D.6 VA Guidance Risk Stratification, Vax Admin, Post Observation and Reporting, 36C25522R0052.pdf

Interim Guidance on Risk-Stratification for COVID-19 Vaccination in VHA

Version 2.0

General Overview ………………………………………………………………………………….2

Risk Stratification Table ………………………………………………………………………….3

Appendix A: Population Enumeration ………………………………………………………

Appendix B: ACIP/CDC Phases for Vaccination ……………………………...……………..5

Appendix C: Where VHA Guidance differs from CDC……………………………………….7

Appendix D: Guidance on Use of Framework ………………………………………………..8

Appendix E: Essential Workers ……………………………………………………………..…13

Veterans who are Essential Workers………………………………………………….13

Staff who are Essential Workers……………………………………………………….15

Appendix F: Ethical Review and Justification ……………………………………………….17

Appendix G: Evidence Review ………………………………………………………………….22

Appendix H: Workgroup Members ……………………………………………………………..32

D.6 VA Guidance Risk Stratification, Vax Admin, Post Observation and Reporting, 36C25522R0052

Interim Risk-Stratification for COVID-19 Vaccination in VHA VHA’s recommendations on risk stratification, also called prioritization, are based on guidance from the independent Advisory Committee on Immunization Practices (ACIP), the Center for Disease Control and Prevention (CDC). This guidance is intended to maximize benefits of COVID-19 vaccine to Veterans and staff when initial supply is limited and help guide outreach and scheduling when supply is robust and larger scale vaccination becomes possible.

It is expected that VA sites will follow the general principles outlined in this framework rather than creating separate guidance for each site, with the understanding that it will need flexibility and customization for local conditions, populations, and storage and handling constraints.

CDC guidance comprises broad categories to maximize feasibility across state and federal jurisdictions. The first groups to be offered vaccine COVID-19 (CDC phase 1a) include healthcare personnel and persons residing and working in long term care facilities, For healthcare personnel, this is based on risk of SARS-CoV-2 infection, risk of transmitting SARS- CoV-2 infection to patients, and public health and infrastructure risk if they are unable to work.

Residents in long term care facilities are also among the first to be offered COVID-19 vaccine because they are at heightened risk of morbidity and mortality during the COVID-19 pandemic.

Following Phase 1a vaccination, ACIP voted on December 20, 2020 to offer vaccine to persons 75 years and older and persons who are essential frontline workers as Phase 1b. For Phase 1c, ACIP recommends including persons who are 65 and older, persons with high risk conditions as defined by CDC, and other essential workers. It is expected that phases will overlap. These recommendations were published as official CDC guidance on December 21, 2020 at:

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x

While the population of enrolled Veterans who are essential workers is not known, more than half of our Veterans are aged 65 and older, and a large proportion of our Veterans have at least one high-risk condition. Because the number of Veterans expected to be offered COVID-19 vaccine during Phase 1 is so high, group 1c was further stratified by risk, to aid sites across VA in an ethical and equitable approach to offering COVID-19 vaccine. With our team of subject matter experts, including ethics, health equity, infectious diseases, infection prevention and control, preventive medicine, occupational health, pharmacy, public health, metrics and measurement, we reviewed risks to specific groups of staff and Veterans associated with COVID-19, and existing evidence and recommendations, to determine which groups should be offered COVID-19 vaccine first within broader categories, in order to maximize benefits to staff and Veterans.

Based on frameworks from the National Academies of Science, Engineering and Medicine (NASEM) (https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus) and discussions of the Advisory Committee on Immunization Practices (ACIP) for CDC (https://www.cdc.gov/vaccines/acip/meetings/index.html) we considered multiple contributors to overall risk, including:

• Risk of acquiring SARS-CoV-2 infection

• Risk of severe morbidity and mortality

• Risk of negative societal impact (risk of harm to society if that person is unable to work)

• Risk of transmitting SARS-CoV-2 infection to others

Note, these risk criteria are not listed in order of weight or importance.

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus https://www.cdc.gov/vaccines/acip/meetings/index.html

Interim Risk Stratification Table Version 2.0 CDC-VA Staff Veterans Comments A- 1a CLC/SCID unit staff Veterans residing in VA CLC/SCID Staff members not listed, including those who travel between units, should be offered COVID-19 vaccine with the group or unit most resembling their risk profile

For COVID-19 vaccines where rate of anticipated systemic side effects is high according to the applicable EUA fact sheet and/or CDC guidance, it is recommended that

COVID-19

vaccination is staggered, so that the number of personnel in each unit receiving vaccine at a given time is low. This will limit absences related to response to the COVID-19 vaccine. Under this scenario, offering COVID-19 vaccine to any HCP would be appropriate, rather than offering sequentially by risk.

*this should comprise the smallest number of staff needed to continue operations, rather than all persons who hold a particular job or role, with intent of keeping the health care system functioning to care for Veterans and keep staff safe.

