Zydus Cadila’s COVID-19 Vaccine Gets Nod for Human Clinical Trials

Ahmedabad-based Zydus Cadila has received the DCGI approval to conduct human trials for its COVID-19 vaccine.

2 min read
Ahmedabad’s Zydus Cadila  has received the DCGI approval to conduct human trials for its COVID-19 vaccine.

Soon after Bharat Biotech’s Covaxin became the first indigenous vaccine candidate to get the nod for clinical trials, Ahmedabad’s Zydus Cadila Healthcare has also received the approval from the Drugs Controller General of India (DCGI) to conduct phase I/II human trials for its vaccine (ZyCoV-D).

An official source told the news agency PTI,

“DCGI Dr V G Somani has given approval for the phase I and II clinical trials (on humans) of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd on Thursday after its animal studies were found to be successful.”

This approval from the DCGI - Central Drugs Standard Control Organisation (CDSCO) was fast-tracked after a recommendation received by the subject expert committee on COVID-19, in response to the ‘emergency and unmet medical need during the pandemic’.

“The phase I and II trials will take around three months to be completed,” the source added.

The company submitted the data of its clinical trials on animals to the regulator, where its vaccine candidate was reportedly found to be successful in terms of safety and immunogenicity. The results from the animal studies are yet to be shared by Zydus. In the press release, the company has said,

  • In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits
  • The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate.
  • In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic.

ZyCoV-D is a plasmid DNA vaccine candidate for COVID-19 developed indigenously at the company’s Vaccine Technology Centre in Ahmedabad.

Zydus plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.

What is a DNA Vaccine?

According to the World Health Organisation (WHO), a DNA vaccine involves the direct injection of genetic material into a living host to produce an immune response. This is done by creating an ‘inappropriate’ gene expression, which creates an immunological response, which in turn causes a specific immune activation of the host in response to that specific gene with the antigen.

This approach offers a number of potential advantages over traditional approaches, including the stimulation of both B- and T-cell responses, improved vaccine stability, the absence of any infectious agent and the relative ease of large-scale manufacture.

This is different from an inactivated vaccine such as Bharat Biotech’s Covaxin, which was India’s first indigenous vaccine to get approval for clinical trials. An inactivated vaccine or a killed vaccine uses the killed version of the pathogen that causes the disease. They are made from viruses or bacteria that have been killed clinically and therefore they cannot cause diseases anymore, according to WHO.

You can read about the different kinds of vaccines here.

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