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What laws exist to protect employees and adults from vaccine mandates?

Information on Adult & Employee Mandates

Under federal recommendations by the National Vaccine Program Office (NVPO) in the National Adult Immunization Plan (NAIP), National Healthy People goals are used to guide adult vaccination recommendations. While the NAIP fails to incorporate informed consent and privacy protections and Healthy People goals are aspirational and carry no statutory impact, it is used by states for guidance in implementing adult vaccine mandates.

Adult vaccine mandates vary from state to state and from employer to employer. Currently, most adult mandates occur in the health care setting and impact health care workers and some contractors and usually involve the hepatitis B and influenza vaccines. NVIC’s state pages provide links to adult mandate information. Information relating to SARS-CoV-2 virus and COVID-19 vaccine mandates and exemption rights also noted below.

OSHA & Declining Employer Required Hepatitis B Vaccination

As noted by the U.S. Department of Labor's Occupational Safety and Health Administriation (OSHA), employers must assure that employees declining to be vaccinated against hepatitis B must sign a declination form. Hepatitis B vaccation is generally required for healthcare workers. To file a complaint relating to hepatitis B vaccine, contact OSHA at 800-321-6742. Learn more about this policy by visiting OSHA's FactSheet.

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Federal Emergency Use Vaccine (EUA) Information

Correspondence received by NVIC on August 26, 2021 from the U.S. Health Resources & Services Administration (HRSA), which administers both the federal Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP), states:

"Your question relates to which Program provides coverage, the CICP or the Vaccine Injury Compensation Program (VICP), for injuries alleged to have been caused by the newly licensed Pfizer COVID-19 vaccine.

As noted, the COVID-19 vaccines currently authorized through Food and Drug Administration (FDA) Emergency Use Authorizations or approved by the FDA are covered countermeasures under the Public Readiness and Emergency Preparedness Act and, therefore, individuals who allege injury as a result of the administration or use of such vaccines are eligible to apply for benefits under the CICP. Full FDA approval of the Pfizer COVID-19 vaccine does not remove its coverage from the CICP or provide coverage under the VICP."

As of September 1, 2021, all vaccines developed for COVID-19 have been granted EUA status by the FDA and are recognized as "countermeasures". Compensation of vaccine injuries while a vaccine maintains an EUA status will be processed by the CICP. Visit NVIC’s EUA vaccine FAQ for more information about EUA vaccines and how EUA vaccine injuries are compensated.

The FDA has stated on their website that vaccines in use under an EUA status require that recipients of these vaccines be informed they have the right to accept or refuse the vaccine, and that they be made aware of any alternative to the product (vaccine). The FDA has also stated that this information is typically included in the patient “fact sheet” posted on their website.1 Federal law governing EUA vaccines states that vaccine recipients must be informed of the following information: 2

  • the vaccine’s authorization for emergency use;
  • the significant known and potential risks and benefits of use;
  • the extent to which risks and benefits are unknown;
  • the option to accept or refuse the vaccine, and the consequences of refusal, if any; and
  • available alternatives to the vaccine, and their risks and benefits.

Fact sheets for the COVD-19 vaccine are now available for recipients and providers. Provider fact sheets contain more information on clinical trial data, adverse events and how to report them, and safety data than patient fact sheets. 

Off-Label Use of EUA Vaccines & Liability - During an Advisory Committee on Immunization Practices (ACIP) meeting held  August 30, 2021, CDC representatives cautioned vaccine providers that while booster doses are under consideration for the general population, they have not been recommended. Further, CDC representatives stated that doses of COVID-19 vaccines administered off label (outside FDA/CDC/ACIP recommendations): 

  • may not be covered under the PREP Act as a countermeasure and vaccine providers may not have immunity from claims;
  • those injured may not be eligible for compensation via the CICP;
  • may not be reimbursed to providers by payers; and 
  • are a violation of the CDC provider agreement and may impact the ability of the provider to be a part of the provider program.
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EUA Vaccines & Military Exemptions

When the Secretary of Defense requests or requires a member of the military to take a new investigative drug or drug unapproved for its applied purpose, the Secretary of Defense must provide the military member with the following information:

  • Clear notice that the drug is an investigational new or unapproved for its applied use.
  • Why the investigational new drug or unapproved drug for its applied use is being given.
  • Any possible known side effects of the investigational new drug or drug unapproved for its applied use including any potential interactions with other administered drugs.
  • Any other information the Secretary of Health and Human Services requires to be disclosed.

