Policy & Regulation
Novavax submits for interim authorisation of NVX-CoV2373 to Singapore Health Sciences Authority
25 November 2021 -

Novavax, Inc. (Nasdaq: NVAX), a US-based biotechnology company, announced on Wednesday that it has submitted for interim authorisation of NVX-CoV2373, the company's COVID-19 vaccine, under the Pandemic Special Access Route (PSAR) to the Singapore Health Sciences Authority (HAS).

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 three clinical trials: PREVENT-19, that included 30,000 participants in the United States and Mexico and showcased 100% protection against moderate and severe disease and 90.4% efficacy; and a trial of 15,000 participants in the United Kingdom that demonstrated efficiency of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. The product is claimed to have showcased a reassuring safety and tolerability profile in both the trials.