Pfizer-BioNTech Vaccine Over 90% Effective at Preventing COVID in Children Ages 5-11
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The data released by Pfizer-BioNTech on Friday reveals that the Pfizer-BioNTech coronavirus vaccine is 91 percent effective at preventing COVID infection in children between the ages of 5 and 11. The companies argue that this level of protection supports the authorization of the vaccine for the 28 million children in that age group in the United States. The Food and Drug Administration (FDA) has scheduled a hearing on Tuesday with expert advisors to review the case for authorization.
Pfizer and BioNTech formally requested FDA approval for the administration of doses to 5- to 11-year-olds two weeks ago. If the review process takes a similar amount of time as it did for vaccines for 12- to 15-year-olds, the FDA could grant authorization before the Thanksgiving holiday. This means that a significant majority of K-12 students could soon be eligible for vaccination.
The vaccine efficacy data is based on a briefing document submitted by Pfizer and BioNTech to the FDA, which was released by the agency on Friday morning. In their trial, the companies administered a 10 microgram dose of the vaccine, which is one-third the size of the dose given to teenagers and adults. They found that this smaller dose produced a "robust" antibody response and that immunity and side effects were comparable to those observed in 16- to 25-year-old patients who received the larger dose.
The trial, which involved 2,268 participants, did not detect any new safety issues or cases of heart inflammation. It is possible that cases of myocarditis, a rare side effect, were too infrequent to be identified in the main study. Previous Israeli studies have shown myocarditis to occur in less than 1 in 5,000 vaccinated teenage males.
According to data published by the American Academy of Pediatrics in mid-October, children now account for over 130,000 weekly coronavirus cases, which represents approximately a quarter of all reported weekly infections nationwide. So far this year, more than 2,250 schools in 580 districts have closed due to virus outbreaks. However, the number of COVID-related school closures has decreased significantly in recent weeks as cases decline and schools implement effective protocols to control the spread of the virus.
The White House has emphasized that vaccinating children will be a priority once the shots are authorized for 5- to 11-year-olds. The Biden administration plans to coordinate schools with COVID-19 vaccine providers, and the Department of Health and Human Services will collaborate with community-based clinics, doctor’s offices, hospitals, and faith-based organizations to ensure efficient distribution of the vaccines.
A recent survey conducted by the COVID-19 Vaccine Education and Equity Project revealed that two-thirds of parents with children aged 5 to 11 years have expressed their intention to vaccinate their children against COVID-19 once the shots are authorized for their age group. However, there is still work to be done to address parents’ concerns and answer their questions about the vaccines.
Currently, the Pfizer-BioNTech vaccine has been fully approved by the FDA for individuals aged 16 and above, and it has emergency use authorization for teenagers aged 12 to 15. Vaccines for children under the age of five may be available early next year.
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