Identifying and Addressing the Legal Issues Implicated by Voluntary Employer-Sponsored COVID-19 Vaccination Programs

CATEGORY: Special Bulletins
CLIENT TYPE: Public Education, Public Employers
PUBLICATION: LCW Special Bulletin
DATE: Mar 04, 2021

While most employers have decided against mandating COVID-19 vaccinations, some employers are considering offering their employees vaccinations on a voluntary basis or other ways to encourage their employees to be vaccinated.[1]

When an employer is deciding whether to adopt a “voluntary vaccination program,”[2] it is important that the employer understand the laws that such program may implicate and how to ensure compliance with such laws. In particular, employers that are considering offering their employees vaccinations should consult legal counsel in order to determine whether they may qualify for liability protections under the Public Readiness and Emergency Preparedness (PREP) Act.[3]

The purpose of this bulletin is to identify and discuss the laws and legal issues that may arise under such voluntary vaccination programs. This bulletin is organized into three sections: (1) Pre-vaccination; (2) Vaccination; and (3) Post-vaccination, and addresses issues that may arise during each stage.


Before an employee may be vaccinated, the party administering the vaccination must determine whether the employee has any pre-existing health or medical conditions that would potentially compromise their safety should they be vaccinated.[4] This section discusses issues related to pre-vaccination screenings, the medical information that such screenings are likely to elicit, and how employers should manage records containing employees’ medical information.


While pre-vaccination screenings are medically necessary,[5] certain questions asked as part of such screenings are subject to restriction under the Americans with Disabilities Act (ADA) and the Fair Employment and Housing Act (FEHA) because they may reveal that the employee has a disability.

Under the ADA and the FEHA, if an employer, or a contractor acting at the employer’s direction, asks an employee a question that is likely to elicit information about a disability, the question is considered a “disability-related inquiry.”[6] Typically, in order to ask such a question, the employer’s inquiry must be “job-related and consistent with business necessity.”[7]

However, where an employer makes a disability-related inquiry as part of a voluntary vaccination program, the Equal Employment Opportunity Commission (EEOC) provides that the ADA would not be implicated and the “job-relatedness and consistency with business necessity” standard would not apply, so long as the employee may refuse to respond to the inquiry.[8]

If, on the other hand, an independent third party will administer the pre-vaccination screening, the EEOC provides that the ADA is not implicated because the employer would not be making the disability-related inquiry, and would not be entitled to review the employees’ responses to such inquiries, including whether they have a disability.

As a result of the protections under the ADA and the FEHA, employers should, as a preliminary matter, decide whether they will administer the pre-vaccination screening or whether the screening will be conducted by an independent third party.[9] If the employer elects to do so itself, or have a contractor do so at its direction, the employer must clearly establish that participating employees may refuse to answer any pre-vaccination screening question and that they may exercise this right without fear that the employer will take any adverse action against them as a result.[10]


Employers must also comply with federal and state laws concerning employees’ medical information and records, which may be generated as a result of a pre-vaccination screening. This requirement is most immediately at issue where the employer or a contractor conducts the pre-vaccination screening, but it may also be at issue where the employer requests medical information or records from an employee who was screened by an independent third party.

1. Protections Required under the ADA and the GINA

As described in the section above, pre-vaccination screenings are likely to elicit medical information and may, in certain circumstances, also elicit protected genetic information, such as information concerning an employee’s family medical history.[11] Under both the ADA and the Genetic Information Non-Discrimination Act (GINA), an employer that receives medical information about an employee has an obligation to protect such information.[12] In order to protect this information, the ADA and the GINA both require that employers maintain records containing medical information in a safe and secure file that is separate from the employee’s personnel file.[13]

Therefore, in order for an employer to comply with its obligations under the ADA and the GINA, the employer should store any and all information that it receives regarding employees’ health or medical conditions in the employee’s medical file, rather than the employee’s personnel file. Employers should also limit access to such medical files in order to ensure that such protected information remains confidential.[14]

