WASHINGTON (AP) — Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November.
The company said Tuesday it provided health regulators with data from a recent study of its vaccine in children 5 to 11 years old. Officials had said previously they would file an application with the FDA to authorize use in the coming weeks.
Once the company files its application, U.S. regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend use.
That process may mean the shots may not be available until closer to Thanksgiving, according to a person familiar with the process but not authorized to discuss it publicly. But it is possible that, depending on how quickly the FDA acts, the shots could become available earlier in November, the person said.
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.” The companies also plan to submit data to the European Medicines Agency and other regulators.