Covid 19 vaccine in India: Zydus Cadila begins enrolment for Phase 3 trial of ZyCoV-D in 4 cities

Covid 19 vaccine in India: In a major step towards having another Covid-19 vaccine after Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin, Zydus Cadila has started enrolment for the late-stage human or clinical trial for its vaccine candidate ZyCoV-D after having received permissions from the Drugs Controller General of India (DCGI).

Zydus Cadila has already commenced human trials for ZyCoV-D this week. The late-stage trials of Zydus Cadila’s ZyCoV-D are expected to take place at five sites across four cities. These cities are Ahmedabad, Surat, Nashik, and Jaipur, the Clinical Trials Registry said, according to a report by The Indian Express.

Key details of Zydus Cadila Covid vaccine

Zydus Cadila’s ZyCoV-D is a three-dose Covid vaccine candidate. It is a plasmid DNA vaccine to prevent COVID-19. The ZyCoV-D Covid vaccine candidate was found to be safe, well-tolerated, and immunogenic in Phase 1 and Phase 2 clinical trials. The Phase 3 human trial of ZyCoV-D Covid vaccine candidate will involve around 30,000 volunteers, according to details provided by Zydus Cadila.

The Phase 2 human trial study of the ZyCoV-D had been conducted in over 1000 healthy adult volunteers as part of the adaptive Phase 1 and Phase 2 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 Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome, Zydus Cadila said in a statement.

“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,” Pankaj R. Patel, Chairman of the Zydus Group said.

The Ministry of Health and Family Welfare has disclosed that Russian Sputnik V’s phase 2 and phase 3 trials are undergoing.