The U.S. Food and Drug Administration announced its full approval of the Pfizer-BioNTech COVID-19 vaccine Monday, opening the door for colleges and universities that have been hesitant to require vaccines for students to begin instituting mandates.
The vaccine will now be referred to as “Comirnaty” rather than the Pfizer vaccine and has been approved for individuals 16 years of age and older. It will still be administered in two doses three weeks apart.
“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 said in a statement.
While hundreds of institutions have already required their faculty, staff and students to get a COVID-19 vaccine, others said they were holding off until at least one of the vaccines received full FDA approval. Monday’s announcement is expected to make colleges and universities more comfortable with having a vaccine mandate, especially since other FDA-approved vaccinations -- such as for tuberculosis or hepatitis B -- are already required on most campuses.
“Some of those institutions said that the fact the vaccine wasn’t fully approved was holding up their willingness to put in a requirement,” said Anita Barkin, co-chair of the American College Health Association’s COVID-19 task force. “Now with the full approval status in place, institutions of higher education who were on the fence because of the emergency use authorization status may feel more willing to move forward with a requirement.”
Some colleges have wasted no time in shifting their policies. The University of Minnesota said it would add the COVID-19 vaccine to those already required for students upon formal approval of any vaccine by the FDA. A few hours after the FDA’s announcement, Minnesota president Joan Gabel and medical school dean Jakub Tolar sent an email to their campuses announcing the addition.
Louisiana State University also plans to require vaccinations for its students now that the FDA has approved it, according to President William Tate IV. An official mandate could come as soon as today.
“Once the vaccinations -- any one of them -- were FDA approved, [we said] we would mandate student vaccinations here at LSU,” Tate said Monday. “In essence, that has happened today. There will be a more formal announcement tomorrow reinforcing that.”
The College Crisis Initiative, or C2i, at Davidson College, has been keeping track of some of the institutions that have said they would mandate the vaccine after full FDA approval. Among those institutions are Davidson College, the University of Northern Colorado, the University of Richmond and the State University of New York system, said Rylie Martin, assistant director of C2i. The University at Buffalo, part of the SUNY system, has already updated its website making note of the FDA approval.
Pfizer’s full FDA approval may lead to more institutions expanding their mandates beyond students and staff, said Hailyn Chen, co-managing partner of the law firm Munger, Tolles & Olson and a member of the National Association of College and University Attorneys. The University of Oregon and Oregon State University became the first Power 5 universities to announce they will require proof of vaccination or a negative COVID test for people older than 12 to attend their football games. Tulane University has also said that the same will be required for fans to attend its home football opener next month.
“I think what you’re going to see is just more and more extensions of vaccine mandates to those situations where there could be a high risk of COVID transmission,” Chen said.
Still, Christopher Marsicano, founding director of C2i, isn’t convinced that vaccination rates will change substantially on campuses, even if colleges and universities feel more emboldened to institute mandates.
“Campuses have worked really, really hard to incentivize the vaccine,” Marsicano said. “As a result of those incentives, you’ve got schools that have not previously required it that have really high vaccination rates,” such as the University of Richmond, which hasn’t had a mandate prior to FDA approval but still has a 93 percent vaccination rate.
Marsicano also noted that the FDA approval may not change much for institutions in states that have prohibited public institutions from mandating the vaccine, including Arizona, Florida, Oklahoma and Texas. But Barkin hopes the announcement will encourage states to change their minds.
“We hope that the full FDA approval will be one more factor in convincing those states that have restrictions in place to reverse their decision and allow institutions of higher education to employ all of the possible mitigation strategies available to control infection and outbreaks on campus,” Barkin said. “Of course, vaccination is the No. 1 on that list of strategies.”
Correction: A previous version of this story said Humboldt State University and Blackburn College would mandate the COVID-19 vaccine following full FDA approval. Humboldt State University already had a vaccine requirement in place, prior to Monday's announcement. Blackburn College does not have a vaccine mandate but said previously that it may re-evaluate its approach following full FDA approval.