CDSCO panel clears Serum Institute's Covovax for emergency use; DCGI approval awaited

With India witnessing a rising surge of Omicron cases in the country, an expert panel of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorisation (EUA) to the Serum Institute of India's (SII) COVID-19 vaccine 'Covovax', officials revealed on Monday. This development comes a few days after the Drugs Controller General of India (DCGI) sought more data from the Serum Institute of India over its application seeking Emergency Use Authorization (EUA) for Covovax. The official application had been submitted by Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII in October. 

"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) reviewed the emergency use authorisation (EUA) application for the second time on Monday and after detailed deliberation recommended granting emergency use authorisation to Covovax," an official source told PTI.

DGCI seeks details on Covovax

Earlier it was reported that the DCGI had asked SII to provide details on the 'Matrix component' used in Covovax, given that it is a technology transfer of the Novovax vaccine. "The apex drug regulator has also asked the SII to provide details on Matrix component used in the vaccine," PTI had stated. Along with its application, the SII had also submitted interim safety and immunogenicity data of phase two and phase three clinical trials in India as well as interim phase three trials data conducted in the US and the UK. 

Notably, the vaccine was granted emergency use approval by the World Health Organisation (WHO) earlier this month. WHO said that NVC-CoV2373 was accessed under the Emergency Use Listing (EUL) based on the data on efficacy, quality, safety, a risk management plan and other things. Since Covovax is part of the COVAX facility portfolio, it will help vaccinate more people in low-income nations, it had said. 

Meanwhile, in a significant development, the Centre has announced a COVID-19 vaccination drive for teenagers and booster dose for healthcare workers and those above 60 years of age and with comorbidities. Only Covaxin will be available for children in the age-group 15-18 years. The vaccination for them will begin on January 3, 2022.

(With agency inputs)