Pfizer Asks FDA to Authorize Its COVID Vaccine for Kids 5 to 11

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 announcement comes a week after the companies submitted initial trial data for that age group. 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. They are now one step closer toward beginning vaccinations for youngsters. 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. 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. 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. This is a breaking news story. Please check back for updates.

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