The U.S. Food and Drug Administration officially approved the Pfizer-BioNTech COVID-19 vaccine for individuals 16 and older Aug. 23.
The Pfizer-BioNTech vaccine, which will now be marketed as Comirnaty, was originally approved under emergency use authorization, or EUA, in December 2020 for individuals 16 and older. For individuals 12 to 15, the vaccine remains under EUA after being approved in May 2021.
Berkeley Mayor Jesse Arreguín predicts the FDA approval will lead to more vaccinations for those who have been hesitant.
“It is clear that vaccines are a key part of ending the pandemic, especially when combined with masking and appropriate social distancing protocols,” Arreguín said in an email. “We are currently exploring vaccine mandates and hope to be able to provide an update on the status of that soon.”
According to the FDA’s press release, clinical trials conducted by Pfizer showed that the vaccine is 91% effective in preventing COVID-19.
In the clinical trials, about 22,000 people received the Pfizer vaccine and 22,000 people received a placebo.
The FDA also evaluated the increased risks of heart issues, such as myocarditis and pericarditis, in young males following the second dose of the vaccine. With short-term data, they found that most symptoms were resolved, though some required intensive care support.
The FDA is also requiring that Pfizer-BioNTech conduct long-term studies on the risks of heart issues in addition to Pfizer-BioNTech’s study of the vaccine’s effect on pregnancies.
“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, ” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the press release.
For Homemade Cafe owner Collin Doran, the official approval prompted him to consider a vaccine mandate for customers who dine indoors. The Homemade Cafe didn’t have an official employee vaccination policy according to Doran, but he said he encouraged all of his employees to get vaccinated.
Doran added that the safety of both his employees and his customers is very important to him.
“Everyone, get vaccinated,” Doran said. “The more people that get vaccinated, the better for everybody.”