Pfizer and its German partner BioNTech said Thursday they have made a formal request to the Food and Drug Administration to extend emergency use of its COVID-19 vaccine in children ages 5 to 11.
The two-dose vaccine is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.
If U.S. regulators agree, shots could begin within a matter of weeks.
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The announcement comes one week after the companies submitted to the federal agency initial trial data for that age group.
Last month, the companies announced topline results of trial data that found the vaccine to be safe, while prompting a "well tolerated" and "robust" antibody response among the younger, targeted group.
For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
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The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.
“I think we really hit the sweet spot,” said Gruber, who’s also a pediatrician.
Now the FDA will have to decide if that evidence is strong enough to expand use to youngsters. An independent expert panel will publicly debate the evidence on Oct. 26.
If the FDA authorizes emergency use of the kid-sized doses, there’s another hurdle before vaccinations in this age group can begin. Advisers to the Centers for Disease Control and Prevention will decide whether to recommend the shots for youngsters, and the CDC will make a final decision.
While kids are at lower risk of severe illness or death than older people, nearly 6 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 520 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.
Sebastian Prybol, 8, of Raleigh, North Carolina is enrolled in Pfizer’s study at Duke University and doesn’t yet know if he received the vaccine or dummy shots.
“It makes me very happy that I am helping other kids get the vaccine,” said Prybol.
His mother, Britni Prybol, told The Associated Press that while "we do want to make sure that it is absolutely safe for them,” she will be "overjoyed" if the FDA clears the vaccine.
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11, and has said there were no serious side effects. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine, mostly in young men.