Posted by Michael Wonder on 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in the coming months.
Pfizer and BioNTech today announced that following a request from the U.S. FDA the companies have initiated a rolling submission seeking to amend the emergency use Authorisation of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population.
