Zydus Cadila seeks Phase 3 clinical trials approval for its Covid-19 vaccine
Pharma major Zydus Cadila has approached the national drugs regulator, seeking approval to start phase 3 clinical trials of its vaccine candidate against the Coronavirus disease (Covid-19), that has proven to be safe for use.
In a statement issued on Thursday, the company informed that it had submitted the phase II/II trials data of its plasmid DNA vaccine candidate, ZyCov-D, to the Drugs Controller General of India (DCGI), Dr VG Somani.
The vaccine has been found to be safe and immunogenic, claims the company.
“…ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials. The company is now planning to initiate Phase III clinical trial in around 30,000 volunteers upon receiving necessary approvals,” the company said in a statement.
The Phase II study of the vaccine candidate had been conducted in over 1000 healthy adult volunteers as part of the adaptive Phase I/II dose escalation, multi-centric, randomized, double-blind placebo controlled study.
The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB), and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.
“After establishing safety in Phase I clinical trial, ZyCoV-D has now completed Phase II clinical trials and the vaccine has been found to be safe and immunogenic. We are optimistic of Phase III clinical trial outcomes as well and that we would be able to start the production of the Novel Vaccine on its successful completion. I would like to thank all the volunteers who have participated in the study so far and helped us in evaluating the vaccine to fight COVID-19,” said Pankaj R. Patel, chairman of the Zydus Group, in a statement.
With ZyCoV-D, the company 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. Further, the platform also provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).
“…the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection. 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,” the company statement further read.
In its Covid-19 vaccine development initiative, Zydus has been supported by national biopharma mission, biotechnology industry research assistance council, department of biotechnology, Indian council of medical research, and national institute of virology, Pune.