Zydus Cadila seeks approval of phase 3 clinical trials for its Covid-19 vaccine
Top pharmacist Zydus Cadila has approached the national drug regulator seeking approval to begin phase 3 clinical trials of its candidate coronavirus disease (Covid-19) vaccine, which has been shown to be safe for use.
In a statement issued Thursday, the company reported that it had submitted data from the phase II / II trials of its plasmid DNA vaccine candidate, ZyCov-D, to the Comptroller General of Medicines of India (DCGI), Dr. VG Somani.
The vaccine has been found to be safe and immunogenic, the company claims.
“… ZyCoV-D was found to be safe, well tolerated and immunogenic in phase I / II clinical trials. The company now plans to initiate a phase III clinical trial in around 30,000 volunteers after receiving the necessary approvals, ”the company said in a statement.
The phase II study of the candidate vaccine had been conducted in more than 1000 healthy adult volunteers as part of the adaptive, dose-escalation, multicenter, randomized, double-blind, placebo-controlled study.
The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB), and reports have been sent to the Central Medicines Standard Control Organization (CDSCO) regularly for the update of safety results.
“After establishing safety in the phase I clinical trial, ZyCoV-D has completed phase II clinical trials and the vaccine has been found to be safe and immunogenic. We are also optimistic with the results of the Phase III clinical trials and that we could begin production of the new vaccine once it is successfully completed. I would like to thank all the volunteers who have participated in the study so far and helped us evaluate the vaccine to combat COVID-19, ”said Pankaj R. Patel, president 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 greatly improved vaccine stability, requiring lower cold chain requirements. This makes the vaccine ideal for accessing the most remote regions of the country.
Administered intradermally, it also allows for ease of administration. Furthermore, the platform also facilitates the manufacture of the vaccine with minimum biosafety requirements (BSL-1).
“… The platform can be used quickly to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still gets protection. Plasmid DNA, when introduced into host cells, would be translated into the viral protein and elicited a strong immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in disease protection and elimination viral. ”Said the company’s statement.
In its Covid-19 vaccine development initiative, Zydus has been supported by the National Biopharmaceutical Mission, the Biotechnology Industry Research Assistance Council, the Department of Biotechnology, the Indian Council for Medical Research and the National Institute. of virology of Pune.