**Front line cemetery workers and Veterans in care who are non- VA HCP may be offered vaccine during “A” as they are CDC 1a essential workers.

A- 1b Emergency Department, EMT

A- 1c COVID-19 ICU staff A- 1d COVID-19 non-ICU inpatient staff

A- 1e Other staff providing face-to-face care and services for COVID-19 patients

A- 1f Staff in other congregate living settings

Veterans residing in other long term/congregate settings without access to COVID-19 vaccine.

A- 2a

Core staff critical to function of the hospital and the COVID-19 response (e.g., logistics, facilities operations, police, food services, occupational health, infection control, environmental engineering, limited executive or leadership roles) *

A- 2b Inpatient staff, non-COVID-19 units

A- 2c Staff performing high risk procedures (non-COVID-19, pre-screened)

A- 3a Hemodialysis staff

A- 3b Oncology/chemotherapy unit staff

A- 4a Homeless Outreach staff

A- 4b

Staff with frequent contact with Veterans who have not been pre-screened for COVID-19 symptoms (screeners, drivers, etc.)

A- 4c Outpatient direct care/contact (pre-screened, non-COVID-19)

A- 4d Other health care personnel and staff **

B- 1a

Veterans age 75+

Homeless Veterans, Hemodialysis patients, Solid Organ Transplant patients, patients listed for transplant, and Chemotherapy patients (chemotherapy in a clinic/hospital setting), or Veterans with spinal cord injuries and disorders

Frontline Essential Workers as defined by CDC

C- 1a

Other VA services, non-health care

Veterans age 65-74 Other Essential Workers, as defined

C- 1b Veterans younger than 65 with high-risk conditions as defined

C- 1c Veterans younger than 65 with high risk conditions

ACIP (CDC) Phases 1a = Blue

(HCP, LTCF)

1b = Green

(Essential Workers, 75 and older) 1c = Brown

(65-74;

high-risk conditions) https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

Appendix A: Population Enumeration Note: this list does NOT contain all conditions that may be on the list of high-risk conditions as defined by CDC. This is because that list is being continually updated. This list may help guide planning, but should not be considered a recommendation for which groups to invite for vaccination. The high-risk conditions as defined by CDC should be used to guide invitation for vaccination.

Category Estimated Population Size % Employees Department of Veterans Affairs (Total) 418,688 Veterans Health Administration (Total) 373,435

HCP 247,239

Essential 41,259 Others 84,937 Volunteers 61,420 Trainees 124,190 Veterans Enrolled Veterans (total) 10,075,834

Age 85 and older 832,973 8% Age 75-84 1,483,666 15%

Age 65-74 2,675,315 27%

>65 4,991,954 50% Veterans Receiving Care 5,821,113 - >65 3,063,682 52.6% High Risk Medical Conditions Please use the CDC high-risk conditions list for vaccination decisions.

Cancer 544,149 9.3% Chronic Kidney Disease 339,435 5.8%

COPD 439,287 7.5%

Obesity (BMI of 30 or greater) 2,278,608 39.1% Cardiovascular disease 2,709,759 46.6% Sickle cell disease 2,998 0.1% Type 2 diabetes mellitus 1,556,431 26.7% Homeless 242,297 Nursing Home 9998 0.1% Other congregate settings 2279 0.04% Rural 1,992,232 34.2% Veterans with disability (100%) 847,580 14.5% Veterans with significant disabilities 291,348 5.0% Home based primary care 144,447 2.5% https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/evidence-table.html https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/evidence-table.html

Appendix B: ACIP/CDC Phases of Vaccination This graphic is from the 12/20/20 meeting of the independent Advisory Committee on Immunization Practice (ACIP).

CDC recommends offering vaccine in phases when supply of vaccine is limited initially.

Phase 1a includes healthcare personnel and residents in long term care facilities and was approved by ACIP 12/1/2020. ACIP voted on Phases 1b and 1c on 12/20/2020 following initiation of vaccination at some sites. Phase 1b includes adults 75 and older and frontline essential workers, and Phase 1c includes adults 65-74 and adults 16-64 with high-risk medical conditions. Phases 1b and 1c were published as official CDC guidance on December 22, 2020.

Phases of allocation are expected to overlap and CDC highlighted the need for local considerations and flexibility:

“State and local health authorities will need to take local COVID-19 epidemiology and demand for vaccine into account when deciding to proceed to the next phase or to subprioritize within an allocation phase if necessary. A flexible approach to allocation will facilitate efficient management and ensure that COVID-19 vaccine is administered equitably and without delay.”

CDC guidance is available at:

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w

Additional interim considerations for phased implementation of COVID-19 vaccines are available at https://www.cdc.gov/vaccines/covid-19/initial-populations.html and https://www.cdc.gov/vaccines/covid-19/phased-implementation.html .

