NOW THAT EMPLOYERS MAY MANDATE THE COVID-19 VACCINE WHAT ARE THE POTENTIAL IMPLICATIONS?

I. BACKGROUND AND ISSUE:

Administration of the COVID-19 vaccine is underway across the nation.?It has been approved under what the FDA classifies as “emergency authorization” in order to allow for expedited use based on public need.??The FDA and CDC ensure that rigorous testing is done prior to EUA and that use of the vaccine is safe for each tested group of individuals as it rolls out.??Section 564 of the Food, Drug, and Cosmetic Act (“FDCA”), authorizes the Food and Drug Administration (“FDA”) to issue an “emergency use authorization” (“EUA”) for a medical product, such as a vaccine, under certain emergency circumstances. This authorization permits the product to be introduced into interstate commerce and administered to individuals even when FDA has not approved the product for more general distribution pursuant to its standard review process.?

With regards to rolling out the COVID vaccine under EUA, the FDA imposed the “option to accept or refuse” condition by requiring the distribution to potential vaccine recipients of a Fact Sheet that states: “It is your choice to receive or not receive the vaccine.?

In addition, the Equal Employment Opportunity Commission (“EEOC”) has set guidelines allowing employers to mandate vaccine administration.??

However, due to the fact that the vaccine is authorized under emergency use only, employer mandates have sparked law suits[1] by groups of employees who are against receiving the vaccine and do not believe they should be forced to obtain it.?The central arguments in these suits is (1) that the vaccine is "experimental" because of the emergency authorization and therefore, they cannot be mandated and (2) Is it inconsistent with “option to accept or refuse” language to allow employer’s to mandate the vaccine.??

II. LAWSUITS FILED IN OPPOSITION TO MANDATES:

a. Texas

Lawsuit was filed by Employees at a Houston hospital which set a June 7, 2021 deadline for its staff to be vaccinated.?The employees who filed suit were part of a group of employees who were suspended without pay for not complying with the deadline.?The lawsuit argued that the COVID-19 vaccine only received emergency authorization from the FDA and as such, the hospital was violating the Nuremberg Code on Permissible Medical Experiments, which bans forced medical experiments and mandates voluntary consent.

U.S. District Judge Lynn Hughes dismissed the action on June 12, 2021 stating in part, “the public’s interest in having a hospital capable of caring for patients during a pandemic far outweighs protecting the vaccination preferences.”?She further emphasized that each vaccine which has been approved has been tested rigorously before being given emergency use authorization and are far from “experimental.”?

b. North Carolina

A similar suit was filed in North Carolina by former Durham County deputy Christopher Neve.?The suit was filed against Sheriff Clarence Birkhead on April 14 claiming that he was fired because he didn't comply with the sheriff's vaccine mandate for department staffers.?The mandate require that either the vaccine was obtained or that the Employee show a doctor's note for an exemption.??The lawsuit also argued that mandating a vaccine that only has emergency authorization violates federal law.

In part, the complaint stated that "these vaccines are not free from risk. In the clinical trials, which are still underway, there were serious adverse events documented following vaccination found by the trial investigators to not only be 'linked' to the vaccines, but in fact related to the vaccines."?

The investigation is still ongoing, though all of the department's 429 employees have been vaccinated with the exception of 20 who are exempt for either medical or religious reasons.

c. New Mexico

An employee of Do?a Ana County Detention Center filed suit against county manager Fernando Macias and jail officials over the vaccine requirement as he faced termination for not receiving the vaccine in March, 2021.?

Directive issued on Jan. 29 requiring county-employed workers to receive the vaccine.?The employee filing suit failed to submit proof of vaccination or a documented reason for an exemption.?He asked for a court order to prevent his employer from coercing him and others from getting the vaccine arguing that ithad not been fully approved by the FDA.

Suit is still pending and has since been amended to state that the mandate "violated his constitutional rights by forcing him to get a vaccine or else lose his job."

III. SECTION 564 PROHIBITION ARGUMENT:

The DOJ put out a slip opinion to address the argument that implemented the “option to accept or refuse,” is contradictory to allowing vaccine mandates.[3]?

Ultimately, the DOJ and FDA have concluded that the language in section 564 specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements.?[4]

The FDA can grant an EUA where, “based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available,” FDA finds that “it is reasonable to believe,” among other things, that “the product may be effective in diagnosing, treating, or preventing” a “serious or life-threatening disease or condition” caused by a “biological, chemical, radiological, or nuclear agent or agents” (a standard less onerous than for final approval of the product); that “the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product”; and that “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.”??[5]

For the three COVID-19 vaccines authorized under EUA, the FDA implemented the “option to accept or refuse” condition through Facts Sheet put out by the three manufacturers.?The Pfizer vaccine fact sheet, for example, states “It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care. ”??[6]

Section 564 directs only that potential vaccine recipients be “informed” of certain information, including “the option to accept or refuse administration of the product.”[7]

In addition, section 564 gives FDA the authority to supplement the information that is conveyed to potential vaccine recipients, including information about “the consequences, if any, of refusing administration of the product.”??

Thus, section 564 does not limit the ability of entities to impose vaccination requirements, and FDA would not be required to change the Fact Sheets in order to allow them to impose such requirement.

IV. What Does this All Mean For Mandating the Vaccine?

Under Equal Employment Opportunity Commission (EEOC) guidelines, the answer is still that, as long as exceptions are provided and accommodations are made where necessary, mandating the vaccine should continue to be upheld.

Accommodations might include allowing an unvaccinated employee to wear a face mask and social distance while at work, working a modified shift, getting periodically tested for COVID-19 or being given the opportunity to telework or accept a reassignment, according to the guidance.?Therefore, an employer would be within its right to terminate staffers where they offer key considerations.

Finally, as soon as the vaccine is no longer under emergency authorization these arguments will become moot.?

Ed Moriarty

MORIARTY & ASSOCIATES, P.C.

1. ?See US Food and Drug Administration, Emergency Response, Emergency Use Authorization
2. ?See Section 564(e)(1)(A)(ii)(III) FDCA
3. ?DOJ Slip Opinion “Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use Authorization”
4. ?Id?
5. ?Id.?Also See FDCA § 564(c).
6. ?Pfizer Fact Sheet at 5
7. ?FDCA § 564(e)(1)(A)(ii)(III)