Novavax, Serum Institute seek DCGI emergency use nod for recombinant nanoparticle COVID vaccine

New Delhi: Novavax, a biotechnology company developing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India, has applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation of Novavax's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-MTM adjuvant.

This came after Novavax, with its partner, Serum Institute of India, announced that the companies have filed regulatory submissions to the Drugs Controller General of India (DCGI) for emergency use authorization of Novavax's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant.

The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines.

"Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax's transformation into a commercial global vaccine company," said Stanley C. Erck, President and Chief Executive Officer, Novavax.

SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and control data. A Good Manufacturing Practice joint site inspection of SII was successfully completed by DCGI in May 2021.

A submission to the World Health Organization (WHO) for emergency use listing (EUL) based on the DCGI submission is expected to be filed in August. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

Novavax's COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°-8° Celsius, enabling the use of existing vaccine supply and cold chain channels.

Novavax's COVID-19 vaccine, NVX-CoV2373, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax's patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor cause COVID-19.

In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited a robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial 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; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°-8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

SII is manufacturing and developing, and is responsible for commercializing the vaccine in India. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.