News and HeadlinesIndiana Coronavirus News


FDA grants full approval for Pfizer's COVID-19 vaccine to those 16 and older

The FDA announced the approval on Monday.
Pfizer full approval
Posted at 7:31 PM, Aug 23, 2021

INDIANAPOLIS — The Food and Drug Administration (FDA) has granted full approval to the Pfizer COVID-19 vaccine for people 16 and older.

It is the first COVID-19 vaccine to go from emergency use authorization status to full approval from the FDA.

This means Pfizer has shown enough effectiveness in its vaccine and enough safety data to satisfy FDA requirements.

“It means that the FDA has done a very rigorous approval process that includes things like manufacturing and plant inspections, validations of the entire supply chain, product quality, and the employees are properly trained,” said George Ball, Associate Professor of Operations and Decision Technologies at Indiana University Kelley School of Business.

Safety, effectiveness, and manufacturing quality were all studied during this process.

For some, that full approval means they will now feel more comfortable getting vaccinated, but others say they are still holding off.

“I made the decision that me and my children will not be taking the COVID shot,” Latahua Gardner, of Indianapolis said.

She said she is not sure what would make her more comfortable to get the vaccine.

"Too new, too soon… I want to make sure it's extremely safe first,” Gardner said.

But experts say this FDA approval shows that the vaccine is and has been safe. They said you can expect to see more companies and universities requiring the shot now as well, which could also increase vaccination rates.