For Emergency Use Only?

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[co-author: Heather Hatcher, Ph.D.]

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While requiring vaccinations for school attendance and in some occupations is common, the issue of employers requiring vaccination for COVID-19 is currently a hot topic. There is currently no Food and Drug Administration (FDA) approved vaccine for the prevention of COVID-19; however, pharmaceutical companies are racing to finish clinical trials and get much-anticipated vaccines into the hands of the public. It is estimated that in less than one year, nearly 10% of the global population may have been infected by SARS-CoV-2, the virus that causes COVID-19, leaving most of the world’s population still vulnerable to infection. Given the negative impact to our global economy, not to mention the devastating loss of more than 1 million lives, should an employer-mandated COVID-19 vaccine even be up for debate?

Immunizations are essential for protecting individuals and communities from vaccine-preventable diseases and have long been recommended by the Centers for Disease Control and Prevention (CDC) and required by individual states for children and young adults entering public schools and universities, with varying exceptions, as well as recommendations for adults to receive boosters of childhood vaccinations and some adult-only vaccines. Outside of the healthcare industry, few companies require that staff be vaccinated annually against influenza or other communicable diseases as a condition of employment. In the US, all vaccine products are licensed by the FDA Center for Biologics Evaluation and Research (CBER), and no vaccine may be marketed without FDA approval. An effective vaccine usually takes more than 10 years to develop and get approved with the associated costs in the hundreds of millions of dollars.

Following the declaration of the public health emergency related to the COVID-19 pandemic in late January 2020, researchers worldwide have been racing to develop safe and effective vaccines for the treatment and prevention of the respiratory disease caused by SARS-CoV-2. Given the unprecedented resources dedicated to this endeavor, it is estimated that a fast-tracked vaccine development process could speed a successful candidate to market in less than 18 months. Under Operation Warp Speed (OWS), a public/private partnership of several US federal government departments and more than 18 biopharmaceutical companies, three vaccine candidates have advanced to Phase 3 clinical trials: Moderna’s mRNA-1273, The University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech’s BNT162.

According to Guidance from the FDA, data from placebo-controlled trials would need to indicate that a vaccine is at least 50% effective against COVID-19 in order to be authorized for use. It is possible that the FDA may consider granting one or more of the COVID-19 vaccines currently in clinical trials (pending review of all available safety data) to be available to select populations under an EUA. Under Section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threat agents when there are no adequate, approved, and available alternatives.

From a legal perspective, there is little to prevent private employers from implementing mandatory vaccine policies. Healthcare, hospitality, and other industries that interact closely with the general public may be among the first to weigh the options for mandating vaccination of their employees as a condition of employment. The US Equal Employment Opportunity Commission’s (EEOC) “Pandemic Preparedness in the Workplace” guidance, originally developed in 2009 in response to H1N1, has been updated to reflect issues surrounding the COVID-19 pandemic. Although the EEOC’s guidance notes that there is currently no vaccine for COVID-19, its previous guidance regarding influenza guidance recommended encouraging employees to be vaccinated, and that vaccines could not be mandatory due to exemptions for religious objections and medical conditions based on Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act (ADA). In the absence of undue hardship, employers may need to provide potential reasonable accommodations for individuals that object to mandatory COVID-19 vaccination, including granting a leave of absence, reassignment or relocation of the employee, or requiring additional personal protective equipment to perform a job.

Employers must assess whether a reasonable accommodation can be made and whether it would impose an undue hardship on the employer or on the health and safety of coworkers. Whether or not a particular accommodation will impose undue hardship on an employer is a case specific inquiry and will vary depending on the circumstances.

Complicating the analysis, any COVID-19 vaccine brought to market under an EUA instead of the normal non-emergency approval process (like a New Drug Application (NDA)), will, by necessity, lack long term safety data. Once a vaccine receives an EUA from FDA, FDA has authorized the vaccine for use according to the terms of the EUA. There is no question that the vaccine authorized under an EUA would be legally on the market, but the question employers should be asking is whether authorization under an EUA changes their liability risk profile.

As employers think about their approaches to a potential vaccine, there are a number of potential risks to consider, including: Could an employee injured as a result of the vaccine bring a claim against the employer for damages? Would this be a workers’ compensation claim or could there be broader civil liability? What is the risk of not requiring vaccines? Is this risk higher in workplaces in which social distancing is difficult to implement, where the employees cannot perform the job tasks remotely, or where the employees work directly with a high risk population (like immunocompromised individuals or the elderly)? Is the particular industry recommending a vaccine?

In other words, as we make progress to an authorized vaccine, employers will need to engage in an ongoing analysis of the risks and overall benefits. There is not a one-size-fits-all answer here. Each employer should carefully conduct its own analysis and weigh the risks and benefits pertinent to its specific workplace and employees. A written protocol capturing an employer’s workplace specific analysis and outlining its policy and any exceptions may be helpful, both as a way to demonstrate the rationale underlying the policy should it be needed later to defend the reasonableness of its actions as well as a way to communicate clearly with employees. Given the current uncertainties surrounding liability issues related to any COVID vaccine, a lack of EEOC guidance on the topic, and the multifactorial workplace specific inquiry required, it would be prudent to seek review and input from an employment lawyer prior to implementation of any new vaccine-related protocols.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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