Pfizer DELAYS FDA application for COVID-19 vaccine for children aged six months to four years old

The application for the Pfizer-BioNTech vaccine to be used in children aged six months to four years old has been delayed, the Food and Drug Administration announced Friday.

The company submitted the emergency use authorization application on February 1. It included data from the first two doses of the three-dose vaccine set to be used in younger children. A FDA advisory committee panel meeting to discuss the merits of the approval was scheduled for February 15

Data for a third shot was supposed to come in later, and the New York City based company planned to apply for authorization for the third shot at another time.

The FDA said Friday it was notified by Pfizer that the company had new data regarding the shot that was worthy of being included in the decision making process.  

As a result, the February 15 meeting has been pushed back to an unknown date. 

Despite the push from regulators to expand eligibility for the shots to include young children, the controversial move would make the U.S. the only nation to jab children under one years old for Covid.

Despite the push from regulators to expand eligibility for the shots to include young children, the controversial move would make the U.S. the only nation to jab children under one years old for Covid.