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In a positive development, the Ahmedabad-based Zydus Cadila is finding its Covid-19 vaccine safe for children in clinical trials.
“We have not seen anything to worry about when it comes to safety for the whole trial and for children also,” company’s managing director Sharvil Patel told The Economic Times.
“Our trial is already approved for children between 12-18 years. We will have the data very soon and then we will also apply for its use in younger age groups. So far, on the safety front we have not seen any concern with administering these doses,” he said.
The Indian multinational pharmaceutical company is carrying out clinical trials involving 1,000 children to test the efficacy of its vaccine against SARS Cov2 virus.
Zydus Cadila is likely to apply for emergency use authorisation (EUA) of its Covid vaccine candidate, currently under the Phase-3 efficacy trials, within the next few days.
If EUA is granted by regulators, ZyCoV-D will become the fourth available vaccine against coronavirus in India.
With plans to manufacture 240 million (24 crore) doses of ZyCoV-D in a year, the drug maker is expecting to submit the efficacy data to the regulator, Drugs Controller General of India (DCGI), by the end of this month.
ZyCoV-D is a DNA-plasmid vaccine. While the vaccine does use genetic material to elicit an immunogenic response in the body, it is not using the mRNA (messenger RNA), instead, it uses the plasmid DNA. A plasmid is a small DNA molecule within a cell that is distinct from chromosomal DNA and can replicate independently and is usually found in bacterial cells.
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