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w https://www.cdc.gov/vaccines/covid-19/initial-populations.html https://www.cdc.gov/vaccines/covid-19/phased-implementation.html

CDC uses Cybersecurity & Infrastructure Security Agency definitions for essential workers and noted that this comprises about 87 million persons in the United States.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html

On December 20, 2020, ACIP separated essential workers into “frontline” and “other”, with “frontline essential workers” falling into Phase 1b, and others falling into Phase 1b.

At that time, they defined “the following non–health care essential workers as frontline workers:

first responders (e.g., firefighters and police officers), corrections officers, food and agricultural workers, U.S. Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the education sector (teachers and support staff members) as well as child care workers”.

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x

Following this, on January 13, 2021, CDC gave more specific definitions and an expanded list of frontline and non frontline essential workers in Phase 1b and Phase 1c.

https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html

For more information on Veterans and staff who are Essential Workers, please see Appendix E:

Essential Workers.

https://www.cisa.gov/publication/guidance-essential-critical-infrastructure-workforce https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html

Appendix C: Differences between CDC and VHA guidance VHA guidance closely follows guidance from CDC with a few branch points that are in keeping with the general CDC framework.

• CDC guidance states: “State and local health authorities will need to take local COVID- 19 epidemiology and demand for vaccine into account when deciding to proceed to the next phase or to sub prioritize within an allocation phase if necessary.”

1. The first exception is that VHA includes a small subgroup of Veterans that may be younger than age 75 in Phase 1b, because they fall into several categories of risk.

• This includes Veterans who are homeless, Veterans with Solid Organ Transplant, with particular emphasis on the peri-transplant period, Veterans who are treated with hemodialysis or chemotherapy in a hospital or clinic setting, and Veterans with spinal cord injuries and disorders in an institutional setting or living independently in the community.

• These groups are not only at elevated risk for morbidity or mortality from COVID-19 disease, but also have an additional exposure/transmission risk, which is of particular importance during surges of SARS-CoV-2 infection.

o For homeless Veterans, there is increased risk of needing to be in congregate living settings/shelters, particularly during the upcoming winter months.

o For Veterans receiving in-facility chemotherapy or hemodialysis, they will be present in a hospital or clinic setting, generally shared with other high risk Veterans, on a regular basis, which means increased risk of exposure to infection or of passing it to others who are also at high risk.

o For Veterans in the peri-transplant period for solid organ transplant, there is not only a very high morbidity and mortality associated with COVID-19 disease, but there is also a planned period of profound immunosuppression and hospitalization in the post-transplant period. Ideally, this group would be offered COVID-19 in the pre-transplant period, when immune response to vaccine might be greatest, and prior to planned hospitalization, surgery, and intensive care unit stay.

o For Veterans with spinal cord injuries and disorders, they are at higher individual risk due to paralysis of respiratory muscles, decreased ability to cough, and autonomic changes resulting in increased secretions. Mortality from COVID-19 infections is approximately 2.4 times higher than the general Veteran population. Approximately half of the deaths from COVID-19 infections have occurred in individuals living independently in the community.

In addition to individual risk, Veterans with SCI/D are at increased risk of exposure because they often have one or more caregivers that come into the home setting to assist with dependent needs and functions and are generally sicker and frequently require care in inpatient and outpatient settings.

2. The second branch-point is a sub-stratification in CDC Phase 1c.

• CDC Phase 1c includes persons who are 65 and older, and persons with high-risk conditions. VHA sub-stratifies this into persons 65 and older, followed by younger persons with a high-risk condition.

o Note that in o Evidence specific to our Veteran population suggests that age has a greater influence on COVID-19-related mortality than even presence of multiple high-risk conditions o A very large proportion of the Veterans served in VA have high-risk conditions and/or are aged 65 or older, making CDC Phase 1c a very large population

CDC guidance is available here:

https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w

Appendix D: Using the risk-stratification (prioritization) table Using the risk-stratification framework: Groups of staff not specified

Note: risk stratification assumes sites are following infection control guidance on personal protective equipment and screening measures.

The above table includes only categories of staff and units with predictable exposure risks across VA; others, such as food service workers, environmental management, IT, radiology and engineering, are not specifically assigned because exposure and risk patterns varies significantly from site to site.

It is expected that all staff will be accounted for in your local COVID-19 vaccine plan.

Because of variation in assignments and movement patterns from site to site, local determination must be made based on local patterns of movement and exposure.

