On July 6, 2021, the Acting Assistant Attorney General for the Office of Legal Counsel (OLC) in the United States Department of Justice issued a legal Opinion that directly addresses a hot button issue that has spawned several lawsuits: whether the fact that the COVID-19 vaccines have only Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) impacts whether employers, public agencies and schools may mandate their use. In the Opinion of the OLC: it does not. Although the OLC’s opinion is not binding authority, nor does it guarantee court approval of any employer vaccine mandate, it does provide insight to employers navigating whether to mandate vaccines for employees in the workplace.
The COVID-19 vaccines currently available were developed in record time under Operation Warp Speed. Generally, federal law prohibits new drugs from being sold unless and until the FDA has determined the drug is safe and effective for its intended uses. However, in 2003 Congress authorized the FDA to authorize unapproved drugs to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions. When the FDA provides EUA for a drug or product, it is required to “ensure that individuals to whom the product is administered are informed” of certain information. Currently, the FDA has provided EUA for three COVID-19 vaccines manufactured by Pfizer, Moderna, and Janssen. As part of its COVID-19 vaccine EUA, the FDA requires that individuals being offered the vaccine be notified as follows:
It is your choice to receive or not receive the [name of manufacturer]’s COVID-19 vaccine. Should you decide not to receive it, it will not change your standard medical care.
Because the FDA has not generally approved the vaccine for use as with other established vaccines and products, many individuals have been reluctant to receive the vaccine, and employers have questioned whether they can lawfully require individuals to obtain a vaccine which has been given only an EUA by the FDA as a condition of employment. For instance, in the case of Bridges v. Houston Methodist Hospital, employees of Houston Methodist Hospital argued that they should not be required as a condition of employment to take the vaccine because, among other reasons, it had not received full FDA authorization, and instead had only been approved under the EUA. Although the U.S. District Court, Southern District of Texas, dismissed the challenge, no appellate court has addressed the issue, and many employers remain uncertain.
The OLC Memorandum states the opinion that the EUA provided by Congress concerns only the provision of information to potential vaccine recipients and does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to EUAs. In other words, the EUA that Congress provided the FDA only requires that individuals be informed of their right to receive or not receive the vaccine, the consequences of refusing administration of the vaccine, and alternative products that are available and their benefits and risks. The OLS Memorandum finds no indication that Congress intended to regulate any entity except those who are responsible for administering the product itself.
As noted above, although this Opinion is not binding legal authority on employers, it does provide powerful evidence that the U.S. Department of Justice does not believe requiring employees to be vaccinated from COVID-19 is prohibited by the Federal Food, Drug, and Cosmetic Act. In just the last few weeks, the Biden Administration has announced that all federal employees will be required to obtain the vaccine or follow strict protocols. California announced a similar requirement for state employees and all workers in health care facilities; whether public or private. Various industry groups – including many in the healthcare sector – are considering endorsing similar vaccine mandates for their constituents.
Employers should, of course, consider a number of factors in deciding whether to require employees to receive a COVID-19 vaccine. Federal and state laws may require accommodations from a vaccine mandate for those with sincerely held religious objections or those with disabilities. More broadly, employers must consider whether a vaccine mandate could affect their ability to retain necessary staff who may have objections to receiving the vaccine. However, along with the Equal Employment Opportunity Commission’s (https://www.mcmahonberger.com/news/eeoc-issues-covid-19-vaccine-guidance/) statement that employers may require vaccination of employees, the OLC’s opinion will provide at least some peace of mind to those employers who choose to require COVID-19 vaccinations for their employees.
The St. Louis employment attorneys at McMahon Berger have been representing employers across the country in labor and employment matters for over sixty years and are available to discuss these issues and others. As always, the foregoing is for informational purposes only and does not constitute legal advice regarding any particular situation as every situation must be evaluated on its own facts. The choice of a lawyer is an important decision and should not be based solely on advertisements.