2. Protections Required under the CMIA

Under the Confidentiality of Medical Information Act (CMIA), additional obligations apply to the protection of employees’ medical information.[15] While employers may use such information for legitimate and non-discriminatory business purposes, the CMIA expressly limits employers’ authority to disclose such information[16] to the purposes provided under the law or as authorized by the employee in a written authorization.[17]

In order to ensure compliance with the CMIA disclosure requirements, employers should request, but not require, that employees who are screened by an independent third party execute a CMIA authorization that expressly authorizing the third party to disclose such information to the employer for use for legitimate and non-discriminatory business purposes. While such authorization would not be required if the employer is administering the pre-vaccination screening, employers that are administering the pre-vaccination screening may provide that they only intend to use the medical information provided by employees for such legitimate and lawful purposes.


While available public health information suggests that the currently available COVID-19 vaccines are very safe,[18] this section focuses on sources of potential legal liability that may, nevertheless, result from vaccinations, how employers may eliminate or mitigate such risk, and other issues related to the actual vaccination of employees.


While employer- and contractor-administered vaccinations may appear to present a direct legal risk to the employer, certain statutory provisions may limit such exposure and there are other contractual means by which to further limit, or eliminate, such exposure.

1. Liability Protections for Covered Entities that Provide COVID-19 Related “Countermeasures” under the PREP Act

The PREP Act provides liability protections for certain entities[19] that respond in specific ways to counter a recognized public health emergency. The PREP Act authorizes the Secretary of the Department of Health and Human Services (HHS Secretary) to grant certain entities immunity from legal claims for “losses”[20] caused by “covered countermeasures”[21] that are intended to help address the emergency.

With respect to the present public health emergency, the HHS Secretary issued an emergency declaration on March 17, 2020, providing that “qualified persons” [22] who are authorized to prescribe, administer, or dispense COVID-19 vaccines[23] will receive liability protections related to such vaccines and vaccinations.[24] The liability protections extend to tort claims that may arise if a vaccinated individual suffers an injury or develops an illness as a result of the vaccination.[25]

Determining whether an employer is a covered entity entitled to liability protections under the PREP Act requires a complex legal analysis involving review of relevant United States Code sections, the initial emergency declaration, and the six (6) subsequent amendments to the declaration. Given the complexity of this undertaking, employers that are considering administering vaccinations or directing a contractor to do so should consult with legal counsel in order to determine whether they are covered by the PREP Act.

2. Additional Liability Protections That May Be Afforded by Consent Forms and Liability Waivers

In order to provide additional protection against potential liability associated with the administration of COVID-19 vaccinations, employers should require that employees who participate in a voluntary vaccination program execute a consent form and waiver of liability as a condition of their participation in such a program. Employers that provide some consideration to employees who agree to be vaccinated (e.g., time off from work, compensation for being vaccinated while off-duty, or some other incentive), as discussed below, may condition the receipt of such consideration on the execution of a consent form and waiver.

This recommendation applies to employers that will administer vaccinations or direct a contractor to do so as well as to employers that will provide incentives to employees to be vaccinated, but will not actually administer the vaccinations.

Consent and liability waivers should be drafted in such a way as to provide maximum protection to the employer against a wide range of potential sources of liability, including for claims not covered by PREP Act protections. Therefore, the forms should clearly provide that the vaccination program is entirely voluntary and that employees may refuse to participate in the program. [26] Furthermore, the forms should state that an employee who exercises their right to refuse vaccination will not be subject to any adverse action by the employer related to such decision.


Under the ADA, the FEHA and Title VII of the Civil Rights Act of 1964 (Title VII),[27] certain employees may be statutorily entitled to refuse vaccination because of qualifying disabilities or because of sincerely held religious beliefs. Taking adverse action against employees who refuse to be vaccinated may implicate such equal employment opportunity (EEO) laws and create potential liability for the employer.

