Novavax, Inc. Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine
December 31, 2021 at 10:45 pm IST
Share
Novavax, Inc. announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the U.S. Food and Drug Administration (FDA) for NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. Novavax expects to submit a request for EUA for the vaccine in the U.S. in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines. Novavax has filed the complete CMC data package, which leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), vaccine manufacturer by volume, with the FDA. The company expects to later supplement the submission with data from additional manufacturing sites across Novavax' global supply chain. About NVX-CoV2373:- NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. The current assigned shelf life of the vaccine is 9 months.
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.