Covid 19 vaccine in India: In a significant step towards getting an additional Covid-19 vaccine just after Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin, Zydus Cadila has began enrolment for the late-stage human or clinical trial for its vaccine candidate ZyCoV-D just after getting received permissions from the Drugs Controller General of India (DCGI).
Zydus Cadila has currently commenced human trials for ZyCoV-D this week. The late-stage trials of Zydus Cadila’s ZyCoV-D are anticipated to take spot at 5 web pages across 4 cities. These cities are Ahmedabad, Surat, Nashik, and Jaipur, the Clinical Trials Registry mentioned, according to a report by The Indian Express.
Key facts of Zydus Cadila Covid vaccine
Zydus Cadila’s ZyCoV-D is a 3-dose Covid vaccine candidate. It is a plasmid DNA vaccine to avert COVID-19. The ZyCoV-D Covid vaccine candidate was identified to be protected, effectively-tolerated, and immunogenic in Phase 1 and Phase 2 clinical trials. The Phase 3 human trial of ZyCoV-D Covid vaccine candidate will involve about 30,000 volunteers, according to facts offered by Zydus Cadila.
The Phase 2 human trial study of the ZyCoV-D had been carried out in more than 1000 healthful adult volunteers as component of the adaptive Phase 1 and Phase 2 dose-escalation, multi-centric, randomized, double-blind placebo-controlled study. The vaccine was identified to be protected and elicit a sturdy immunogenic response. The trial has reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) often for the update on security outcome, Zydus Cadila mentioned 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 mentioned.
The Ministry of Health and Family Welfare has disclosed that Russian Sputnik V’s phase 2 and phase 3 trials are undergoing.