Novavax, Inc. Announces Submission to the Singapore Health Sciences Authority for Interim Authorization of Its Covid-19 Vaccine Under the Pandemic Special Access Route
November 24, 2021 at 09:15 am EST
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Novavax, Inc. announced its submission to the Singapore Health Sciences Authority (HSA) for interim authorization of its COVID-19 vaccine under the Pandemic Special Access Route (PSAR). Novavax has made the submission for the regulatory evaluation by HSA of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M? adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease and 90.4% efficacy; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile. Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA 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, the European Union 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 chemistry, manufacturing and controls (CMC) data package submitted to HSA and other global regulatory agencies leverages Novavax' manufacturing partnership with SII, the world's large vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.
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.
Novavax, Inc. Announces Submission to the Singapore Health Sciences Authority for Interim Authorization of Its Covid-19 Vaccine Under the Pandemic Special Access Route