UPDATE: Aug. 23, 2021: The U.S. Food and Drug Administration on Monday gave full approval to the Pfizer-BioNTech coronavirus vaccine for preventing COVID-19 in individuals ages 16 and older. It will be marketed under the name Comirnaty. The vaccine is still under an Emergency Use Authorization for children and teens ages 12 through 15 and for administration of a third booster shot in some immunocompromised individuals.
ORIGINAL STORY: When originally crafting plans to reopen in the fall, the California State University System said it would require students to be vaccinated against the coronavirus, contingent upon the U.S. Food and Drug Administration giving one of the shots full approval.
But so far, the FDA has granted all three vaccines available in the U.S. an Emergency Use Authorization, a designation enabling the federal government to get them out quicker during the health crisis.
Late last month, amid the flood of new coronavirus cases spurred by the ultra infectious delta variant, the Cal State system changed course and said it would mandate the shot regardless of the FDA's approval type. But it spoke volumes that California State — as the largest public four-year system in the U.S., based in a liberal state where politicians haven't attacked COVID-19 mitigation attempts — was at first waiting for the FDA.
The system's initial decision underscored the barriers college leaders navigate when deciding whether to require a vaccine. Individuals unfamiliar with the thoroughness of the FDA's emergency use evaluation can be suspicious that vaccines are untested or rushed. And colleges sometimes hesitate to take steps that are new or controversial.
Full approval entails the FDA reviewing hundreds of thousands of pages of documents, or about 10 times the data necessary to give emergency authorization, according to The New York Times. That doesn't mean the vaccines being given out under emergency use authorization have been rushed. They underwent rigorous evaluation, and years of groundwork already occurred in developing them.
College leaders might not be concerned about the distinction anymore soon. The FDA is aiming to give full approval to the Pfizer-BioNTech version of the shot as early as Monday, the Times reported.
Policy and public health experts believe this will set off another round of vaccine edicts among colleges and cement their confidence they can legally require them. Recent court rulings have already affirmed such mandates at colleges in several states — but not all.
Still, the biggest obstacle in many cases may be perception, and a shot with full FDA approval could change that.
"It's more of a kind of policy objection than a legal barrier," said Audrey Anderson, a lawyer at Bass, Berry & Sims in Nashville and a former general counsel of Vanderbilt University. "And that is, 'How can you make me put this in my body when it's not even approved by the Food and Drug Administration?' This will take away one obstacle in making it mandatory."
Vaccine mandates nationwide
About a quarter of two- and four-year nonprofit colleges are requiring the vaccines, and three-quarters are incentivizing their student bodies to get them, according to Chris Marsicano, founding director of the College Crisis Initiative at Davidson College, which is tracking institutional responses to the pandemic.
Other institutions like the Cal State system initially intended to delay their requirements until full FDA approval but have since moved forward with them. Among those colleges are Rhodes College, in Tennessee, and the University of Northern Colorado.
Full authorization would prompt a sea change at two levels, said Anita Barkin, co-chair of the COVID-19 task force of the American College Health Association.
Institutions at first reluctant to institute vaccine requirements would feel more comfortable doing so. Barkin said some colleges held back on a mandate after discussions with administrators and legal counsel, though the law is on their side.
The U.S. Supreme Court recently declined to take up a lawsuit against Indiana University's vaccine mandate, preserving it for the fall, and other such legal challenges have hit similar roadblocks. Language in the emergency use authorization law does not prohibit vaccine requirements, according to a U.S. Department of Justice opinion issued in July.
Students and their families will also likely be more accepting of a fully approved vaccine, Barkin said. This, coupled with the knowledge that the delta variant is driving up case counts, hospitalizations and deaths, will persuade some of those initially resistant, Barkin said.
As of early August, 70% of adults had received at least one dose of the vaccine.
"Seeing hospitals fill up, the increasing number of unvaccinated individuals who end up in intensive care compared to the vaccinated, will help move individuals," she said.
Barriers will remain
While some college-goers may be convinced to get the shots after full authorization, the shift almost certainly won't change the minds of Republican policymakers who have banned vaccine mandates through new laws or executive action, Anderson said. States such as Florida and Oklahoma have enacted rules preventing colleges from putting vaccine conditions in place.
"They see it as a question of individual rights, of individual bodily integrity," Anderson said. "A change by the FDA really doesn't matter for them."
Barkin agreed that colleges in these GOP-led states will be the most hamstrung. More institutions will announce their vaccine mandates upon the FDA's endorsement — and others will want to but won't be able to, she said.
Once the FDA does give its full approval to the vaccine, distribution on campuses won't be difficult, even if it's happening as the fall term is already underway, Marsicano said.
Colleges can host vaccination clinics or give students the jab as they're moving into on-campus housing, he said.
Institutions should focus on the positives of vaccines when communicating about them and their FDA status, Barkin said. They should not dwell on myths or disinformation in their missives. If they're in a state that bars vaccine mandates, then colleges can use the FDA approval as a jumping-off point to encourage the shot.
"Schools that are requiring the vaccination or intend to put a requirement in, at this point in their communications, should be educating about the safety and efficacy of the vaccine," Barkin said