The Secretary must also provide health care providers who will be administering the investigational new drug or drug unapproved for its intended use with the following information:

  • Any possible known side effects of the investigational new drug or drug unapproved for its applied use including any potential interactions with other administered drugs.
  • Any other information that the Secretary of Health and Human Services requires to be disclosed.

When the use of the investigational new drug or drug unapproved for its applied purpose is given due to the participation of a member of the military in a particular military operation, the requirement that the military member give consent prior to receiving the drug pursuant to 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be waived by the President if the President concludes in writing that obtaining consent is not in the interests of National Security. The Secretary of Defense may request that the President remove the prior consent requirement for an investigational new drug or drug unapproved for its applied purpose.3

For more information on vaccines and exemptions as they pertain to military personnel and their families, please visit NVIC’s Military Personnel Vaccine Concerns FAQ.

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The Civil Rights Act of 1964 & Employee Vaccine Exemptions

Title VII of the Civil Rights Act of 1964 (“the Act”) offers legal protection to employees when their religious beliefs prevent them from receiving vaccines. Title VII of the Act prohibits public and private sector employers with 15 or more employees from refusing to hire, fire or otherwise use discriminatory practices against current and prospective employees on the basis of sex, race, color, national origin or religion.4

Should discrimination in the workplace occur, Title VII provides for compensation and punitive damages. At a state level, rules and policies mandating vaccines in the workplace without offering exemptions or accommodations have been successfully challenged by the federal Equal Employment Opportunity Commission (EEOC), which enforces Title VII of the Civil Rights Act.5 Health care workers who have been denied religious exemptions have received punitive damages and back wages.6 7

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Religion Broadly Defined in Civil Rights Act

While Title VII protects religious beliefs, the U.S. Equal Employment Opportunity Commission (EEOC), states that religion is defined broadly and includes “theistic beliefs as well as non-theistic “moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of traditional religious views.” Religious beliefs can be personal and do not require affirmation by an organized major religion or church.  The key factor is that a belief is sincerely held with the strength generally associated with religion and that the beliefs are related to concern about “ultimate ideas”, “life, purpose and death”.

EEOC guidance additionally states:

“Religious beliefs include theistic beliefs (i.e. those that include a belief in God) as well as non-theistic “moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of traditional religious views.” Although courts generally resolve doubts about particular beliefs in favor of finding that they are religious, beliefs are not protected merely because they are strongly held. Rather, religion typically concerns “ultimate ideas” about “life, purpose, and death.” Social, political, or economic philosophies, as well as mere personal preferences, are not “religious” beliefs protected by Title VII.

Title VII protects all aspects of religious observance and practice as well as belief and defines religion very broadly for purposes of determining what the law covers. For purposes of Title VII, religion includes not only traditional, organized religions such as Christianity, Judaism, Islam, Hinduism, and Buddhism, but also religious beliefs that are new, uncommon, not part of a formal church or sect, only subscribed to by a small number of people, or that seem illogical or unreasonable to others. An employee’s belief or practice can be “religious” under Title VII even if the employee is affiliated with a religious group that does not espouse or recognize that individual’s belief or practice, or if few – or no – other people adhere to it. Title VII’s protections also extend to those who are discriminated against or need accommodation because they profess no religious beliefs.”8

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Requesting Religious Accommodation to Exempt from Vaccines

Prior to requesting a religious accommodation (exemption) to vaccination, employees may benefit from legal advice by an attorney specializing in Civil Rights and employment law who may be able to clarify what questions an employer may and may not ask an employee, what accommodations are reasonable, and to review whether an employee’s statement of belief meets the criteria defined in Title VII. 

