Pfizer and BioNTech have announced that their COVID-19 vaccine has shown favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age.
According to a media release, this comes after a Phase 2/3 trial using a two-dose regime of 10 micrograms administered 21 days apart.
This is a third of the dose currently given to persons 12 years and older.
The companies say the 10 microgram dose was carefully selected as the preferred dose for safety in children 5 to 11 years of age.
CEO and co-founder of BioNTech, Dr. Ugur Sahin says, “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.”
Meanwhile, Pfizer Chairman and CEO, Albert Bourla says, “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.”
These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.