Pfizer asks FDA to authorize Covid vaccine for teenagers ages 5 to 11

Jamie Blank (L) holds her son Ari Blank’s hand when he was born on Jan.

Jeff Kowalsky | AFP | Getty Images

Pfizer said Thursday it had asked the Food and Drug Administration to co-approve its Covid-19 vaccine BioNTech for children from 5 to 11 years.

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

Last month, Pfizer new data published This showed that a two-dose regimen of 10 micrograms – one third of the dose used for adolescents and adults – is safe and elicits a “robust” immune response in a clinical study in young children. The syringes are well tolerated and have caused an immune response and side effects that are comparable to those observed in a study with 16 to 25 year olds.

Common side effects in teenagers and adults include fatigue, headache, muscle aches, chills, fever, and nausea, according to the Centers for Disease Control and Prevention.

The company’s request on Thursday could mean the footage won’t 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 adolescent syringe on April 9 and received FDA approval on May 10.

A key FDA vaccine advisory group is scheduled to meet on October 26th to discuss Pfizer’s data. The shots could be approved shortly after that meeting, depending on how fast the FDA and CDC move.

Dr. Scott Gottlieb, who sits on Pfizer’s board of directors and served as FDA commissioner in the Trump administration for two years, said CNBC last week that the recordings for young children could come by Halloween.

The FDA 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.

“I wouldn’t rule out the possibility that this could come out in October,” he said.