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Pfizer vaccine given full FDA approval for ages 16 and older

University of Rochester

Almost nine months after its initial emergency use rollout, Pfizer and BioNTech COVID-19 vaccine has been granted full approval by the U.S. Food and Drug Administration for people ages 16 and older.  

On Monday the FDA said the public can rest assured that the Pfizervaccine meets its high standards for safety, efficacy, and manufacturing quality. Pfizer is the first mRNA vaccine to be given this distinction since granted emergency use authorization on December 11, 2020.

Since then more than 200 million doses have been administered according to the Centers for Disease Control and Prevention.

“The CDC has been very meticulous in tracking side effects through essentially nine months, and they have been able to uncover any of the concerns that anyone would have with the vaccine, said UR Medicine’s infectious disease specialist, Dr. Edward Walsh.

Walsh said the FDA approval could possibly remove vaccine hesitancy, and allow for employers to mandate vaccination as a requirement. This approval also comes as the highly contagious delta variant continues to cause a surge in COVID-19 cases nationwide and locally 

“This certainly is a vote of confidence in favor of the vaccine," said Monroe County public health commissioner, Dr. Michael Mendoza. “But when it comes to the delta variant, we have to look at all of the strategies that are available to us.”

Mendoza said that while vaccination is the most important tool to fight the variants, the community must still practice wearing masks indoors and in crowded areas.

Racquel Stephen is a health and environment reporter. She holds a bachelor's degree in English literature from the University of Rochester and a master's degree in broadcasting and digital journalism from the S.I. Newhouse School of Public Communications at Syracuse University.