With the grant of full approval by the Food and Drug Administration (“FDA”) to the Pfizer COVID-19 vaccine, one major legal hurdle to employer-mandated COVID-19 vaccines has been cleared. The approval could not come soon enough, given the Delta and other variants that have been driving infection numbers up. We are likely to see a flood of employers implementing vaccine mandates for their employees in the coming days; what do they need to know in crafting their vaccine policies?
Emergency Use Authorization Status of COVID-19 Vaccines
Unlike influenza and similar vaccines, the COVID-19 vaccines have been made available not through the formal approval process of the FDA, but rather through a more streamlined “emergency use authorization” (EUA) process. (See our prior client alert on this topic here.) The statutory provisions governing the FDA’s emergency process include language that raised concerns about the legality of employers mandating vaccines authorized under an EUA. Specifically, the relevant provision requires that recipients of EUA products, including the vaccines, be informed, to the extent practicable, that they have “the option to accept or refuse administration of the [EUA] product….” (See Federal Food, Drug, and Cosmetic Act, Section 564(e)(1)(A)(ii)(III); “Drugs and Biological Products” and approval letters and fact sheets, found here.) This is a logical requirement, given the increased potential risk involved in taking an EUA drug as compared to a drug approved through the formal, more rigorous FDA process.
There is a single, very limited exception to this requirement: It may be waived for the armed forces if the U.S. president determines, in writing, that complying with this requirement is not in the interests of national security. (See 10 U.S.C. section 1107a.) The clear implication is that, in the absence of such a written waiver by the president, each member of the armed forces has the right of refusal and must be informed of such right. Given that Congress has not enacted any other exceptions, it stands to reason that the general rule is that each individual in the United States has these same rights. Many lawsuits have been filed around the country challenging employer vaccine mandates on this and similar grounds. Many cautious employers refrained from vaccine mandates pending full approval of the vaccine.
The FDA’s Full Approval of the Pfizer Vaccine
On Aug. 23, 2021, the FDA issued full approval of the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty, for individuals age 16 and older. (Link to FDA press release here.) This means that the vaccine has undergone the FDA’s standard process for reviewing the quality, safety and effectiveness of medical products. (Notably, the Pfizer vaccine continues to be under EUA status for children age 12 through 15, and for the administration of a third dose in certain immunocompromised individuals.) Moderna submitted its application for full approval about a month later; it is expected that it will receive full FDA approval in the near future. Johnson & Johnson/Janssen has not yet submitted its application for full approval but expects to do so later this year.
Employers Can Now Mandate Vaccines, Subject to Certain Exceptions
Accommodations Required Under Civil Rights Laws: As outlined in Section K of guidance issued by the Equal Employment Opportunity Commission (the “Guidance,” which can be found here, last updated May 28, 2021), employer vaccine mandates are subject to legally required exemptions. This includes accommodations for medical conditions (such as pregnancy or allergy to components of the vaccine), disabilities and sincerely-held religious beliefs under laws such as the Americans with Disabilities Act (ADA), the Rehabilitation Act, the Genetic Information Nondiscrimination Act and Title VII of the Civil Rights Act as amended by, among other things, the Pregnancy Discrimination Act. Employers must also consider state laws of similar effect.
For medical conditions and disabilities, employers should engage in the interactive process contemplated by the ADA. This entails asking the employee claiming an exemption to provide a health care provider’s certification regarding the inability to get the vaccine, outlining the accommodation needed and determining whether there are reasonable accommodations the employer can make. For some individuals, it may be that the health care provider is advising the employee not to get the vaccine for a certain time period (e.g., during the early stages of pregnancy); if so, the certification should specify when the employee will be able to obtain the vaccine. Employers should treat accommodation requests with the requisite degree of confidentiality accorded to other employee medical information.
Requests for religious accommodation may be based on objections to the concept of vaccines generally, or specific to a particular vaccine (e.g., gene-based vaccines). This requires a similar analysis to that required of employers with respect to, for instance, flu shots. Employers are much more restricted in their ability to challenge accommodation requests made on religious grounds.
