Serum Institute seeks DCGI nod for clinical trials of Covid vaccine Covovax

Pharma giant Serum Institute of India (SII), whose Covishield vaccine has already received restricted emergency use approval by the Drugs Controller General of India (DCGI), has now sought permission to start clinical trials of 'COVOVAX', a COVID-19 vaccine developed by Novavax.

In a tweet on Saturday, Adar Poonawalla, CEO of SII said: "Our partnership for a COVID-19 vaccine with Novavax has also published excellent efficacy results. We have also applied to start trials in India. Hope to launch COVOVAX by June 2021."

According to a government official, "Serum Institute has applied to the DCGI for its Novavax vaccine. The Subject Expert Committee (SEC) sometime back has reviewed their application and asked them to submit the revised protocol.

"The application would be evaluated thoroughly by the expert panel as and when the revised will be submitted by the firm."

It may be noted that the SII is already manufacturing millions of doses of Covishield vaccine in technical collaboration with Oxford University and AstraZeneca.

In the latest press statement, Novavax announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3 per cent, in its Phase three clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government's Vaccines Taskforce.

The study, which has enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the European Union and other countries.

NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax' recombinant nanoparticle technology and the company's proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.