Obtaining a religious accommodation in the workplace begins with the employee. Employees must notify  their employer that the mandatory vaccination policy conflicts with their sincerely held religious beliefs and request a religious accommodation.

Once an employer has received notification and the request for accommodation, the EEOC advises employers to assume the belief is sincerely held and to enter into good faith discussions with the employee and to offer reasonable accommodations. Employers may also ask questions to determine the sincerity of the belief. 

Legally, a reasonable accommodation is one that does not place undue hardship on the employer. For example, healthcare workers wearing a mask during the flu season is deemed a reasonable accommodation to not receiving an annual flu shot.

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Enforcement of Religious Accommodations in the Workplace

The EEOC enforces Title VII of the Act and investigates charges of unlawful employment discrimination. There are strict time limits for submitting claims of religious discrimination to the EEOC and employees must file religious discrimination complaints within 180 days of the incident, unless state law extends the time limit. Federal employees have 45 days to contact an EEO Counselor.

The EEOC requires documentation that the employer was informed of the employee’s religious belief preventing vaccination and that a request was made for a religious accommodation, and that the employer took disciplinary action or otherwise sanctioned the employee for refusing vaccination.

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Employers Can Be Penalized for Religious Discrimination

When an employer is found to have unlawfully discriminated against an employee’s sincerely held religious beliefs, courts have ordered employers to stop unlawful employment practices, to reinstate wrongfully terminated employees, and to award payment of back wages, damages, and/or other equitable relief.

Court decisions relating to religious accommodations and employer vaccine mandates have been mixed. The majority of vaccine related decisions have been based on annual flu shot mandates for healthcare workers. However, EEOC complaints against employers are likely to increase as employers and employees are pressured by government to comply with federal vaccine policy recommendations. 

To be eligible for compensation and damages under a Title VII action, a charge must be filed within 180 calendar days from the day the discrimination took place. To learn more about filing a charge, visit the EEOC’s website and NVIC’s page, 1964 Civil Rights Act Protects Some Healthcare Workers with Religious Objections to Employer Flu Shot Mandates.

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Challenges to Employer Vaccine Mandates

According to the current guidance provided by the EEOC, COVID-19 will not change how the EEOC has previously applied "undue hardship" when challenging employer influenza vaccine mandates and religious accommodation for those whose religious beliefs prevent them from receiving the influenza vaccination. The EEOC appears positioned to continue to defend employees against religious discrimination in relation to influenza vaccine mandates in the workplace.9 Guidance issued by the EEOC on December 16, 2020 also states:

“Once an employer is on notice that an employee’s sincerely held religious belief, practice, or observance prevents the employee from receiving the vaccination, the employer must provide a reasonable accommodation for the religious belief, practice, or observance unless it would pose an undue hardship under Title VII of the Civil Rights Act.  Courts have defined “undue hardship” under Title VII as having more than a de minimis cost or burden on the employer. EEOC guidance explains that because the definition of religion is broad and protects beliefs, practices, and observances with which the employer may be unfamiliar, the employer should ordinarily assume that an employee’s request for religious accommodation is based on a sincerely held religious belief.  If, however, an employee requests a religious accommodation, and an employer has an objective basis for questioning either the religious nature or the sincerity of a particular belief, practice, or observance, the employer would be justified in requesting additional supporting information.”

“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.”

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Seniors and the Disabled

For information on the consequences of vaccine refusal by the disabled and/or their guardians, those receiving Medicaid, Medicare or other agency benefits, and in settings such as assisted living and long-term care and skilled nursing facilities it is advisable to consult with professionals experienced with this type of law. Below are some resources to consider:

  • Elder and Special Needs Law Attorneys: Attorneys that have expertise in addressing legal issues such has estate planning, long-term care, and coverage by Medicare and Medicaid as it relates to seniors and the disabled. Attorneys with this specialty may also be able to advise on the consequences of refusing an EUA or licensed vaccine. The National Academy of Elder Law Attorneys and the National Elder Law Foundation are national organizations that can provide basic information on this area of law and provide state level information on locating an elder law attorney;.
  • Long-Term Care Ombudsman Program: Every state has a long-term care ombudsman who assists residents living in nursing homes, assisted living facilities and other similar care facilities. These individuals help residents work through issues and understand their rights. The Administration for Community Living provides basic information about this type of ombudsman and your rights in these settings. You may also find the ombudsman in your state by visiting The National Consumer Voice for Quality Long-Term Care website.

