Zydus Cadila vaccine gets emergency nod
- ZyCoV-D is the first jab to be cleared for those in 12-18 age group in India
New Delhi: Zydus Cadila said it got emergency use authorization for its ZyCoV-D coronavirus vaccine on Friday, becoming the first jab to be cleared for children in the 12-18 age group in India.
The Drugs Controller General of India’s (DCGI’s) approval of the country’s second indigenously developed vaccine will also help India speed up its immunization effort to halt the spread of the deadly virus.
On Thursday, an expert panel recommended authorizing Zydus Cadila’s three-dose covid-19 vaccine for emergency use, clearing the way for the formal approval by the DCGI.
The vaccine from the Ahmedabad-based drugmaker is the world’s first DNA-based vaccine for covid-19 to be administered in adults as well as children aged 12 years and above.
The drugmaker has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dosage, and the effectiveness of the vaccine was found to be equivalent to the three-dose regimen.
“We have also asked the company to submit additional data for the 2-dose regimen of its vaccine,” a government official said, adding that the expert panel is already evaluating the initial data for the 2-dose regimen and is likely to give final approval.
Zydus Cadila applied for emergency authorization for ZyCoV-D to the DCGI on 1 July.
“We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the global map for novel vaccine development,” said Dr Renu Swarup, secretary, department of biotechnology at the ministry of science and technology, and chairperson of the Biotechnology Industry Research Assistance Council, or BIRAC.
Zydus Cadila said last month that an interim analysis of clinical trial data showed 66.6% efficacy against symptomatic covid cases. It said that the vaccine is also “safe and very well tolerated” in the adolescent population in the 12-18 years age group, potentially making the jab an important weapon in India’s efforts to vaccinate children.
The trial data showed no moderate case of covid-19 was observed in the vaccine arm, post administration of the third dose, suggesting 100% efficacy for moderate disease. In addition, the company said that no severe cases or deaths due to covid-19 occurred in the vaccine arm after administration of the second dose of the vaccine earlier.
“We are extremely happy that our efforts to put out a safe, well-tolerated and efficacious vaccine to fight covid-19 has become a reality,” said Pankaj R. Patel, chairman, Zydus Group.
“To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges is a tribute to the Indian research scientists and their spirit of innovation,” Patel said.
Zydus’s covid-19 vaccine would become the fifth vaccine to get government approval after Covishield, a vaccine manufactured by Serum Institute of India (SII) and developed by the Oxford University and AstraZeneca Plc; Bharat Biotech’s locally developed Covaxin; Russia’s Sputnik V; and the US’s Moderna.
The company said an independent data safety monitoring board had monitored its clinical trials, and its plug-and-play technology on which the plasmid DNA platform is based is ideally suited for dealing with coronavirus variants as it can be easily adapted to deal with mutations in the virus, such as the deadlier delta variant.
Zydus Cadila said in the company statement that its covid-19 vaccine was tested in the adolescent population in the 12-18 years age group in India.
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First Published:20 Aug 2021, 07:43 PM IST
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