Zydus Cadila seeks DCGI's emergency nod for ZyCoV-D - world's first DNA COVID vaccine

In a boost to India's vaccination drive, Zydus Cadila applied for Emergency Use Authorisation (EUA) for its COVID-19 vaccine (ZyCoV-D) on Thursday to the Drugs Controller General of India (DCGI). The Ahmedabad-based company which has developed the world's first DNA COVID-19 vaccine, seeks to launch it for 12 years & above. The vaccine has completed the third phase of trials.

ZyCoV-D seeks emergency usage

According to the company's website, Phase-3 clinical trials were conducted on  30,000 healthy adult volunteers and was found to be safe, well-tolerated and immunogenic. In phase-1/2 trials, after conducting trials on 1000 volunteers, the vaccine was found to be safe and elicit a strong immunogenic response. The vaccine trials were conducted in over 60 plus sites and is stable at 2 to 8 degrees as a result in a normal refrigeration temperature. The vaccine is also very thermostable at 25 degrees.

On June 27, Centre's COVID working group Chairman Dr. NK Arora said that ZyCoV-D said, "Trial for Zydus Cadila vaccine is almost complete. By July end or in August, we might be able to start administering this vaccine to children of 12-18 age group. We have a window period of 6-8 months to immunise everybody in the country. In coming days, our target is to administer 1 crore doses every day."

About ZyCoV-D

As per its website, ZyCoV-D is a DNA vaccine based on plasmid DNA - a small, circular and extrachromosomal bacterial DNA. The plasmid DNA can be used in different kinds of molecular genetic research, such as gene therapy, gene transfer and recombinant DNA technology, due to its property of self-replication. ZyCoV-D is a three-dose vaccine. Currently, India is administering vaccines of Serum Institute of India (COVISHIELD) and Bharat Biotech (COVAXIN), while Russia's Sputnik-V, US' Moderna have already been given emergency approval.

Zydus Cadila has already gotten approval for clinical trials of a biological therapy ZRC-3308 that claimed to have neutralizing monoclonal antibodies (mAbs)-based cocktail for the treatment of mild COVID-19. It has also gotten emergency approval for its anti-viral drug 'Virafin' for treatment of moderate COVID-19 infection in adults. The company has stated that a single dose of the antiviral drug has shown that 91.15 per cent of patients were shown to be COVID-19 negative within seven days.