logo
  

Novavax Files For Interim Authorization Of COVID-19 Vaccine In Singapore - Quick Facts

Biotechnology company Novavax, Inc. (NVAX) announced Wednesday 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. The PREVENT-19 trial included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease and 90.4% efficacy.

Another trial of 15,000 participants in the U.K. 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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Privately-held biotechnology company On Target Laboratories, Inc. announce that the U.S. Food and Drug Administration or FDA, has approved Cytalux (pafolacianine) for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. Cytalux is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively. The Federal Trade Commission or FTC has ordered Walmart, Amazon, Kroger and certain other large wholesalers and suppliers to provide information to help it study causes of supply chain disruptions. The agency has launched an inquiry to find the reasons for empty shelves and exorbitant prices. Along with Walmart, Amazon.com, and Kroger, the order has been sent to C&S Wholesale Grocers, Associated.. Covid vaccine maker Moderna Inc.'s Chief Executive Stéphane Bancel has predicted that existing COVID-19 vaccines will be much less effective against Omicron than earlier strains, according to the Financial Times.
Follow RTT