FDA may soon authorize the Pfizer COVID-19 vaccine for kids ages 5 to 11. Teens, like the 17-year-old pictured, are already eligible for the vaccine.
Patrick T. Fallon/AFP via Getty Images
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Patrick T. Fallon/AFP via Getty Images
A panel of independent advisers to the Food and Drug Administration is recommending that the agency issue an emergency use authorization for the Pfizer-BioNTech vaccine in children ages 5 to 11 years old. The vote was 17 in favor and one abstention.
The FDA panel accepted Pfizer’s data indicating the vaccine is safe and 90.7% effective in preventing COVID-19 infections in this age group.
The agency typically goes along with the advice of its expert panels, though it isn’t bound to do so. It will issue a decision within the next several days. If the FDA authorizes the vaccine for these younger children, as seems likely, another panel of experts advising the Centers for Disease Control and Prevention would make its own recommendations and offer guidelines next week on its use among this age group.
The vaccine provides a broad defense against COVID-19 and “effectively neutralized the delta variant” in young kids, said Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, speaking during the committee hearing.
A dose of Pfizer for young children contains one-third the amount of active ingredient compared to the adult dose. Children would receive a second dose 21 days or more after their first shot.
Gruber said the dose size was chosen to “strike the right balance” between providing strong immunity and limiting side effects. He said that the observed adverse effects seen in the company’s studies “did not suggest any safety concerns.” An FDA review supported that conclusion.
Children 5-11 years of age have accounted for approximately 9% of reported COVID-19 cases in the U.S. overall, and currently account for approximately 40% of all pediatric COVID-19 cases, says Dr. Doran Fink, clinical deputy director of the division of vaccines and related products for the FDA. Currently, the case rate among children ages 5 to 11 is “near the highest” of any age group, he says.
Fink and others testifying at the meeting acknowledged that serious effects of infection, including long COVID-19, hospitalizations …….