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.

Vaccine Allocation Confusion

Are Vaccines Even Accessible?

Tracy Waller, Esq., MPH, is an attorney with the Maryland Center for Developmental Disabilities (MCDD) at Kennedy Krieger Institute as part of the MCDD’s grant to develop a Center for Dignity in Healthcare for people with Disabilities (CDHPD).

Vaccine Prioritization Decisions

If you are confused about the vaccine allocation priority groups in your county or state, you are not alone. The Centers for Disease Control and Prevention (CDC) is providing recommendations to federal, state, and local governments about who should be vaccinated first. The CDC’s recommendations are based on those from the Advisory Committee on Immunization Practices (ACIP), an independent panel of medical and public health experts. The ACIP’s vaccine allocation recommendations aim to: (1) decrease death and serious disease as much as possible, (2) preserve functioning of society, and (3) reduce the extra burden COVID-19 is having on people already facing disparities. 

States as Decision-Makers: People With Disabilities Affected Disproportionately 

While the CDC makes recommendations for who should be offered the COVID-19 vaccine first, each state has its own plan for deciding who will be vaccinated first and how its residents can receive vaccines. So, if it seems like your state hasn’t updated its website recently, or has gone “rogue” with its prioritization, you are probably right on both counts. The ACIP’s, and therefore the CDC’s,  recommendations exclude large groups of people with disabilities. People with disabilities continue to face increased morbidity and mortality from COVID-19. However, many states are still failing to prioritize people with disabilities in their vaccine allocation plans, and some states have even removed people with high-risk medical conditions from the priority list

Rather than including all people with disabilities, state allocation plans are using inconsistent definitions with language that is difficult to decipher. For example, who is included in “long-term care facility residents”? Current CDC recommendations ignore a majority of people with disabilities by only prioritizing people with disabilities living in congregate care or calling out only one specific diagnosis within a subgroup. For example, Down syndrome has recently been added to the list of “conditions [putting people] at an increased risk of severe illness from the virus,” but people with other intellectual or developmental disabilities are left off this list. And although some states have included people with intellectual and developmental disabilities, most have excluded people with physical disabilities and sensory disorders. 

Inconsistencies Within States

Figuring out your state’s vaccine allocation plan can be difficult for many. Many states don’t highlight their vaccine prioritization and eligibility links, embedding them within other information. And once you find the information, it can be inconsistent. For example, in Nevada, the state may make recommendations, but each county has its own COVID-19 vaccine distribution plan. A list of current vaccine-eligible categories of residents can be found on Page 3 of Nevada’s “COVID-19 Playbook,” as well as on, a separate website. Although long-term care facility residents are not included in either of these lists, the Playbook, at the top of Page 4, does include “Long Term Care Facility Staff & Residents” in a list of “Vaccination Priority Group Descriptions.” So, are you included if you are a long-term care resident, or not? 

Maryland lists its priority groups for all phases in a two-page PDF infographic last updated January 14, 2021, and in a one-page pyramid infographic PDF. Other than people living in group homes, people with disabilities are not listed on either of these pages. Yet a third webpage lists Phase 1B as including “Individuals with intellectual and developmental disabilities.” 

Nevada and Maryland are only two out of many examples of states with many inconsistencies occurring within them. However, thanks to a partnership between the Johns Hopkins Disability Health Research Center and the Center for Dignity in Healthcare for People with Disabilities, the vaccine COVID-19 Vaccine Prioritization Dashboard is now available to help people with disabilities determine when they might be eligible for a vaccine in their state.

Lack of Access—State Websites 

Title II of the Americans with Disabilities Act (ADA) requires state and local governments and governmental entities receiving federal funding to provide qualified individuals with disabilities with equal access to their programs, services, and activities. Many people use assistive technologies to browse the internet. This includes screen readers that vocalize the text on each page, speech recognition software that converts speech into text, Braille terminals, and even alternative keyboards that accommodate individuals with disabilities. However, many states’ vaccination websites are difficult to navigate, even without assistive technology, making them also inaccessible. The websites fail to include headers structuring content, links are hidden within text, and graphics are difficult to interpret and do not include alternative text. Many states provide information hidden within PDF documents. Although some states’ websites include graphics for those who may not be able to read or who are non-English speakers, most of the graphics are also buried within difficult-to-find webpages.

