THE EEOC HAS NOW STATED TO ICAN THAT ITS COVID-19 VACCINE GUIDANCE “ONLY ADDRESS COVID-19 AS IT IMPACTS THE ANTI-DISCRIMINATION LAWS ENFORCED BY THE EEOC” AND OTHERWISE DEFERRED TO THE FDA’S EUA PAGE WHICH PROVIDES THAT EUA COVID-19 VACCINES ARE OPTIONAL
ICAN, through its attorneys, reached out to the EEOC multiple times to request that the agency make its COVID-19 guidance clear and in line with federal law and the CDC and FDA’s position, which all provide that vaccines in use pursuant to Emergency Use Authorization cannot be mandated. On April 22, 2021, the EEOC finally stated that: “The EEOC’s materials only address COVID-19 as it impacts the anti-discrimination laws enforced by the EEOC.” On May 12, 2021, the EEOC’s Office of Legal Counsel further confirmed that “other federal and state laws govern COVID-19 vaccinations of employees” and “[a]ccordingly, those seeking more information about the legal implications of EUA or the FDA approach to vaccines can visit the FDA’s EUA page.”
In December 2020, just days after the first COVID-19 vaccine had been issued emergency use authorization, the EEOC released a guidance titled “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.” This guidance includes a section on vaccinations. Throughout its questions and answers, the guidance discusses vaccines that have been “approved” or “authorized.” However, in the questions dealing with employer mandates of COVID-19 vaccines, the EEOC discusses mandates when vaccines “are available” with no mention of authorization or approval status. This caused confusion as it was being interpreted by some employers to mean that they may require the COVID-19 vaccines while they are in use pursuant to emergency use authorization.
ICAN, through its attorneys, sent a letter on March 17, 2021 to the EEOC advising it of the relevant federal law regarding informed consent and emergency use authorization, and to clarify in response that its guidance was not addressing whether an employer can mandate a EUA authorized COVID-19 vaccine.
As explained to the EEOC, the same section of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.” Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”
In light of this, ICAN asked the EEOC to clarify its guidance. After receiving no response or acknowledgement from the EEOC, on April 19, 2021, ICAN again wrote to the EEOC with the same request. After this second letter, ICAN received a response from the EEOC, dated April 22, 2021, confirming that “[t]he EEOC’s materials only address COVID-19 as it impacts the anti-discrimination laws enforced by the EEOC” and therefore, the EEOC’s advice and guidance regarding COVID-19 vaccines relate solely to “employment discrimination based on race, color, religion, sex (including pregnancy), national origin, age (40 or older), disability, or genetic information.” Therefore, its guidance does not account for the prohibition on requiring an emergency use authorized product in 21 U.S.C. § 360bbb-3.
On April 27, 2021, ICAN sent a third letter to the EEOC informing the commission that ICAN would publicize its response, including that the EEOC’s advice does not account for 21 U.S.C. § 360bbb-3 which prohibits employers from requiring the COVID-19 vaccine, unless the commission had any further clarification or comment prior to our doing so. ICAN received no objection from the EEOC.
Subsequently, on May 12, 2021, ICAN received a response from the Office of Legal Counsel to the EEOC. The response letter makes clear that the EEOC’s guidance only applies to specific labor law provisions and, importantly, that the guidance does not address other laws, such as the federal law related to EUAs which prohibits requiring an EUA product such as a COVID-19 vaccine. The EEOC’s legal counsel even cites to the FDA’s EUA page for additional information in that regard. The FDA page states that, “FDA must ensure that recipients of the vaccine under an EUA are informed… that they have the option to accept or refuse the vaccine.” The FDA page cited by the EEOC also links to the EUAs themselves which, in turn, approved the prescribing information which makes clear that administration of a COVID-19 vaccine must remain the choice of the recipient. Hence, any interpretation of the EEOC’s guidelines as the federal government condoning mandates of an EUA product is clearly misplaced.