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

(RTTNews) - 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.