Pfizer plans to seek FDA nod for COVID-19 shot in kids 5 to 11 after positive data

With coronavirus cases on the rise among children, Pfizer and BioNTech brought welcome news on Monday, reporting their COVID-19 vaccine is safe and generated a strong antibody response in kids aged 5 to 11.

The companies are the first COVID-19 vaccine makers to release data for children of this age. They will apply for emergency use authorization in the United States, Europe and elsewhere “as soon as possible,” the companies said.

In the phase 2/3 trial, 2,268 children received two 10 µg doses three weeks apart. Investigators observed antibody responses comparable to those seen in people aged 16 to 25 who received 30 µg doses, the companies said. Side effects for children ages 5 to 11 were consistent with those in the 16 to 25 age group.

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“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S., underscoring the public health need for vaccination,” Pfizer CEO Albert Bourla said in a statement. “These results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old.”

Meanwhile, Pfizer said that data readouts for two younger age groups—age 2-5 years and 6 months to 2 years—are expected as soon as the fourth quarter of this year.

The American Academy of Pediatrics reports that as of September 9, nearly 5.3 million children have tested positive for COVID-19 since the start of the pandemic. Nearly 500,000 of those cases have come in the last two weeks.

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On Friday, during a meeting of an FDA advisory committee panel considering approval of the Pfizer-BioNTech vaccine as a booster, Dr. Jay Portnoy of Children’s Mercy hospital in Kansas City said he wished vaccines had been approved for children earlier.

“It would be great to wait until we have all of the data about safety,” Portnoy said. “But my hospital is filling up with kids who have COVID. We didn’t want to rush in to approve the vaccine for them and now, look where we are.”