Zydus gets DCGI nod for phase-3 vaccine trials | Ahmedabad News


Ahmedabad: City-based pharmaceutical major Zydus Cadila has received the Drugs Controller General of India (DCGI)’s approval for conducting the phase-3 clinical trials of its plasmid DNA vaccine to prevent Covid-19. With this permission, Zydus Cadila will now begin the third phase trials of its vaccine candidate called ZyCoV-D, which is India’s first indigenously developed DNA vaccine against Covid-19.
The company will be initiating the phase-3 clinical trial with about 30,000 volunteers. “ZyCoV-D was found to be safe, well tolerated and immunogenic in the first and second phase clinical trials,” the company said in a statement. The phase-II study had been conducted in over 1,000 healthy adult volunteers. The vaccine candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC) and the department of biotechnology, government of India. On Saturday, the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended granting permission to Zydus Cadila to commence phase-III clinical trials of the vaccine.
“We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine,” said Pankaj Patel, chairman, Zydus Cadila. “The launch of the phase-III trial will determine the efficacy of our vaccine in preventing Covid-19, which continues to pose a major threat across the world,” he added.
Zydus Cadila currently manufacturers other vaccines at its Zydus Biotech Park located in Changodar, Ahmedabad. The facility was visited by the Prime Minister Narendra Modi in November to take stock of the vaccine development. Zydus Cadila is also in the process of ramping up the vaccine production capacity at the facility as it aims to reach a capacity of 100-150 million doses per annum.
The group hopes to start the production of the novel vaccine after successful completion of the third phase. The group is also conducting the phase-III clinical trials with its biological therapy — Pegylated Interferon alpha-2b (PegiHep) — in Covid-19 patients.


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