"I do think we need it as a tool in our armamentarium for high risk children, for equity issues, for parents who really would like to protect their children, and because of the long term, very profound implications of schools being disrupted," Dr. Mark Sawyer, one of the panel's members, said ahead of the vote.
Seventeen members of the committee voted in favor of authorizing the shots, and one abstained.
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"Far from being spared from this harm of COVID-19, in the 5-to-11-year-old age range there have been over 1.9 million infections, over 8,300 hospitalizations, about a third of which have required intensive care unit stays, and over 2,500 cases of multisystem inflammatory disorder from COVID-19," Dr. Peter Marks, the FDA's top vaccines official, told the panel as it began its meeting.
The FDA's advisers were also presented with figures tallying the growing toll of the disease in younger children, underscoring a public health need to avert more severe cases and other disruptions from COVID-19 outbreaks.
"There have also been close to 100 [COVID-19] deaths, making it one of the top 10 causes of death in this age range during this time," added Marks.
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"Vaccinating children has other large societal benefits: for example, children likely play an important role in transmission and vaccinating children can help reach herd immunity," Dr. William Gruber, Pfizer's senior vice president of vaccine clinical research and development, told the panel.
In weighing the risks of Pfizer's vaccine, much of the panel's discussion focused on concerns over rare cases of heart inflammation known as myocarditis and pericarditis, seen mostly in younger male recipients of the mRNA-based vaccines made by Pfizer and Moderna.