Within healthcare facilities, for each subset of staff not directly mentioned in this framework, the three major risk-based criteria that form the basis for prioritizing healthcare personnel vaccination should be compared to those of the units listed (risk of acquiring SARS-CoV-2 infection, risk of transmitting SARS-CoV-2 infection to others, and societal/hospital impact if unable to work). Staff members should be offered vaccine along with the group or unit most resembling their risk profile. For example, Home Based Primary Care providers who care for COVID-19 patients may fall under “Other staff providing face-to-face care for COVID-19 patients”; those who perform high risk procedures in the home but do not care for COVID-19 patients may fall under “Staff performing high risk procedures”; and those who perform general outpatient care of patients without COVID would fall under “Outpatient direct care”. Similarly, food service workers may be offered vaccine along with the COVID+ units if they spend significant time interacting with patients in that setting. See additional examples at the end of this section.

Staff who do not interact with patients at all may be considered health care personnel depending on their role and location. CDC definition of health care personnel is here https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html and includes:

“all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP may include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the health care facility, and persons (e.g., clerical, dietary, environmental services, laundry, security, maintenance, engineering and facilities management, administrative, billing, and volunteer personnel) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted among from HCP and patients.”

Additionally, some staff may also be considered to be “core staff critical to the function of the hospital and the COVID-19 response” even if their role is virtual, but caution must be taken to ensure that front line staff at highest risk for exposure to COVID-19 are at the forefront, and this https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html exception should be used judiciously. See additional examples at end of this section. A subset of these staff may be offered vaccine as part of A-2a to ensure continued hospital operations, but many would be offered vaccine in A-4d, which is the last group in Phase 1a and which is expected to overlap with Phase 1b.

Using the priority framework: Progressing through phases The intent of the framework is to collaborate in the public health response to the COVID-19 pandemic and follow the national COVID-19 vaccine framework per CDC guidance to maximize benefit when vaccine quantities are limited. It is important to note that CDC recommends local flexibility in determining when to progress from one phase to the next: “State and local health authorities will need to take local COVID-19 epidemiology and demand for vaccine into account when deciding to proceed to the next phase or to sub prioritize within an allocation phase if necessary.”

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x It is expected that there will be overlap between phases as vaccine is offered.

Using the priority framework: Age stratification and Risk stratification The relative effects of comorbid ‘high-risk’ conditions on overall COVID-19 risk are attenuated in older age groups (because of the high level of risk associated with increasing age). The role of high-risk conditions as defined by CDC and membership in certain high-risk racial or ethnic minority groups becomes increasingly important in younger age groups, as overall risk decreases. The expectation is that VA will have ample availability of COVID-19 vaccine within Phase 1c, and it is for this reason that risk groups are addressed as a priority for outreach but are not tightly stratified.

If vaccine supply locally is not sufficient to offer vaccine to all persons in a phase, CDC noted that sub prioritization may be needed, and local decisions may be made on how to best to approach subgroups within a phase. Use of the Veteran Outreach Tool allows sub-stratification by presence of one or multiple high-risk conditions as defined by CDC. Veterans may be further stratified based on presence of 5+ high-risk conditions, 4+ high-risk conditions, and onward.

Outreach and education to ensure that we communicate with and promote access for Veterans in high-risk racial and ethnic minority groups and Veterans with high-risk medical conditions must be a focus of COVID-19 vaccination planning at all sites.

Using the risk-stratification framework: Flexibility of the framework

• Flexibility for Staff As above, it is expected that the general principles of this framework will be followed to ensure that benefits to staff and Veterans are maximized during periods of limited vaccine supply and that vaccine is offered in a way that is ethical and equitable.

However, local flexibility is needed in assigning staff not specifically mentioned, as noted under “Groups of staff not specified”. Additionally, significant flexibility may be needed for feasibility of use with vaccine products requiring ultra-cold storage methods. While it is expected that general principles of this framework will be followed, it is possible that additional staff or Veterans who are not in the highest risk groups may need to be included in several scenarios, including if: interest in initial vaccine is low (i.e., vaccine hesitancy); there are cancellations among scheduled staff or Veterans and a waitlist https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fneed-extra-precautions%2Fgroups-at-higher-risk.html https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html must be utilized to avoid wasting vaccine; or significant side effects from vaccine are expected (e.g., it may be preferable not to vaccinate entire units of staff simultaneously if potentially work-curtailing side effect from vaccination are common, as this would jeopardize ability to work, and potentially affect safety of other staff and Veterans).

• Flexibility for Veterans It is expected that this framework will be followed when offering COVID-19 vaccine to Veterans to ensure equitable vaccination across VA. While it is expected that general principles of this framework will be followed, it is possible that additional Veterans who are not in the highest risk groups may need to be included in several scenarios, including if: interest in initial vaccine is low (i.e., vaccine hesitancy); there are cancellations among scheduled staff or Veterans and a waitlist must be utilized to avoid wasting vaccine; or outreach to a particular area means offering vaccine to persons from different risk groups.

For the first dose in the vaccine series, reasonable attempts should be made to reach those at highest risk but it is not expected that COVID-19 vaccines be held if there is delay in returning calls and mailings for scheduling; it is reasonable to continue movement through priority groups.

