Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines
November 17, 2021 at 09:29 am EST
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Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M? adjuvant. The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX?. Because the vaccine is stored with standard refrigeration at 2? to 8? Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas. The Novavax/SII vaccine has recently received EUA in Indonesia 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, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
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.