Updated 4/1/2021

Now that vaccines have become more widely available, can employers require their employees to take COVID-19 vaccinations?

Back in December 2020, I wrote a blog advising that it appeared that employers in New York State are legally allowed to enact mandatory COVID-19 vaccine policies, with certain guiderails, including providing reasonable accommodations for people with a disability or sincerely held religious belief preventing vaccination.

Current federal guidance continues to support this position.

Vaccines Authorized Under an Emergency Use Authorization (“EUA”)

Some commentators have suggested that mandatory vaccine policies are not allowed because COVID-19 vaccines are currently available under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration.

All of the COVID-19 vaccines currently available in the United States – manufactured by Pfizer-BioNTech, Moderna, and Johnson and Johnson’s Jansen – have been authorized by the FDA under the EUA statute.

What is an EUA?  Under the Federal Food, Drug and Cosmetic Act, the Secretary of Health and Human Services may declare that emergency circumstances exist (meaning an emergency involving chemical, biological, radiological, and nuclear agents, including infectious disease threats).  21 USC § 360bbb-3(b)(1).  After the HHS declares an emergency, the FDA may issue an emergency use authorization (EUA), authorizing the emergency use of a drug, device, or biological product intended for use in connection with the emergency.

The controversy over the EUA statute involves language in the statute which requires the Secretary of HHS to provide certain notices to recipients of the vaccine, including the following information:

(I) that the Secretary has authorized the emergency use of the product;

(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

21 USC § 360bbb-3(e)(1)(ii) (Emphasis added.)

The statute does not state that the above notice requirement applies to private employers or states.  Some commentators have indicated that the reference in this section of the statute to “the consequences, if any, of refusing administration of the product” indicates Congress’ intention that the administration may in some instances be mandated.  [There is a law allowing the President to waive the requirement to advise members of the armed forces that a drug or vaccine is optional under an EUA if it is not in the interest of national security.  10 USC § 1107a.]

The FDA explains that the Section 360bbb-3(e) notice for COVID-19 vaccines is being provided in a patient fact sheet available on its website, as is its usual practice. The fact sheet for the Moderna vaccine is here.

There is no requirement that an employer require employees get the vaccine administered by a third-party provide similar notice.

CDC and FDA Guidance

The CDC’s guidance, updated March 25, 2021, seems to resolve this issue.  The CDC states that while the FDA does not make COVID-19 vaccines mandatory, a state, local government, or employer may mandate vaccination based on state or other applicable law:

The Food and Drug Administration (FDA) does not mandate vaccination. However, whether a state, local government, or employer, for example, may require or mandate COVID-19 vaccination is a matter of state or other applicable law.

Employer Vaccine Mandates and Proof of Vaccination

Whether an employer may require or mandate COVID-19 vaccination is a matter of state or other applicable law. If an employer requires employees to provide proof that they have received a COVID-19 vaccination from a pharmacy or their own healthcare provider, the employer cannot mandate that the employee provide any medical information as part of the proof.

[Then the CDC identifies the factors to consider relative to accommodations for disability or religious belief.]

EEOC Guidance Supports the Employer’s Right to Require Vaccination

The EEOC is responsible for enforcing laws that prohibit discrimination in employment based on disability, religion, or other protected classes, and approaches this issue from the standpoint of whether requiring vaccinations violates the Americans With Disabilities Act, Title VII, or other anti-discrimination laws.

The EEOC’s guidance continues to indicate that an employer may institute a mandatory COVID-19 vaccination policy as long as it provides reasonable accommodations to people with disabilities that prevent them from receiving a vaccine under the Americans With Disabilities Act, and also provides reasonable accommodations to people with a sincerely held religious belief that prevents vaccination.  There are additional guidelines if the employer is administering the vaccine (rather than a third-party provider, such as a pharmacy or health care provider).

The EEOC’s guidance references the EUA statute, acknowledging that a patient fact sheet is supposed to be provided to recipients of the vaccine stating that they may refuse the vaccine.  Of note, the EEOC does not state that the EUA statute prohibits an employer from mandating vaccination or even requires the employer to provide this notice (as opposed to the FDA providing the notice, as is the current practice).  Instead, the EEOC provides guidance as to how an employer may implement a mandatory COVID-19 vaccine policy.

It is expected that courts will follow the EEOC’s guidance.  Courts routinely hold that, while EEOC guidance is not controlling on the courts, the EEOC’s interpretation of discrimination laws “constitute[s] a body of experience and informed judgment to which courts and litigants may properly resort for guidance.”  Jin v Metro. Life Ins. Co., 310 F3d 84, 95 (2d Cir 2002), quoting Meritor Sav. Bank, FSB v Vinson, 477 US 57, 65, 106 S Ct 2399, 2404, 91 L Ed 2d 49 (1986).

