FDA full approval of Pfizer vaccine should reduce risk of employer mandates


covid-19 vaccine

On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer vaccine for those 16 and older – the first full approval of the three COVID-19 vaccines available in the U.S. The Moderna and Johnson & Johnson vaccines currently remain under only an emergency use authorization (EUA), and the Pfizer vaccine itself remains under EUA for those aged 12 to 15.

Full approval may be welcome news to some employers, as EUA status has reportedly been a driver of hesitancy among some 30% of unvaccinated employees. Full approval also reduces employers’ legal risk in mandating vaccines. A legal argument used against employers (though unsuccessfully) who have mandated vaccines was the lack of full FDA approval. Further, full approval should significantly limit potential employer exposure to intentional tort claims based on requiring the vaccine should employees have adverse reactions to the Pfizer vaccine.

While more employers may now feel comfortable requiring the vaccine, the EEOC has approved of doing so since December 2020. Regardless, employers who decide to mandate vaccines must continue to provide reasonable accommodation to employees with disabilities that prevent them from getting the vaccine under the Americans with Disabilities Act (ADA) and to employees who are unable to receive the vaccine because of a sincerely held religious belief, practice or observance under Title VII, unless the accommodation poses undue hardship on the employer.

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