Aiden Arthurs receives the Pfizer-BioNTech Covid-19 vaccine from pharmacist Andrew Mack at the Jewish Federation/JARC offices in Bloomfield Hills, Michigan, on May 13, 2021.
Jeff Kowalski | AFP | Getty Images
Federal health regulators said late Friday that child-sized doses of Pfizer’s Covid-19 vaccine appear to be highly effective in preventing accidental infections in elementary school children and cause no unexpected safety issues, as the United States weighs the start of vaccinations in youngsters.
The Food and Drug Administration released its analysis of Pfizer’s data ahead of a public meeting next week to discuss whether the shots are ready for the nation’s nearly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on it. That question.
In their analysis, FDA scientists concluded that in nearly every scenario, the vaccine’s benefit in preventing hospitalization and death from Covid-19 would outweigh any potentially serious side effects in children. But the agency’s auditors stopped short of calling for a permit for Pfizer.
The agency will ask this question to a panel of independent advisors next Tuesday and weigh their advice before making its own decision.
If the FDA allows the injections, the Centers for Disease Control and Prevention will make additional recommendations for who should receive them in the first week of November. Kids can start vaccinating early next month – with the first babies fully protected by Christmas.
Full-strength Pfizer shots are already recommended for anyone 12 or older, but pediatricians and many parents are eagerly waiting to protect younger children to stop infections from the highly contagious delta variant and help keep kids in school.
An FDA review confirmed results published by Pfizer earlier today that showed the two-dose dose was approximately 91% effective in preventing symptomatic infection in young children. The researchers calculated the number based on 16 cases of Covid-19 in children who were given dummy shots versus three cases among children who were vaccinated. No serious illnesses were reported among any of the young adults, but the vaccinated children had milder symptoms than their unvaccinated counterparts.
Most of the study data was collected in the United States during August and September, when the delta variant became the dominant COVID-19 strain.
An FDA review found no new or unexpected side effects, which mostly consisted of arm inflammation, fever, or pain experienced by teens.
However, FDA scientists note that the study was not large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that sometimes occurs after the second dose.
The agency used statistical modeling to try to predict the number of hospitalizations and deaths from COVID-19 that a vaccine would prevent versus the number of potential cardiac side effects it might cause. In four pandemic scenarios, the vaccine clearly prevented more cardiac side effects from hospitalization than would be expected.
Only when the incidence of the virus is very low, the vaccine may cause more hospitalizations than it may prevent. But overall, the regulators concluded that the vaccine’s protective benefits would “clearly outweigh” its risks.
While children are at lower risk of serious illness or death than older adults, Covid-19 has killed more than 630 Americans age 18 or younger, according to the CDC. Nearly 6.2 million children have contracted the coronavirus, the American Academy of Pediatrics said, more than 1.1 million in the past six weeks with the delta variable rising.
The Biden administration has purchased enough child-sized doses — in special orange-covered vials to distinguish them from the adult vaccine — for children ages 5 to 11. If the vaccine is approved, millions of doses will be immediately shipped across the country, along with baby-sized needles.
More than 25,000 pediatricians and primary care providers have already signed up for injections into tiny arms.