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Vaccine Mandates at Work Set for Uptick After Full FDA Approval

May 10, 2021, 9:30 AM

More employers will likely require their workers to be inoculated against Covid-19 once federal regulators upgrade the vaccines from their current approval as emergency products, according to employment lawyers who counsel companies.

Pfizer Inc. and its partner BioNTech SE on Friday asked the U.S. Food and Drug Administration for full approval of their vaccine, which was the first to receive emergency authorization. Moderna Inc., which got emergency approval shortly after Pfizer, could soon follow suit. Johnson & Johnson is further behind.

Although employers generally have the authority to impose inoculation mandates—and enforce such policies under the threat of termination—the vaccines’ emergency use status has been one of several complicating factors prompting many companies to shy away from requirements, attorneys said.

“We expect to see an increase in employer mandates for workforce vaccinations after full FDA approval,” said Christina Janice, an attorney at Barnes & Thornburg LLP. “That increase is likely to occur in first-responder, front-line workplaces, such as health care, emergency services, and schools.”

Workplace vaccine requirements have been rare, although some employers in health care, legal services, and higher education have called on staffers to get inoculated.

Employer mandates that push some people to overcome their hesitancy and get the shot could help the U.S. reach herd immunity against Covid-19. Approximately 255 million total vaccine doses have been administered and reported to the Centers for Disease Control and Prevention, but the number of jabs per day has been trending downward since mid-April, according to government data.

The controversy over mandating vaccines while they’re under emergency authorization stems from language in the Food, Drug and Cosmetic Act that says that individuals can refuse the vaccines.

No government or court interpretation of that section has said it prohibits employers from taking action against workers who refuse to comply with a vaccine mandate, said James Paul, an attorney at Ogletree Deakins. The Equal Employment Opportunity Commission has said companies can require vaccination if they reasonably accommodate disabilities and religious objections, he noted.

“Nonetheless, the FDCA language fuels the fire of those protesting mandatory vaccination,” Paul said.

The emergency approval status has given rise to at least two ongoing federal lawsuits challenging workplace vaccine mandates, one in California and the other in New Mexico.

Mandates will remain divisive, but “full FDA approval of a Covid vaccine will at least dismantle the argument that employees should not have to choose between their job and accepting a vaccine they regard as experimental due to its emergency use authorization,” said Deena Merlen, an attorney at Reavis Page Jump.

Full Approval Months Away

The full FDA approval process for vaccines has taken an average of 12 months, according to a study by researchers at Yale University and Duke University.

Regulators will try to speed the Covid-19 vaccines through the process, but it’s likely to be a matter of months, rather than days or weeks, said Dorit Reiss, a law professor at the University of California Hastings College of the Law who specializes in vaccine policy.

Applying for full vaccine approval requires six months of data, Reiss said. That puts Pfizer and Moderna, which received emergency approval in December, ahead of Johnson & Johnson, which got authorization at the end of February, she said.

Full FDA approval will help employers justify—and feel more confident about—polices requiring workers to get vaccinated, said Randi May, a lawyer at Hoguet Newman Regal & Kenney LLP. It will also soothe some of the fears among people who worry about the emergency authorization process being too rushed, she said.

But some lawyers who represent employers said the upgrade in FDA authorization would have a small impact on workplace vaccine mandates, or perhaps none at all.

The liability for lawsuits based on their emergency authorization status have always been hypothetical and not something that drove employer decisions against requiring vaccination, said Brett Coburn, an attorney at Alston & Bird LLP. Any effect it might have on reducing individual resistance to taking the shot is likely to be small, he said.

Another issue is the potential for state laws that interfere or prohibit workplace vaccine mandates, attorneys said. Montana lawmakers are pushing legislation that would block employers from firing workers who reject mandates, and bills are pending in Florida and Iowa.

“Larger employers operating in multiple states have to worry about varying state laws that are each individually different,” said Susan Bickley, a lawyer at Blank Rome LLP. “And a lot of these companies are already down the road in planning, anyway.”

To contact the reporter on this story: Robert Iafolla in Washington at riafolla@bloomberglaw.com

To contact the editors responsible for this story: Jay-Anne B. Casuga at jcasuga@bloomberglaw.com; Andrew Harris at aharris@bloomberglaw.com

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