Covovax Approval To Strengthen Immunisation Efforts In India, Lower & Middle-Income Countries: SII

Vaccine major Serum Institute of India (SII) on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunisation initiatives across India and various lower and middle-income countries (LMICs) across the world.

"The approval of Covovax by DCGI is a significant milestone in strengthening our immunisation efforts across India and LMICs. We are proud to deliver a highly-effective protein-based COVID-19 vaccine of more than 90 per cent efficacy rate, based on clinical data demonstrating a favourable safety profile.

"We are certain that as the repertoire of the COVID-19 vaccine increases, we will be poised strongly to save the lives of millions of people against the pandemic," SII CEO Adar Poonawalla said in a statement.

He was responding to Union Health Minister Mansukh Mandaviya's announcement that the Central Drug Authority, the Central Drugs Standard Control Organisation (CDSCO), has approved the SII's vaccine Covovax for restricted use in emergency situations.

Covovax is produced by Pune-based SII under licence from US-based vaccine maker Novavax Inc.

In August 2020, Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

Poonawalla also thanked Mandaviya for the approval.

"Thank you, Shri Hon. @mansukhmandviya for granting Emergency Use Authorization for COVOVAX in India. This is a highly effective vaccine and is a big step in India's fight against COVID-19," he tweeted.

The Covovax/Novavax vaccine has recently received Emergency Use Listing (EUL) with the World Health Organisation (WHO), Emergency Use Authorization (EUA) in Indonesia and the Philippines.

Novavax also announced regulatory filings for its vaccine in Australia, Canada, the European Union, New Zealand and the United Kingdom.

Additionally, Novavax and SK bioscience have announced a Biologics License Application (BLA) submission in South Korea.

Novavax expects to submit the complete package to the United States Food and Drug Administration (USFDA) by the end of the year.

"We expect the authorisation of our vaccine to serve a vital need in India, helping to increase the vaccination rate in a country where a significant number of doses is needed to control the pandemic," Novavax President and Chief Executive Officer Stanley C Erck said.

Novavax and SII continue to increase forward momentum, and the entities would carry on with their objective to deliver vaccines to those in India and across the globe, he added.