How employers can proceed now that a vaccine has full FDA approval

Now that the FDA has removed the Emergency Use Authorization (EUA) and fully approved the Pfizer COVID-19 vaccine, the risk of legal exposure diminishes by the day. That begs questions: What do employers need to know about this recent development? Does this change prior decisions? And what steps need to be considered if an employer is deciding whether to impose a workplace vaccine mandate?

‘Emergency use’ label is dropped

The Pfizer, Moderna and Johnson & Johnson vaccines were all approved pursuant to the FDA’s EUA, which permits the agency to clear drugs, vaccines, medical devices and other products for use on an expedited basis. Although the development process for the vaccines was expedited, they were still subject to trials by tens of thousands of people to determine safety and efficacy — the same process as for other vaccines.

Recently the FDA gave the Pfizer-BioNTech vaccine the highest level of clearance that a medical drug can receive from the government. The acting FDA commissioner stated, “The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

Despite confusion, legal exposure remains low

The FDA’s 2017 guidance on EUA products notes that recipients must be informed about the right of refusal and any accompanying consequences. For example, the EUA includes paperwork instructing health care providers administering the vaccine to tell recipients that they can “refuse” the shot.

This language has caused confusion among those who believe they should not be subject to an employer mandate. But this directive is targeted at whether an individual can be forced to take the vaccine by a government entity, not whether an employer can condition an individual’s continued employment on vaccination. After all, in at-will employment settings, an employee can always pursue alternative employment instead of receiving a vaccine.

Employers that previously mandated the vaccine should not fret. Late last year, the Equal Employment Opportunity Commission (EEOC) stated that employers can require their workers to get the current COVID-19 vaccines without violating most federal antidiscrimination laws (subject to reasonable accommodation principles, of course). Multiple courts have upheld mandates in the face of lawsuits filed by disgruntled workers who did not want to comply with a vaccine requirement. Moreover, less than a month ago, the U.S. Department of Justice expressed the opinion that EUA status does not prevent employers, schools and other entities from mandating COVID-19 vaccinations.

Still, despite the mounting body of evidence that legal exposure was low, some employers were waiting for removal of the EUA designation as the final step before considering a mandate. Now that the Pfizer vaccine has been fully cleared and other COVID-19 vaccine approvals are sure to follow in the coming weeks and months, the time is right for employers hesitant to mandate vaccination to brush up on the basics.

Six steps to consider with a vaccine mandate

If you decide that it’s time to impose a vaccine mandate on your workforce, here are the six steps you should consider:

• Spend time considering how your employees, customers and other constituents are likely to respond to the policy, including how you will handle pushback. Anticipate and prepare for certain levels and forms of anxiety and/or resistance — even now that the EUA has been removed.
• Figure out the best way to communicate your policy to employees, including how much notice to provide before implementing the requirement, how proof of vaccination will be kept, and who within the company will have access to the confidential information.

• Consider related logistics, including compensation issues that may be implicated for the time spent traveling to and receiving the vaccine and any related reimbursement costs. Make sure you also understand when employees are entitled to be paid for their time, such as supplemental paid sick leave for time taken to receive the vaccine or to recover from any side effects.
• Develop a robust and clear reasonable accommodation policy to address religious and disability issues. Take special care to communicate and administer the accommodation process in a thoughtful way, with emphasis on individualized, confidential consideration of each request.
• Be wary about the issues raised by posing prescreening vaccination questions that may trigger an ADA requirement.
• Develop a designated “vaccine team” for coordinating this entire process.

If you’re not ready to impose a mandate …?

For employers still not ready to require their workers to get inoculated against COVID-19, there are at least four other options to consider.

• You could launch an information campaign, driving to improve vaccination rates by offering targeted educational opportunities to employees.
• You could offer workplace incentives to any employee who can prove full vaccination.
• You could require all non-vaccinated personnel to be subject to regular COVID-19 testing to ensure the highest level of workplace safety.
• You could also require those who do not prove full vaccination to comply with additional safety restrictions as necessary to maintain a safe working environment.

Each option requires some level of consideration and should be planned carefully, with the help of counsel, as there are potential pitfalls related to discrimination, accommodation, retaliation and compensation.

Stephen Scott is an associate in the Portland, Oregon office of Fisher Phillips.