Using the priority framework: sub-stratification If vaccine supply does not cover the size of a population group in the risk stratification table, consider further stratifying by age, as risk rises significantly with increased age. For example, scheduling vaccination could start with persons 85 and older if there is insufficient vaccine for all persons 75 and older. Further stratification by high risk conditions, as defined by CDC can also be done using the Veterans Outreach tool, which will allow sorting by number of high-risk conditions. Tools have been provided as an aid but it is not required that sites follow a specific model or order for sub-stratification. Given the scale of COVID-19 vaccination in VA, it is important to ensure that risk stratification does not create a barrier to maximizing the number of Veterans offered and scheduled for vaccination.

Using the priority framework: staff and Veterans who opt out for the first vaccine For staff and Veterans who opt out of receiving the first COVID-19 vaccine but are in a priority group to vaccinate early, they should still be eligible to receive COVID-19 vaccine later even if unwilling or unable to receive COVID-19 vaccine initially, unless they have changed jobs/roles and no longer meet criteria for prioritization. These staff and/or Veterans should be considered and scheduled along with whichever priority group is prioritized for COVID-19 vaccine at the time they ‘opt in’ but should not be allowed to take the place of another Veteran that has already been scheduled for COVID-19 vaccination. There is possibility of delays in scheduling due to high demand or limited quantity of COVID-19 vaccine.

Using the priority framework: COVID-19 vaccine requirements.

Being in a high priority group for COVID-19 vaccination means that COVID-19 vaccine should be offered. However, COVID-19 vaccination will not be required while a vaccine is available under an Emergency Use Authorization. Many healthcare personnel are at risk for SARS-CoV-2 infection, and may also transmit SARS-CoV-2 to others, including patients who may be at high-risk for severe COVID-19 disease if they become infected. For this reason, healthcare personnel will be encouraged to get vaccinated to lower risks to themselves, and potentially to lower risk to colleagues and patients.

Assignments, Infection Control and Personal Protective Equipment after COVID-19 vaccine

Veterans and staff should continue to follow infection control recommendations regardless of COVID-19 vaccination status, including masking for source control and distancing. Staff should not be assigned differently based on their decision to accept or decline vaccine, as this may create incentives to either receive or decline vaccination.

Additional Examples:

There is some degree of risk associated with any in-person work during the COVID-19 pandemic and the goal is to eventually offer COVID-19 vaccine to all staff. While supply of COVID-19 vaccine is limited, it must first be offered to those with highest risk of exposure to COVID-19 in the workplace, those caring for the most vulnerable patients, and those critical to continued ability to maintain operations, care for Veterans, and keep staff safe. This list is not inclusive of all occupations and is meant to provide examples to guide decision making at the facility level.

CLC – to start with a unit listed, it is expected that all staff performing roles on this unit where they will be interacting closely with Veterans and other unit staff will be offered vaccination with the unit. This may include, for example, nurses, physicians, technicians drawing blood, other unit-based personnel.

Food Services –personnel should be prioritized based on with whom they interact, which determines their risk of COVID exposure in the workplace. If frequent close contact* with COVID-positive patients is expected, it may be most appropriate to offer those staff vaccine along with staff in those units. If they do not enter rooms on those units, it may be more appropriate to offer vaccine with non-COVID inpatient or outpatient staff, depending on pattern of service.

Environmental Management Services –should be considered similarly to food services, based on units in which service is provided.

Nursing staff who work in multiple units – nursing staff working across multiple units should be offered vaccine with the highest risk unit in which they are assigned.

Scheduling staff – when to offer vaccine to scheduling staff will depend on the environment in which they work. If they have direct contact with Veterans, they should be assigned according to whether that includes close contact with COVID positive, unscreened, or pre-screened Veterans.

Van Drivers – van drivers interacting with Veterans who have been pre-screened as with hospital entry may be considered at similar risk to outpatient non-COVID clinics, provided they have the same personal protective equipment (PPE). If Veterans have not been pre-screened, it would be most reasonable to consider them along with persons who interact with Veterans who have not been pre-screened.

Entry Screeners – entry screeners for hospitals and clinics may have close contact* with persons who have not been pre-screened for COVID signs and symptoms.

Vaccination Providers – risk should be considered based on screening processes and likelihood of close contact with persons who are COVID positive, in comparison to units listed.

Anesthesiology – risk should be considered based on whether services are performed on COVID-positive patients (similar risk to COVID ICU personnel), pre-screened patients only (risk similar to those performing high-risk procedures) or include roles such as functioning on a cross-cutting code team (risk similar to the staff in the highest-risk unit that the code team serves).

Gastroenterology – this is an example of a specialty where some may be performing high risk procedures, some on COVID-positive patients (similar risk to COVID unit personnel), some on pre-screened patients (similar risk to those performing high risk procedures) while others may provide virtual care only (offered vaccine after it has been offered to staff providing in-person care). Risk stratification should align with services provided.

