The Food and Drug Administration granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for individuals 16 and older Monday morning.
Pfizer-BioNTech’s vaccine is now the first COVID-19 vaccine to be fully licensed, after receiving emergency use authorization in December. The vaccine continues to be available for individuals between the ages of 12 and 15 under emergency use authorization.
University spokesperson Rick Fitzgerald wrote in an email to The Michigan Daily that while the University does not anticipate any changes to the current vaccine exemption process as a result of the FDA’s decision, the full authorization reinforces their initial vaccine mandate.
“Today’s action by the FDA to grant full approval to the Pfizer/BioNTech Covid-19 vaccine for individuals age 16 and older supports the University’s earlier decision to adopt a vaccine requirement for our community,” Fitzgerald wrote.
In July, the University of Michigan mandated that faculty, staff and students across all three campuses and Michigan Medicine must get vaccinated by August 30, with limited exceptions.
According to a press release on Monday, the FDA used data from a Pfizer-BioNTech ongoing clinical trial involving 44,000 people over the age of 16 to evaluate the safety and effectiveness of the vaccine in the agency’s standard review process. Half of these trial participants were vaccinated while the other half were given a placebo.
The FDA analyzed the effectiveness of the vaccine and determined that it is 91% successful at preventing COVID-19 infection. Recipients were also followed for six months after receiving their second doses to monitor safety outcomes.
“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release.
UM Assistant Epidemiology Professor Abram Wagner studies vaccine hesitancy. He wrote in an email to The Daily that his research suggests full FDA approval could motivate previously hesitant people to get the vaccine.
“We do know that people express strong preferences for a vaccine to have full approval vs an EUA,” Wagner wrote. “I could imagine this would help convince some to become vaccinated. However, increases in vaccination coverage in the next few weeks could also be due to changes in how severe people think COVID-19 is or what their likelihood of getting infected is, particularly with the rise in the number of delta cases.”
Fitzgerald echoed the hope that full FDA approval will persuade more individuals to get vaccinated.
“We hope this action motivates any unvaccinated individuals in our community who were hesitant to get vaccinated while the vaccine was approved under Emergency Use Authorization to now get vaccinated,” Fitzgerald wrote.
As of Monday, 90% of students, 85% of faculty and 71% of staff at the University have self-reported as fully vaccinated.
The University has set up vaccination clinics around campus and the Ann Arbor community, several of which accept walk-in appointments. Vaccines are also available through several pharmacies and health care providers; more information can be found on the Campus Maize & Blueprint website.
Daily News Editor Hannah Mackay can be reached at firstname.lastname@example.org.