84 (1) 6.33 (10/158) Autoimmune condition 479 (1) 262 (1) 3 (1) 214 (2) 1.13 (3/265) Psychologic/psychiatric condition 353 (1) 191 (1) 4 (1) 158 (1) 2.05 (4/195) Admission to hospital N = 83,202 N = 55,415 N = 591 N = 27,196 — Yes 6,832 (8) 4,207 (8) 518 (88) 2,107 (8) 10.96 (518/4,725) Admission to ICU N = 33,694 N = 22,545 N = 377 N = 10,772 — Yes 1,684 (5) 662 (3) 295 (78) 727 (7) 30.83 (295/957) Abbreviation: COVID-19 = coronavirus disease 2019. * Variable completeness varied by case characteristic: age (>99%), sex (99%), race and ethnicity (69%), hospitalization status (83%), ICU admission status (34%); characteristic-specific sample size for cases with available information are presented for each grouping. N = number with available information. † Death outcomes were known for 67,746 (67%) HCP cases; of these, 91 additional new fatal cases were included based on data from the supplementary mortality project (89 newly identified as HCP and two newly identified deaths among known HCP). Additional available data for these 91 cases were incorporated if missing in the national case surveillance data. § Deaths per 100 HCP cases with known death status. ¶ Cases reported as Hispanic were categorized as “Hispanic or Latino persons of any race” regardless of availability of race data. ** Underlying medical condition status was classified as “known” if any of these 10 conditions, specified on the standard case report form, were reported as present or absent: diabetes mellitus, cardiovascular disease (includes hypertension), severe obesity (body mass index ≥40 kg/m2), chronic renal disease, chronic liver disease, chronic lung disease, immunosuppressing condition, autoimmune condition, neurologic condition (including neurodevelopmental, intellectual, physical, visual, or health impairment), or psychologic/psychiatric condition. Status for these conditions was “known” for 40,582 persons. Responses include data from standardized fields supplemented with data from the free text field for “other chronic disease/underlying condition” for the 10 specific medical conditions, if not originally specified. Among HCP with COVID-19 overall, the median age was 41 years (interquartile range = 30–53 years); 79% of cases were in females. Among 69,678 (69%) HCP cases with data on race and ethnicity, 47% were in non-Hispanic Whites (Whites), 26% were in Blacks, 12% were in Hispanics or Latinos of any race (Hispanics), and 9% were in Asians. Of persons with known hospitalization or ICU admission status, 8% (6,832 of 83,202) were hospitalized and 5% (1,684 of 33,694) were treated in an ICU. Vital status was known for 67% (67,746) of HCP with COVID-19; among those, 641 (1%) died. Deaths among HCP with COVID-19 were reported in 22 jurisdictions. Compared with those who survived, decedents tended to be older (median age = 62 versus 40 years), male (38% versus 22%), Asian (20% versus 9%), or Black (32% versus 25%). Among HCP cases with data on one or more of 10 underlying medical conditions specified on the case report form, 17,838 (44%) persons had at least one condition. The most common were cardiovascular disease (18%), chronic lung disease (16%), and diabetes mellitus (13%). The vast majority (92%) of fatal HCP cases were among HCP with an underlying medical condition. More than one half had cardiovascular disease (61%) or diabetes mellitus (52%), conditions known to increase the risk for severe COVID-19 ¶ ; 32% were reported to have both conditions (Table 1). Six jurisdictions reported the occupation type** or job setting †† for at least five HCP with COVID-19 (Table 2). Among HCP with COVID-19 in these jurisdictions, occupation type was available for 59% (5,913 of 9,984) and job setting for 41% (6,955 of 17,052). Health care support workers accounted for the largest overall group of occupation types (32%), and nurses constituted the largest single occupation type (30%) (Table 2). Within this subset of HCP cases, two thirds (67%) were in persons reported to work in nursing and residential care facilities. TABLE 2 Occupation type and job setting of health care personnel (HCP) with COVID-19 — six jurisdictions,* February 12–July 16, 2020 Characteristic (no. with available information)† No. (%) Occupation type (5,913)§ Health care support worker¶ 1,895 (32.1) Nurse** 1,742 (29.5) Administrative staff member 581 (9.8) Environmental services worker 330 (5.6) Physician 190 (3.2) Medical technician 135 (2.3) Behavioral health worker 128 (2.2) First responder 113 (1.9) Dietary services worker 113 (1.9) Dental worker 98 (1.7) Laboratorian 68 (1.2) Occupational, physical, or speech therapist 65 (1.1) Pharmacy worker 62 (1.1) Respiratory therapist 44 (0.7) Phlebotomist 25 (0.4) Physician assistant 13 (0.2) Other 311 (5.3) Job setting (6,955)§ Nursing and residential care facility††,§§ 4,649 (66.8) Hospital 1,231 (17.7) Ambulatory health care service¶¶ 804 (11.6) Other 271 (3.9) Abbreviation: COVID-19 = coronavirus disease 2019. * Alaska, Kansas, Michigan, Minnesota, North Carolina, and Utah. † Occupation type data are included for five jurisdictions (Alaska, Kansas, Minnesota, North Carolina, and Utah) that reported occupation type for at least five HCP COVID-19 cases; occupation type data were known for 59% (5,913 of 9,984) of HCP cases in those jurisdictions. Job setting data are included for five jurisdictions (Alaska, Kansas, Michigan, Minnesota, and Utah) that reported job setting for at least five HCP COVID-19 cases; job setting