Zydus Cadila seeks emergency use nod for ZyCoV-D; targets 1 crore vaccines a month
Zydus today said the company has conducted the largest clinical trial for COVID-19 vaccine in India so far in over 50 centers with over 28,000 volunteers
- Jul 1, 2021,
- Updated Jul 1, 2021 5:53 PM IST
Zydus Cadila has applied for Emergency Use Authorisation (EUA) with the Indian authorities and plans to commercially launch, ZyCoV-D, the world's first Plasmid DNA vaccine for COVID-19, within 45-60 days of getting the approval. The pharma company plans to produce over 1 crore doses per month by August or September.
Zydus today said the company has conducted the largest clinical trial for COVID-19 vaccine in India so far in over 50 centers with over 28,000 volunteers. The results indicate primary efficacy of 66.6% for symptomatic RT-PCR positive cases in the interim analysis. The vaccine has also been tested in about 1,000 adolescent population in the 12-18 years age group in India. No moderate case of COVID-19 disease was observed in the vaccine post administration of the third dose suggesting 100% efficacy for moderate disease.
Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said the company is creating capacities to manufacture 1-1.2 crore doses a month, possibly by August or September. "Now we are scaling up from 500 litres to 5,000 litres at a refurbished facility and at a new plant, which will be commissioned in a month's time," he said.
The company has so far invested Rs 400-500 crore to develop the vaccine and is readying to produce over 5-6 crore doses before the end of this year.
"We have not decided on the price of the vaccine and the needle free system, and those details can be shared only after the approval processes and required demand," he said, ruling out chances of exports in near future.
He said the company has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit. Immunogenicity results have been found to be equivalent to the current three dose regimen. The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with COVID-19 as it can be easily adapted to deal with mutations in the virus. Most of the clinical trials were held among COVID-19 patients who were infected with the fast-spreading delta variant.
ZyCoV-D, a three-dose intradermal vaccine is applied using the 'PharmaJet' needle free system. When injected, it produces the spike protein of the SARS-CoV-2 virus and elicits an immune response in the human immune system. It has to be stored at 2-8 degrees Celsius but has shown good stability at temperatures of 25 degrees Celsius for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage, said Zydus Cadila.
Also Read: Zydus Cadila seeks emergency use nod for its COVID-19 vaccine for 12+ age
Also Read: COVID-19: Zydus Cadila vaccine likely to be available for 12-18 years age group by Aug
Zydus Cadila has applied for Emergency Use Authorisation (EUA) with the Indian authorities and plans to commercially launch, ZyCoV-D, the world's first Plasmid DNA vaccine for COVID-19, within 45-60 days of getting the approval. The pharma company plans to produce over 1 crore doses per month by August or September.
Zydus today said the company has conducted the largest clinical trial for COVID-19 vaccine in India so far in over 50 centers with over 28,000 volunteers. The results indicate primary efficacy of 66.6% for symptomatic RT-PCR positive cases in the interim analysis. The vaccine has also been tested in about 1,000 adolescent population in the 12-18 years age group in India. No moderate case of COVID-19 disease was observed in the vaccine post administration of the third dose suggesting 100% efficacy for moderate disease.
Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said the company is creating capacities to manufacture 1-1.2 crore doses a month, possibly by August or September. "Now we are scaling up from 500 litres to 5,000 litres at a refurbished facility and at a new plant, which will be commissioned in a month's time," he said.
The company has so far invested Rs 400-500 crore to develop the vaccine and is readying to produce over 5-6 crore doses before the end of this year.
"We have not decided on the price of the vaccine and the needle free system, and those details can be shared only after the approval processes and required demand," he said, ruling out chances of exports in near future.
He said the company has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit. Immunogenicity results have been found to be equivalent to the current three dose regimen. The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with COVID-19 as it can be easily adapted to deal with mutations in the virus. Most of the clinical trials were held among COVID-19 patients who were infected with the fast-spreading delta variant.
ZyCoV-D, a three-dose intradermal vaccine is applied using the 'PharmaJet' needle free system. When injected, it produces the spike protein of the SARS-CoV-2 virus and elicits an immune response in the human immune system. It has to be stored at 2-8 degrees Celsius but has shown good stability at temperatures of 25 degrees Celsius for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage, said Zydus Cadila.
Also Read: Zydus Cadila seeks emergency use nod for its COVID-19 vaccine for 12+ age
Also Read: COVID-19: Zydus Cadila vaccine likely to be available for 12-18 years age group by Aug