Does it matter that the COVID-19 Vaccine is for Emergency Use Authorization Only and not Full-FDA Approval?

By Tracy Waller

The History of Vaccines

Vaccinations are recommended for children from birth. The Advisory Committee on Immunization Practices (ACIP)develops recommendations on the use of vaccines, and the Centers for Disease Control and Prevention (CDC) sets U.S. adult and childhood vaccinations schedules based on those recommendations.[1] Before leaving the hospital or birthing center, a baby receives the first of three doses of the vaccine that protects against Hepatitis B. Starting at one to two months of age, babies receive six different vaccines: Hepatatis B (second dose), Diptheria, tetanus, and whooping cough (pertussis) (DTaP), Haemophilus influezae type b (Hib), Polio (IPV), Pneumococcal (PCV), and Rotavirus (RV). 

All 50 states and the District of Columbia, within their state law, established mandatory vaccinations requirements for students in public schools and daycare facilities. Forty-six states and the District of Columbia also established mandatory vaccination requirements for students in private schools.

Occasionally, a new vaccine is added to the routine requirements for school attendance or international travel. Chickenpox was commonplace in the United States until a vaccine became available in 1995. Children (and adults who have never had chickenpox) are now routinely vaccinated against chickenpox, with the first dose given around 12 to 15 months. 

But all of the aforementioned vaccines have received full U.S. Food and Drug Administration (FDA) approval. 

After nearly a year in lockdown, the world took a collective exhale when the  FDA granted Emergency Use Authorization (EUA) to three COVID-19 vaccines, the Pfizer-BioNTech on December 11, 2020, Moderna vaccine on December 18, 2020, and most recently, on February 27, 2021, the Johnson & Johnson/Janssen vaccine. In addition, on May 10, 2021, the FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to be used for children as young as 12. 

There is a noticeable caveat to the COVID-19 vaccines—their designation as “Emergency Use Authorization (EUA).”The EUA provision was added to the federal Food, Drug, and Cosmetic Act (FDCA) in 2004 by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) to give the government increased flexibility to respond to a chemical, biological, radiological, and nuclear threats, including infectious diseases.

The designation of EUA and the quick availability (as compared to other vaccines) of the COVID-19 vaccine has created vaccine hesitancy[2] for some. It has also created questions about whether a vaccine that has EUA rather than full FDA approval can be mandatory.

What does EUA mean for mandating vaccines? 

When the pathway was created, special language was included for informational disclosures for individuals offered a medical product under an EUA. Specifically, under 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), each individual must be informed “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.”

There is a hesitancy to mandate COVID-19 vaccines ethically, because they have not yet received full FDA approval; however, no U.S. court[3] has interpreted the provision, and we can understand it two different ways. The first is that mandates are prohibited because individuals have the option to refuse the product (or vaccine); the second is that although an individual has the right to refuse the product, there also may be consequences for refusal (that the individual must be informed of). 

In its guidance on the issue, while the U.S. Equal Employment Opportunities Commission (EEOC) did not provide a definitive answer about whether it is permissible to mandate a vaccine under the EUA just as other vaccines, its guidance does not differ from that of other vaccines with full FDA approval

Can businesses require proof of vaccination as a condition of working or getting service? 

Businesses have a legal and ethical obligation to provide a safe environment for their employees and for their customers. Employers can generally mandate vaccinations. Provided the COVID-19 vaccinations are treated the same, despite their EUA, “[i]t is lawful and ethical for a business to require proof of vaccination as a condition of working or getting service.” However, the employer must offer medical and religious exemptions. 

In their article, “Mandating COVID-19 Vaccines,” the authors address vaccination as a condition of service. “It is foreseeable that businesses in certain high-risk settings could require proof of vaccination as a condition of service, such as in long-distance travel (plane, rail, bus), restaurants, and entertainment (sports, movies, theater). . . Local or state governments could also require vaccination as a condition of service.” 

The EEOC has also published frequently asked questions on their website specifically related to the COVID-19 vaccine. Relevant sections of five are included below:

K.1. Under the ADA [the Americans with Disabilities Act], Title VII, and other federal employment nondiscrimination laws, may an employer require all employees physically entering the workplace to be vaccinated for COVID-19?

The federal EEO laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19, subject to the reasonable accommodation provisions of Title VII and the ADA and other EEO considerations discussed below.  These principles apply if an employee gets the vaccine in the community or from the employer.  

K.4.  Is information about an employee’s COVID-19 vaccination confidential medical information under the ADA?

Yes.  The ADA requires an employer to maintain the confidentiality of employee medical information such as documentation or other confirmation of COVID-19 vaccination.  This ADA confidentiality requirement applies regardless of where the employee gets the vaccination.  Although the EEO laws themselves do not prevent employers from requiring employees to bring in documentation or other confirmation of vaccination, this information, like all medical information, must be kept confidential and stored separately from the employee’s personnel files under theADA.          

K.6. Under the ADA, if an employer requires COVID-19 vaccinations for employees physically entering the workplace, how should an employee who does not get a COVID-19 vaccination because of a disability inform the employer, and what should the employer do?

