Zydus Cadila vaccine candidate gets nod for Phase III clinical trials

The candidate has been supported by the National Biopharma Mission (NBM) under the aegis of BIRAC and the Department of Biotechnology, Government of India

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New Delhi: The Nation’s first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by Zydus Cadila has been approved by the Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials. The candidate has been supported by the National Biopharma Mission (NBM) under the aegis of BIRAC and the Department of Biotechnology, Government of India.
The Phase II study of the vaccine ZyCoV-D 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 vaccine was found to be safe and elicit a strong immunogenic response. The trial has reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.
Speaking on the development, Pankaj R. Patel, Chairman of the Zydus Group said, “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. The launch of the Phase 3 trial will determine the efficacy of our vaccine in preventing COVID-19 which continues to pose a major threat, the world over.”
Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC expressed happiness and hoped that the candidate vaccine continues to show positive outcomes. Speaking on the occasion, she said, “The Department of Biotechnology, Government of India has partnered with Zydus Cadila, to address the need for accelerated development of an indigenous vaccine for COVID-19. The partnership exemplifies that such research endeavors demonstrate the Government’s focus on creating an ecosystem that nurtures and encourages new product innovation with societal relevance”.