Courts Have Not Yet Ruled on Whether Employers May Require Vaccination

There are no court decisions stating whether private employers may mandate vaccines or other drugs authorized under an EUA.

In the first lawsuit by an employee subject to a mandatory COVID-19 vaccine requirement, just weeks after filing the lawsuit, in March 2021 the plaintiff withdrew his request for relief, and the Court did not enter any decision.  This short-lived litigation may foreshadow how other lawsuits would unfold.

In early March 2021, in the US District Court, District of New Mexico, a detention center employee filed a complaint seeking a temporary restraining order and preliminary injunction against Dona Ana County.  The employee argued that the County’s mandatory COVID-19 vaccination requirement for first responders is preempted by the EUA statute, 21 USC § 360bbb-3, and violates his 14th Amendment right to a zone of privacy.  (See scheduling order at Legaretta v. Macias, 21-CV-179 MV/GBW, 2021 WL 833390 (DNM Mar. 4, 2021).)

The County/defendant filed a well-reasoned response to the motion for an injunction on March 15, 2021, explaining the EUA statute 21 USC § 360bbb-3 at most requires vaccine recipients to be informed of the consequences of refusing the vaccine.  The County cited the above-stated guidance by the CDC, stating “whether a state, local government, or employer . . . may require or mandate COVID-19 vaccination is a matter of state or other applicable law.”

In response to the Fourteenth Amendment argument, the County/defendant cited numerous authorities holding that the argument that mandatory vaccination program violates the Fourteenth Amendment was “foreclosed by the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905).”  See Phillips v. City of New York, 775 F.3d 538, 542 (2d Cir. 2015).

Just four days after the defendant/County filed the response brief, the plaintiff filed a notice withdrawing the motion for injunction on March 19, 2021.  Thus the Court did not rule on any of these issues.

In one other case that mentions the EUA statute relative to COVID-19, Aviles v Blasio, 20 CIV. 9829 (PGG), 2021 WL 796033 (SDNY Mar. 2, 2021), parents sued the City of New York seeking a preliminary injunction requiring the reopening of all public schools for in-person instruction and forbidding the City from requiring students to take COVID-19 tests for in person instruction.  The Southern District of New York denied the motion, holding that the students were not deprived of any constitutional rights because they were offered remote learning, and their parents could opt out of COVID-19 testing and still receive remote instruction.  In a footnote the Court dismissed the parents’ argument that the COVID tests are EUA products, and thus cannot be mandatory under 21 USC § 360bbb-3, because the testing program is premised on parental consent and is not mandatory.  The Court did not reach the issue of whether the statute would prohibit the school from requiring testing if it were a mandatory requirement.

New York State

New York State has not issued any guidance or law indicating whether an employer may require employees to take a COVID-19 vaccine.  A new law does require that New York employers provide up to four hours of paid leave to get the vaccine, in addition to sick leave or other types of leave available to the employee.  (New York Labor Law § 196-c.)

The New York State Human Rights Law has requirements similar to federal discrimination laws that require accommodations for those with a disability or religious belief preventing vaccination.

It is still possible that a state, county, or municipality could issue laws or guidance either allowing or prohibiting employers from enacting a mandatory vaccine policy.  This is an area that employers should keep an eye on.

Should I Enact a Mandatory Vaccine Policy?

It depends on an analysis of factors including your particular industry, business needs, employee composition, and safety concerns.  At this time, there does not appear to be any legal prohibition on requiring that employees take one of the COVID-19 vaccines.

In some industries, such as construction, government entities or prime contractors are starting to require that sub-contractors comply with mandatory vaccine policies.  Employers who are contractually required to mandate the vaccine should make sure that they are in compliance with any union obligations, and otherwise complying with the requirement to accommodate those with disabilities and/or sincerely held religious beliefs.

In the restaurant industry, employers are starting to enact mandatory vaccine policies which they believe will be helpful for marketing purposes in an effort to bring customers back to indoor dining.  This may be a crucial policy for retail businesses and restaurants that have been hard-hit by the pandemic.

It is still relatively early on in terms of vaccine availability, and if possible, it may be beneficial to wait a few weeks or months to see if the State or courts provide additional guidance on this issue.  An employer should weigh its options to determine whether a more flexible policy may achieve the same or similar goals.  An employer should also seriously consider the consequences for non-compliance with the policy with respect to employees, vendors, and customers, the effects of terminating employees who do not comply, and the impact of the policy generally on the morale of employees who will be impacted.

Stacey E. Trien is a partner with the law firm of Adams Leclair LLP.  She focuses her practice on employment law and commercial litigation.  She can be reached at strien@adamsleclair.law.