WEB EXCLUSIVE | The US Food and Drug Administration granted approval of the Pfizer/BioNTech COVID-19 vaccine for those 16 and older on Monday, the first COVID-19 vaccine to be granted approval by the FDA.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock, M.D. said in a press release. “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.”

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since Dec. 11 for individuals 16 years of age and older. The authorization was expanded to include individuals age 12 and older on May 10. 

“I am definitely glad that the FDA approved the Pfizer vaccine because it will hopefully encourage and promote others to get the vaccine,” sophomore Brennan Damond said. “I feel it is necessary to keep everyone safe and healthy.”

The decision is expected to open up the possibility of more vaccine requirements by universities, employers, and other organizations. The approval is also expected to boost the confidence of unvaccinated individuals that are eligible to be vaccinated, according to Woodcock.

“I definitely feel safer about going to public events that have mandated COVID-19 vaccines such as concerts and sporting events,” junior Ginny Cross said. “Given the FDA approval, I’m hoping that COVID-19 vaccine mandates will become more refined after this.”

Pfizer presented data based on the analysis of 46,307 trial participants, according to a Pfizer press release. The data showed the vaccine was 9.13% effective against COVID-19, a slight decrease from the 95% reported when the vaccine was approved for emergency use.

On Aug. 16, Pfizer and BioNTech released their plan to seek approval for a booster shot for individuals 16 years of age and older after 6 months of primary vaccination. The data demonstrated that a third dose promotes significantly higher antibody levels of protection compared to a two-dose series.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”