Biotech | January 03, 2022
Novavax submits data to U.S. FDA for Covid-19 EUA
Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance
Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance
SK bioscience secures long-term license to supply the Novavax vaccine for the Korean market
SAGE recommends additional third dose of the vaccine administered to immunocompromised persons
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
The vaccine will be manufactured and marketed in the Philippines by SII under the brand name Covovax
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO
The vaccine can be stored at 2 to 8 degrees celsius and traditional cold chain capabilities will suffice
Filing marks first protein-based vaccine submitted to MHRA for authorization
It is a recombinant nanoparticle protein-based vaccine
The pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine
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