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12/3/20 COVID-19 Brief: When to Vaccinate Your Workforce – Practical and Ethical Considerations

Because of the phased rollout, planning for COVID-19 vaccination will be significantly more complicated than an annual flu shot program. To simplify planning, I recommend employers think in terms of three groups. The first two groups are relatively straight-forward, the third presents companies with an ethical dilemma.

A Message on COVID-19 from WorkSTEPS Chief Medical Officer, Dr. Ben Hoffman

When to Vaccinate Your Workforce – Practical and Ethical Considerations

Take-Aways

  • About 40 million doses of COVID-19 vaccine – enough to fully immunize 20 million people – will be distributed in the US by the end of the year.
  • Vaccines will be distributed in phases recommended by the CDC, with vaccines available to at-risk and essential worker populations before the general public.
  • Plans for employee vaccination should align with CDC phases to maximize vaccination of employees and dependents as they are eligible.
  • Medical supply brokers are saying they may be able to legally source supplies of approved vaccines and make them available for sale to corporate customers, creating an ethical dilemma.
  • Employers can address the dilemma by applying the same ethical principles that guide the CDC’s decisions on vaccination phases.  

Things are moving quickly now. Just two weeks ago, we were breathing a collective sigh of relief at the promising results coming out of Pfizer and Moderna. In light of that good news, I wrote this article to encourage and inform corporate COVID-19 vaccine strategies. Fast-forward to yesterday, and the Advisor Committee on Vaccination Practices (ACIP) has made the first in what will be a series of recommendations about how to allocate vaccine supplies.

Meanwhile, our phones are ringing with two types of calls: 1) Brokers who are saying they may be able to procure some supplies of approved vaccines from excess and unused inventories; and 2) Companies eager to vaccinate their employees and wanting to balance their urgency with the ethics and legalities of vaccination.

This article will seek to summarize the supply/demand landscape and to then examine practical implications and ethical considerations for workforce vaccination against COVID-19.

Vaccine Supply

A quick summary of what we think we know:

  • We expect Pfizer to gain FDA approval for its vaccine on December 10th, followed by the approval of Moderna’s vaccine on about the 18th.
  • Both companies have been producing vaccines in parallel with their clinical trials, so vaccine distribution will begin within hours of the approval announcements.
  • An estimated 40 million doses will be distributed through the end of December. Because the vaccine regimen involves two doses given three to four weeks apart, the initial supply is enough to fully immunize about 20 million people.
  • After the New Year, federal officials estimate enough vaccine supply will be produced to vaccinate 25 to 30 million people per month.
  • Based on that estimate, the US should have enough vaccine supply to vaccinate 170 to 200 million people by the end of June.
  • The critical caveat – these estimates assumes approvals (including anticipated approvals of vaccines from J&J, AstraZeneca, Novovx and others), manufacturing and distribution go smoothly.

Vaccine Demand

Again, a summary of what we think we know:

  • To achieve population-wide protection from COVID-19 (herd immunity) experts estimate we need about 70% of the population to be vaccinated or to have contracted the virus – about 220 million people.
  • Based on guidance from ACIP, the CDC will recommend a phased distribution of vaccines. ACIP recommendations are rooted in four ethical principles: 1) Maximize benefits and minimize harms; 2) Promote justice; 3) Mitigate health inequities; and 4) Promote transparency.
  • Based on the recommendations announced yesterday – which the states are not required to follow, but likely will with perhaps some minor modifications – Phase 1A of vaccine distribution will prioritize health care workers (21 million people) and residents of long-term care facilities (another 3 million people).
  • While details are forthcoming, it is anticipated that Phase 1B will prioritize other high-risk populations, including adults with underlying health conditions, people ages 65 and over who aren’t in communal settings, and essential workers.
  • Notably, it is estimated that the Phase 1B group totals nearly 200 million people, so decisions will need to be made within states regarding sub-priorities in this phase.
  • For employers, a critical issue is: Which, if any, of my employees will be considered essential workers? We will need to wait for ACIP’s Phase 1B recommendations for specifics (which may be informed by a committee from the Department of Homeland Security), but in principle the notion of “essential” is pretty broad, including workers whose “ability to remain healthy helps to protect the health of others or to minimize societal and economic disruption.” With such a broad definition, it is likely that Phase 1B demand for vaccines to protect essential workers will exceed supply well into the second quarter.
  • Only after the above populations have been covered is it likely that younger, low-risk and non-essential workers and others will have access to vaccines.