data were known for 41% (6,955 of 17,052) of HCP cases in those jurisdictions. § Occupation type and job setting categories were determined either by inclusion on the CDC case report form or by manual review and categorization of free-text entries within “other, specify” fields. Free-text data were used to supplement existing categories for occupation (nurse, environmental services worker, physician, respiratory therapist) and setting (long-term care facility [including nursing home/assisted living facility], hospital, rehabilitation facility) and create new categories. ¶ Includes nursing assistant (1,444), medical assistant (123), and other care provider or aide (328); free-text fields were used to create new categories. **Includes data from standardized fields (1,724) supplemented with data from free-text fields (18); types of nurses or nursing specialties are not specified. †† Includes long-term care facility (including nursing home/assisted living facility) (4,424), rehabilitation facility (131), and group home (94). §§ Michigan provides job setting data only for cases identified from long-term care facilities (2,800). ¶¶ Includes outpatient care center (422), home health care service (317), and dental facility (65); free-text fields were used to create new categories. Discussion State, local, and territorial health departments voluntarily submit COVID-19 case notification data to CDC, and these critical data help provide a national picture of cases. The first report on HCP with COVID-19 using national case surveillance data in April 2020 ( 2 ) described characteristics of 9,282 HCP cases and 27 deaths among approximately 315,000 total cases. As of July 16, 2020, among approximately 2.5 million reported U.S. COVID-19 cases, 100,570 cases in HCP and 641 deaths among HCP with COVID-19 have been reported to CDC. Continued national surveillance is vital to evaluate the effect of the pandemic on HCP, and this update emphasizes the ongoing impact on this essential working population. Among reported HCP with COVID-19, age and sex distributions remain comparable to those of the overall U.S. HCP workforce §§ ; however, compared with nonfatal COVID-19 cases in HCP, fatal HCP cases were more common among older persons and males. Similar to findings described in the overall population ( 4 , 5 ), HCP with underlying medical conditions who developed COVID-19 were at increased risk for death. Almost all reported HCP with COVID-19 who died had at least one of 10 underlying conditions listed on the case report form, compared with fewer than one half of those who survived. Asian and Black HCP were also more prevalent among fatal cases; disproportionate mortality of persons from some racial and ethnic groups among cases has also been described in the general population ( 3 ). Long-standing inequities in social determinants of health can result in some groups being at increased risk for illness and death from COVID-19, and these factors must also be recognized and addressed when protecting essential workers in the workplace, at home, and in the community. Ensuring adequate allocation of PPE to all HCP in the workplace is one important approach to mitigating systemic inequalities in COVID-19 risk ( 6 ). As the COVID-19 pandemic continues in the United States, HCP are faced with increasing fatigue, demands, and stressors. HCP who are at higher risk for severe illness and death from COVID-19 should maintain ongoing communication with their personal health care providers and occupational health services to manage their risks at work and in the community. In this update, most HCP with COVID-19 were reported to work in nursing and residential care facilities. Large COVID-19 outbreaks in long-term care facilities suggest that transmission occurs among residents and staff members ( 7 , 8 ). During the COVID-19 pandemic, multiple challenges in long-term care settings have been identified, including inadequate staffing and PPE, and insufficient training in infection prevention and control. As the pandemic continues, it is essential to meet the health and safety needs of HCP serving populations requiring long-term care. Importantly, HCP cases were also identified from a variety of other health care settings. Therefore, increased access to resources, appropriate training, and ongoing support are needed across the health care spectrum to protect all HCP and their patients. HCP with COVID-19 were reported among a diverse range of occupations. Nurses represented 30% of HCP cases with known occupation type, but account for only approximately 15% of the total U.S. health care and social assistance workforce. ¶¶ Nurses and health care support workers often have frequent, close contact with patients and work in settings that might increase their risk for acquiring SARS-CoV-2, the virus that causes COVID-19. HCP who do not provide direct patient care, such as administrative staff members and environmental service workers, were also reported to have COVID-19. Risk to HCP can occur through pathways other than direct patient care, such as exposure to coworkers, household members, or persons in the community. HCP who acquire SARS-CoV-2 can similarly introduce the virus to patients, coworkers, or persons outside the workplace. Thus, practices such as universal use of face masks at work, wearing masks in the community, observing social distancing, and practicing good hand hygiene remain critical strategies to protect HCP and the populations