Zydus Cadila seeks nod for needle-free vaccine

Zydus Cadila has requested emergency use approval for its ZyCoV-D three-dose Covid shot that is the “world’s first Plasmid DNA vaccine”. The shot is “needle-free”, says the company, and “safe for children”. The company plans to manufacture up to 120 million doses of the shot annually.

An approval for ZyCoV-D would make it the fifth vaccine cleared for use in India after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna. Zydus claims its vaccine is 66.6 per cent effective against symptomatic Covid cases and 100 per cent for moderate disease. It also says the vaccine is safe for children between 12 and 18 years. But its trial data is not peer-reviewed yet. ZyCoV-D showed safety and efficacy in a late-stage trial with more than 28,000 volunteers across the country, including about 1,000 subjects in the 12-18 year age group, Zydus says. The vaccine, which is in its second phase of trials, is a “plasmid DNA” vaccine that can be stored at 2-8 degree Celsius.

According to the company, its Phase 3 trials were carried out through the outbreak of Delta, the fast-spreading Covid variant first detected in India and believed to be driving new cases in parts of the world. DNA vaccination is a novel approach for inducing an immune response. Purified plasmid DNA containing an antigen’s coding sequences and the necessary regulatory elements to express them is introduced into the tissue via intramuscular injection.