Legal Resources - Employee Vaccine Mandates

NVIC does not provide legal advice or endorse any legal firm or organization. We encourage the public to obtain legal advice to further understand and protect their rights and to be informed of any course of action available that may be taken to remedy any violation of these rights. Prior to requesting a religious accommodation under Title VII, employees may benefit from legal advice by an attorney specializing in Civil Rights and employment law who may be able to clarify what questions an employer may and may not ask an employee, what accommodations are reasonable, and to review whether an employee’s statement of belief meets the criteria defined in Title VII.  

NVIC discourages the use of form letters and templates for statements of religious beliefs, as they can have the effect of undermining the sincerity of one's personal and sincerely held religious beliefs with your employer. However, seeking legal advice on whether your statement of beliefs meets Title VII criteria may be of benefit.  

Below are legal resources relating to vaccine mandates and exemptions in the workplace that may be helpful when considering legal options to workplace vaccine mandates. NVIC does not endorse any legal firm or organization and provides the below list for informational purposes only. There are many law firms accepting COVID-19 vaccine mandate cases. The list below is a partial list and additional legal resources can easily be found by searching the internet with keywords like COVID-19 mandate lawsuits, civil rights attorneys, Title VII attorneys. It is also advisable to ask many questions of any prospective attorney regarding their expertise in vaccine mandate lawsuits, Title VII lawsuits, as well as the success of any vaccine related lawsuit the attorney has filed, costs associated with filing a lawsuit that you may expect to pay, and how long a lawsuit may take to conclude.

The Equal Employment Opportunity Commission, which enforces Title VII of the Civil Rights Act, defends religious beliefs in the workplace. Visit the EEOC's Filing A Charge of Discrimination webpage to file a charge of discrimination or to submit your questions to the EEOC about possible workplace discrimination and your options. The public may also call the EEOC at 1-800-669-4000 for more information and to get answers to their questions, and can also visit the EEOC's website to obtain information on contacting the nearest field EEOC office.  

It may be of benefit to employees to consult with a private attorney, as outlined above, prior to filing an EEOC complaint against an employer or contacting the EEOC.

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References

1 FDA. Emergency Use Authorization for Vaccines Explained: How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA? Accessed Dec. 3, 2020. FDA Revised Nov. 20, 2020.  

2 Office of the Law Revision Counsel – United States Code. 21 U.S. Code 360bbb-3- Authorization of medical products for the use in emergencies. Viewed Dec. 10, 2020.

3 Office of the Law Revision Counsel – United States Code 10 USC 1107: Notice of use of an investigational new drug or a drug unapproved for its applied use. Viewed Dec. 22, 2020.

4What You should Know About COVD-19 and the Rehabilitation Act, and Other EEO Laws. U.S. Equal Employment Opportunity Commission. Sept. 8, 2020.

5 Opel, D. Sonne, J. Mello, M. Vaccination without Litigation – addressing Religious Objections to Hospital Influenza-Vaccination Mandates. N Engl J Med 2018; 278:785-788. Mar. 1, 2018.

6 Thompson, C. Memorial Healthcare in Owosso settles religious discrimination suit for $75,000Lansing State Journal, Jun. 28, 2019.

7  U.S. Equal Employment Opportunity Commission. Press Releases – Saint Vincent Health Center to Pay $300,000 to Settle EEOC Religious Accommodation Lawsuit. Dec. 23, 2016.

8 U.S. EEOC. Questions and Answers: Religious Discrimination in the Workplace. Jan. 31, 2011.

9 U.S. EEOC. Pandemic Preparedness in the Workplace and the Americans with Disabilities Act. Mar. 21, 2020.
 

 


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