Home Based Primary Care – risk will depend on whether care is provided for COVID-positive patients, whether high-risk procedures are performed, and on symptom screening processes.

Support staff on site, no patient contact –staff will need to be considered based on risk.

Limited personnel may be considered as critical to operations, while most would be offered vaccine after all Veteran/patient-facing staff have been offered.

VA Central Office Employees – on January 13, CDC updated guidance indicating that persons working in administration of Veterans Affairs should be offered vaccination as part of Phase 1c.

https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html

Health Care Personnel working virtually or offsite – some health care personnel working virtually may be offered vaccine to keep a minimum core of staff for ongoing care of Veterans.

This may include staff who may be needed to provide face-to-face care either locally or via deployment (i.e. surge capacity). This could also include staff supporting the COVID-19 response, such as intensive care unit physicians providing supervision virtually to support an area with surging COVID-19 cases. Additionally, some services are necessary for continued care of Veterans, such as VA Consolidated Mail Outpatient Pharmacy (CMOP). Staff not falling into these roles would still be considered essential personnel as of CDC January 13 updates to the essential workers list and would be eligible for vaccination within Phase 1c.

Staff working outside a medical center – on January 13, CDC updated guidance indicating that persons working in administration of Veterans Affairs should be offered vaccination as part of Phase 1c. https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html . A small subset who are critical to continued safe provision of Veteran care or to the COVID-19 response may be offered vaccine earlier.

* definition of close contact should follow CDC definitions.

Appendix E: Essential Workers On December 20, 2020, ACIP separated essential workers into “frontline” and “other”, with “frontline essential workers” falling into Phase 1b, and others falling into Phase 1b.

At that time, they defined “the following non–health care essential workers as frontline workers:

first responders (e.g., firefighters and police officers), corrections officers, food and agricultural workers, U.S. Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the education sector (teachers and support staff members) as well as child care workers”.

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x

Following this, on January 13, 2021, CDC provided more specific definitions of frontline and non frontline essential workers in Phase 1b and Phase 1c. The full list is available here:

https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html

Veterans who are Essential Workers While the exact numbers of enrolled Veterans who are essential workers is not known, there is some data on employment among Veterans in the United States. Noting that this includes data on Veterans not enrolled in VA care, a 2019 Pew Research Center report noted that, among Veterans, 8.4% were in education and health services, 7.3% in transportation and utilities, 1.8% in agriculture, 4.3% in financial activities, 2.0% in information, and 6.4% in construction.

There is not a simple mechanism for identifying who among Veterans is in the essential workforce, which creates a challenge in inviting these Veterans for vaccination. States and jurisdictions will have different approaches to offering vaccine to essential workers as well, which limits planning for this on a national level. Most states will have plans for vaccination of essential workers, and discussion with local public health authorities is recommended. CDC has some recommendations regarding reaching groups of essential workers: Strategies for Populations Recommended to Receive Initial Doses of COVID-19 Vaccine | CDC. The goal of the COVID-19 vaccination plan is ultimately to maximize protection against COVID-19 across the United States, so essential workers who are Veterans should not be prevented or discouraged from being vaccinated by their jurisdiction if there is a plan in place for this. If there is not a plan for vaccination of essential workers locally, or if a Veteran prefers or has better access to vaccine through VA, VA should be prepared to offer vaccine to essential workers in Phase 1b and 1c according to their industry as listed by CDC https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html. Self-report may be the most practical means of identifying persons who are essential workers, as proof of occupation may present barriers on the patient end and staffing and training challenges on the VA side. However, if state or local jurisdictional plans include a means to identify persons in these industries, this may aid in vaccination of enrolled Veterans among them. As with all risk stratification and vaccination planning, care should be taken to avoid any processes that slow vaccination.

https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_x https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html https://www.cdc.gov/vaccines/covid-19/implementation-strategies.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finitial-populations.html https://www.cdc.gov/vaccines/covid-19/implementation-strategies.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finitial-populations.html

DeSilver, Drew. How Veterans and non-Veterans fare in the U.S. job market. Pew Research Center. 17 September 2019. https://www.pewresearch.org/fact-tank/2019/09/17/how-veterans-and-non-veterans-fare-in-the-u-s-job-market/ https://www.pewresearch.org/fact-tank/2019/09/17/how-veterans-and-non-veterans-fare-in-the-u-s-job-market/

VA Staff who are Essential Workers In keeping with CDC Guidance on Phased allocation of COVID-19 vaccine, healthcare personnel have been offered COVID-19 vaccine in the initial phase of vaccination (Phase 1a/VHA “A”). CDC’s updated guidance on essential workers indicates that cemetery workers are also included in 1a. Note that VA did extend vaccination to health care personnel who are not traditionally eligible for vaccination services through VA, for COVID-19 vaccination only, including contractors and some students and trainees. This was done because of the nature of work in health care during the COVID-19 pandemic, but a similar extension is not expected for non health care personnel.

