August 24, 2021
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.”