Pfizer Submits Data for Kids Ages 5-11 to FDA

Pfizer BioNTech has submitted data on it’s Covid-19 vaccine to the FDA for approval for children ages 5 to 11. Yesterday the company said they submitted the data for initial review but they aren’t seeking emergency use authorization yet. They are expected to submit that request in the upcoming weeks. Submission to the European Medicines Agency and other regulatory authorities are also planned.

The submission marks the first for the vaccine for younger children. Currently, the Pfizer BioNTech vaccine is approved for people ages 16 and older and has an EUA for people ages 12 to 15. Last week, Pfizer released details of a Phase 2/3 trial that showed the vaccine was safe and generated a ‘robust’ antibody response in children ages 5 to 11.