On Monday, August 23, the Food and Drug Administration (FDA) gave full approval to the COVID-19 vaccine manufactured by Pfizer-BioNTech. The federal agency made the announcement on its website. “Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older,” the agency announced. “The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Acting FDA Commissioner Janet Woodcock, M.D., said, in a statement contained in the announcement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Further, the agency stated, “Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.”
With regard to anticipated corporate vaccine mandates, The Washington Post’s Ben Guarino, Laurie McGinley and Tyler Page wrote on Monday that “The biggest impact could come from employers, experts said, not from individual decisions. This summer, many employers, including federal agencies and companies such as Google and United Airlines, began to tell workers they would need to be vaccinated or face termination.” And they quoted Scott C. Ratzan, M.D., an expert in health communication at the City University of New York Graduate School of Public Health & Health Policy on the subject. Ratzan and his colleagues found that “3 to 5 percent of unvaccinated Americans said they would get immunized based on this change in status. If that group does, the total U.S. vaccinated population would increase by a few million.”
“At the corporate level, that’s where I think it’s going to matter,” Ratzan, a co-founder of CONVINCE, a London, England-based initiative created to improve vaccine literacy, told the Post reporters. “People are supportive of their employer recommending it and requiring it. … They are willing to follow if their employer recommends it.” And Sandra C. Quinn, Ph.D., M.Ed., a University of Maryland School of Public Health professor, who has studied public acceptance of vaccines under emergency authorization since the H1N1 influenza outbreak in 2009, told the Post reports that “A full approval takes away that ‘Oh, it’s experimental’ kind of language. For some people, it might make a difference. They will feel more confident and comfortable. Quinn said, “My expectation is that the biggest change will likely be less from individuals and more from organizations, be they industry, municipalities, etc.”
Last week, as the FDA approval announcement was anticipated, Healthcare Innovation Editor-in-Chief Mark Hagland interviewed Ivan D. Smith, a New York City-based attorney who is a shareholder in the labor and employment section, and an expert in labor law, including employment discrimination, at the Pittsburgh-based Buchanan Ingersoll & Rooney law firm. Among the topics they discussed was whether full FDA approval of the vaccines would make a difference in the plans of many corporate employers to impose vaccine mandates. Below are excerpts from that interview.
Let’s start at a high level here. How would you frame the legal standing of vaccine mandates, in the broader context of current U.S. employment law?
Unless a person has a religious belief or there’s a disability that stops an individual from getting a vaccine, a company has a right to mandate a vaccine if they choose to do so.
Will the ruling in the Houston Methodist Health case have been precedent-setting?
The case involving Houston Methodist was not as big a deal, to be very candid with you, in that their lawsuit was not an effective way to challenge vaccine mandates. There will be cases that will be more substantive in terms of arguments. In the Houston Methodist case, they were simply attacking the concept of mandating vaccines, purely based on the idea of emergency-use authorization from the FDA. The reason that that is not a major argument is that employers have the right to do anything, as long as they’re not being discriminatory, in at-will states, and Texas is an at-will state. So unless they’re being discriminatory, employers have a lot of leeway to do what they want. And the issue here is—the emergency use question was not a big enough impediment. I think you’ll see more arguments around religious belief, more than anything else.
Will the religious beliefs arguments go anywhere?
They could, because the question is how you can challenge something. And if you look at the makeup of the Supreme Court, religious belief is going to be supported more than it ever has; so if you can make some sophisticated challenges, there’s a possibility for expansion of that attack against the employee mandates.
Does it matter legally if the FDA full authorizations come?
Legally, probably not, but once people see the authorization, more people will be willing to be vaccinated.
How does union organizing intersect with this issue?
From the union standpoint, vaccine mandates are about the rights of workers, in terms of safety and their individual rights. Unions have been successful in organizing a lot of industries regarding worker safety, such as with regard to PPE [personal protective equipment]. Now, the reality is that unions are standing on different sides of this. Some unions are advocating employee vaccine mandates, to protect the employees. Other unions are taking the position that we have to talk about your rights, and that employers should give you a say in what you put in your body, etc. So it really depends on the industry. And I’ve seen it being very effective in both ways. And even in fields where there aren’t unions, there have been issues in terms of how they’re reacting to the mandates.
Usually in hospitals, the only workers who are unionized are nurses. Will that matter?
Well, residents are often unionized also. But the law protects workers in engaging in concerted activity. And one form of concerted activity is unionized. But for the non-unionized group, if they want to have discussions with the employer about the vaccine mandate, how the employer deals with those people is important. As long as they don’t discipline them for expressing their concerns or ability to engage in concerted activity, the employer will be able to do what they want to do. But some employers might have to be careful. Now, once you’re unionized, then the idea of mandates becomes a term and condition of employment, and the union has the right to negotiate on behalf of the workers. There’s a requirement for companies that are unionized that they at least have to negotiate over the implementation, over how it’s done. So in the example you gave, the union can force the employer to negotiate over how to implement the mandate.
Will it matter that it’s healthcare?
Yes. The situation on the ground in healthcare makes it harder for healthcare workers to argue against mandates, if they’re involved in patient care—harder than in any other industry. And if there’s a way that the full authorization could make a legal impact, it might be in that kind of case, because once it’s fully authorized, it would take away any grain of argument legally. Employers are waiting for full authorization because it will make it easier for them. It’s more a psychosocial and political issue, because full authorization will take away arguments against vaccination; so it adds to it psychologically.
Is there anything you’d like to add?
The other thing that people don’t understand when they see unions fighting against vaccination, is that unions are always thinking not only about today, but tomorrow. In hospitals, flu shots are mandated. In some hospitals, they say, if you don’t get the flu shot, you have to wear a mask. And a union might argue that there should be accommodations made, that you shouldn’t mandate flu vaccination, but you can require masking. They don’t want to give up ground, they don’t want to lose ground legally.
How will this play out?
There will be a lot of litigation. Once the FDA provides full authorization, companies will mandate vaccination, and you’ll see litigation. You’ll see certain female employees saying I’m pregnant or might become pregnant, and I have concerns. So I believe you’ll see more companies mandating vaccines, and then litigation.
But for those individuals opposing vaccines, it will be an uphill climb in healthcare, correct?
I think it will be an uphill climb everywhere, but especially in healthcare. But overall, employers will prevail.