Cadila seeks DCGI emergency use authorisation for first plasmid DNA COVID-19 vaccine

Drug manufacturer, Zydus Cadila announced on Thursday that it has 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.  

The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centres. It was tested in the adolescent population of 12-18 years age group for the first time in the country. The vaccine was found to be safe and very well tolerable in this age group, which included around 1,000 subjects.  

The same was seen with the adult population. The company reported that it attained a primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases in the interim analysis. There were no moderate cases of the disease observed in the vaccine arm post-administration, suggesting 100 per cent efficacy for moderate disease.  Moreover, no severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of the second dose of the vaccine.  

ZyCoV-D had already shown robust immunogenicity, tolerability, and safety profile in phase I & II clinical trials carried out earlier. The clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).  

At 12.06 pm on Thursday, the stock of Cadila Healthcare was trading at Rs 637.50, down by 1.17 per cent.  The 52-week high and 52-week low of the scrip was recorded at Rs 673.70 and Rs 347.05, respectively on BSE.