Keltner: Mandating the Vaccine
Chances are, you’ve changed a test answer at the last second, only to find out your original response was correct. Second-guessing your visceral response is a common occurrence.
Professional test preparation companies generally offer a key piece of advice to deal with this situation: Never change an answer, unless you’re sure you made a mistake or uncover new information that was not considered in your original response.
Fortunately, the consequences of this common mistake are usually not too steep when it’s a school examination or a standardized test. But making this mistake in the business world can have far-reaching consequences.
Take, for example the emerging question: Can a private company mandate Covid-19 vaccination for its employees?
According to the Equal Employment Opportunity Commission (EEOC), and based on previous experience with mandating influenza vaccines, the answer would appear to be “yes.” As long as employers follow the American Disabilities Act (ADA) guidelines issued for previously mandated vaccines and allow exemptions for people who are pregnant, allergic to a component of the vaccine or object to the vaccine for religious purposes, mandating Covid-19 vaccines seems reasonable.
Here’s the new information not considered in the original response:
The guidance of the EEOC is limited in perspective and focuses on assuring the vaccinations are given in accordance with the ADA and other civil rights laws. Appropriately, the EEOC does not, and should not, consider other laws which lie outside its scope of review. As it turns out, Congress created such a law almost twenty years ago.
After the attacks of Sept. 11, 2001, Congress identified the need to rapidly respond to potential bio-terrorist attacks in the future. Clearly, the lengthy “formal” approval process used by the Food and Drug Administration (FDA) to authorizes drugs was impractical in such a situation. Therefore, Congress created the streamlined Emergency Use Authorization (EAU) process under Section 564 of the Federal Food, Drug and Cosmetic Act (FDCA).
Because new drugs or devices approved under this process are not fully vetted for efficacy and long-term safety, Section 564 placed conditions on all drugs or devices administered to a recipient under EUA approval. In short, Congress protected potential recipients by including a “right of refusal” requirement with only one exception. Specifically, members of the military do not have the “right of refusal” if the U.S. President determines the requirement is not in the best interest of national security (10 U.S.C. § 1107a). Interestingly, no such Presidential determination has been made to date with respect to Covid-19 vaccinations.
The truth is, mandating ordinary vaccinations authorized under the FDA’s formal approval process has been deemed legally acceptable if EEOC standards are met. However, authors of the article titled “Federal Government Says Employers Can Mandate Covid-19 Vaccines? Not So Fast,” point out that mandating vaccinations authorized using EUA standards (rather than the formal process), could be a violation of laws set forth by the FDCA Section 564(e)(1)(A)(ii)(III).
There are currently a handful of lawsuits regarding mandatory Covid-19 vaccinations for employees. Companies who have decided to adopt this position should carefully reconsider their stance. Terminating employees for non-compliance could lead to expensive class-action litigation and deliver a crushing blow to company morale that would surely follow such action.
So, if your company is considering such a mandate, it might be prudent to offer the following options to the board of directors:
- Push the mandate regardless of the risk to the company
- Continue to simply encourage vaccinations
- Neither 1 nor 2
- All of the above
Now that you have all the information, choose the most appropriate response . . .
Go with your gut.
Steven Keltner, PA, has practiced in one of Indiana’s medically underserved and busiest emergency departments for 20 years. He also served 10 years as an adjunct faculty member in the Health Sciences Department at of one Indiana’s premier private universities as well as serving 12 years on its board of visitors.