Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization
November 17, 2021 at 11:25 am EST
Share
Novavax, Inc. announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for Novavax' COVID-19 vaccine, which will be marketed in the European Union under the brand name Nuvaxovid?. The company announced earlier this month that it had completed the submission of all data and modules required by EMA for regulatory evaluation of NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M? adjuvant. EMA has indicated that its assessment will proceed under an accelerated timeline, with an opinion issued potentially within weeks. The chemistry, manufacturing and controls (CMC) data package submitted to EMA and other global regulatory agencies leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII). It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. The Novavax/SII vaccine has recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines, and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year. The brand name NuvaxovidTM has not been authorized by the U.S. FDA.
Novavax, Inc. is a biotechnology company, which discovers, develops and commercializes vaccines to prevent serious infectious diseases. The Company offers a differentiated vaccine platform that combines a recombinant protein approach, advanced nanoparticle technology and its patented Matrix-M adjuvant to enhance the immune response. It has one commercial program, for vaccines to prevent COVID-19, which includes Nuvaxovid prototype COVID-19 vaccine (NVX-CoV2373 or prototype vaccine) and Nuvaxovid updated COVID-19 vaccine (NVX-CoV2601 or updated vaccine) (collectively, COVID-19 Vaccine). The Company is advancing the development of other vaccine candidates, including its COVID19-Influenza Combination (CIC) vaccine candidate and additional vaccine candidates. Its COVID-19 Vaccine and its other vaccine candidates incorporate the Companyâs proprietary Matrix-M adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response.