Planning for Your Workforce

Because of the phased rollout, planning for COVID-19 vaccination will be significantly more complicated than an annual flu shot program. To simplify planning, I recommend employers think in terms of three groups. The first two groups are relatively straight-forward, the third presents companies with an ethical dilemma.

Group #1 – At-Risk and Essential Employees

Unless your organization is a hospital or health system, you’ll sit out Phase 1a, but because of health risk and age criteria, you will have vaccine-eligible employees and dependents in Phase 1b, even if you don’t employ any essential workers.

As noted in this recent article, your vaccine communication plan should align with the CDC’s distribution Phases. Vaccination priorities should be well-understood and clearly communicated to eligible employees with encouragement and support to get vaccinated.

For essential workers, consideration may be given to making vaccination mandatory – a tactic that may sound extreme, but which has legal standing. This article in the National Law Review notes: “In the absence of state or local law to the contrary, employers may require employees to get vaccinated from the flu. However, even in a pandemic, the Equal Employment Opportunity Commission (EEOC) has emphasized that an employee may be exempt from a mandatory vaccine if the employee has a disability covered by the Americans with Disabilities Act (ADA) that prevents them from taking the vaccine.” The bottom line – requiring vaccination may be possible, but it won’t be straightforward, and employers will likely be required to go through the accommodation process with employees who request to opt out of mandatory vaccination. It is likely the EEOC will weigh in shortly on their opinion regarding mandatory vaccination.

Group #2 – General Vaccination

Mid-2021 or later, after at-risk populations and essential workers are vaccinated and vaccines become more generally available to the public, your company’s plan should be to launch an intensive campaign in concert with phased eligibility so that at least 70% of your workforce is vaccinated as quickly as possible. As noted in a prior article, this is will be a heavy lift requiring substantial leadership commitment, community-level collaboration and strong communications.

Group #3 – The “We Can but Should We?” Group

Earlier I noted that I’m getting calls from brokers who say they may be able to legally source supplies of approved vaccines and make them available for sale to corporate customers. This opens the opportunity for companies to vaccinate employees apart from consideration of the CDC’s phased priorities.

I’m not trying to be dramatic but want to make the point: The ability to purchase vaccines commercially means that Jessica, your healthy, 45-year-old head of sales could be vaccinated before her daughter’s teacher, local first responders, or even her 79-year-old father.  

That example illustrates the can/should dilemma companies face: Just because we can vaccinate our people out of alignment with the CDC’s guidance, should we?

To address the dilemma, I recommend turning to the ethical principles at the root of ACIP’s recommendations. Let’s consider them relative to company vaccine policy:

  • Maximize the Benefits and Minimize the Harms. This principle states that: “Allocation of COVID-19 vaccine should maximize the benefits of vaccination to both individual recipients and the population overall.” And, relative to essential workers, notes: “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).”
  • Promote Justice. This principle states: “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.”
  • Mitigate Health Inequities. This principle acknowledges disparities in COVID-19 infections and deaths during the pandemic, and notes: “Vaccine allocation strategies should aim to both reduce existing disparities and to not create new disparities.”
  • Promote Transparency. This principle states: “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.”

If your organization uses these principles to guide its decisions regarding employee vaccination, I expect you’ll discover three things:

  • Your strategy will be well-aligned to CDC recommendations (including essential worker recommendations). For example, a decision to prioritize front-line, customer-facing workers ahead of office-based employees who are primarily working from home anyway maximizes benefits, promotes justice and, because front-line workers often represent marginalized groups, helps mitigate health inequities.
  • You will identify special circumstances where it makes sense to vaccinate certain workers ahead of CDC-recommended eligibility. Considering the example above, it may be completely justifiable to vaccinate Jessica and her entire sales team if doing so will enable them to again begin traveling so they can generate sales essential to the future of the company and its employees.
  • The transparency principle will improve your plan. Whatever you decide to do in terms of employee vaccination, it will become known to internal and external stakeholders. So, whether you ever publish your vaccination plan, it’s a good idea to write it up as if that is your intent.

Spelling out who you plan to vaccinate, when, and why/how the plan abides by the ethical principles outlined above will force clear-headed thinking. Skipping this step could result in a plan that – in reality or perception – values the health of some employees over others or values the interests of your company over the health and lives of more at-risk populations in your community.  

