Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children.
Moderna today announced that it has submitted a request for emergency use authorisation for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. FDA and that similar requests are underway with international regulatory authorities.
The requests are based on a 25 μg two dose primary series of mRNA-1273.
