Serum Institute secures CDSCO panel nod for bridge trial of Novavax Covid-19 vaccine

Medical dialogues team had earlier reported that Novavax, Inc. had announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom (U.K.) of NVX‑CoV2373, the company's vaccine candidate.

Novavax had licensed its NVX-CoV2373 technology to the Serum Institute of India (SII) with no upfront, milestone or technology transfer payments. With this strategic partnership in place, Novavax and SII were jointly committed to delivering 1.1 billion doses to the COVAX Facility.

NVX-CoV2373 is a protein-based vaccine candidate which is constructed by the genetic sequence of SARS-CoV-2. The genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease, was used to construct NVX-CoV2373, a protein-based vaccine candidate.

NVX-CoV2373 was constructed by using Novavax 's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax's patented saponin-based Matrix-M to boost the immune response and trigger the high levels of neutralizing antibodies. NVX-CoV2373 consists of purified protein antigen that can not replicate or induce COVID-19.

Responding to the proposal, after detailed deliberation, the committee recommended the conduct of the clinical trial with observer-blind design.