Novavax seeks DCGI's nod for emergency use of 1st protein-based COVID-19 vaccine 'Covovax'

On Thursday, the US-based biotechnology firm Novavax applied to the Drugs Controller General of India seeking the emergency use approval of its COVID-19 vaccine called Covovax in India. In June itself, Novavax's Indian partner Serum Institute of India commenced the production of the first batch of this vaccine at its Pune facility. As per the agreement, the SII is responsible for manufacturing and commercializing Covovax in India. 

Besides the DCGI, applications have been submitted with the regulatory authorities in Indonesia and the Philippines as well. Speaking on this development, Novavax CEO Stanley Erck stated, "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' transformation into a commercial global vaccine company". He added, "This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with Serum Institute of India, and it demonstrates the power of global collaboration". 

The company also mentioned that it will apply to the WHO for its vaccine's inclusion in the Emergency Use List in August. The emergency use approval can be a gamechanger amid the COVID-19 crisis as it is likely to encourage countries to import the vaccine, facilitate its manufacturing abroad and ease global travel for those vaccinated with it. Notably, Novavax and SII have pledged to provide over 1.1 billion doses to the COVAX facility. Until now, the DCGI has accorded emergency use authorization to Covishield, Covaxin, Sputnik V, and Moderna. 

What is Covovax? 

Covovax is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. It was created using recombinant nanoparticle technology and formulated with Novavax's Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. As per the phase 3 trial conducted in the UK, it demonstrated an overall efficacy of 89.7% and 86.3% efficacy against the Alpha (B.1.1.7) variant.

On the other hand, the results of the phase 3 trials in the US and Mexico showed an overall 90.4% efficacy and 100% efficacy against moderate and severe COVID-19 disease. The two doses of Covovax, packaged as a ready-to-use liquid formulation, have to be administered 21 days apart. Most importantly, this vaccine can be stored at 2°- 8° Celsius enabling the use of existing vaccine supply and cold chain channels.