On January 13, CDC updated guidance indicating that persons working in administration of Veterans Affairs could be eligible for vaccination as essential workers as part of Phase 1c.

https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html.

A small subset of VA administration will be critical to continued safe provision of Veteran care during the COVID-19 pandemic and these persons should be offered vaccine earlier, either as A-2a (very limited, individuals whose absence would negatively impact operations) or A-4d (persons who may be working within groups critical to health care operations or the COVID-19 response).

Additionally, there are some VA staff who serve in occupations that are designated as being eligible for vaccination in CDC Phase 1b as non health care front line essential workers.

Persons who may be VA-employed front line essential workers offered COVID 19 vaccine during CDC Phase 1b (VHA “B”) – see table below.

Examples of Industry or Occupations within VA within CDC Phased Allocation Groups CDC 1a/VHA “A”

Health Care Personnel, including front line cemetery work

• Health Care Personnel includes persons working in health care facilities in administrative roles, per CDC definition, for example

• PIV card offices within a health care facility

• Benefits services offices within a health care facility

• Grand transportation to bring patients for care (DAV van)

Terminology | HCP | Infection Control Guidelines Library | CDC A-2a A-4d

Additional staff critical to health care operations and/or the COVID-19 response, for example:

• Consolidated Mail Outpatient Pharmacy/CMOP staff

• Health care operations or COVID-19 response leads in VA Central

Offices

• Area Emergency Managers

• DEMPS, TNC (if not eligible earlier through VHA “A”)

• Veterans Crisis Line

A small subset of VA administration will be critical to continued safe provision of Veteran care during the COVID-19 pandemic and these persons should be offered vaccine either as A-2a (very limited, individuals whose absence would negatively impact operations) or A-4d (persons who may be working within groups critical to health care operations or the COVID-19 response).

CDC 1b/VHA “B” Non Health Care Front Line Essential Workers, as per CDC

• Police

• Food services

• Grocery

• Vocational rehabilitation

• Bus/shuttle transportation (other than health care, which is 1a)

• Electronic or equipment repair (if VA-employed)

• Child care services (if VA-employed).

https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html CDC 1c/VHA “C” All other VA staff (92314x: Administration of Veterans Affairs), for example

• Virtual employees

• VACO employees who would not be providing close support in a

COVID surge environment

• VHA researchers who work off-site from medical centers

• OGC

• VHA program office employees in off-healthcare site offices

(financial services) CDC notes: This industry comprises government establishments primarily engaged in the administration of programs of assistance, training, counseling, and other services to Veterans and their dependents, heirs, or survivors.

https://www.cdc.gov/vaccines/covid-19/categories-essential-workers.html.

https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html

Appendix F: Ethical Justifications for COVID-19 Vaccine Allocation in a Situation of Scarcity VHA’s National Center for Ethics in Health Care

When allocating a scarce health care resource, such as a vaccine, VA health care leaders and experts must develop an ethically justifiable plan or framework for how to allocate the resource.

When vaccines against SARS-Cov-2, the virus that causes COVID-19, first become available, there will be a limited supply of doses, requiring a fair plan to determine who will receive the vaccine first. If we only have 100 doses of a vaccine, and 1000 people need to be vaccinated, selecting who should receive the vaccine will depend on several factors. Are the individuals being considered for COVID-19 vaccination similar to those on whom safety and efficacy of the vaccine has been demonstrated? Will targeting the COVID-19 vaccine to these individuals or groups better stop the spread of the virus? What are practical methods for vaccine administration? Unfortunately, there are many unknowns related to COVID-19 that challenge the ability to unequivocally predict which vaccine allocation framework will provide the most benefit and avoid the most harm to individuals and society. However, VA has developed an ethically defensible approach to vaccine allocation that has been informed by a wide range of subject matter experts.

In the very early phase of vaccine availability, the goal will be to select only individuals meeting certain scientific and ethical criteria to vaccinate so that benefit to Veterans and VA staff is maximized, and everyone is treated with equal respect. As more vaccine becomes available, the goal will be to expand outreach so that the greatest number of Veterans and VA staff will be vaccinated to achieve community immunity (also referred to as “herd immunity”) from COVID-

19. Below, we expand on the ethical justifications for the VA’s proposed allocation plan. This includes maximizing benefit to Veterans, treating people with equal concern (meaning attributing the same worth to all individuals regardless of their vaccine allocation priority), and addressing health inequities as they relate to vaccination.

