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 looking 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 used for adolescents and adults – is safe and produces a “robust” immune response in a clinical trial 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 syringe in adolescents on April 9th and were approved by the FDA on May 10th.
A key FDA vaccine advisory group is scheduled for 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, noted Gottlieb. 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.