they serve. Screening HCP for illness before workplace entry and providing nonpunitive sick leave options remain critical practices. The findings in this report are subject to at least five limitations. First, although reporting completeness increased from 16% in April to 22% in July ( 2 ), HCP status remains missing for most cases reported to CDC. HCP might be prioritized for testing, but the actual number of cases in this population is most certainly underreported and underdetected, especially in asymptomatic persons ( 9 , 10 ). Second, the amount of missing data varied across demographic groups, underlying medical conditions, and health outcomes; persons with known HCP status and other information might differ systematically from those for whom this information is not available. Third, details of HCP occupation type and job setting were not included on the CDC case report form until May 2020, and only six jurisdictions reported these data. Fourth, testing strategies and availability can vary by jurisdiction and health care setting, influencing the numbers and types of HCP cases detected. Finally, this report does not include information on whether exposure to SARS-CoV-2 among HCP cases occurred in the workplace or in other settings, such as the household or community. As of July 16, 2020, 100,570 COVID-19 cases in HCP and 641 deaths among HCP with COVID-19 were reported in the United States. Information on COVID-19 among essential workers, including HCP, can inform strategies needed to protect these populations and those they serve, including decisions related to COVID-19 vaccination, when available. Factors such as demographics, including race and ethnicity, underlying health conditions, occupation type, and job setting can contribute to the risk of HCP acquiring COVID-19 and experiencing severe outcomes, including death. Given the evidence of ongoing COVID-19 infections among HCP and the critical role these persons play in caring for others, continued protection of this population at work, at home, and in the community remains a national priority.*** Summary What is already known about this topic? Health care personnel (HCP) are essential workers at risk for COVID-19. What is added by this report? HCP with COVID-19 who died tended to be older, male, Asian, Black, and have an underlying medical condition when compared with HCP who did not die. Nursing and residential care facilities were the most commonly reported job setting and nursing the most common single occupation type of HCP with COVID-19 in six jurisdictions. What are the implications for public health practice? Continued surveillance is vital to understand the impact of COVID-19 on essential workers. Ensuring access to personal protective equipment and training, and practices such as universal use of face masks at work, wearing masks in the community, and observing social distancing remain critical strategies to protect HCP and those they serve.
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              The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020

              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: 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). 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. 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 assessing 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. TABLE 2 Application of ethical principles to four candidate groups for initial COVID-19 vaccine allocation — United States, 2020 Principles (with transparency across the decision-making process) Candidate groups* (approximate no.) Health care personnel† (21 million) Other essential workers† (87 million) Adults with high-risk medical conditions§ (>100 million) Adults aged ≥65 years (53 million) Maximize benefits and minimize harms Preserves health care services essential to the COVID-19 response and the overall health care system Preserves services essential to the COVID-19 response and overall functioning of society Reduces morbidity and mortality in persons with high incidence of COVID-19 disease and death** Reduces morbidity and mortality in persons with high incidence of COVID-19 disease and death†† Multiplier effect¶ Multiplier effect¶ Promote justice Addresses elevated occupational risk for SARS-CoV-2 exposure for those unable to work from home Addresses elevated occupational risk for SARS-CoV-2 exposure for those unable to work from home Will require focused outreach to vaccinate persons in this group who have no or limited access to health care or experience inequities in social determinants of health Will require focused outreach to vaccinate persons in this group who have no or limited access to health care or experience inequities in social determinants of health Promotes access to vaccine across a spectrum of HCP job types and settings Promotes access to vaccine and reduces barriers to vaccination in occupations with low vaccine uptake§§ Mitigate health inequities Racial and ethnic minority groups are disproportionately represented in low-wage HCP¶¶ Racial and ethnic minority groups are disproportionately represented in many essential industries*** Increased prevalence of obesity and diabetes (most prevalent conditions in this group) among some racial and ethnic minority groups; increased prevalence of some medical conditions for persons in rural areas§§§ Although racial and ethnic minority groups are underrepresented among adults aged ≥65 years, certain