Pfizer is asking the FDA to approve the Covid vaccine for youngsters ages 5-11


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 approve its Covid-19 vaccine with BioNTech for children ages 5-11.

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 exposure has led to an increase in hospital admissions in the United States, including young children who are currently unable to be vaccinated.

Last month Pfizer released new data showing that a two-dose dose of 10 micrograms – one third of the dose for adolescents and adults – is safe and elicits a “robust” immune response in a clinical trial in young children. The shots were said to be well tolerated and to have an immune response and side effects comparable to those seen in a study with people aged 16 to 25.

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, told CNBC last week that the shots for young children could come by Halloween.

The FDA has a lot of experience with the Pfizer vaccine, Gottlieb noted. Adding the Covid vaccination for young children is the same two-dose regimen as for adults, but it is 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.