Drug firm Zydus Cadila on 1st June said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.

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The company has conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centres. This was also the first time that any COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India, Zydus Cadila said in a regulatory filing. Around 1,000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated, it added. The company has applied for emergency use authorisation (EUA) with the office of the Drug Controller General of India (DCGI) for ZyCoV-D -- its plasmid DNA vaccine against COVID-19.

"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," Cadila Healthcare Managing Director Sharvil Patel said. A new facility to manufacture this vaccine will come up by the end of July which will start producing ZyCoV-D at scale, he said in a virtual media interaction. "...we believe we can start from mid-August to have a run rate of around 1 crore doses per month," he added. So far, Zydus Cadila has invested around Rs 400 crore to Rs 500 crore for the development of the vaccine, Patel said.

Asked if the company was also looking at exports, Patel said, "With the scale of manufacturing that we are going to achieve and obviously we still need to demonstrate that capability, we are only currently focusing our efforts on making sure we can make these doses available for India." The company is not looking at exports in the near term as it does not have sufficient quantities to supply to other countries, he added. Primary efficacy of 66.6 per cent has been attained for symptomatic RT-PCR positive cases in the interim analysis.

No moderate case of COVID-19 disease was observed post administration of the third dose, suggesting 100 per cent efficacy against moderate disease, Zydus Cadila said. No severe cases or deaths due to COVID-19 occurred after administration of the second dose of the vaccine. The company has 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, Zydus Cadila said. This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future, it added.