Posted by Michael Wonder on 01 May 2022
Moderna files to expand conditional marketing authorisation for its COVID-19 vaccine to include children six months to under six years in the European Union
29 April 2022 - The filing follows the European Medicines Agency's Committee for Medicinal Products for Human Use recent decision to adopt a positive opinion recommending marketing authorisation for Moderna's COVID-19 vaccine to include children six years of age and older.
Moderna today announced that it has submitted for a variation to the conditional marketing authorisation with the EMA for the evaluation of a 25 µg two dose series of Spikevax, the Company's vaccine against COVID-19, in children six months to under six years of age. Similar requests are underway with international regulatory authorities and are based on a 25 μg two-dose primary series of mRNA-1273.
