Leading pharma company, Serum Institute of India (SII) is reportedly seeking regulatory approval from DCGI (Drugs Controller General of India) to start clinical trials of its COVID-19 vaccine COVOVAX, which is being developed by Novavax.

The recent development comes after Serum Institute had received a restricted emergency use approval for its Coronavirus vaccine Covishield from DCGI.

Adar Poonawalla, CEO of SII mentioned that their partnership with Novavax for a COVID-19 vaccine has shown outstanding efficacy results. He added that they have also applied to commence trials in India and expect to launch COVOVAX in the country by June 2021.

As per a government official, the application has been reviewed by the Subject Expert Committee, which has asked them to submit the revised protocol. The application will be extensively reviewed by the expert panel as and when the amended request will be submitted by the company.

Notably, the Serum Institute of India, in cooperation with Oxford University and AstraZeneca, is already manufacturing millions of doses of the Covishield vaccine.

Meanwhile, Novavax reportedly announced that the results of the Phase Three clinical trial performed in the United Kingdom proved that its protein-based COVID-19 vaccine candidate, NVX-CoV2373, fulfilled the primary endpoint with a vaccine efficiency of 89.3%.

Sources knowledgeable with the matter cited that the research was conducted in partnership with the UK Government’s Vaccines Taskforce, evaluated the efficiency during a period with high transmission and a new UK variant strain of the virus spreading widely.  It enrolled 15,000 individuals between the ages of 18 and 84, is intended to be used for applications in the European Union, Britain, and other nations.

Sources confirmed that NVX-CoV2373 includes a full-length, prefusion spike protein developed using the recombinant nanoparticle technology from Novavax and the proprietary Matrix-M adjuvant based on saponin.

The purified protein is determined by the SARS-CoV-2 spike (S) protein genetic sequence and is produced in insect cells. It is steady at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and delivered in a ready-to-use liquid formulation that facilitates distribution using existing supply chain vaccine networks.

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https://www.business-standard.com/article/current-affairs/serum-institute-seeks-dcgi-nod-for-clinical-trials-of-covid-vaccine-covovax-121013000716_1.html