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The Pfizer-BioNTech coronavirus vaccine is 91 percent effective at preventing COVID infection in youth ages 5 to 11, the pharmaceutical companies’ data released Friday reveal.
The protection provided by the shots, the companies say, supports authorization of the vaccine for the 28 million U.S. children in that age group. The Food and Drug Administration has a hearing scheduled Tuesday with expert advisors to review the case for authorization.
Two weeks ago, Pfizer and BioNTech submitted their formal request to the FDA for the green light to deliver doses to 5- to 11-year olds.
If the review timeline spans a similar length as that of vaccines for 12- to 15-year olds, the agency could grant authorization ahead of the Thanksgiving holiday — meaning that the vast majority of K-12 students may soon be eligible for immunizations.
The vaccine efficacy numbers come from a briefing document Pfizer and BioNTech provided to the FDA, released Friday morning by the federal agency. In their trial, the companies tested a 10 microgram dose of the vaccine, one-third the size of the shot for teenagers and adults, and found that it produced a “robust” antibody response. Immunity and side effects, they said, were comparable to those produced by the larger dose in 16- to 25-year-old patients.
No new safety problems or cases of heart inflammation were observed in the trial, which tested 2,268 participants. Israeli studies have found myocarditis to occur in less than 1 in 5,000 vaccinated teenage males, so it’s possible the condition would have been too rare to have been detected in the main study.
The news comes as children make up over 130,000 weekly coronavirus cases, amounting to about a quarter of all reported infections per week nationwide, according to mid-October data published by the American Academy of Pediatrics. Over 2,250 schools in 580 districts have closed so far this year due to outbreaks of the virus, according to Burbio, an organization that has tracked schools through the pandemic, though COVID-related school closures have slowed considerably in recent weeks as cases fall nationally and schools hone their protocols to curb spread.
The White House has made it clear that immunizing children will be a priority once shots are authorized for 5- to 11-year olds. The Biden administration will match schools with COVID-19 vaccine providers, the White House announced Wednesday. The Department of Health and Human Services will also enlist community-based clinics, doctor’s offices, hospitals and faith-based organizations in rapidly distributing vaccines.
Two-thirds of parents of children aged 5 to 11 years say they will immunize their children against COVID-19 once shots are authorized for the age group, according to a recent survey by the COVID-19 Vaccine Education and Equity Project.
“While we’re encouraged to see that a majority of parents intend to vaccinate their children against COVID-19 once they are eligible, there is clearly more work to be done to help address parents’ questions and ease concerns about the vaccines,” Beth Battaglino, CEO of the nonprofit HealthyWomen, one of the partner organizations behind the polling, said in a statement.
Pfizer-BioNTech vaccinations have been fully approved by the FDA for individuals ages 16 and above, and have emergency use authorization for teenagers ages 12 to 15. Shots for kids younger than five may arrive early next year.
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