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 But its trial data is not peer-reviewed yet.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.
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.
The study was carried out "during the peak of second wave of COVID-19 (in India), reaffirming the vaccine's efficacy against the new mutant strains especially the Delta variant," Zydus said in a statement to the stock exchanges, according to Reuters.
The ZyCoV-D vaccine has a three-dose regimen, unlike the shots used so far in India. It is applied through a needle-free system.
The vaccine is stored at 2 to 8 degrees celsius, but has shown good stability at temperatures of 25degrees for at least three months, says the company, which makes it easier to transport and store the shot and reduce any cold chain breakdown challenges.
"Also, being a plasmid DNA vaccine, ZyCoV-D doesn't have any problem associated with vector based immunity," the company says in a statement.
A plasmid DNA vaccine, when injected, produces the spike protein of the coronavirus and incites an immune response. Plasmid DNA platforms can be quickly modified to deal with new mutations, says Zydus.