- September 12, 2021
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. 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 potential COVID-19 vaccine mandates are also noted below.
Vaccine Refusal, Exemptions & Accommodations
FDA & HRSA Guidance on EUA Vaccines. 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.
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):
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
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.
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:
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:
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.
Declining Hepatitis B Vaccine. The U.S. Department of Labor provides health care professionals with a declination statement for those who choose to decline the hepatitis B vaccination.
Employee Vaccine Exemptions. Title VII of the Civil Rights Act of 1964 states that employers are prohibited from discriminating against employees on the basis of race, color, religion, sex and national origin and must provide reasonable accommodations for employees with deeply held religious beliefs. Title VII continues to apply during public health emergencies including the current COVD-19 crisis.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 Commission5 and health care workers who have been denied religious exemptions have received punitive damages and back wages.6 7
Religious beliefs are defined very broadly in Title VII and are not dependent on a belief in God, as follows:
“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
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.
Challenges to Employer Influenza 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
Employer SARS-CoV-2 and COVID-19 Mandates: According to guidance dated December 16, 2020, the EEOC has stated the following generally:
The EEOC and the ADA classifies COVID-19 as a "direct threat" which is defined as, "a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation." This classification allows for more medical inquiries and controls to be put in place in the work environment.
Guidance issued by the EEOC on December 16, 2020 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.”
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:
NVIC does not provide legal advice. 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.
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.
4 What 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 $75,000. Lansing 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.