Serum Institute of India's Covovax has been granted Emergency Use Authorisation by DCGI for adults and for children aged 12 years and above, announced CEO Adar Poonawalla on Wednesday, 9 March.
Poonawalla added that authorisation for younger age groups will follow shortly.
Novavax in global trials has demonstrated more than 90 percent efficacy, he added.
Union Health Minister Dr Mansukh Mandaviya on Tuesday, 28 December, had announced that the CDSCO had approved Covovax for restricted emergency use in India.
The Journey to Here
In August 2020, Novavax Inc, a US-based vaccine maker, and SII had announced a licence agreement for the development and commercialisation of its vaccine candidate NVX-CoV2373 in low and middle-income countries and India.
In October 2021, Prakash Kumar Singh, the director of government and regulatory affairs at the Serum Institute of India, had submitted an application to the DCGI, asking for the market authorisation for Covovax for restricted use in emergency situations.
On 17 May 2021, SII had got permission from DCGI to manufacture and stock Covovax. After receiving the approval, SII manufactured and stockpiled the vaccine doses.
On 17 December, Covovax received the emergency use listing by the World Health Organization (WHO), making it the 9th coronavirus vaccine to have received the approval.
About the Vaccine
The vaccine, produced by the SII under licence from Novavax, is part of the COVAX facility, a worldwide initiative aimed at providing equitable access to COVID-19 vaccines.
Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at 2 to 8 °C refrigerated temperatures.
The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.