Accommodations should be tied to medical and scientific data; federal, state and local laws; and public health agency requirements and guidance. Employers should address accommodation requests on a case-by-case basis, taking into account the employee’s role and duties, and should fashion narrowly tailored protocols. For instance, excluding all unvaccinated employees from the workplace, including those who are unable to get the vaccine for a protected reason, could result in a discrimination claim (for instance, claiming that the individual was deprived of training opportunities, client contact and collaboration with coworkers necessary to succeed at the job). Conversely, particularly after months of remote work due to COVID, employers must tread cautiously in denying requests for continued remote work due to an inability to get vaccinated and/or a heightened susceptibility to adverse effects of COVID-19.
The FDA’s full approval of the Pfizer vaccine, with at least one other anticipated to follow soon, likely will put the brakes on future lawsuits related to the EUA status of mandated vaccines and may moot many of the pending cases. However, employers are likely to see a proliferation of cases alleging failure to accommodate medical conditions, disabilities and religious objections, as well as claims of discrimination, in their stead.
Employees Who Have Recovered from COVID-19: Some employees have been claiming an exemption from vaccine mandates on the ground that they previously contracted and recovered from COVID-19, and their “natural immunity” obviates the need for a vaccine. Several lawsuits have been filed objecting to employer vaccine mandates on this basis, and these claims will doubtless increase in number as more employers issue such mandates.
Current guidance from the Centers for Disease Control and Prevention (“CDC”) indicates that even those individuals who have already had COVID-19 should still get vaccinated, subject to certain medical restrictions (e.g., in some cases, individuals are advised to wait 90 days, depending on the treatment they received for COVID-19). (See link to guidance here, updated Aug. 19, 2021.) Employers who carve out an exemption to their vaccine mandates on this basis therefore may not be following best practices. Instead, employers should treat this as a medical exemption; in other words, if the employee requests an exemption and his or her health care provider certifies that the employee should be exempt for that reason, the employer can provide the requested “medical condition” exemption, documenting it accordingly.
Continued Restrictions: Some jurisdictions—such as San Francisco and the City and County of Denver—have already issued broad vaccine mandates; the FDA approval of the Pfizer vaccine significantly reduces the risk of compliance, which previously put employers between a rock and a hard place. Other jurisdictions, though, have prohibited vaccine mandates (either generally, or from state and local governments), and some have precluded employers from seeking vaccination information from employees, which would render it impossible to ensure compliance with a vaccine mandate. For employers operating in those jurisdictions, the FDA’s approval of the Pfizer vaccine will not be enough to allow them to issue vaccine mandates.
Moreover, because only the Pfizer vaccine has been approved, and only for treatment of individuals age 16 and older, employers may not mandate vaccines for minor employees. In addition, employers should not attempt to dictate which vaccine employees get, as long as it is one that has FDA approval or authorization (i.e., currently Pfizer, Moderna and J&J/Janssen). For instance, some employees may prefer the one-dose Johnson & Johnson/Janssen vaccine; employers should support that choice.
Booster Shots Are Another Story
“Fully vaccinated” is not a static status. Reports from around the world confirm that the efficacy of the vaccines decreases over time, particularly in the face of the Delta variant. As noted above, the Pfizer vaccine continues to be under EUA status for children age 12 through 15 and for the administration of a third dose in certain immunocompromised individuals. The plan for boosters, which is still pending authorization from the FDA and a recommendation from the CDC, contemplates that individuals will be able to obtain booster shots beginning the week of Sept. 20, provided at least eight months have passed since they received their second dose (there is no booster plan contemplated as yet for the Johnson & Johnson/Janssen vaccine, given its later entry into the market). Until the boosters are fully approved by the FDA, however, employers should refrain from mandating them, even if recommended by the CDC and other public health agencies. (In other words, the same analysis applied to EUA-authorized vaccines will apply to boosters until fully approved by the FDA.)
Employer Considerations for Mandatory Vaccine Policies
Documentation and Confidentiality Requirements: The EEOC and many state agencies have indicated that employers may request proof of vaccination of employees on a non-discriminatory basis, and requiring proof of vaccination does not in and of itself violate the ADA or other civil rights laws. (As noted above, though, employers should review applicable state laws for prohibitions on such inquiries.) However, although requesting proof of vaccination is not deemed to be a medical inquiry, the information received by the employer (e.g., a copy of a CDC vaccination card) is considered medical information that must be treated in a confidential manner and maintained in a file separate from the employee’s personnel file.
