Zydus Cadila Seeks DCGI's Nod For Three-Dose ZyCoV-D Vaccine - World's 1st Plasmid DNA Shot For Covid
The company has applied for emergency use authorisation (EUA) of ZyCoV-D with the Drug Controller General of India (DCGI).
New Delhi: It could be a major breakthrough for India if Ahmedabad-based pharmaceutical firm Zydus Cadila gets emergency use approval for its 'ZyCoV-D' - the three-dose Covid vaccine that is the world’s first Plasmid DNA shot.
According to reports, the company has applied for emergency use authorisation (EUA) of ZyCoV-D with the Drug Controller General of India (DCGI).
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The company said it has conducted the largest clinical trial for its Covid-19 vaccine in India so far in over 50 centres that showed efficacy of 66.6 per cent in an interim study, lowest rate among the vaccines approved in India so far.
If the company gets nod from Indian regulator it could become the second home-grown Covid vaccine.
Notably, ZyCoV-D is world's first Plasmid DNA vaccine against Coronavirus as it makes use of a portion of the genetic code - DNA or RNA - in the SARS-CoV-2 virus to stimulate an immune response against its spike protein.
The company claims that ZyCoV-D vaccine will help not only adults, but also adolescents in the 12 to 18 years age group.
"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," Zydus Cadila said in an official statement.
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.
According to a report by news agency ANI, the pharma giant expect to produce one crore vaccine doses per month from August onwards after approval.
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"We expect to produce 1 crore vaccine doses per month from August onwards and 5 crore doses by December this year. Our target is to produce 10-12 crore vaccine doses in a year," Managing Director of Cadila Healthcare Dr Sharvil Patel said.
As per the company statement, ZyCoV-D vaccine can be stored at 280 degrees celsius, but has shown good stability at temperatures of 250 degrees Celsius for at least three months.
The company also said that it will reveal the price of a vaccine once it gets clearance from regulators.
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