On September 20th, Pfizer and BioNTech announced positive results in the Phase 2/3 clinical trial of their COVID-19 vaccine (Comirnaty) in children aged 5 to 11.
A Pfizer-BioNTech press release stated, “In participants 5 to 11 years of age, the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses.”
In the clinical trial, participants aged 5-11 received a ten microgram dose approximately 21 days apart. (30 micrograms is used for people aged 12 and older.)
Participants’ antibody responses were reported similar to those observed in people aged 16-25, who received 30 micrograms doses of the vaccine in a previous Pfizer-BioNTech study.
According to the press release, the companies intend to submit the clinical data to regulatory bodies worldwide, including the FDA and the European Medicines Agency (EMA).
