This Jan. 24 file photo shows a vial of the Pfizer vaccine for COVID-19 in Seattle. Pfizer and BioNTech announced Monday that results from their trial in Phase 2/3 show a favorable safety profile and robust neutralizing antibody responses in children ages 5 through 11.

Pfizer and BioNTech announced Monday that results from their trial in Phase 2/3 show a favorable safety profile and robust neutralizing antibody responses in children ages 5 through 11. The results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age.

In the trial, children were administered the COVID-19 vaccine using a two-dose regimen of 10 micrograms administered 21 days apart, a smaller dose than the 30-microgram dose used for those 12 and older.

The antibody responses in the participants given 10-microgram doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30-microgram doses. The 10-microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age, Pfiezer said, of the first results from a pivotal trial of a COVID-19 vaccine in this age group.

“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

Bourla emphasized that since July, pediatric cases of COVID-19 have risen by about 240% 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,” he said.

The companies plan to submit these data to the FDA, EMA and other regulatory agencies around the world as soon as possible.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech.

“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose,” Sahin said.

The Pfizer/ BioNTech vaccine is currently approved for those 16 years of age and older, and authorized for use in people in ages 12 to 15.

Results in children under 5 years of age are expected as soon as later this year.

Results of the study come as local school districts vacillate between enforcing a mask mandate through school dress codes, and encouraging COVID-19 vaccinations within staff and students.