ZyCoV-D (Pic Via Zydus Website)The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has reportedly recommended granting of emergency use approval to Zydus Cadila's three-dose COVID-19 vaccine, making it the second indigenous jab after Covaxin to get regulatory nod.
Ahmedabad-based Zydus Cadila had announced last month that it applied for Emergency Use Authorisation (EUA) to the office of Drug Controller General of India (DCGI) for ZyCoV-D - its Plasmid DNA Vaccine against COVID-19.
"Subject Expert Committee recommends EUA for ZyCoV-D, Cadila Health’s 3-dose COVID vaccine," sources were quoted by CNBC-TV18 as saying.
The SEC had met on Thursday (19 August) to review Zydus' application for EUA.
"The SEC has sent recommendations to Drugs Controller General of India (DCGI)," the CNBC-TV18 reported.
Zydus had claimed that its Covid-19 vaccine, ZyCoV-D, has a primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases in the interim analysis.
Further, SEC has asked Zydus to submit additional data for two-dose regimen of its Covid-19 vaccine.
ZyCoV-D is a plasmid DNA vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.
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