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Zydus Cadila COVID-19 vaccine passes phase 1 human trials

Anthony Fernandes
/ Categories: DSIJ Mindshare, DSIJ News
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Zydus Cadila COVID-19 vaccine passes phase 1 human trials

Global pharmaceutical major, Zydus Cadila announced on Wednesday that its plasmid DNA vaccine to prevent COVID-19, namely ZyCoV-D, was found to be well-tolerated and safe in phase 1 clinical trial.

The company further plans to commence phase 2 trials from Thursday i.e. August 6, 2020.

As per the company reports, the doses of the vaccine administered to healthy volunteers in phase I clinical trial, which began on July 15, 2020, was “well-tolerated”. Previously, the vaccine was found to be safe, immunogenic, and well-tolerated in the pre-clinical toxicity studies.

The seven-day safety of the vaccine in all the subjects enrolled in phase I clinical trial was endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial.

The phase 2 study of ZyCoV-D will be conducted in over 1,000 healthy adult volunteers and will be evaluating the humoral and cellular immune response for the vaccine candidate in line with the current global clinical trial protocols in general.

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

According to the company, the platform is also known to show the much-improved vaccine stability and lower cold chain requirements, making it easy for transportation to remotest regions of the country.

At 2.30 pm on Wednesday, the stock of Cadila Healthcare was trading at Rs 397.50 per share, lower by 1.33 per cent or Rs 5.35 per share on BSE, against a 0.12 per cent gain in the benchmark index. The 52-week high is recorded at Rs 411.60 and the 52-week low is Rs 206.45 on BSE.

 

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