Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11.
The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in September or October of this year, and the [two-to-five-year-old] group to follow soon thereafter,” Alejandra Gurtman, MD, Pfizer’s vice president of vaccine clinical research and development, said during a virtual symposium.
FDA has already authorized the vaccine for people 12 and older.
Pfizer’s Phase 1/2/3 study testing vaccine safety and efficacy in children has enrolled approximately 4,500 participants aged six months to 11 years old. Some 90 clinical trial sites in the U.S., Poland, Spain and Finland are taking part in the trial.
The Phase 1/2/3 trial involving children aged six months to 11 years old has sorted participants into three groups. Children in the first group are five to 11 years old. The second consists of children two to five years old. In the final group are children who are six months to two years old.
As with adult study participants in earlier trials, the children in the study are receiving two doses administered 21 days apart.
Clinical trial investigators decided to test 3-µg levels in children aged six months to two years and the two-to-five-year-old group. Those aged five to 11 are receiving the 10-µg doses of the vaccine
To infer efficacy, Pfizer is comparing the results from the trial with those from clinical trial participants who are 16 to 25 years of age.
The study is randomizing participants using a 2:1 ratio with the greater amount receiving the BNT162b2 vaccine.