Vaccine Approval Could Lead to Mandates
When the Food and Drug Administration (FDA) announced official approval of the Pfizer-BioNTech COVID-19 vaccine on August 23, employers and employees around the nation began to reassess their stances. Although millions of Americans have received the vaccine already, thanks to its emergency use authorization (EUA), this full approval could mean that some people may be less hesitant to receive it. It could also mean that some employers will begin to demand it.
Many Americans viewed the availability of the COVID-19 vaccine as a triumph and eagerly stood in line to get their shots. However, others have been hesitant to get the vaccine, citing concerns about its safety and doubts about the virus’s severity.
By mid-August, the Centers for Disease Control and Prevention (CDC) reported that approximately 170 million Americans had been fully vaccinated, which is approximately 52% of the population. Meanwhile, the U.S. Census Bureau found that almost 26 million Americans have stated that they will definitely not or probably not choose to receive the vaccination.
FDA Review and Approval
Standard vaccine approvals can often take several months or even years to obtain, but the FDA was pressured to approve the COVID-19 vaccine as quickly as possible. As part of their process, FDA scientists reviewed hundreds of thousands of pages of data from vaccine trial records involving 40,000 participants. After studying all the information, the agency determined that the vaccine met the necessary standards for safety, quality, and effectiveness.
Scientists and healthcare professionals hope that this FDA approval will result in more Americans feeling comfortable receiving the vaccine. This hope is supported by a Kaiser Family Foundation survey that reported 3 in 10 unvaccinated adults would be more apt to get vaccinated after one of the vaccines received full FDA approval.
The Pfizer COVID-19 vaccine is the first one to receive full U.S. regulatory approval for ages 16 and up. The EUA is still in effect for children ages 12 to 15, and the FDA intends to move swiftly to approve the vaccine for children under 12.
Pfizer-BioNTech is also seeking FDA approval for a third dose, which will serve as a booster shot. According to the Biden administration, booster shots will be available beginning the week of September 20.
Possible Mandates to Follow
Now that the vaccine has full approval, more and more U.S. companies and agencies may feel more justified in setting vaccine mandates for their employees. Even before FDA approval, Walmart and Disney had already announced deadlines and mandates for some employees, and some healthcare facilities and universities followed suit. In addition, the U.S. government has issued mandates and deadlines for federal workers and service members. Meanwhile, some private businesses had been hesitant to require their employees to get a vaccine approved only for emergency use, but within days of the FDA approval, businesses such as CVS Health and Chevron issued mandates for their employees.
Even with this new FDA approval, companies who set vaccine mandates must be open to making exceptions. They will need to accommodate employees who have conditions covered by the Americans with Disability Act (ADA), as well as religious or cultural beliefs protected by Title VII. In those instances, employers must offer these employees other options, such as working remotely, alternating shifts, wearing masks, and physically distancing.
Unvaccinated employees may also be subject to higher health insurance premiums. Since employers are seeing healthcare costs going up, they want to pass along those increases to their unvaccinated employees, and they have been waiting for FDA approval to do so. This practice will likely be most common in industries where employees cannot work remotely, such as construction, manufacturing, and hospitality. In fact, on August 25, Delta announced it would charge unvaccinated employees $200 more a month for health insurance. Just as tobacco users pay more for health insurance, so might those who are not vaccinated.
How OSHA’s General Duty Clause Applies
Osha’s general duty clause, which is section 5(a)(1) of the Occupational Safety and Health Act, states the following: “Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” This broad statement is designed to address hazards not yet regulated by OSHA, and the dangers of COVID-19 might fall into that category.
When referencing the general duty clause for a citation, an OSHA investigator must prove that 1) an employer did not prevent a hazard its employees were exposed to, 2) the hazard was known to the employer, 3) the hazard could cause serious harm or death, and 4) there was a realistic way to prevent the hazard.
While such requirements could be hard to prove in many instances, it seems that COVID-19 could meet those benchmarks. Employees can be easily exposed to the coronavirus in the workplace, everyone knows about it and realizes it is serious, and now we have a fully approved FDA vaccine to prevent its spread.
Based on the general duty clause, could a company receive an OSHA citation for not mandating the COVID-19 vaccine? Not likely. However, the question of a vaccine mandate could be included as evidence regarding an employer’s ability to keep the workplace safe.
To Mandate or Not?
There are several factors you must consider before issuing a vaccine mandate. Think about your company culture, what the physical workspace is like, and who your employees are. If a mandate seems too extreme, there are alternatives, including vaccine incentives, regular testing, social distancing, and required mask-wearing. Nevertheless, some may argue that mandating the vaccine is the most sure-fire way to keep employees safe as COVID-19 continues to be a recognized threat.
If you are uncertain how to handle the vaccine question at your company, be sure to consult legal counsel. At Cotney, our experienced OSHA defense lawyers and safety consultants can help you review your options and determine the best course of action.
Disclaimer: The information contained in this article is for general educational information only. This information does not constitute legal advice, is not intended to constitute legal advice, nor should it be relied upon as legal advice for your specific factual pattern or situation.