Pfizer has submitted initial trial data to the Food and Drug Administration of its COVID-19 vaccine for use in children ages 5 to 11, a key step toward beginning vaccinations for youngsters.
Pfizer and its German partner BioNTech said in a joint release that formal submission to request emergency use authorization of the companies' vaccine for this age group is expected to follow in the coming weeks. They also plan to make submissions to the European Medicines Agency and regulatory authorities in other countries.
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.
Last week, 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.
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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.
The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 kindergartners and elementary school-aged kids.
The companies also said they planned on submitting data from the full Phase 3 trial for scientific peer-reviewed publication
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.