Whatever your vaccination plan, if you need a trustworthy source to procure vaccine supplies, contact us – we may be able help.

More to Come

There is so much more to say on the subject of vaccination, and the landscape will be rapidly evolving in the weeks and months ahead. I invite and encourage you to share suggestions and feedback here as we strive to meet your need for insights and sound guidance.

Ben Hoffman, MD, MPH
Chief Medical Officer, WorkSTEPS

For more from Dr. Hoffman, connect with him on LinkedIn.

Medical:


Area Reported Cases Deaths Recovered
Global 64,328,508 1,489,829 44,612,016
United States 14,108,606 276,979 8,333,255

Source

From the first COVID-19 case, it took 90 days for the global total to reach 1 million cases. From there:

1 million to 10 million- 86 days

10 to 20 million- 44 days

20 to 30 million- 37 days

30 to 40 million- 31 days

40 to 50 million- 21 days

50 to 60 million- 17 days

Source

United States

The US CDC reported 13.30 million total cases and 266,051 deaths. The US surpassed 13 million cumulative cases on November 28. From the first case reported in the US on January 22, it took 96 days to reach 1 million cases. From there:

1 to 2 million- 44 days

2 to 3 million- 27 days

3 to 4 million- 15 days

4 to 5 million- 17 days

5 to 6 million- 22 days

6 to 7 million- 25 days

7 to 8 million- 21 days

8 to 9 million- 14 days

9 to 10 million- 10 days

10 to 11 million- 7 days

11 to 12 million- 5 days

12 to 13 million- 7 days

New hospitalizations record: On Tuesday, US COVID-19 hospitalizations soared to a new record. States are closely tracking ICU capacity and staffing to ensure they have enough  coverage in anticipation of a post-Thanksgiving holiday spike in infections. As of yesterday, the number of Americans currently hospitalized for COVID-19 reached 96,039, up from 93,219 the day before.  

Blood donations suggest SARS-CoV-2 was in US last December: A study published Monday found that 1% of US blood donations from December 2019 and in early 2020 contained SARS-CoV-2 antibodies, suggesting that the virus was circulating in the US. earlier than thought, and before cases in China were publicly reported. The initial US case was identified on Jan 19. Researchers performed serologic testing of 7,389 blood samples from regularly donated American Red Cross blood samples  from Dec 13, 2019 to Jan 17, 2020 in nine states.  Of the 7,389 samples, 1.1%—84 samples from residents in all nine states—showed virus-neutralizing activity suggesting the presence of anti–SARS-CoV-2–reactive antibodies.

AstraZeneca/Oxford Vaccine Reaches 90% Efficacy:  Last week AstraZeneca/Oxford University announced interim results from a Phase 3 vaccine trial. Their COVID-19 vaccine has up to 90% efficacy against SARS-CoV-2—and would be easier to distribute than other promising candidates. The vaccine uses weakened version of a common cold virus to shuttle a gene from SARS-CoV-2 into cells to make the coronavirus spike proteins that the body will use to defend against natural COVID-19 infection. The trial looked into 2 dosing regimens: A half dose followed by a full dose 1+ months later showed ~90% efficacy. Two full doses a month apart had 62% efficacy. Of significance: The Oxford vaccine can be stored in the fridge, as opposed to needing subzero transport and storage freezers – this will be a major advantage for global distribution.

Severe COVID-19 may cause permanent lung damage: A study published this week detailed irreversible lung damage in three patients with severe COVID-19 infection. The patients who suffered from severe COVID-19 received bilateral lung transplants. The researchers examined the lungs removed from the three transplant patients and two patients who had died from COVID-19. All patients had required prolonged mechanical ventilation and extracorporeal membrane oxygenation (ECMO) support and had non-resolving COVID-19 related respiratory failure. The researchers found extensive thickening or scarring of the air exchange tissues of the lung with cavities containing bacterial pathogens, suggesting secondary infections. All lung samples had regions of diffuse bleeding, in the air sacs where gas exchange occurs. They compared RNA sequences of the diseased lung tissue with samples from pulmonary fibrosis patients, finding similarities. The study suggests COVID-19 may cause a fibrotic lung disease in some patients necessitating lung transplants as an option for survival.

