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

Company to initiate trials with around 30,000 volunteers

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

With this, the firm, also known as Zydus Cadila, will initiate phase 3 clinical trials on around 30,000 volunteers. Depending on the progress of researches and outcomes, Zydus is hoping to launch the vaccine in the first quarter of the next financial year.

According to Zydus Group Chairman Pankaj Patel, the launch of such trials will determine the efficacy of the vaccine.

The company had applied for permission with the DCGI after the phase 2 study of the ZyCov-D vaccine was conducted on over 1,000 volunteers.

The vaccine was found to be safe and give a strong immunogenic response during the study. The trial was reviewed by an independent Data Safety Monitoring Board (DSMB) and the reports were submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcomes.

The National Biopharma Mission, Biotechnology Industry Research Assistance Council, Department of Biotechnology, Indian Council of Medical Research, and National Institute of Virology have supported the development of ZyCoV-D, the company had earlier informed.

With ZyCoV-D, Zydus Cadila has established the DNA vaccine platform in the country. 

The platform is also known to show improved vaccine stability, thus requiring lower cold chain requirements.

This makes the plasmid DNA vaccine ideal for access in the remotest regions of the country. Administered through the intradermal route, it is easy to inject.

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

Further, the platform makes the vaccine easy to manufacture, with minimal bio-safety requirements (BSL-1). At a time when a new strain of the novel coronavirus has led to lockdown and travel bans in the UK and other countries and with cases emerging in India as well, Zydus’ plasmid DNA platform can allow the vaccine to be modified in case the virus mutates.

Currently, a team of 300 scientists is working on Covid vaccine research. The company has 1,400 researchers working on chemical entities (NCEs), biologicals, vaccines, and pharmaceutical technologies.

Its manufacturing facilities in Gujarat are ready to manufacture 120 million doses of the vaccine to start with, with capabilities of a further ramp-up.

In addition, the company is also looking to partner contract manufacturing organisations (CMOs) to produce another 50-70 million doses.

According to Patel, the nod for phase 3 clinical trials amounts to the group reaching a critical milestone in its vaccine development programme.

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