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Wednesday, August 12, 2020

Plasmid DNA vaccine candidate safe, developed indigenously: Global pharma firm

The company’s chairman, Pankaj Patel, told The Indian Express that they had undertaken different animal studies since March, conducted toxicity studies in two different animal species, and found that the vaccine was safe.

By: Express News Service | Pune | Published: July 3, 2020 10:58:49 pm
Coronavirus cure, plasmid DNA vaccine, COVID 19 vaccine, Pune news, Indian express news “We have successfully completed the preclinical phase and received permission from Drug Controller General of India-Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India,” Patel said. (Representational)

Zydus -a part of the Cadila health care group said they have indigenously developed its plasmid DNA vaccine candidate for COVID 19 – called ZyCOV-D. Pre clinical trials have been completed and they have received the go ahead for human clinical trials. The company said that the vaccine had been developed at its vaccine technology centre at Ahmedabad

The company’s chairman, Pankaj Patel, told The Indian Express that they had undertaken different animal studies since March, conducted toxicity studies in two different animal species, and found that the vaccine was safe.

“We have successfully completed the preclinical phase and received permission from Drug Controller General of India-Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India,” Patel said.

He added that they were planning to initiate clinical trials this month across multiple sites with over 1,000 subjects.

Saying he preferred to reserve his opinion, Patel refused to comment on Indian Council of Medical Research (ICMR) partnering with Bharat Biotech to launching its own phases of clinical human trials and plans to come out with a vaccine by August 15.

An official statement issued by the company on Friday read that in animal studies, the vaccine was found to elicit a strong immune response in multiple species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralization assay, indicating the protective potential of the vaccine candidate, it read.

It further stated that there was no safety concern observed for the vaccine candidate in repeat dose toxicology studies by intramuscular as well as intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated, and immunogenic, the statement added.

The statement further read that with ZyCoV-D, the company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid, carrying the gene of interest, making it safe. Further, with no vector response and absence of any infectious agent, the platform provides ease of manufacturing with minimal biosafety requirements (BSL-1), it read.

The company statement also pointed out that the platform is known to show improved vaccine stability and lower cold chain requirements, making it easy for transportation to remote regions.

Furthermore, the statement added, the platform can rapidly be used to modify the vaccine in a couple of weeks, in case the virus mutates, to ensure that the vaccine still elicits protection.

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