Clinical symptoms among ambulatory patients tested for SARS-CoV-2: A CDC study published late last week reported wide overlap between symptoms of COVID-19 and those of other respiratory illnesses. The researchers studied a total of 4,961 patients, 916 tested positive for SARS-CoV-2 via PCR, and 4,045 had respiratory symptoms but tested negative for the virus. Cough was the most common symptom in both SARS-CoV-2–positive and negative patients (86% and 83%). Shortness of breath was reported less often by those with COVID-19 than without (40% vs 47%), and 99% of patients reported fever and/or cough. 59% of persons with COVID-19 versus 19% of persons without COVID-19 reported diminished taste or smell. Generalized symptoms (muscle aches or headache) and gastrointestinal symptoms (vomiting, diarrhea, or abdominal pain) were more common among persons with COVID-19 (91% and 57%) than among those without COVID-19 (83% and 50%). Because of the wide overlap in COVID-19 symptoms with those of other respiratory illnesses, laboratory confirmation of SARS-CoV-2 infection will be key especially for assessing the effectiveness of interventions during periods of co-circulation of COVID-19 and other respiratory illnesses, including influenza.

Estradiol hormone therapy may protect against COVID-19 death:

A study  published late last week found that pre-menopausal women with higher natural levels of the sex hormone estradiol are 15% more likely to be infected with SARS-CoV-2 than men but less likely to become seriously ill or die. The study also found that estradiol hormone therapy for peri- and post-menopausal women significantly improves survival rates for infected women.

Estradiol appears to play a role in blocking cytokine production pathways, which may be implicated in the "cytokine storm. Researchers collected retrospective data from 68,466 COVID-19 patient electronic health records from 17-countries.

Younger, pre-menopausal women have 15% higher frequencies of COVID-19 than age-matched men, but men have 50% higher fatality rates than women, suggesting a possible association with higher estrogen levels, the study authors wrote. Researchers posited that a brief, 7-day course of estradiol, via a transdermal patch, could be a safe approach to reduce symptom severity in adult men and in older women, when administered prior to intubation.

In nearly all US jurisdictions, less than 10% of people had antibodies against SARS-CoV-2, according to a study spanning July–September 2020. JAMA

Mitigation/Suppression:

U.S. Isolation and Quarantine Duration

Last week, White House Coronavirus Task Force member ADM Brett Giroir commented that senior health officials are reevaluating the recommended time that individuals should quarantine after a known exposure to SARS-CoV-2 with an eye toward shortening the quarantine period. A recent study published in The Lancet found that the length of time that individuals can shed viable SARS-CoV-2 is shorter than previously believed. The US CDC currently recommends that exposed individuals quarantine for 2 weeks after their last close contact with a COVID-19 case and that infected individuals should isolate for at least 10 days after the onset of symptoms and at least 24 hours after the fever resolves. Updated CDC guidance could potentially include a provision to shorten quarantine or isolation if accompanied by negative results for a diagnostic test administered after a certain amount of time. This story was initially covered by news media outlets this time last week; however, no formal announcement has been made regarding changes to the official CDC guidance.

Reducing the quarantine or isolation period could potentially increase compliance by individuals who are not willing or able to isolate or quarantine for the full period currently recommended by the CDC. It could also reduce the impacts on employers and the US economy that result from workers being unavailable to perform in-person duties. There are concerns, however, that removing individuals from quarantine or isolation earlier could result in transmission by individuals who become or remain infectious after that point.

CDC Guidance for Expanded Screening Testing to Reduce Silent Spread of SARS-CoV-2: To reduce SARS-CoV-2 transmission, jurisdictions should consider expanding testing of persons without symptoms (with and without known exposure) to reduce asymptomatic (silent) spread in addition to comprehensive community-wide mitigation efforts and testing of individuals with symptoms consistent with COVID-19. All communities should test close contacts of cases (e.g., depending on case burden and available resources; close contacts should be tested immediately after identification as a contact, and if negative, could be tested again about 5-7 days after last exposure or immediately if symptoms develop during quarantine), and consider implementing a tiered approach to expand testing similar to the guidance for institutions of higher education, high-density critical infrastructure workplaces, select non-healthcare workplaces, and healthcare personnel.  This testing will not reduce the 14-day quarantine of close contacts.

