“Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination,” said Albert Bourla, Pfizer chairman and CEO. “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 trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart.
The trial used a 10-microgram dose —smaller than the 30-microgram dose that has been used for those 12 and older.
The trial initially enrolled up to 4,500 children ages 6 months to 11 years in the United States, Finland, Poland and Spain from more than 90 clinical trial sites.
It was designed to evaluate the safety, tolerability and immunogenicity of the Pfizer vaccine on a two-dose schedule (approximately 21 days apart) in three age groups — ages 5 to 11 years, ages 2 to 5 years, and ages 6 months to 2 years.
In the trial’s first phase, children ages 5 to 11 years were on a two-dose schedule of 10 µg each while children younger than 5 received a lower 3 µg dose for each injection in the Phase 2/3 study.
The trial enrolled children with or without prior evidence of a coronavirus infection
“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 Germany company that developed the vaccine alongside Pfizer.
“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.