While voluntary vaccination programs inherently provide employees a right to refuse to participate, employers should be mindful not to engage in conduct that could be perceived as disadvantaging or discriminating against employees who refuse to be vaccinated and who are statutorily entitled to refuse such vaccination.


As mentioned above, employers may elect to provide certain incentives to employees in order to encourage that they be vaccinated. Employers that elect to incentivize employee vaccination should be prepared to provide notice of the incentive program and an opportunity to bargain the incentive with the employee organizations that represent employees and that are eligible to participate, as the incentive likely constitutes a benefit that would make it a mandatory subject of bargaining.

While there are clearly many ways that an employer could design and structure a vaccination incentive program, employers should be mindful that the design of such program and the specific incentive or incentives offered under it may implicate federal and state laws unrelated to the actual vaccination of employees. For example, an incentive program may violate EEO laws if it discriminates or appears to discriminate against employees who, under the ADA, the FEHA or Title VII, are unable or unwilling to be vaccinated for medical or religious reasons. In order to avoid potentially violating these EEO laws, employers should provide any employees protected by such laws in this context the same or a substantially similar benefit that they are providing to other employees who are participating in the program and are willing and able to be vaccinated.

Given the range of vaccination incentive program designs and the myriad laws that may be implicated by the specific incentives provided, employers that are considering incentivizing vaccination should contact counsel in order to assess the potential legal risks, if any, that may be associated with a specific design and incentive.


Even after employees are vaccinated, certain issues remain for which employers must account, including employees who develop symptoms associated with COVID-19 or become ill after being vaccinated. This section addresses those issues and provides guidance as to how employers should respond to them.


Certain individuals who receive COVID-19 vaccinations may develop symptoms associated with COVID-19 as a result of the vaccination,[28] while others may experience an adverse allergic reaction to the vaccine.[29] Still others may contract the virus that causes COVID-19 and develop the disease before the vaccine takes effect.[30] Finally, for some individuals, the COVID-19 vaccine may not be completely effective in preventing contraction of the virus.

As a result of the continued risk of contracting COVID-19 following vaccination, employers should anticipate needing to undertake certain actions to manage employees following their vaccination.

1. Continuing Obligation to Provide for a Healthy and Safe Workplace and to Comply with Cal/OSHA Regulations to Provide Such a Workplace

Under the Labor Code and associated regulations, including the recently promulgated Cal/OSHA COVID-19 regulations,[31] employers have an obligation to provide for a safe and healthy work environment for their employees.[32] Both the Labor Code and the Cal/OSHA COVID-19 regulations apply to and cover vaccinated employees[33] and require that the employer remove from the workplace employees who present symptoms associated with COVID-19 or who are ill.[34]

2. Managing Symptomatic and Ill Employees Who Are Excluded from the Workplace

Employers should treat recently vaccinated employees who present symptoms associated with COVID-19 or become ill as they would treat unvaccinated employees who present a symptom associated with COVID-19 or who are ill.[35] For example, vaccinated employees who present symptoms associated with COVID-19 or who become ill should remain at their home or place of residence until the resolution of such symptoms just as an unvaccinated employee should do.

If a recently vaccinated employee becomes ill and must be excluded from the workplace, employers should first determine if teleworking is an option for the employee before assessing paid leave options. For employees who are well enough to work and whose job duties permit them to perform their work remotely, the employer should allow the employee to telework until the employee no longer presents any symptoms associated with COVID-19 or recovers from the illness.

For employees who are not well enough to work or whose job duties do not permit them to telework, the employer should advise the employee of their leave options, which may include paid sick leave and other paid leave specifically available for COVID-19-related reasons.

3. Workers’ Compensation May Not Be Available to Employees Who Become Ill as a Result of a Voluntary Vaccination

The Labor Code entitles employees who sustain disabling work-related injuries and illness to temporary disability benefits under workers’ compensation law.

