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 early next month – with the first children in line fully protected by Christmas – if regulators give the go-ahead.
Details of Pfizer’s study posted online Friday. Advisers to the Food and Drug Administration will publicly debate the evidence next week.
The FDA is expected to post its independent review of the company’s safety and effectiveness data later Friday. If the FDA ultimately authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them in early November.
Full-strength Pfizer shots already are authorized for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections from the extra-contagious 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 – in special orange-capped vials to distinguish them from adult vaccine – for the nation’s roughly 28 million 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.
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 teens and adults.