(ABC4) – Pfizer and BioNTech have officially submitted a request for Emergency Use Authorization from the U.S. Food and Drug Administration for its COVID-19 vaccine for children between the ages of 5 and 11. Pfizer is currently the only COVID-19 vaccine with Emergency Use Authorization for children between the ages of 12 and 15.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer says in a series of posts to Twitter Thursday morning. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
In late September, Pfizer and BioNTech submitted data to the FDA from a trial on the effects of the COVID-19 vaccine on children between 5-12 years old. The Phase 2/3 trial resulted in “robust neutralizing antibody responses” for the children, who received two doses that were smaller than what has been administered to everyone else. The strong immune response came one month after getting the second dose, according to the companies.
The side effects were also “generally comparable” to the ones that people who are 16-25 years old experienced, according to the companies. The trial included 2,268 participants who were 5 to 11 years of age and received a 10 µg (microgram) dose level in a two-dose regimen.
Currently, the Pfizer COVID-19 vaccine is the only one approved by the FDA for people 16-years-old and older.
U.S. officials recently allowed certain populations who received the Pfizer vaccine to get booster shots — a third dose administered six months after the last dose to combat waning immunity.