Under a mandatory vaccination program, injuries and illnesses sustained by employees as a result of vaccination would be covered by workers’ compensation and the employee would be entitled to temporary disability benefits. However, under a voluntary vaccination program, even one administered by the employer or a contractor acting at the employer’s direction, it is not settled whether an employee who sustains a disabling injury or illness would qualify for temporary disability benefits because the vaccination may not be considered “work-related.”[36]

4. Additional Obligations Under the Cal/OSHA COVID-19 Regulations

In addition to the requirement that employers exclude from the workplace employees who present symptoms associated with COVID-19 or who are ill, employers must continue to comply with the following obligations under the Cal/OSHA COVID-19 regulations: (1) Offer testing to vaccinated employees following a “close contact” exposure at work;[37] (2) Require that vaccinated employees quarantine following a “close contact” exposure;[38] (3) Provide for the vaccinated employee’s continued compensation during such quarantine;[39] and (4) Require that the vaccinated employee satisfy the return-to-work criteria before allowing the employee to return to work.[40]

Employers should be mindful to comply with all of the Cal/OSHA COVID-19 regulatory obligations, which, for the time being at least, apply with the same force and effect to vaccinated employees as they do to unvaccinated employees.


Under the ADA, it is permissible for employers to ask employees whether they have been vaccinated.[41] The EEOC provides that such questions do not constitute disability-related inquiries because “[t]here are many reasons that may explain why an employee has not been vaccinated, which may or may not be disability-related.” Nevertheless, under the CMIA, employee vaccination records likely constitute confidential medical information, and would, therefore, be subject to the CMIA’s limited use and disclosure requirements.

Employers that did not administer the vaccination and, therefore, do not possess employee vaccination records should request that employees execute a written CMIA authorization for the custodian of such records to disclose such information to the employer. As previously provided with respect to medical information from pre-vaccination screenings, employers should provide that they will only use such confidential medical information for legitimate and non-discriminatory business purposes.


Voluntary vaccination programs implicate a wide range of potential legal issues. Employers that are considering adopting and implementing a voluntary vaccination program, whether it is one administered by the employer, a contractor acting at the employer’s direction or an independent third party, should consider the specific issues that each type of program may implicate and be prepared to address such issues.

Given the complexity of many of the issues discussed herein, employers that wish to adopt a voluntary COVID-19 vaccination program should consider contacting employment counsel for additional guidance. LCW attorneys are available to help employers through their vaccination programs and the accompanying laws, regulations, and guidance that apply.