Collection of such information also may be required under applicable state or local law. For example, both the current version of the Emergency Temporary Standards (“ETS”) promulgated by the California Occupational Safety and Health Standards Board define “fully vaccinated” employees, subject to less stringent protocols as outlined in the ETS, to mean that the employer has documentation showing that the employee received, at least 14 days prior, either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. San Francisco’s Public Health Order (“Safer Return Together,” linked here) requires that employers confirm the vaccination status not just of their personnel, but also of their patrons.
The review and retention of such information implicates medical privacy and confidentiality concerns; employers must ensure they are handling and using this information in accordance with applicable laws and obtaining appropriate authorization and consent where needed.
Impact on Other COVID-19 Mitigation Protocols: Employers should bear in mind that CDC, OSHA and other public health agency guidance and requirements still come into play, even when workers are fully vaccinated. For example, current CDC and OSHA guidance recommends that even fully vaccinated workers continue to wear masks in public indoor settings in areas of substantial or high transmission, subject to certain exceptions. (Link to CDC guidance as of Aug. 19, 2021 here.) While employers may, with reference to medical and science-based recommendations, implement different protocols for fully vaccinated employees and those who are not fully vaccinated, it is still too soon to lift protocols altogether, even with a fully vaccinated workforce.
Paid Leave and Compensation Requirements: Whether they mandate vaccines or not, employers should keep in mind that many jurisdictions require paid leave for employees to obtain the vaccine and for those who suffer adverse reactions after receiving the vaccine. In addition, even in jurisdictions that do not require paid leave for these purposes, where an employer mandates vaccines, the time spent in obtaining the vaccine very likely will be compensable, and expenses incurred may also be required to be reimbursed (e.g., in California and other jurisdictions with strict expense reimbursement requirements).
Business Considerations: This article addresses the topic of whether employers can mandate vaccines and considerations related to that. A related business consideration is whether they should do so. That is a question that each employer will need to address based on its own particular circumstances. These may include its geographic location, the makeup and sentiments of its workforce (e.g., whether it will lose a significant number of employees in response to a vaccine mandate and the ability to replace those workers), the percentage of the workforce already vaccinated, the administrative burden of a mandate, customer perception and public relations concerns, and other relevant considerations.
Even Without an Employer Mandate, FDA Approval Can Be Helpful
Even for those employers who will continue to encourage vaccines but not mandate them, the FDA’s full approval of the Pfizer vaccine can be helpful. Some individuals have refrained from getting the vaccine due to concerns about the “emergency” nature of the FDA’s approval process; the FDA’s full approval after a more rigorous review may help assuage some of those concerns. Employers should consider publicizing this news to their workforces along with renewed encouragement to get vaccinated. Indeed, the FDA’s press release contains information regarding the safety and effectiveness of the vaccines and the approval process overall, which employers can cite to reassure vaccine holdouts.
Employers Can Provide Incentives for Vaccinations
Employers also may wish to consider implementing an incentive program to increase the percentage of vaccinated employees. The EEOC Guidance outlines, among other things, the parameters of incentives that may be provided by employers to employees for obtaining the vaccine. As expected, and in keeping in line with the proposed regulations issued by the EEOC last year, incentives may be offered to employees obtaining the vaccine through the employer, but the incentives cannot be so substantial as to be considered coercive. What’s the reasoning for this? Administering the vaccine requires prescreening questions that would be prohibited under the ADA unless they are voluntary; excessive incentives undermine the voluntary aspect of responding to the screening questions. Notably, this concern is not present to the same extent when employees are rewarded for obtaining vaccines through their own health care providers rather than directly through the employer. (Employers should keep in mind though that incentives, regardless of size, generally are taxable to the employee.)
The FDA’s full approval of the Pfizer vaccine has removed the most significant legal hurdle for most employers who wish to mandate the COVID-19 vaccine. While employers now can legally mandate the vaccine (other than in those jurisdictions that expressly prohibit it), there still exist a number of legal landmines to navigate. The situation is evolving rapidly, and employers should continue to monitor it and work with legal counsel in developing and updating their vaccine strategy.