SHREVEPORT, La. -- Pfizer continues to move toward authorization for its vaccine for children ages 5 to 11. The drug company has submitted the first round of data to the Food and Drug Administration for review.
Dr. John Vanchiere, the lead investigator in the Pfizer vaccine study at LSU Health Shreveport, said it could still be several weeks before the FDA review is complete.
“We expect that to take at least four to six weeks of time,” he said. “And Pfizer and Moderna are both starting additional enrollment in the pediatric studies in that 5- to 11-year-old age range, so that they can get more data under the research protocol to submit to the FDA when it’s appropriate.”
The initial trial included 2,268 5- to 11-year-olds. Vanchiere said the drug companies and the FDA want to make sure they have enough data for a thorough review. So, it could still be several weeks to months before the shots are available for that age group.
“So, we’re still thinking at the earliest, maybe end of October, but it could just as well be after the first of the year. There are just too many unknowns at this point in time,” Vanchiere said. “The good news is that the data we have available from Pfizer shows very good antibody responses, very comparable to the antibody responses we see in adults, even with the lower dose and fewer side effects in kids. So, it looks very promising, but may not quite have enough data.”
The vaccine dose for 5- to 11-year-olds is 10 micrograms, with two doses given 21 days apart. The dose for people 12 years old and over is 30 micrograms.