"Emergency Use" No More: FDA Approves First COVID-19 Vaccine

gloved hand holding vaccine and syringe

There was a time in which employers and employees weren’t vexed with viruses, vaccines, and their respective duties and rights.

That seems like a long time ago, but it wasn’t. The World Health Organization declared the novel coronavirus ("COVID-19") a pandemic, and President Trump declared a national emergency in the wake of the pandemic in early 2020.  But, as put by a U.S. district judge just last month (in a conspicuous case in which students of Indiana University sued the school claiming that its requirement that they be vaccinated against COVID-19 or wear masks and be tested regularly violated their Constitutional rights), "COVID-19 caught the world unaware. Initially, there were no vaccines or treatments, and testing was expensive and difficult to secure. Four days after the United States Department of Health and Human Services ("HHS") … declared a public health emergency, it issued a second declaration allowing the United States Food and Drug Administration ("FDA") … to grant emergency use authorizations" ("EUAs") for "interventions to combat the pandemic." (By the way, EUAs are not new. There have been six significant public health emergencies for which the FDA has authorized them: anthrax, swine flu (also known as "H1N1"), MERS (Middle East Respiratory Syndrome coronavirus), Ebola, Zika, and now COVID-19.)

Those who haven’t been living under a rock know some of those "interventions" by name – vaccinations manufactured by Pfizer, Moderna, and Johnson & Johnson. The speed with which they seemed to appear out of the blue left some people with the distinct but incorrect impression that an "emergency use authorization" means "experimental" and thus "dangerous."

But that's not true. According to the judge, "[d]espite creating an expedited pathway to distribute new medical products during emergencies, products that receive EUA approval still must adhere to specified safety, efficacy, and manufacturing criteria, and HHS must ensure medical providers and individuals are informed of the product's EUA status, the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown."

And deployment of the COVID-19 vaccines seems to have been unusually methodical. The judge points out that, "[b]ecause of the widespread use of a COVID-19 vaccine, the FDA informed manufacturers that it expected the same level of endpoint efficacy data as required for full approval, enough safety data to justify by clear and compelling evidence the vaccine's safety, and confirmation of the technical procedures and verification steps necessary to support full approval. … In setting these more stringent standards, the FDA invited EUA applications only for vaccines positioned well to receive full approval."

So perhaps we shouldn’t be surprised that the FDA, today, announced that it has "approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine … for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization …, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals." You can find the news release at https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

Employers should take note because the FDA's approval of the Pfizer-BioNTech vaccine, which will be marketed as "Comirnaty" (koe-mir’-na-tee, which you may as well learn), eliminates a potential objection to a COVID-19 vaccination mandate of the kind that has been litigated repeatedly in various contexts. The objection – that an employer shouldn’t be permitted to require an employee to get, as a condition of employment, a vaccine that has acquired only "emergency use authorization" – has met with little if any legal success. However, an employer can still be required to litigate the objection in court. A Texas hospital, for example, recently had to fend off a federal lawsuit in which 117 employees sued it, claiming that a policy requiring employees to be vaccinated against COVID-19 by a certain date was invalid because "no one can be mandated to receive 'unapproved' medicines in emergencies" and "no currently-available vaccines have been fully approved by the Food and Drug Administration." The lawsuit was dismissed, but the dismissal has been appealed to a federal appellate court, so the fight will continue at the employer's expense. The suit might never had been brought had the FDA previously approved at least one COVID-19 vaccine. That's impossible to know, but today's approval surely makes such claims less likely now.

There are other grounds on which many employees can possibly object to vaccination mandates, such as objections based on disabilities or sincerely held religious beliefs, but today's announcement, at least as far as the "Pfizer/Comirnaty" vaccine is concerned, strikes one objection off the list.

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