Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group.
The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators give the go-ahead.
Details of Pfizer’s study were posted online. The Food and Drug Administration was expected to post its independent review of the company’s safety and effectiveness data later in the day.
Next week, FDA advisors will debate publicly the evidence. If the FDA approves shots, then the Centers for Disease Control and Prevention (CDC) will decide who should get them.
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Pfizer is already allowing full-strength Pfizer shots for adults over 12 years old. But, parents and pediatricians anxiously await protection for children younger than 12, to prevent rising strains of the deadly delta virus and keep them in school.
Already, more than 25.000 primary and pediatric care professionals have registered to receive the shot into their little ones.
The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s roughly 28 million 5- to 11-year-olds. Once the vaccine passes inspection, the millions of doses and kid-sized needles will be quickly shipped across the country.
Pfizer conducted a study on 2,268 young people in the same age group. They received three shots of low-dose or placebo vaccines, and they were followed for three weeks. The doses given to teenagers and adults were one-third each.
Based on the 16 cases of COVID-19 in children who received dummy shots, and three among those who were vaccinated, researchers calculated that low dose vaccines are nearly 91% efficacious. None of the children suffered from severe illness, however the vaccines produced milder symptoms in the unvaccinated.
Additionally, the coronavirus-fighting antibodies levels of young children who received low dose shots were just as high as those in teens or young adults who had regular-strength vaccines.
That’s important information considering that hospitalizations of mostly unvaccinated children reached record levels last month.
The CDC earlier reported this week that Pfizer vaccines proved 93% effective in preventing hospitalizations for 12- and 18-year olds, despite the rise of the delta mutant between June and September.
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.
The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men.
The CDC reports that COVID-19 has claimed the lives of more than 630 Americans aged 18 and younger, despite children being at lower risk than people older than them. The American Academy of Pediatrics reports that nearly 6.2 million children were infected by the coronavirus. This is more than the 1.1 million who contracted it in six weeks.
Moderna has also begun to study its COVID-19 shots among elementary school-aged children. Moderna and Pfizer also study children below 6 months of age. More information will be available later this year.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. All content is the sole responsibility of The Associated Press.