An employee with a disability who does not get vaccinated for COVID-19 because of a disability must let the employer know that he or she needs an exemption from the requirement or a change at work, known as a reasonable accommodation.  To request an accommodation, an individual does not need to mention the ADA or use the phrase “reasonable accommodation.” 

Under the ADA, it is unlawful for an employer to disclose that an employee is receiving a reasonable accommodation or to retaliate against an employee for requesting an accommodation.

 K.9.  Under the ADA, is it a “disability-related inquiry” for an employer to inquire about or request documentation or other confirmation that an employee obtained the COVID-19 vaccine from a third party in the community, such as a pharmacy, personal health care provider, or public clinic? 

No.  When an employer asks employees whether they obtained a COVID-19 vaccine from a third party in the community, such as a pharmacy, personal health care provider, or public clinic, the employer is not asking a question that is likely to disclose the existence of a disability. There are many reasons an employee may not show documentation or other confirmation of vaccination in the community besides having a disability.  Therefore, requesting documentation or other confirmation of vaccination by a third party in the community is not a disability-related inquiry under the ADA, and the ADA’s rules about such inquiries do not apply.

K.17.  Under the ADA, may an employer offer an incentive to employees for voluntarily receiving a vaccination administered by the employer or its agent?

Yes, if any incentive (which includes both rewards and penalties) is not so substantial as to be coercive.  Because vaccinations require employees to answer pre-vaccination disability-related screening questions, a very large incentive could make employees feel pressured to disclose protected medical information. As explained in K.16., however, this incentive limitation does not apply if an employer offers an incentive to employees to voluntarily provide documentation or other confirmation that they received a COVID-19 vaccination on their own from a third-party provider that is not their employer or an agent of their employer.

Can long-term care facilities mandate the vaccine for employees or residents?

The Centers for Medicare & Medicaid Services (CMS) have stopped short of requiring the COVID-19 vaccine; however, under 42 CFR 483, long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as “nursing homes”) and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet education requirements to participate in the Medicare and Medicaid programs. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the CDC. Under this rule, CMS requires LTC facilities to educate LTC facility residents, ICF-IID clients, and staff serving both populations about COVID-19 vaccines, and requires, when available, for vaccines to be offered to all residents, clients, and staff. And some state departments of developmental disabilities are keeping stricter mitigation strategies in place whether people are vaccinated or not. For example, although Ohio is no longer enforcing COVID-19 mask mandates in retail businesses, mask mandates remain in effect for Ohio’s nursing homes and assisted living facilities.

Reasonable Accommodation

The Centers for Disease Control and Prevent (CDC) has recently revised its guidance permitting vaccinated people to “resume activities without wearing a mask or physically distancing.” This shift in guidance that permits people to engage in activities without masks, presumes only fully vaccinated people will engage in maskless activities. And therefore, people who have not been vaccinated, either because they are not able to, or because they have not had the opportunity to, may be at an increased risk for contracting COVID-19. People who are immunocompromised, even if already vaccinated, may also be at an increased risk of COVID-19 because their bodies do not produce adequate antibodies to fight the virus. Given the relaxed mask rules and safety measures, some people feel more at risk now than they did at the peak of the pandemic.

Under the ADA, employers are required to make reasonable accommodations, so individuals with disabilities can apply for a job, perform a job, or enjoy benefits and privileges of employment. If requested by an employee or potential employee, an employer is required to provide reasonable accommodations unless it would pose undue hardship, meaning significant difficulty or expense, to the employer. An employer has the discretion to choose among effective accommodations. Because of the CDC’s recently revised guidance, reasonable accommodations may be a more difficult for employers in some types of businesses.

A person’s disability status is protected health information. However, by wearing a mask when a mask is otherwise not required, or needing additional surveillance and testing, an employee’s disability status may indirectly be revealed. Because some people cannot get vaccinated or must continue to wear a mask (i.e., immunocompromised or pregnant individuals), they may face difficult decisions in the workplace.

Why full FDA approval matters?

The issue of whether or not the COVID-19 vaccine can be mandated is being actively litigated in several states.[4][5][6] Because the issue of mandating the COVID-19 vaccine as an EUA has not been fully litigated, schools and businesses may be hesitant to mandate the vaccine for fear of backlash or legal repercussions. While some have still opted for mandating the vaccine, others have opted for incentivizing their employees and customers (without being coercive) to get vaccinated. Fortunately, because both Pfizer and Moderna have applied for full FDA approval, the legal issues presented by EUA will be moot.

[1] The American Academy of Pediatrics follows CDC guidance for its vaccine recommendations.

[2] It should be noted that no safety measures were sidestepped.  

[3] However, the European Court of Human Rights has ruled that “compulsory vaccination can be considered ‘necessary in a democratic society’”.

[4] Seven employees of the Los Angeles School District have filed a lawsuit challenging a school district’s right to require the vaccine for its employers.

[5] An employee of the Dona Ana Detention Center in Las Cruces, New Mexico has filed a federal lawsuit challenging the right of his employer to require him to receive the COVID-19 vaccination. 

[6] One hundred-seventeen unvaccinated nonmanagerial employees from Houston Methodist Hospital have filed a lawsuit to challenge the hospital’s vaccine mandate.

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