Posted by Michael Wonder on 04 Jan 2022
Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorisation application request for COVID-19 Vaccine
30 December 2021 - EUA application request to be submitted following one month required by FDA EUA guidance.
Novavax today announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfil the prerequisites for emergency use authorisation application request to the U.S. FDA for NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.
