Former FDA Chief Says COVID Vaccines for Children Age 5-11 Could Be Approved by Late October

Former Food and Drug Administration (FDA) chief Scott Gottlieb on Sunday said that children aged five to 11 years old could be eligible for the Pfizer vaccine by the end of October.

Gottlieb, who served as the FDA chief under the Trump administration, told "Face the Nation" that the pharmaceutical giant is expected to file as early as September the required paperwork for the authorization of the vaccine for the said demographics.

The former FDA chief serves as one of Pfizer's board of directors. The said paperwork that Scott Gottlieb mentioned was the data of the COVID vaccine in young children.

Dr. Özlem Türeci, the chief medical officer of BioNTech, told Spiegel that they would present the results of their study on the five- to 11-year-old worldwide to the authorities in the coming weeks and apply for approval for the said age group.

"I have confidence in Pfizer in terms of the data that they've collected," Gottlieb said. However, he noted that it's still up to the FDA to "make an objective determination."

Former FDA Chief: Pediatricians Can Exercise Discretions on Vaccine for Children

Despite sharing that the Emergency Use Authorization (EUA) for children ages five to 11 could be granted by the end of October, Scott Gottlieb said parents still have the option not to let their children get the jab if they are wary of it.

The former FDA chief noted that children may receive at least one dose of Pfizer COVID vaccine "for now" or "potentially" wait for the lower dose of the vaccine to be available, adding that pediatricians could make that judgment. Gottlieb also said that if a child had COVID, then a dose of the vaccine "may be sufficient."

Türeci noted that the vaccine formula for the said demographics is the same as the one approved for adolescents and adults. However, the dose size for the 5-11 years old will be smaller.

"There's a lot of discretion that pediatricians can exercise... but exercising discretion within the individual's needs are, their risk is, and what the parent's concerns are," Gottlieb noted.

The former FDA chief said he thinks the COVID vaccine will be among the vaccines that would be required for children in public schools, adding that "more local districts and governors" would likely make the said recommendations.

Scott Gottlieb further noted that the Advisory Committee on Immunization Practices (ACIP) may also make a recommendation on whether the COVID vaccine will be included in the "childhood immunization schedule."

"My guess is they're [ACIP] waiting for more of the vaccines to be fully licensed to make that kind of recommendation," the former FDA chief said.

To date, the Pfizer COVID vaccine is only authorized for children between the ages of 12 and 15.

COVID-19 Among Children

As of September 2, the American Academy of Pediatrics (AAP) recorded at least five million children who tested positive for COVID since the onset of the pandemic. About 225,000 cases of children were added in the past week, marking the largest number of child cases in a week.

Meanwhile, the head of the National Institutes of Health, Dr. Francis Collins, said the spike of COVID cases among children was "very worrisome." Collins noted that more than 400 children have already died from COVID since the pandemic began.

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Written by: Joshua Summers

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