COVID-19 Vaccines 

The Moderna COVID-19 vaccine received an Emergency Use Authorization from the Food and Drug Administration for use in adults. On Saturday, the Advisory Committee on Immunization Practices (ACIP), which offers guidance to the CDC concerning vaccine policy, unanimously recommended the vaccine. The Moderna vaccine currently is only authorized for use in individuals 18 years of age or older, whereas Pfizer requested and was granted authorization for its vaccine’s use in 16 & 17 year olds as well as adults. Distribution of the Moderna vaccine begins this week.

On Sunday, the ACIP refined their recommendations on who to prioritize in the next phases of vaccination distribution, following health care workers and residents in Long Term Care facilities. According to the Committee, their recommendations were an attempt to direct access of the limited number of vaccines in a way that concurrently advanced two primary goals: maximizing the prevention of virus-related illness and death, and the preservation of societal functions. Other ethical principles factoring into these recommendations included the maximization of benefits and minimization of harms, the promotion of justice, and mitigation of health inequities.

The ACIP currently recommends that the next groups to be vaccinated should be:

Stage Two (or 1b):

• Adults aged 75 and older,
• Approximately 30 million “Frontline” Essential Workers, who are defined as “workers who are in sectors essential to the functioning of society and are at substantially higher risk of exposure to SARS-CoV-2,” including
  • First Responders (Firefighters, Police)
  • Education (teachers, support staff, daycare)
  • Food & Agriculture
  • Manufacturing
  • Corrections workers
  • U.S. Postal service workers
  • Public transit workers
  • Grocery store workers.

In Stage 3 (or 1c), the additional populations who should receive priority for vaccination include:

• Persons 65-74 years of age
• Persons 16-64 with high-risk medical conditions
• 57+ million “Other” essential workers, including those working in
  • Transportation and logistics
  • Food Service
  • Shelter & Housing (construction)
  • Finance
  • IT & Communication
  • Energy
  • Media
  • Legal
  • Public Safety (Engineers)
  • Water & Wastewater

This guidance is not binding, and should be updated as necessary based upon new findings concerning the vaccine, as well as supply and demand feedback. It will be up to individual states to make their own determinations as to how best to prioritize populations for vaccine distribution.

According to STAT News,

Operation Warp Speed, the federal government’s program to fast-track vaccine production, estimates there will be enough vaccine to vaccinate 20 million people in December, another 30 million in January, and an additional 50 million by the end of February.

Phase 1a of the vaccination effort, which began last week, involves offering vaccine to 24 million people. In Phase 1b, 49 million people will be eligible to receive vaccine. Phase 1c is a much larger group, including roughly 129 million people. In total, the first three priority groups will cover 202 million people — double the number of people the country expects to have vaccine for by the end of February.

For further reading on ethical considerations in scarce vaccine distribution, see:

• This commentary from scholars at the Hastings Center
• This NPR interview with public health ethicist Ruth Faden
• The National Academies of Science, Engineering and Medicine report on Equitable COVID-19 Vaccine allocation from earlier this fall.

Preventing COVID-19 Vaccine “Line Jumping”

Multiple stories recently have discussed concerns about wealthy individuals finding ways to “skip the line” and get earlier access to the COVID-19 vaccine. In a statement last week, California Governor Newsome voiced his disapproval but came short of stating how, exactly the state would prevent such actions from taking place. However, the language he used — in which he indicated the state will be “very aggressive in making sure that those with means, those with influence, are not crowding out those that are most deserving of the vaccines,” that “We will be monitoring that very, very, closely,” and that “we will expect that everyone in the health care delivery system is held to the same ethical standard of prioritizing truly, those that are most in need” —  seems to imply a possible pathway for oversight, through such steps as auditing vaccine distribution plans as they are implemented, as well as professional and institutional licensure board oversight. Alternatively, one columnist suggests “naming and shaming” those who cut the line.

Employment Vaccine Mandates: EEOC Guidance Released

This past week the U.S. Equal Employment Opportunity Commission updated its technical assistance on COVID-19 and the Americans with Disabilities Act, the Rehabilitation Act, and other Equal Opportunity laws to address questions pertaining to employer mandates of the COVID-19 vaccine.