[1] Only certain employers will receive COVID-19 vaccines and be able to offer and administer vaccinations. For most employers, employees will be vaccinated by an independent third-party, whether by the federal government, the local health department or a private provider.
[2] For the purpose of this bulletin, a “voluntary vaccination program” means a program in which the employer provides or makes available COVID-19 vaccinations for its employees that they may elect, but are not required, to receive. Such a program may be structured in one of the following three (3) ways: (1) the employer administers COVID-19 vaccinations directly to employees; (2) the employer contracts with a third-party provider (“contractor”) that, at the employer’s direction, administers COVID-19 vaccinations to the employees; or (3) an independent third party (e.g., a pharmacy, free clinic or health care provider) that is wholly independent from the employer administers the COVID-19 vaccinations to employees, just as it would for other individuals.
[3] The PREP Act offers important legal protections to qualified entities, but determining qualification for coverage entails complex legal analysis for which counsel may be useful. See discussion of the PREP Act at Section II. A.1., infra.
[4] See Centers for Disease Control and Prevention (CDC) “Prevaccination Checklist for COVID-19 Vaccines,” https://www.cdc.gov/vaccines/covid-19/downloads/pre-vaccination-screening-form.pdf (Last updated on January 5, 2021); see also CDC “Screen for Contraindications and Precautions,” https://www.cdc.gov/vaccines/hcp/admin/screening.html (Last updated on May 7, 2019).
[5] Employers that are considering administering COVID-19 vaccinations and pre-vaccination screenings should consult with qualified medical professionals in order to prepare effective screening questions. The contents, presentation, and other specifics about medical screening questions extend beyond the scope of this bulletin.
[6] 42 U.S.C. § 12112(d)(4)(A); Gov. Code § 12940(f)(1).
[7] In order to satisfy the “job-relatedness and consistency with business necessity” standard, the employer must have “a reasonable belief, based on objective evidence, that: (1) an employee’s ability to perform essential job functions will be impaired by a medical condition; or (2) an employee will pose a direct threat due to a medical condition.” See 42 U.S.C. § 12112(d)(4)(A); Gov. Code § 12940(f)(2); 29 C.F.R. § 1630.2(r); 2 C.C.R. § 11071(d)(1); EEOC, “Enforcement Guidance on Disability-Related Inquiries and Medical Examinations of Employees under the ADA,” Question 5, https://www.eeoc.gov/laws/guidance/enforcement-guidance-disability-related-inquiries-and-medical-examinations-employees (Issued on July, 26, 2000).
[8] 42 U.S.C. § 12112(d)(4)(B); 29 C.F.R. § 1630.14(d); see EEOC “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws” (EEOC FAQ), Question K.2., https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws (Last updated on December 16, 2020).
[9] Typically, the pre-vaccination screening is conducted by the same party administering the vaccination.
[10] Employers should note and explain to employees that an employee’s refusal to answer a pre-vaccination screening question may disqualify the employee from receiving the vaccination if such question is necessary for the employer or contractor to determine whether the vaccination can be safely administered to the employee.
[11] Genetic information, including information about family members’ medical histories, is covered and protected by the Genetic Information Nondiscrimination Act (GINA) See 42 U.S.C. §§ 2000ff(4), 2000ff-1, 2000ff-5; see EEOC FAQ, supra, note 8, Questions K.8, K.9.
[12] 29 C.F.R. § 1630.14(d)(4); 42 U.S.C. § 2000ff-5.
[13] 29 C.F.R. § 1630.14(d)(4)(i). See also 42 U.S.C. § 2000ff-5(a) (providing same requirement for genetic information under the GINA).
[14] EEOC FAQ, supra note 8, Question B.1.
[15] See Cal. Civ. Code §§ 56.20 et seq.
[16] The CMIA defines “medical information” as “any individually identifiable information, in electronic or physical form, in possession of or derived from a provider of health care, health care service plan, pharmaceutical company, or contractor regarding a patient’s medical history, mental or physical condition, or treatment.” Cal. Civ. Code § 56.05(j).
[17] See Cal. Civ. Code §§ 56.20(c) & 56.21.
[18] The currently available COVID-19 vaccines were approved under the Food, Drug & Cosmetic Act’s (FD&C Act) Emergency Use Authorization (EUA) which means that they have not been subjected to the full range of testing and clinical trials under the more robust Biologics Licensing Agreement (BLA). Therefore, there may be additional and unknown risks associated with such vaccines.
[19] The PREP Act grants liability protections to “covered persons,” a defined term that includes six subgroups of people and entities. (See 42 U.S.C. § 247d-6d(i)(2).) This bulletin uses the phrase “covered entity” for the purposes of clarity and to avoid confusion.
