US approval of COVID-19 vaccine is a “seismic” change to the legality of mandates, experts say

August 24 (Reuters) – Formal US approval of the Pfizer Inc. (PFE.N) / BioNTech SE COVID-19 vaccine will make it nearly impossible to successfully challenge employers’ mandates, legal experts said.

The Food and Drug Administration’s decision to give full approval to the vaccine is “seismic,” said Brian Dean Abramson, author of vaccine legislation.

He said it will be extremely difficult to challenge the FDA decision and the mandates that result from it.

On Monday, the Pfizer / BioNTech vaccine became the first to ensure full validation by the FDA, prompting governments and private entrepreneurs to make the shots mandatory.

COVID-19 vaccines have been available in the United States since December under the FDA’s Emergency Use Authorization.

The language of U.S. law states that recipients must be informed of the benefits and risks of the vaccine and must be given the option to accept or reject it.

This language caused some uncertainty about the mandates of employers, which are usually considered legal, said Dorit Reiss, a professor at UC Hastings Law. “With full approval, that is removed.”

Following the FDA announcement Monday, CVS Health Corp. (CVS.N), Chevron Corp. (CVX.N), the second-largest U.S. oil producer, and Goldman Sachs (GS.N) issued warrants for some employees. .

Legal experts said there was already a growing consensus that employers could demand an emergency vaccine. During the pandemic, both the Equal Employment Opportunity Commission and the Department of Justice issued guidelines in support of vaccination warrants, provided exceptions were made for medical conditions and religious beliefs.

But emergency vaccination requirements have not been indisputable. At least a dozen lawsuits have been filed, mostly by students against colleges, but also by employees battling allegations of wrongful termination for denying a shooting.

Most cases present strong arguments that emergency-approved vaccines could not be required, taking advantage of the language of the emergency authorization law that requires the consent of the recipient of the vaccine.

Isaac Legaretta, for example, said he was never told he could deny the vaccine required by the Dona Ana Detention Center in New Mexico where he worked.

“Quite the contrary, he was warned he would be fired if he did,” said the Legaretta lawsuit, which was filed in February and is pending.

In July, in one of the few rulings on a private employer, a Texas federal judge upheld vaccination warrants for employees of a Houston Methodist hospital, which found that employees did not understand the language of U.S. law. .

Legal experts said challenges to vaccination warrants will almost certainly persist, especially against public entrepreneurs or public universities and colleges, which involve complaints from governments that violate an individual’s constitutional rights. This argument does not apply to private entrepreneurs.

But whenever the government demands the vaccine as a working or educational condition, legal experts said it will be difficult cases to do.

“You can always go to work for someone else or go to a school that doesn’t need a vaccine,” said Jeffrey Nolan, a lawyer for Holland & Knight, which represents employers.

Many employers have tried to use incentives such as gift cards and free time to encourage vaccination. It seems that this approach has followed its course, according to legal experts.

With full FDA approval, employers seem willing to move forward to order staff vaccination.

Samantha Monsees, an attorney for Fisher Phillips, which represents employers, said, “I think based on my workload over the past two days, FDA approval will tip the scales with a lot of employers.”

Reports of Tom Hals in Wilmington, Delaware; Editing by Noeleen Walder and Bill Berkrot

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