FDA to Soon Approve Pfizer / BioNTech for Teens Use

The US drug authority FDA is preparing to approve Pfizer / BioNTech’s corona vaccine for teens ages 12 through 15 early next week, and The New York Times reports based on federal officials.

 

The drug manufacturers filed with the FDA earlier this month to approve the drug, which is already being administered in the United States to people 16 and older. After both companies announced in March, the approval is being sought that a clinical trial showed the vaccine to be safe and effective for 12 to 15-year-olds.

If approved, the National Center for Disease Control and Prevention (CDC) vaccine advisory panel will review the research data the next day and issue an opinion, the US newspaper writes.

The manufacturers Pfizer and BioNTech also submitted a similar application to the European Medicines Agency (EMA) late last week. It often takes four to six weeks for the EMA to make a decision.

Children between 12 and 15 years old can be vaccinated with the vaccine in Europe from mid-June at the earliest. Most countries first inject the elderly, so it will not be the turn of the young in June.