Pfizer plans to ask the Food and Drug Administration to authorize a COVID-19 vaccine for children under 5 in November, according to CEO Frank D’Amelio.

D’Amelio added that COVID vaccine data for children between the ages of 5 and 11 is expected to come by the end of the month, and data for the younger group is expected by the end of October.

Once the application is submitted the availability of the vaccine will depend on the speed of the FDA review, a process that could take between four to six weeks.

“It’s up to the FDA to take their time and then make a decision,” said Pfizer CEO Albert Bourla in an interview with Research! America’s 2021 National Health Research Forum.

Both CEO’s comments come as the Delta variant continues to spread across the country leading to a surge in hospitalizations, many of them have been children who are too young to receive the vaccine.

COVID-19 cases have risen “exponentially” since July, according to the American Academy of Pediatrics. The group reported there have been 243,373 new pediatric Covid cases in the past week compared to 251,781 cases being reported the previous week. This marks a 240% increase since July when reported cases were only 71,726 per week.

"After declining in early summer, child cases have increased exponentially with nearly 500,000 cases in the past two weeks," AAP said in a statement.

The AAP added that as of Thursday, nearly 5.3 million children have tested positive for the virus, accounting for 29% of the nation’s cases.

The FDA said on Friday they are “working around the clock” to support the approval of vaccines for children under 12.

Dr. Peter Marks said last month the agency is moving as “swiftly” as possible, saying there are trials going on and that the agency is waiting for Pfizer to submit the data for those trials.

“We certainly want to make sure we get this right,” Marks said.

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