[20] Under the PREP Act, “loss” means “any type of loss, including (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss.” (42 U.S.C. § 247d-6d(a)(2)(A).) In order to receive immunity, the loss must have a causal relationship with the covered countermeasure’s administration to or use by individuals, and other conditions must be met. (See 42 U.S.C. § 247d-6d(a)(2).)
[21] A “covered countermeasure” can be defined to include a wide array of products, procedures, or devices used in response to a public health emergency. See 42 U.S.C. § 247d-6d(i)(1). The HHS Secretary’s March 17, 2020 declaration, as amended, includes COVID-19 vaccines as a covered countermeasure. (See 85 Fed. Reg. 15,198; see HHS “PREP Act,” https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx (Reviewed: Feb. 11, 2021).)
[22] A “qualified person” is one of the subgroups of “covered person.” It means “a licensed health professional or other individual who is authorized to prescribe, administer, or dispense [covered] countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed,” or any person within a category identified by the HHS Secretary in the relevant PREP Act declaration. (42 U.S.C. § 247d-6d(i)(8).) The March 17, 2020 declaration, as amended, currently includes several additional categories of “qualified persons” (mostly different types of licensed medical professionals) who receive immunity under the PREP Act. (See HHS, “PREP Act,” supra note 21.)
[23] The PREP Act also covers and provides liability protections to “program planners” (another subgroup of “covered persons”) which is defined to mean “a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product . . . .” (See 42 U.S.C. § 247d-6d(i)(6).)
[24] Employers should note that the PREP Act declarations have effective periods after which the protections provided thereunder expire. The March 17, 2020 HHS Secretary declaration related to COVID-19, as amended, lasts until October 1, 2024. (See 85 Fed. Reg. 15,198; HHS, “PREP Act,” supra note 21.)
[25] Note that the PREP Act does not extend immunity to circumstances where there is “willful misconduct” by the covered entity. Under the PREP Act, “willful misconduct” means “an act or omission that is taken – (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.” Willful misconduct must be something more than mere negligence or recklessness. 42 U.S.C. § 247d-6d(c)(1), (d)(1).
[26] It is not settled whether a post-vaccination illness sustained by an employee as part of a voluntary vaccination program administered by an employer or a contractor acting at the direction of the employer would be considered work-related for workers’ compensation purposes.
[27] The Food, Drug and Cosmetic Act (FD&C Act) also provides a statutory right to individuals to refuse vaccination with a vaccine approved under the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) process. While the FD&C Act does not expressly prohibit employers from taking adverse employment actions against employees who refuse to be vaccinated with a vaccine approved under the EUA process, employers should nevertheless be cautious about taking action against employees who exercise their rights under the FD&C Act.
[28] See CDC “What to Expect after Getting a COVID-19 Vaccine,” https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html (Last updated on February 12, 2021).
[29] See CDC “Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine – United States, December 14-23, 2020” (“Allergic Reactions Report”), Morbidity and Mortality Weekly Report, https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm (Last updated on January 15, 2021).
[30] The CDC keeps an updated, non-exhaustive list of COVID-19 symptoms on its website: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Currently, the symptoms include (1) Fever or chills; (2) Cough; (3) Shortness of breath or difficulty breathing; (4) Fatigue; (5) Muscle or body aches; (6) Headache; (7) New loss of taste or smell; (8) Sore throat; (9) Congestion or runny nose; (10) Nausea or vomiting; and (11) Diarrhea.
[31] See 8 C.C.R. §§ 3205-3205.4.
[32] Lab. Code § 6400.
[33] Cal/OSHA, “COVID-19 Emergency Temporary Standards Frequently Asked Questions: Vaccines,” Question 1, https://www.dir.ca.gov/dosh/coronavirus/COVID19FAQs.html#vaccines (Last updated on January 26, 2021).
[34] Both the EEOC and the Department of Fair Employment and Housing (DFEH), which enforces the FEHA, provide that employers possess the authority to remove from the workplace employees who present symptoms associated with COVID-19 or who are otherwise ill.
[35] Depending on the symptoms, and other circumstances, the employer may encourage the employee to be tested for COVID-19.
[36] Employers should note that employees who actually contract COVID-19 following their vaccination may be entitled to workers’ compensation and temporary disability as a result. (See Labor Code §§ 3212.86-88, 4850.)
[37] 8 C.C.R. § 3205(c)(3)(B)4.
[38] 8 C.C.R. § 3205(c)(10)(B).
[39] 8 C.C.R. § 3205(c)(10)(C).
[40] 8 C.C.R. § 3205(c)(11).
[41] See EEOC FAQ, supra note 8, Question K.3.

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