COVID-19 Vaccines and Emergency Use Authorization Challenges
With employers reopening fully and employees returning to the workplace from the pandemic, there has been a steady flow of challenges -- both legal filings and political and public opposition -- by individuals opposing mandatory requirements from employers and institutions to be vaccinated in order to return to work or school, subject to certain legal requirements under the ADA and valid religious objections.
The legal challenges have centered, in large part, on the Food and Drug Administration (FDA) ability to issue “emergency use authorization” (EUA) for medical products in certain emergency circumstances. This was the procedure used for approval of the COVID-19 vaccines by the FDA of three vaccines in December 2020. In each of these authorizations, the FDA imposed the “option to accept or refuse” condition by requiring the distribution to potential vaccine recipients of a fact sheet that states (among other items): “It is your choice to receive or not receive [the vaccine]. Should you decide not to receive it, it will not change your standard medical care.” (FDA Fact Sheet for Recipients and Caregivers, revised 6/25/21).
Recently, the Office of Legal Counsel (OLC) to the President issued a memorandum opinion (7/6/21) addressing the issue of whether the “option to accept or refuse” language under the EUA prohibits public and private entities from requiring individuals to be vaccinated. Thus, the question of whether schools, public event sponsors or employers can mandate required vaccinations is the focus of the OLC memo. While the OLC memo is not considered binding legal authority, it delivers a strong opinion favoring mandatory vaccines by schools, employers and other entities.
Federal law generally prohibits anyone from introducing into interstate commerce any “new drug” or “biological product” until the product or drug is approved by the FDA as safe and effective for the intended purposes. In 2003, President George W. Bush and Congress addressed a problem raised in emergency situations where the American people were at risk due to exposure to biological, chemical or other similar harmful agents and associated diseases, where countermeasures were not available or approved to treat such conditions. At that time, the FDA exempted drugs from the ordinary approval process only for investigational use by experts to study safety and effectiveness purposes. The proposed BioShield Act and ultimate Project BioShield legislation established FDA emergency use of previously unapproved drugs to protect the public health, with certain required conditions. The legislation directed the FDA to impose conditions on an EUA “designed to ensure that individuals to whom the product is administered are 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.”
As of January 2021, the FDA had issued more than 600 EUAs for products, drugs, tests and other equipment to combat COVID-19. Furthermore, with widespread access to COVID-19 vaccines, more schools and employers are announcing the requirement that teachers, students and employees will be required to be vaccinated in order to enroll in school and attend class in person or return to work, respectively. As noted above, a significant challenge to these requirements has been the EUA’s requirement that individuals have the “option to accept or refuse” the vaccine. The OLC memo concludes that this language concerns only the provision of the information to the potential vaccine recipient and does not prohibit public or private entities from imposing vaccination requirements for vaccines subject to EUAs. (emphasis added)
Specifically, the OLC opines that the language directs only that recipients be “informed” of their option to accept or refuse the vaccine, meaning that they only have to receive the information regarding their option, not that an employer cannot require them to be vaccinated once they have been so informed. Thus, having been so informed and then directed to be vaccinated by the entity, the individual then must decide to accept or refuse, and deal with the consequences of their decision to refuse the vaccine mandate. The OLC memo states that if Congress had intended for entities to be restricted from imposing EUA vaccination requirements, it would have chosen more direct language than the requirement that individuals be provided only certain information. The OLC also notes that the only court to have addressed this issue so far summarily rejected the challenge based on the EUA option to accept or refuse provision (Bridges v. Houston Methodist Hosp., WL 2399994 (S.D. Tex. 6/12/21)).
Thus, while the OCL memo is not binding legal authority on the courts and certainly doesn’t guarantee all legal challenges will now go by the way side, it does give support to those entities and employers that have either enacted or are considering enacting mandatory vaccines. Finally, the OLC memo expressly states it is not addressing any potential legal issues under the ADA or Title VII religious objections to the vaccine, so employers must remain prepared to address those concerns as they arise.
