Pfizer COVID Vaccine FDA Approval - What Employers Should Know

The U.S. Food and Drug Administration (FDA) fully approved the Pfizer-BioNTech COVID-19 vaccine on Aug. 23, which may prompt more employers to mandate the shot.

However, employers should note that they still need to explore reasonable accommodations for employees with religious and disability-related objections.

Previously, some employers raised concerns about the legal risks associated with a vaccination mandate, particularly since the approved COVID-19 vaccines only had emergency use authorization. Now that the Pfizer vaccine has gained full FDA approval, employers may be more likely to go forward with these policies, said Zach Siegel, an attorney with Hogan Lovells in Philadelphia.

Additionally, workers who were hesitant to get vaccinated may feel more confident now, noted Lindsey Self, an attorney with Eastman & Smith in Toledo, Ohio.

Employment law attorneys generally have said that private employers can require at-will employees to get a vaccine authorized for emergency use. But the full authorization does mitigate concerns from some people who thought there hadn't been enough research into the vaccines, observed Krista Mitzel, an attorney with The Mitzel Group in San Francisco. "Many employers are still struggling to find ways of keeping businesses open and their workers safe," she said, "and this FDA approval provides a way to more confidently move toward going back to normal."

To obtain full licensure, Pfizer had to provide more information about the manufacturing process and its facilities and submit to in-depth FDA inspections. Moderna's COVID-19 vaccine also is expected to receive full FDA approval soon.

Trend to Mandate Vaccination

Over the summer, more employers started requiring vaccination or regular testing to fight the surge in COVID-19 cases caused by the fast-spreading delta variant.

Federal employees and onsite contractors must confirm that they are vaccinated or complete other steps, such as getting tested once or twice a week for COVID-19 and keeping physically distant from other employees and visitors. President Joe Biden has urged businesses to require employees to get vaccinated and said the federal government will continue to support employers that do so. 

Along with the federal government, many state and local governments and large employers have implemented stricter COVID-19 vaccination, testing and safety policies.

Recent research from law firm Littler Mendelson showed the number of employers that are currently mandating vaccines or planning to roll out some form of requirement has more than doubled from less than 10 percent of survey respondents in January to about 21 percent in August.
"While most employers are still encouraging—rather than requiring—vaccination, there was a notably greater openness to mandates," Littler said. Additionally, 46 percent of respondents were more strongly considering a vaccine mandate due to the delta variant and recent rise in cases.

According to the U.S. Centers for Disease Control and Prevention (CDC), cases in the U.S. recently surpassed 130,000 a day on average, following a drop in June to about 12,000 new cases each day. 

The main concerns employers have regarding vaccine mandates include resistance from employees, the potential impact on company culture and employee morale, and the possibility of losing employees in a tight labor market, according to Littler's research.

Self noted that more employees might be comfortable getting vaccinated now that the Pfizer shot is fully approved, and employers therefore might be more willing to risk some turnover and decide to require vaccination.
"There is no one-size-fits-all approach to setting workplace vaccination policies," said Devjani Mishra, an attorney with Littler in New York City. "Employers need to gather the type of information that would guide any employment-related decision, including determining the number of workers who already have been vaccinated, understanding workforce sentiment, addressing and removing obstacles to vaccination, evaluating industry trends, and accounting for public safety and health policies and infection rates in their particular geographies."

Reasonable Accommodations Still Required

Under guidance from the U.S. Equal Employment Opportunity Commission (EEOC), employers generally can mandate COVID-19 vaccinations for employees who physically enter the workplace without running afoul of the federal anti-discrimination laws the EEOC enforces. However, businesses that require employees to get vaccinated need to consider religious and disability-related objections and explore reasonable accommodations.

Employers that are revisiting their vaccination policies in light of Pfizer's full FDA approval should remember that, despite FDA approval, employees may still qualify for such exemptions, Self explained. "An employee with a valid exemption must be provided a reasonable accommodation, which may or may not mean allowing the employee to come to work unvaccinated."

Kevin Troutman, an attorney with Fisher Phillips in Houston, said accommodations could take various forms, depending on the employee's job and setting. Employers may offer remote work, change the physical workspace, revise practices or provide a leave of absence.

"In each situation, the employer must determine whether an accommodation would enable the unvaccinated employee to perform the essential functions of the job without posing a direct threat to anyone in the workplace," he noted. 

As always, Self said, employers should have a conversation with employees who request religious or disability-related exemptions to determine reasonable accommodations, and they should seek the advice of counsel if necessary.

Mitzel said employers should ensure their written policies are updated and proper COVID-19 guidelines are being followed. "Businesses will need to be savvy and consider every angle through a lens of public health and safety. They should engage with workers, making sure there is transparent communication for workers to know the 'why' behind established policies."


Article originally published on SHRM.