There are, however, some states, such as Oregon, that offer a Health Information Center number to contact for the website information to be provided in alternative formats. But others make the process confusing and inaccessible. For example, in Idaho, residents have to determine their public health district from a PDF document and then call the number that corresponds to their district to make an inquiry about vaccine eligibility and to be notified when a vaccine is available. The state COVID-19 vaccine website also directs its residents to two pharmacies, Albertsons and Walmart, to find out more information and schedule an appointment. Many of the pharmacy websites are difficult to access and require users to refresh appointment pages multiple times, making them impossible to use with assistive technologies. 

Lack of Access—Vaccine Sites

It’s not just vaccine information that’s inaccessible—so, too, are COVID-19 vaccination sites. It is not uncommon to hear about people waiting overnight or for hours in their cars for the chance to get vaccinated, making those sites inaccessible to many people, especially for those who require healthcare or treatments throughout the day. Many mass vaccination sites are also drive-up only and inaccessible to people without cars, who do not drive, whose family members do not drive, or who reside in settings that do not provide transportation. Other sites are inaccessible to people who require wheelchair assistance.

While most states fail to accommodate people with disabilities at their vaccination and testing sites, some states are trying. For example, Minnesota’s website provides some ideas and examples for how to make testing and vaccination sites more accessible.

The majority of people with disabilities face an uphill battle for qualifying for vaccinations, accessing vaccination website information, making appointments, and finding accessible vaccination sites. If the CDC goals for the COVID-19 vaccine are to “[d[ecrease death and serious disease as much as possible, [p]reserve functioning of society, and [r]educe the extra burden COVID-19 is having on people already facing disparities,” we need to focus on vaccine accessibility. For a group that continues to face increased morbidity and mortality from COVID-19, we need to do better.

Blog with us!

The Center for Dignity in Healthcare for People with Disabilities invites your blog submissions.

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  • We are looking for submissions about healthcare inequities faced by people with disabilities and proposed solutions to make healthcare more equitable. We want posts that will educate, inform, empower, and challenge people to think in new ways.
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Send your 500-to 100-word posts with a suggested title wo [email protected]. Include a brief bio, picture with image description, and social media accounts that you’d like to share.

Steps to Develop a Disability Advocacy Response to Vaccine Roll-Out Plans

family photo of Stephanie Meredith and her husband and 3 children
Stephanie Meredith is the author and co-author of multiple resources for new and expectant parents who receive a diagnosis of Down syndrome or other genetic disabilities. Ms. Meredith leads the Center for Dignity’s Prenatal Diagnosis Subcommittee. Ms. Meredith shares her advocacy letter to Georgia state leadership as an example for other advocates who would like to ensure people with intellectual and developmental disabilities have equitable access to vaccines.
  • Assess your state’s vaccine plan to find out what phase would include people with developmental or intellectual disabilities. If your state doesn’t specifically identify ID/DD, they would likely be included in the population described as “individuals under 65 with particularly high risk or high-risk comorbidities and health conditions.
    Clarify with your state which category covers people with ID/DD and their caregivers (family members, direct support professionals, group home staff, and nursing home/assisted living staff) under their definitions. Ideally, we want to advocate for people with ID/DD and their caregivers in the same home to be vaccinated in the phase immediately following first responders, with the other highest risk groups.
  • Determine if your state needs to better clarify group homes and other congregate facilities that serve people with ID/DD as long-term care facilities. Ideally, we want to make sure that the staff at group homes and other facilities that serve people with ID/DD are included in the first responder phase. In addition, we want to make sure that people with ID/DD who live in those settings are treated as long-term care facility residents.
  • Advocate for your state to provide a plan that accommodates
    for “reasonable modifications
    to ‘drive-up only’ sites or other testing facilities, such as establishing mobile vaccination programs or providing no-cost transportation, to ensure that vaccinations are accessible to people with developmental disabilities whose family members do not drive or who reside in settings that do not provide transportation. Additionally, the vaccine protocol and accompanying information must
    be accessible to people with developmental disabilities in plain language, in screenreader accessible formats, and in alternative formats needed by people with developmental disabilities, including graphic format that is understandable by people who may not be able to read, and in non-English languages spoken in the US.
  • Point to a politically similar state that has similarly modified its guidelines. Current examples include Oregon, Texas, Ohio, and Tennessee.
  • Recruit collaborators:
  • Develop a plan to spread the word about your advocacy efforts, concerns, and proposal:
    1. Write a press release and contact local media. Compile 3-5 stories to share. Here’s an example of a media story.
    2. Host an email, phone, and social media contact to contact your governor, lawmakers, and state department of public health.

Helpful Resources

CDC Revised guidelines
AADMD Statement
New York Times article on vaccines
Risk Factors Among Privately Insured Patients: A Fair Health White Paper