Kid-size doses of the Pfizer BioNTech COVID-19 vaccine appear to be safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday.
This news comes as the nation considers opening vaccinations to that age group, with shots beginning in early November if regulators give the green light.
The U.S. Food and Drug Administration (FDA) was expected to post its own independent review of the company's safety and effectiveness data later in the day.
In addition, the agency's advisers will publicly debate the evidence next week.
Should the group ultimately authorize the shots, the U.S. Centers for Disease Control and Prevention (CDC) will make the final decision on who should receive them.
In September, a Pfizer/BioNTech booster dose was authorized for emergency use by the FDA for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to the virus.
On Wednesday, a booster dose was also authorized for emergency use by the FDA for eligible individuals who have completed a primary vaccination with a different authorized COVID-19 vaccine.
While full-strength Pfizer shots are already authorized for anyone 12 or older, pediatricians and many parents are anxiously awaiting protection for younger children to curb rising infections from the highly transmissible delta variant and help keep kids in school.
More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.
The Biden administration has purchased enough kid-size doses for the country's approximately 28 million 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped out.
A Pfizer study tracked 2,268 kids in that age group who got two shots three weeks apart of either a placebo or the low-dose vaccine. Each dose was one-third the amount given to both teens and adults.
Researchers calculated that the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in kids who had been given placebo shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the children, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.
Additionally, young kids who had been given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who received the regular-strength vaccinations.
Earlier this week, the CDC reported that even as the delta mutant surged, Pfizer vaccinations were 93% effective at preventing hospitalizations among 12- to 18-year-olds.
Pfizer’s study of younger kids found the low-dose shots proved safe, with similar or fewer temporary side effects such as sore arms, fever or achiness that teens experience. However, the study isn’t large enough to detect any extremely rare side effects.
While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans aged 18 and under, according to CDC data.
The American Academy of Pediatrics says that nearly 6.2 million children have been infected with the coronavirus, including more than 1.1 million in the last six weeks.
Moderna, Inc. also is studying its COVID-19 shots in elementary school-age youngsters.
Nearly 190 million Americans are fully vaccinated, 66.9% of whom are older than or equal to 12 years of age and 68.7% who are older than or equal to 18 years of age.
More than 733,000 people have died from coronavirus in the U.S., according to the John's Hopkins Coronavirus Resource Center.
The Associated Press contributed to this report