I’m frequently asked: Can employers require their employees to get vaccinated against COVID-19? My response is: first, anything I say should not be considered legal advice, and second, as is stated in this article, in general, yes…BUT…

Just because an employer can doesn’t mean they should, especially in the early days of the vaccine rollout. As a researcher who focuses on how laws and policies can affect vaccine uptake, I worry that doing so may further undermine trust in the vaccines, especially within minority communities, where there already is significant work to be done to increase trust in the public health and health care systems generally, and in COVID-19 vaccines in particular.

Instead of mandates, employers should strongly encourage employees to get vaccinated, and make it as easy as possible for them to do so. Hopefully, most of the public will voluntarily get vaccinated when the vaccine becomes available to them. Furthermore, given the way things have gone over the past 10 months, those who mandate vaccination are likely to face legal challenges to such actions.

The new section on Employment and Vaccinations is section K of the document linked in the first paragraph, and the most interesting passages are questions K.5 through K.7. According to the EEOC, employees may request reasonable accommodations from employment-based mandates on the grounds of having either a sincerely-held religious belief or a disability. Employers then must make a determination as to whether the accommodations can be met (e.g., can the job be performed remotely?), or if doing so would create either a direct threat to other individuals in the workplace or an undue hardship on the employer. According to the EEOC, “If an employee cannot get vaccinated for COVID-19 because of a disability or sincerely held religious belief, practice, or observance, and there is no reasonable accommodation possible, then it would be lawful for the employer to exclude the employee from the workplace.  This does not mean the employer may automatically terminate the worker.  Employers will need to determine if any other rights apply under the EEO laws or other federal, state, and local authorities.”

This past week, a new research letter on public opinions related to COVID-19 vaccine mandates also was published in JAMA. According to the authors, just over 3 out of 5 respondents overall indicated they likely would get a COVID-19 vaccine. However, certain subpopulations of people were far less likely to do so. According to the studies, just over 2 out of every 5 people who self-identified as Republican or Black indicated they likely would get a COVID-19 vaccine.

For more guidance on the EEOC report, seek legal counsel.

Stimulus Bill Passed, Eviction Moratorium Extended, Record Rise in Poverty

Congress will vote today on a new Coronavirus relief package, which includes a new infusion of federal funds into the nation’s unemployment system, funding to schools and universities to improve their ventilation systems, an end to surprise medical billing of patients, as well as an extension of the federal eviction moratorium until January 31.

A new report indicates that, since Summer, when many of the CARES Act benefits expired, 7.8 million Americans have fallen into poverty, raising the national poverty rate to nearly 1 out of every 8 Americans. The rate rose over this period by the highest percentage recorded in the 60 years such data has been kept, and rates have risen by a greater percentage for blacks, children, and those with a high school education or less. By November, 1 in 6 children in this country was living in poverty. These numbers rose over this period even though the unemployment rate fell during this same time by 40%. According to the report, “This disconnect between poverty and unemployment is not surprising given that some government benefits have expired, unemployment insurance benefits are typically only about half of pre-job loss earnings, and five million people have left the labor force in the past year and therefore are not counted as unemployed.”

Short Takes:

• A number of jurisdictions have closed restaurant and bars to indoor dining through the holidays, including Minnesota and Washington, DC, which has closed indoor dining, museums, and libraries until January 15.
• The Supreme Court declined to override the Kentucky governor’s requirement that all schools (including religious schools) go to remote learning during December. However, the explanation handed down by the court seems less like support for the Kentucky governor’s authority and more a technical side step, as the court indicated that the students would be going into winter break and the Governor’s order was set to expire the first week of January.
• An interesting NPR piece from last week on why police departments are reluctant to enforce public health orders
• A fascinating piece on the COVID-19 Vaccine Distribution Data and Tracking Systems
• Measles vaccination efforts have been taking a back seat during COVID-19, and vaccine hesitancy is increasing around the globe.

Thank you to everyone for reading these Law & Ethics updates during 2020. I’ll be taking a break over the holidays, but will return on January 11 with more updates. Take care!