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 The decision by the Food and Drug Administration to give full
approval to the vaccine is "seismic," said Brian Dean Abramson, an
author on vaccine law.
He said it will become extremely difficult to challenge the FDA's
decision and the mandates that flow from it.
On Monday, the Pfizer/BioNTech vaccine became the first to secure
full FDA validation, prompting calls for governments and private
employers to make the shots mandatory.
COVID-19 vaccines have been available in the United States since
December under the an emergency use authorization (EUA) by the FDA.
Language in the EUA law states that recipients must be informed of
benefits and risks of the vaccine and given the option to accept or
refuse it.
That language raised some uncertainty regarding employer mandates,
which are usually considered legal, said Dorit Reiss, a professor at
UC Hastings Law. "With full approval, that is removed."
Following the FDA announcement on Monday, CVS Health Corp, Chevron
Corp - the second-largest U.S. oil producer - and Goldman Sachs
issued mandates for some employees.
Legal experts said there already was a growing consensus that
employers could mandate an emergency vaccine. During the pandemic,
both the Equal Employment Opportunity Commission and the Department
of Justice issued guidance in support of vaccine mandates, provided
exceptions were made for medical conditions and religious beliefs.
But emergency vaccine requirements have not gone unchallenged. At
least a dozen lawsuits have been filed, mostly by students against
colleges, but also by employees fighting allegations of wrongful
termination for refusing a shot.
Most of the cases prominently feature arguments that vaccines
approved on an emergency basis could not be required, seizing on
language in the emergency authorization law that requires consent
from the vaccine recipient.
Isaac Legaretta, for example, said he was never told he could refuse
the vaccine required by the Dona Ana Detention Center in New Mexico
where he worked.
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 "Quite the opposite, he was
advised that he would be fired if he did so,"
said the Legaretta lawsuit, which was filed in
February and is pending. In
July, in one of the few rulings involving a private employer, a
federal judge in Texas upheld vaccine mandates for employees at a
Houston Methodist Hospital, finding the employees misunderstood the
language in the EUA law.
Legal experts said challenges to vaccine mandates will almost
certainly persist, particularly against public employers or public
universities and colleges, which involve allegations of governments
infringing on an individual's Constitutional rights. That argument
does not apply to private employers.
But as long as the government is requiring the vaccine as a
condition of employment or education, legal experts said those will
be difficult cases to make.
"You can always go work for somebody else or go to a
school that doesn't require a vaccine," said Jeffrey Nolan, an
attorney with Holland & Knight, which represents employers.
Many employers have tried to use incentives such as gift cards and
time off to encourage vaccinations. That approach seems to have run
its course, legal experts said.
With full FDA approval, employers appear ready to move toward
ordering staff to get vaccinated.
Samantha Monsees, an attorney with Fisher Phillips, which represents
employers, said: "I think based on my workload in the last two days
the FDA approval is going to tip the scales with a lot of
employers."
(Reporting by Tom Hals in Wilmington, Delaware; Editing by Noeleen
Walder and Bill Berkrot)
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