How full FDA approval could pave the way for COVID-19 vaccine mandates

The companies behind two of the COVID-19 vaccines authorized for emergency use in the United States have applied to the Food and Drug Administration for full approval, which would allow them to market directly to consumers—and potentially boost confidence in the doses.

FDA approval could also lead more employers and schools to issue vaccine mandates.

On May 7, Pfizer and BioNTech became the first companies to apply for approval for their two-shot mRNA vaccine; Moderna, which also offers a two-dose mRNA vaccine, followed on June 1.

Both vaccines were authorized for emergency use in December, after clinical trials showed they were more than 94 percent efficacious against infection and extremely safe; these vaccines, along with a one-dose vaccine by Johnson & Johnson, have been plunged into the arms of more than 300 million Americans, with nearly 140 million Americans—about 42 percent—fully vaccinated.

But a recent survey found that about one-third of unvaccinated adults say they would be more likely to get a COVID-19 vaccine if it is approved by the FDA, underscoring the importance of full approval in combating vaccine hesitancy—and suggesting that some Americans may have misperceptions about what exactly emergency use authorization (EUA) is and how it is granted.

Here’s the difference between the two—and what approval could mean for you.

Emergency use authorization and approval, explained

“I think if you hear the term ‘emergency use authorization’ and you don’t hear much else about it, then you might draw the conclusion that [the authorized vaccine] has not been tested, is not safe, and that it’s unknown if it’s efficacious,” says Maria Sundaram, an infectious disease epidemiologist and postdoctoral fellow at ICES, a not-for-profit research institute in Ontario that conducts population-based health research. “That might cause some hesitancy.”

But in reality, vaccines that have been given an EUA have gone through a rigorous examination by the FDA that is very similar to its full approval process.

In the case of the authorized COVID-19 vaccines, the FDA evaluated data from clinical trials that included tens of thousands of study participants, as well as the companies’ manufacturing plans to ensure the quality and consistency of the vaccines. An EUA is only given after the FDA’s Vaccines and Related Biological Products Advisory Committee—15 scientists with expertise in immunology, epidemiology, vaccine safety, and more—determines the “known and potential benefits outweigh the known and potential risks of the vaccine,” according to the FDA.

“Emergency use isn’t taken lightly,” says C. Buddy Creech, director of the Vanderbilt Vaccine Research Program. “Emergency use brings with it a full understanding of the safety and the efficacy of a product over several months following exposure. And it’s always a bridge to get into full licensure. We would never want to leave a product at the emergency use stage.”

As with an EUA review, the process to grant full vaccine approval requires the vetting of copious amounts of data and the analysis of manufacturing plans. An application for an EUA, however, only needs to include two months of follow-up data after a completed Phase-3 trial—allowing an expedited analysis and deployment of vaccines amid an emergency, such as the pandemic. An application for full approval, however, must include at least six months of follow-up data on the vaccine’s safety and effectiveness.

Both the Pfizer-BioNTech and Moderna vaccines were highly efficacious against COVID-19 infection during clinical trials, and they have demonstrated similar effectiveness in real-world scenarios. Their impressive effectiveness and safety are “like hitting the lottery,” says Sundaram, “and bodes really well for full approval.”

A standard vaccine review also includes negotiations with manufacturers to determine how the vaccines will be labeled and how the companies can advertise their shots. It’s an important part of the process, Creech says: “You don't want to be creating fear in individuals in order for them to go out and ask their doctor for a particular vaccine,” he says. But “you want to display risk, and you want to provide people with the knowledge they need to make a good decision.”

If the vaccines are approved, what can we expect?

The Kaiser Family Foundation's latest survey shows that 32 percent of unvaccinated adults said they would be more likely to get a COVID-19 vaccine if it was FDA-approved. It was, the survey revealed, the top incentive to be vaccinated among the 1,500 vaccine-hesitant adults polled.

FDA approval of the COVID-19 vaccines, then, could spur more people to get vaccinated, potentially driving the U.S. ever closer to its herd immunity threshold: when as much as 80 percent of the country’s population has been vaccinated, according to recent estimates.

But the vaccine approval process can take more than six months from the date of application, and experts caution that people should not wait for FDA approval to be vaccinated. “They’re not only putting themselves at very high risk,” says Maria Elena Bottazzi, a professor of pediatrics at Baylor College of Medicine and co-director of the Texas Children's Hospital Center for Vaccine Development, “but they are also putting their communities at risk.”

The approval process would create brand names for the vaccines and bring advertising to consumers’ TVs, radios, and other media in an attempt to drive vaccinations and sales.

It will allow vaccine manufacturers to hike their prices—which they’ve already said they will do as the pandemic wanes—and usher in an era in which the vaccines are no longer given for free.

But like other vaccines, such as the seasonal influenza vaccine, the COVID-19 vaccine will likely be covered, at least partially, Creech says. “For the most part, because vaccines are one of the most profoundly effective public health maneuvers that we have for infectious diseases, they are typically covered either through public health funds or through private insurance, where the out-of-pocket expenses to the individual are either none, or extremely minimal,” he explains.

And it could pave the way for more employers and schools to mandate COVID-19 vaccines.

Some employers and schools have pressed forward with mandates for the authorized vaccines, but others—such as the University of California and California State University, for example—have said that they will only impose COVID-19 vaccine mandates for FDA-approved vaccines.

Dorit Reiss, a law professor who specializes in vaccine policy at the University of California, Hastings College of the Law, says FDA approval of the Pfizer-BioNTech and Moderna vaccines would make it more likely that more employers and schools impose mandates.

“Full approval removes a propaganda point,” Reiss explains, and eliminates the potential legal argument that these vaccines are experimental, and should not be used.

Any COVID-19 vaccine mandates by employers would likely need to “provide accommodation to workers with real medical barriers,” Reiss says, and could include exemptions for people with religious objections. School mandates will likely follow states’ leads: all states currently allow for medical exemptions to the existing slate of required vaccines, such as the MMR vaccine, Reiss says, but only some allow non-medical exemptions for those mandates.