Zydus Cadila said it has applied to the Drug Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for ZyCoV-D, its plasmid DNA vaccine to counter COVID-19.
It will be the world’s first plasmid DNA vaccine for COVID-19, the company said.
The company had conducted clinical trials at over 50 centres in India, it said. Phase III clinical trials had been conducted on over 28,000 volunteers. This was the first time that any COVID-19 vaccine had been tested in adolescent population in the age group of 12-18 years in India.
“Around 1,000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population,” said Sharvil Patel, managing director, Cadila Healthcare Ltd, at a briefing.
“Our vaccine has attained primary efficacy of 66.6% for symptomatic RT-PCR positive cases in the interim analysis. No moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose, which suggests 100% efficacy for moderate disease.” He said no severe cases or deaths had been reported after administration of the second dose of the vaccine.
“ZyCoV-D had already exhibited a robust immunogenicity, tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” Mr. Patel said.
“The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with COVID-19, as it can easily be adapted to deal with mutations in the virus, such as those already occurring,” he said.
“This breakthrough marks a key milestone in scientific innovation and advancement in technology. As the first ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against COVID-19. The vaccine, when approved, will help not only adults but also adolescents in the 12 to 18 years age group,” he said.
The company said it had also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit, and the immunogenicity results had been found to be equivalent to the current three-dose regimen.
Needle-free applicator
This would further help in reducing the full course duration of vaccination, while maintaining the high safety profile of the vaccine in the future. The vaccine will come with PharmaJet, a needle-free applicator that will ensure painless intradermal vaccine delivery. This would cost extra. The company had not revealed the price of the vaccine or the applicator.
Mr. Patel said the company had made an investment of ₹500 crore for this vaccine project, including the manufacturing unit, and it planned to manufacture 10-12 crore doses annually. By December, it targeted to produce 5 lakh doses, with a run rate of 1 crore doses per month from August, 2021. The gap between the first and second dose is 28 days.
