Gottlieb says FDA approval for younger youngsters by Halloween potential

Aidan Mohl, 13, will be born on November 11th.

Christopher Aluka Berry | Reuters

Dr. Scott Gottlieb told CNBC on Wednesday that it is still possible for the Food and Drug Administration to grant approval Pfizer and BioNTechCovid-19 vaccine for young children by Halloween.

“I wouldn’t rule out the possibility that this could come out in October,” said Gottlieb, who sits on Pfizer’s board of directors and served as FDA commissioner in the Trump administration for two years.

Pfizer submitted an initial Covid Vaccine study data for children ages 5 to 11 with the FDA on Tuesday, and the company should file a formal application for emergency approval “shortly,” Gottlieb said in an interview Wednesday “Squawk Box.”

The Food and Drug Administration has a lot of experience with the Pfizer vaccine, noted Gottlieb, adding that the Covid vaccination is for young children the same two-dose regimen like adults, but given in smaller amounts. The agency has already approved the recordings for Americans aged 12 and over.

“You saw a lot of clinical data,” he said. “I’ve said for a long time that October is a possibility, but it’s an optimistic possibility. If it fails, it could fall by mid-November.”

Gottlieb’s comments come a day after the Wall Street Journal reported that regulatory clearance of the Pfizer vaccine for children ages 5-11 may not come before November.

Last week, Pfizer released new data showing that in a clinical study in children ages 5-11 years old, a two-dose 10 micrograms dose – one third of the dose for adolescents and adults – is safe and elicits a “robust” immune response .

Pfizer was expected to apply for emergency approval to use the vaccine in young children by the end of this month, but now the company says it will apply “in the coming weeks”.

That could mean the footage might not be available until November, when the FDA spends as much time reviewing the data for this age group as it does for 12-15 year olds. Pfizer and BioNTech filed for expanded use of their syringe in adolescents on April 9th ​​and were approved by the FDA on May 10th.

A Pfizer spokesman declined to comment on an approval schedule, saying the company couldn’t speculate on exactly when the FDA would make a decision on whether or not to approve the vaccine’s use.

“We are still on track to formally apply for EEA very soon,” Jerica Pitts told CNBC.

Approval couldn’t come sooner as children are starting the new school year, the Delta variant spills across America, and many parents are anxious to get their younger children vaccinated. The stress has led to an increase in hospital admissions in the United States, including among young children that currently cannot be vaccinated.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.