Maximizing benefit

The ethical principle of utility involves seeking the greatest good for the greatest number of people—that is, maximizing benefit to society. Assuming that an FDA authorized or licensed vaccine mounts a sufficient immune response against the SARS-CoV-2 virus, three categories of benefit may be achieved: (1) sparing infection, illness, and death from COVID-19 in vaccinated individuals; (2) not spreading the virus; and (3) allowing vaccinated individuals to continue serving as essential workers. In the early phase of COVID-19 vaccine deployment, when there is more demand than supply, benefit is maximized by vaccinating individuals for whom all three categories of benefit can be achieved. Because COVID-19 spreads fastest in areas where there are people in close quarters and harms are greatest for those who are vulnerable to becoming seriously ill (e.g., elderly people with multiple medical conditions), prioritizing health care workers who care for such individuals will mitigate the spread of the virus to the patients in their care. COVID-19 vaccination would thus begin with the staff of community living centers (CLCs) and spinal cord injury and disorder (SCID) facilities, followed by vaccinating patients in these facilities. This is justified because the patients there are at higher risk of contracting COVID-19 and suffering severe or fatal outcomes. In a modeling study from CDC, vaccinating staff first was likely to more effectively halt viral contagion in such facilities.

This is because staff interact with a greater number of individuals and can more easily spread the virus, especially when infected with SARS-CoV-2 but showing no symptoms of COVID-19.

Also, staff (being generally younger and healthier) may more effectively mount an immune response as a result of receiving the COVID-19 vaccine.

The categories of persons allocated to receive the vaccine next represent evaluations, in decreasing order of priority, of which VA staff and Veterans are most likely to transmit SARS- CoV-2to others, be removed from critical professional functions, and/or are most at risk of contracting SARS-CoV-2 and suffering serious or fatal illness. The latter (individuals at highest risk of suffering serious or fatal illness) are those with advancing age and presence of comorbid conditions such as asthma, kidney disease, diabetes, high blood pressure, and obesity. As more becomes known about COVID-19, adjustments may be made to these allocation phases to achieve maximum benefit to the most people from the vaccine allocation framework.

It is important that Veterans and VA staff maintain trust in VA’s plan for COVID-19 vaccine allocation. Allocation decisions should be based on the principles outlined here and not on arbitrary factors or individual favoritism or perceived social worth. For example, if COVID-19 vaccine is dispatched to a CLC facility and all CLC staff with direct patient contact are eligible to be vaccinated, all such staff should have an equal opportunity to be selected for vaccination, rather than using an ad hoc process. Effectively informing COVID-19 vaccine-eligible individuals of the risks and benefits of the candidate vaccine and establishing a fair and transparent process for selecting which individuals to vaccinate is essential. All communication should be truthful and respectful to earn, secure, and maintain trust in the COVID-19 vaccination program.

Independent of the COVID-19 vaccine allocation protocol, vaccine acceptance will be critical for any vaccine program because to achieve community immunity, most VA Veterans and staff will need to be vaccinated against COVID-19. A recommended approach is to provide tailored education to individuals on both the benefits (both to them individually and to society) and burdens of and concerns with accepting the vaccine and to appeal to altruism and solidarity in achieving vaccine acceptance. Special efforts are necessary to minimize the number of vaccine non-adopters, a term encompassing individual hesitant to accept vaccine (due to lack of information, misinformation, or emotional ambivalence) as well as individuals refusing vaccine (Su et al., 2020). Wilson and Wiysonge (2020) demonstrated a correlation between misinformation spread through false news outlets and social media and vaccine non-adoption.

This underscores the importance of effective messaging and education.

There are limits to what is justifiable in the interest of maximizing societal benefit. For example, quarantine of individuals who test positive for COVID-19 has been voluntary to date. However, as stated in VHA’s Ethics Guidance for Pandemics, 2020, “individual liberties may be limited to prevent harm to others; public health measures are established on this basis.” Because individual liberty is highly valued, the notion of using the least restrictive means is critical in promoting COVID-19 vaccine acceptance among Veterans and VA staff. Mandating vaccination either when COVID-19 vaccines are first released or later is a matter for discussion; no decision has been made thus far. A COVID-19 vaccine mandate might be justified if a proven safe and effective vaccine is the least restrictive means to prevent serious harm to others and no alternative is available. This evokes the concept of proportionality, which involves weighing risks, benefits, and alternatives.

Criteria to mandate COVID-19 vaccine will not likely be met in the early vaccination program, since COVID-19 vaccines will initially only be available under emergency use authorization

(EUA). An EUA is a mechanism through which the U.S. Food and Drug Administration (FDA) may facilitate the availability and use of certain unapproved medical countermeasures, including vaccines, during public health emergencies. Under an EUA, FDA may allow the use of an unapproved medical product, or unapproved uses of approved medical products, in an emergency when certain statutory criteria have been met. FDA has stated that, for a COVID-19 vaccine for which there is adequate manufacturing information, FDA may issue an EUA if FDA determines that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.