Pfizer and BioNTech say their COVID-19 vaccine prompted a strong antibody response in children ages 5 to 11, and the companies plan to seek emergency use authorization soon from the U.S. Food and Drug Administration.
In a Monday news release, the drugmaker said early data from a Phase 2 and 3 trial showed “a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age” who received two doses of the Pfizer-BioNTech coronavirus vaccine.
The study’s nearly 2,300 participants received smaller doses of the vaccine than adults but got the shots at the same 21-day interval used for other age groups, the release said. Even so, elementary-age children developed antibody levels comparable to those of 16- to 25-year-olds, the companies said. The vaccine also was “well-tolerated” in the elementary age group, with the children reporting comparable side effects to the adults, according to the release.
The study has not yet been peer-reviewed.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer Chairman and CEO Albert Bourla said in a statement. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
The companies plan to share their data with the FDA, European Medicines Agency and regulators in other countries “before the start of the winter season,” added BioNTech CEO and co-founder Dr. Ugur Sahin.
“For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group,” the news release continued.
The companies said readouts for children from 6 months to 5 years old will be available “as soon as the fourth quarter of this year.”
The Pfizer-BioNTech vaccine already has received full FDA approval for residents ages 16 and up, and it is authorized for emergency use in 12- to 15-year-olds. Two other COVID-19 vaccines – one made by Moderna and another by Johnson & Johnson – have been approved for emergency use in people ages 18 and up.
– The Associated Press contributed to this report.
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