Pfizer applies to FDA for COVID-19 vaccine authorization in children 5-11
Pfizer said Thursday that it had submitted an application to the Food and Drug Administration (FDA) for emergency use authorization of its COVID-19 vaccine in children ages 5 to 11.
The application has been highly anticipated, as millions of parents are eager to vaccinate their kids. No vaccine is currently available for children under 12.
The FDA has previously said it would move quickly to review the application, “likely in a matter of weeks rather than months.”
An FDA advisory committee is meeting to discuss the application on Oct. 26.
Children generally do not get severely ill with COVID-19 as much as older people do, but there were still almost 175,000 cases among children in the week ending Sept. 30, according to the American Academy of Pediatrics (AAP).
Between 0.1 percent and 1.9 percent of COVID-19 cases in children resulted in hospitalization, according to AAP.
Pfizer has tested a dose for children that is one-third the amount used in adults. Late last month, it announced positive results from its studies, pointing to a “favorable safety profile and robust neutralizing antibody responses.”
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” acting FDA Commissioner Janet Woodcock said when the advisory committee meeting was scheduled.
The FDA has been facing calls to make the authorization a priority and not delay it.
More than 100 lawmakers wrote to the agency in August asking for a timeline.
“The current situation is alarming for parents, whose children ages 2-11 will be in months of school without vaccinations available,” the lawmakers, led by Reps. Ro Khanna (D-Calif.) and Katie Porter (D-Calif.), wrote.
Updated at 8:50 a.m.
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