CDC advisory panel: Health workers, long-term care facilities should get COVID-19 vaccine first: An expert panel that advises the CDC voted 13-1 to recommend that health care providers and residents in long-term care facilities should be first in line to get a COVID-19 vaccine when one becomes available. Together, the two groups represent 24 million Americans. Health care workers have always been at the top of the list, and long-term care residents have been hit particularly hard by the pandemic, with over 100,000 deaths in this population. State governments have to put in their orders for a COVID-19 vaccine by Friday, and yesterday's vote by the Advisory Committee on Immunization Practices is meant to help officials decide how to allocate the first doses that will arrive.

‘We’re drowning’: COVID cases flood hospitals in America’s heartlandReuters: COVID-19 cases and hospitalizations are spiking nationally. But the Midwest - encompassing a dozen states between Ohio and the Dakotas - has been especially brutalized. Reported case rates are more than double that of any other region in the United States, according to the COVID Tracking Project, a volunteer-run data provider. From mid-June to mid-November, reported cases in the Midwest rose more than twentyfold.

Rising staff shortages: 1,000+ hospitals across the US are “critically“” short on staff; 21% of all hospitals anticipate critical staffing shortages in the next week, according to the first federal data released on the topic. NPR

The Grass Is Greener in the Green Mountain State:

Anthony Fauci has endorsed Vermont as “a model for the country” for its robust response and consistently low coronavirus spread.

What sets it apart:

  • Measures like curfews, which mostly benefit those who can stay home and isolate, take a back seat to proactively serving at-risk groups.
  • Free, pop-up testing travels to where it’s needed most.
  • Social service groups liaise with the state to house homeless families in motels.

And Gov. Phil Scott (R), has proposed $1,000 stipends for those asked to self-isolate.

Vermont's lesson for the US: “An equitable program would support people to do the right thing,” says Stefan Baral, an associate professor at the Johns Hopkins Bloomberg School of Public Health. Vox

Majorities of people across the U.S. support restrictive measures to curb COVID-19 spread: Six in 10 people across all 50 U.S. states support a combination of restrictive measures to curb the spread of COVID-19, according to a new survey from the COVID States Project. Nearly 20,000 people were surveyed between November 3-23 about their views on seven measures to help stop the spread of the pandemic, including restricting travel and large gatherings, and 60% or more supported all seven measures. Large majorities in every state supported five of the seven measures, the exceptions being prohibiting in-person K-12 instruction and closing nonessential businesses. Across the board — including across party lines — people were least supportive of closing businesses beyond pharmacies and grocery stores.

Corporate:

Domestic Travel During the COVID-19 Pandemic

  • If you are traveling, consider getting tested with a viral test 1-3 days before your trip. Also consider getting tested with a viral test 3-5 days after your trip and reduce non-essential activities for a full 7 days after travel, even if your test is negative. If you don’t get tested, consider reducing non-essential activities for 10 days after travel.
  • Keep a copy of your test results with you during travel; you may be asked for them.

The Work From Home WorkSTEPS Medical Team:

Ben Hoffman, MD, MPH
Chief Medical Officer

Tony Nigliazzo, MD
Medical Director

Loraine Kanyare, MSN, MPH, RN
Director of Case Management

Robert L. Levitin, MD
Physician Consultant

Lynda Phillips, LVN
Nurse Case Manager

Codey Church, LVN
Nurse Case Manager

Kerry Womack, LVN
Nurse Case Manager

Chuck Reynolds
Strategic Communications Consultant

This Guidance (“Guidance”) is provided for informational and educational purposes only. It is not intended as Legal Advice or Medical Advice. Adherence to any recommendations included in this Guidance will not ensure successful diagnosis or treatment in every situation. Furthermore, the recommendations contained in this Guidance should not be interpreted as setting a standard of care or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific therapy must be made by the physician and the patient in light of all the circumstances presented by the individual patient, and the known variability and biological behavior of the medical condition. Similarly, this Guidance is based on current advice, comments, and guidance from the EEOC, CDC and the CMS made publicly available. The ultimate judgement regarding the propriety of any specific employment action must be made by the company and attorney in light of all of the circumstances presented by the company, state and federal rules existing at the time and the then current state of the National Pandemic. This Guidance and its conclusions and recommendations reflect the best available information at the time the Guidance was prepared. The results of future studies or changes in rules, regulations or laws may require revisions to the recommendations in this Guidance to reflect new data. WorkSTEPS does not warrant the accuracy or completeness of the Guidance and assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this Guidance or for any errors or omissions.

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