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
The shots could begin in early November, with the first children in line fully protected by Christmas, if regulators give the go-ahead. That would represent a major expansion of the nation's vaccine drive, encompassing roughly 28 million elementary school-age youngsters.
Details of
Advisers to the FDA will publicly debate the evidence next week. If the agency itself authorizes the shots, the
Full-strength
Dr.
She said it was encouraging to see that the vaccine was effective with a one-third dose. That reduces the chance of sore arms, fever and other mild effects that can occur with any immunization, Rasmussen said.
“I don’t see any red flags here that would have people concerned,’’ said Rasmussen, who wasn't involved in the research. The results are good news for “so many families out there that are waiting to have the vaccine before the holidays.’’
The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 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.
More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.
The
Researchers calculated the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.
Most of the study data was collected in the
In addition, young children given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who got regular-strength vaccinations.
In another piece of encouraging news, the
Pfizer’s study of younger children 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.
While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the
AP Medical Writer
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