Zydus gets DCGI nod for conducting phase-3 clinical trials of ZyCoV-D

Paving way for timely roll out of another indigenous Covid-19 vaccine, the Drugs Controller General of India (DCGI) has approved phase 3 of Ahmedabad-based Cadila Healthcare Ltd. (Zydus Cadila)’s plasmid DNA vaccine ‘ZyCov-D’.

With this, will now initiate phase-3 in around 30,000 volunteers. According to Zydus Group chairman Pankaj Patel, the launch of the phase 3 trials will determine the efficacy of the vaccine in preventing Covid-19.

The company had applied for permissions with the DCGI after the phase 2 study of the ZyCov-D vaccine was conducted in over 1000 healthy adult volunteers. The study was part of the adaptive Phase I/II dose escalation, multi-centric, randomized, double-blind placebo controlled study.

The vaccine was found to be safe and elicit a strong immunogenic response during the study. The trial was reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome. National Biopharma Mission, BIRAC, Department of Biotechnology, ICMR and NIV Pune have also supported the development of ZyCoV-D, the company had earlier informed.

With ZyCoV-D, has successfully established the DNA vaccine platform in the country. The platform is also known to show much improved vaccine stability thus requiring lower cold chain requirements.

This makes the vaccine ideal for access in remotest regions of the country. Administered through the intradermal route, it also allows for the ease of administration.

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The plasmid DNA when introduced into the host cells would be translated into the viral protein and will elicit a strong immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.

Further, the platform also provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). At a time when a new strain of the novel has led to lockdown and travel bans in the UK and other countries with cases emerging in India as well, Zydus’ plasmid DNA platform can allow the vaccine to be modified in case the virus mutates to ensure that the vaccine still elicits protection.

Currently, a team of 300 scientists is working on the Covid vaccine research, whereas, the company has 1400 researchers working on our research programmes in new chemical entities (NCEs), biologicals, vaccines and new pharmaceutical technologies.

It’s manufacturing facilities in Gujarat are ready to manufacture 120 million doses of the vaccine to start with, with capabilities of further ramp up based on demand also made possible. In addition, the company is also looking to partner with contract manufacturing organisations (CMOs) to produce another 50-70 million doses.

According to Patel, the nod for phase 3 amounts to the group reaching a critical milestone in its vaccine development programme and towards its goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine.

Meanwhile, depending on the progress of the study and the outcomes, Zydus is hoping to launch ZyCov-D vaccine in the first quarter of next financial year.

The Zydus vaccine gameplan

-Phase-1 and 2 clinical trials conducted in over 1,000 volunteers

-Phase-3 clinical trials to involve 30,000 volunteers

-A team of 300 scientists is working on Covid vaccine research

-Capable of making 120 million doses of ZyCov-D initially and ramping up later

-To partner with CMOs to produce another 50-70 million doses

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