NEW YORK (NEXSTAR) – Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children as it moves closer to seeking approval for expanded use of the shots. However, according to The Wall Street Journal, the FDA may not give authorization until November.
The drugmaker and its partner, Germany’s BioNTech, say they expect to request emergency use authorization of their vaccine in children ages 5 to 11 “in the coming weeks.”
According to the The Wall Street Journal, the drugmaker initially targeted submitting its application as early as the end of September. However, Pfizer may not be ready to submit its application until mid-October — which means the FDA may not be in a position to make a decision until as late as November.
Pfizer didn’t immediately respond to a request for comment on why the company is waiting to submit the application.
The two-shot Pfizer vaccine is currently available for those 12 and older. An estimated 100 million people in the U.S. have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.
Pfizer tested a lower dose of the shots in children. The drugmaker said last week that researchers found the vaccine developed coronavirus-fighting antibody levels in children that were just as strong as those found in teenagers and young adults getting regular-strength doses.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids.
Another U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Results are expected later in the year.
The Associated Press contributed to this report.