Pfizer submits data to FDA on COVID-19 vaccine in kids ages 5 to 11

Pfizer-BioNTech has submitted data to the U.S. Food and Drug Administration from the late-stage trial of its COVID-19 vaccine in children ages 5 to 11, saying the companies expect to formally submit a request for emergency approval in "the coming weeks."

The Phase 2/3 trial data, collected from more than 2,2600 participants, will be reviewed by the FDA. A formal submission to request emergency use authorization of the companies’ COVID-19 vaccine is expected to follow in the coming weeks, company officials said.

The Pfizer COVID-19 vaccine is currently available in the U.S. for those 12 and older, leaving many younger children still vulnerable amid the rapid spread of the delta variant of the coronavirus. With millions of kids now back in school and the delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.

In a statement, Pfizer said its two-dose vaccine demonstrated that it is safe, with similar or fewer temporary side effects, and prompted a "robust neutralizing antibody response" in the younger age group. 

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For elementary school-aged kids, a much lower dose was tested — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed the coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots.


FILE - A 12-year-old boy receives a dose of the Pfizer-BioNTech Covid-19 vaccine in Espoo, Finland on September 24, 2021. (Photo by EMMI KORHONEN/Lehtikuva/AFP via Getty Images)

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.

About 182 million Americans are fully vaccinated, or just 55% of the total population, according to data from the U.S. Centers for Disease Control and Prevention. Three-quarters of those 12 and older — the ages eligible for vaccination — have had the first dose. 

As new COVID-19 cases and hospitalizations have increased in recent months, the vast majority of both figures are among the unvaccinated, U.S. health officials say. And all three COVID-19 vaccines in the U.S. offer strong protection against severe illness, hospitalization and death despite the extra-contagious delta variant that caused cases to soar.

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This story was reported from Cincinnati. The Associated Press contributed.