What FDA Approval Might Mean for Vaccine Mandates

As the Delta variant continues to spread, COVID cases surge among the unvaccinated, and rates of new vaccinations decline, the U.S. Food and Drug Administration is receiving pressure from President Joe Biden to approve a COVID vaccine. Biden recently said during a town hall event that he expects a fully approved vaccine to be made available by fall. 

“They’re not promising me any specific date, but my expectation, talking to the group of scientists we put together… plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they’ll get a final approval,” Biden said.

Pfizer-BioNTech, Moderna, and Johnson &Johnson vaccines have been authorized for emergency use in the U.S., and Moderna and Pfizer have filed applications for full licensure at the start of the summer in May-June, but a full FDA approval typically requires six months of efficacy data.

Pfizer issued a statement in July that the FDA granted the vaccine for priority review designation for the Biologics License Application for the mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older, and the goal date for the decision by the FDA is in January 2022. Acting FDA Commissioner Janet Woodcock issued a statement that a decision should come well before that time. 

The conflict posed by having only an emergency use authorization for vaccines is whether or not COVID-19 vaccines can be legally mandated.

That’s why a full approval of a vaccine could mean a wave of new mandates from employers, schools, hospitals, etc.

The University of California system initially announced that they would require students to get vaccinated “with FDA approval” and has since decided to require vaccinations anyway under the emergency use approval. 

Already there have been lawsuits filed over vaccine mandates, such as a situation at Houston Methodist Hospital, in which 200 employees were suspended without pay for failing to get vaccinated, leading to 117 suspended employees filing a lawsuit that the vaccines were experimental and dangerous. 

The courts dismissed the lawsuit, indicating that the requirement does not violate federal or public policy.

Many companies and universities will continue to toe the line on whether a vaccine could be mandated without full FDA approval, and other potential lawsuits could emerge if an individual does not wish to comply with the mandate.