The Pfizer and BioNTech vaccine against COVID-19 has been set for approval for children younger than five years old in the coming months, with a plan to file for Food and Drug Administration emergency authorization in November. 

Clinical trial data on the vaccine’s effectiveness in 6-month to 5-year-old children could be released as early as the end of October, Pfizer CEO Albert Bourla said on Sept. 14. Vaccine data for kids between the ages of 5 and 11 should come much sooner, potentially ready for submission to the FDA by the end of this month, Bourla said.

Following the application’s submission, the vaccine’s availability for children depends solely on the speed of the FDA review process. Former FDA officials have said that the review could take between four and six weeks, while others say the process could be as short as three weeks. The FDA’s top vaccine regulator, Dr. Peter Marks said last month that the agency would move as “swiftly” as possible in approving the shot for kids under 12 once research companies submit data. 

The Pfizer-BioNTech vaccine already received authorization  for children ages 12-15 in the U.S., and has been fully approved by the FDA for people over 16 since late August of last year.

As schools reopen, and the highly contagious Delta variant affects COVID-19 cases among youth, the FDA has been under pressure to receive Pfizer vaccine authorization for children younger than the age of 12. Many parents have expressed concern towards getting their children vaccinated as the novel Delta variant continues to spread..