Pfizer asks FDA to clear Covid vaccine for children ages 5-11

Pfizer said Thursday it has asked the Food and Drug Administration to clear its Covid-19 vaccine with BioNTech for children aged 5 to 11.

The news couldn’t come sooner for parents concerned about getting their kids vaccinated as kids begin the new school year with the delta variant sweeping across America. The strain has led to an increase in hospitalizations in the United States, including among young children who are not currently eligible for the vaccine.

Last month, Pfizer released new data that showed that a two-dose diet of 10 micrograms – one-third of the dose used for adolescents and adults – is safe and generates a “robust” immune response in a trial clinic on young children. He said the injections were well tolerated and produced an immune response and side effects comparable to those seen in a study in people aged 16 to 25.

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

The company’s request on Thursday could mean the injections won’t be available until around November if the FDA spends as much time reviewing the data for that age group as it did for 12 to 15-year-olds. Pfizer and BioNTech requested expanded use of their injection in adolescents on April 9 and were cleared by the FDA on May 10.

A key FDA vaccine advisory group is scheduled to meet on October 26 to discuss Pfizer’s data. The plans could be approved soon after that meeting, depending on how quickly the FDA and CDC act.

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

The FDA has a lot of experience with the Pfizer vaccine, Gottlieb noted, adding that the Covid vaccine for young children is the same two-dose regimen as adults but is given in smaller amounts. The agency has already cleared the shots for Americans 12 and older.

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