Zydus Cadila seeks regulatory approval for its COVID vaccine, ZyCov-D

Zydus Cadila, an Indian pharmaceutical company, has reportedly approached the top drug regulator in the country to seek restricted emergency approval of its 3-dose COVID-19 vaccine, ZyCov-D.

Following the anticipated approval, ZyCov-D will become the 1st DNA vaccine against coronavirus ever developed across the globe. The vaccine had undergone late-stage clinical trials among nearly 28,000 participants over the past months. As per the trial results, it has a primary efficacy of 66.6%, denoting its ability to lower the symptomatic cases of the disease.

Despite the comparatively low efficacy rate as compared to other COVID-19 vaccines being approved in India, ZyCov-D is notably deemed to be effective against the Delta variant, according to Dr. Sharvil Patel, Zydus Cadila’s Managing Director.

The clinical study of the vaccine was conducted at 50 clinical sites across the country amid the peak of the 2nd COVID wave, which further reaffirms its efficacy against the new mutant strain, he added.

Dr. Patel further cited that DNA vaccines are considered to be non-infectious as they do not have any viral vectors linked with toxicity. Therefore, they offer low risks of developing vaccine-enhanced diseases owing to the non-availability of any infectious agent.

Currently, Zydus Cadila is testing ZyCov-D against other variants as well and is planning to later upgrade it as per the results or infectiousness of the new strains. The pharmaceutical company has also conducted the vaccine trial to examine its safety and ability to prompt an immune response among 1,000 adolescents aged between 12-18 years and above.

As per the company’s statement, it has been evaluating the possibility of this vaccine to use a 2-dose regimen, revealing that this dosing regimen induces an equivalent immune response as that of the 3-dose regimen. Zydus Cadila is targeting to produce over 100 million-120 million doses of the vaccine per year as well as supply 50 million doses to India by December end.

Source credit:

https://indianexpress.com/article/india/zydus-cadila-applies-for-emergency-use-nod-for-covid-19-vaccine-7383843/