groups have disproportionate COVID-19–related hospitalization and death rates¶¶¶ Approximately one quarter of essential workers live in low-income families††† Could increase health inequities because diagnosis of high-risk medical conditions requires access to health care Strict age-based criterion could increase disparities due to racial and social inequities, such as occupation, income, access to health care Abbreviations: COVID-19 = coronavirus disease 2019; HCP = health care personnel. * 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; 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. † Essential workers during the COVID-19 response have been defined by the U.S. Department of Homeland Security Cybersecurity and Infrastructure Security Agency. https://www.cisa.gov/sites/default/files/publications/Version_4.0_CISA_Guidance_on_Essential_Critical_Infrastructure_Workers_FINAL%20AUG%2018v2_0.pdf . § Medical conditions considered high-risk are updated routinely based on the best available scientific data: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. ¶ The ability of one or more groups to remain healthy helps protect the health of others and/or minimize disruption to society and the economy. ** As of October 31, 2020, nearly 90% of persons with COVID-19–associated hospitalizations have at least one high-risk condition. Data are routinely updated through COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) (https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html); in-hospital deaths reported to COVID-NET during March–May, 2020 were associated with certain underlying medical conditions (https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1012/5872581 ). †† As of November 12, 2020, 80% of COVID-19 deaths were among adults aged ≥65 years. Data are routinely updated through CDC case-based surveillance (https://covid.cdc.gov/covid-data-tracker/#demographics ); long-term care residents account for a large proportion of deaths among adults aged ≥65 years (https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/ ). §§ Influenza vaccination coverage is low among many non–health care essential workers; such coverage is lowest among construction workers (10.7%) (https://www.cdc.gov/niosh/docs/2012-161/pdfs/2012-161.pdf?id = 10.26616/NIOSHPUB2012161 ). ¶¶ Health Resources and Services Administration estimates from American Community Survey 2011–2015 (https://bhw.hrsa.gov/sites/default/files/bhw/nchwa/diversityushealthoccupationstechnical.pdf ). *** Among 742 food and agriculture workplaces in 30 states, 73% of workers were Hispanic or Latino and 83% of COVID-19 cases occurred in racial or ethnic minority workers (https://wwwnc.cdc.gov/eid/article/27/1/20-3821_article ). ††† Center for Economic and Policy Research estimates from American Community Survey, 2014–2018 (https://cepr.net/a-basic-demographic-profile-of-workers-in-frontline-industries ). §§§ National Center for Health Statistics. National Health Interview Survey, 2018. Estimates not available for Hawaiian/other Pacific Islander persons or for chronic kidney disease among American Indian/Alaska Native persons (https://www.cdc.gov/nchs/nhis/ADULTS/www/index.htm; https://www.cdc.gov/mmwr/volumes/69/wr/mm6929a1.htm ). ¶¶¶ As of October 31, 2020, compared with COVID-19 hospitalization rates for adults aged ≥65 years who are non-Hispanic White, such rates were higher among adults aged ≥65 years who were non-Hispanic Black (rate ratio [RR] = 3.3), Hispanic or Latino (RR = 2.6), and non-Hispanic American Indian or Alaska Native (RR = 2.4). Data are routinely updated through COVID-NET (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html ); adults aged ≥65 years who are Hispanic or non-Hispanic Black experience disproportionate COVID-19–associated death rates (https://www.cdc.gov/nchs/nvss/vsrr/covid19/health_disparities.htm ). 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: 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. Summary 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.
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                Author and article information

                Journal
                MMWR Morb Mortal Wkly Rep
                MMWR Morb Mortal Wkly Rep
                WR
                Morbidity and Mortality Weekly Report
                Centers for Disease Control and Prevention
                0149-2195
                1545-861X
                11 December 2020
                11 December 2020
                : 69
                : 49
                : 1857-1859
                Affiliations
                CDC COVID-19 Response Team; General Dynamics Information Technology, Falls Church, Virginia; Epidemic Intelligence Service, CDC; University of Washington, Seattle, Washington; Stanford University School of Medicine, Stanford, California; Vanderbilt University School of Medicine, Nashville, Tennessee; Arkansas Department of Health, Little Rock, Arkansas.
                Author notes
                Corresponding author: Kathleen Dooling, vic9@ 123456cdc.gov .
                Article
                mm6949e1
                10.15585/mmwr.mm6949e1
                7737687
                33301429
                26af7d73-1702-44dc-b905-21c06dd8b8bb

                All material in the MMWR Series is in the public domain and may be used and reprinted without permission; citation as to source, however, is appreciated.

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