Pfizer said Thursday it asked the Food and Drug Administration to authorize its Covid-19 vaccine with BioNTech for kids ages 5 to 11.
The news couldn’t come any sooner for parents anxious to get their children vaccinated as kids start the new school year with the delta variant surging across America. The strain has led to a surge in U.S. hospitalizations, including among young kids who are currently ineligible to get vaccinated.
Last month, Pfizer released new data that showed a two-dose regimen of 10 micrograms — a third the dosage used for teens and adults – is safe and generates a “robust” immune response in a clinical trial of young children. It said the shots were well tolerated and produced an immune response and side effects comparable to those seen in a study of people ages 16 to 25.
Common side effects for teens and adults include fatigue, headache, muscle pain, chills, fever and nausea, according to the Centers for Disease Control and Prevention.
The company’s request Thursday may mean the shots 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 shot in adolescents on April 9 and were authorized by the FDA on May 10.
A key FDA vaccine advisory group is scheduled to meet on Oct. 26 to discuss Pfizer’s data. The shots could be approved shortly after that meeting, depending on how quickly the FDA and the CDC move.
Dr. Scott Gottlieb, who sits on Pfizer’s board and served as FDA commissioner for two years in the Trump administration, told CNBC last week that the shots for young kids could come by Halloween.
The FDA has a lot of experience with the Pfizer vaccine, Gottlieb noted, adding the Covid shot for young kids is the same two-dose regimen as adults but is administered in smaller quantities. The agency has already cleared the shots for Americans age 12 and up.
“I wouldn’t foreclose the possibility that this could be out in October,” he said.