Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in five to 11-year-olds and said they would make a formal request to U.S. regulators for emergency use in the coming weeks.
The U.S. Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months.
The companies, however, have yet to start the official process for authorization, which could slow the decision. According to the Wall Street Journal, the FDA may not make its decision until sometime between Halloween and Thanksgiving, citing a person familiar with the matter.