FDA Reportedly Set To Approve Pfizer Vaccine For 12- To 15-Year-Olds

The Food and Drug Administration is preparing to expand authorization for the use of the Pfizer-BioNTech coronavirus vaccine to children ages 12 to 15 next week, granting access to millions of young Americans, according to multiple reports.

The New York Times, citing officials familiar with the plans, first reported Monday that the FDA is set to grant the drugmakers expanded emergency use authorization, a key step in raising the country’s immunity levels that would in turn reduce the numbers of hospitalizations and deaths. 

The U.S. Centers for Disease Control and Prevention would then convene its vaccine advisory panel and make recommendations for how the inoculations should be used in the adolescent age group. The Pfizer vaccine is already approved for those 16 and older.

The expansion would provide a great deal of comfort to schools preparing to return to some semblance of normal activity by the fall.

In March, Pfizer and BioNTech said clinical trial data showed their vaccine was extremely effective in children ages 12 to 15, with strong antibody responses and no serious side effects. The companies have also begun a clinical trial into the use of the vaccine in children ages 5 to 11.

“Across the globe, we are longing for a normal life. This is especially true for our children,” Ugur Sahin, the CEO of BioNTech, said in a statement in March. “It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”

Children are much less likely to suffer severe cases of COVID-19, but they can still be infected with the coronavirus.

More than 147 million people have received at least one dose of a coronavirus vaccine in the United States, and about 131 million jabs have been of the Pfizer-BioNTech shot, according to the CDC. The Biden administration has been working on a new phase of its vaccination blitz, however, as demand for the shots has begun to wane. 

The Times also reported Monday that experts say reaching “herd immunity” in the country is increasingly unlikely due to a combination of vaccine hesitancy and the rise of troubling COVID-19 variants.