The drug maker announced on Thursday (24 December 2020) that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials.
The company is now planning to initiate Phase III clinical trial in around 30,000 volunteers upon receiving necessary approvals.
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 immunogenic. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.
The domestic equity benchmarks ended near the day s high on Monday, supported by positive global cues. Barring the Nifty Pharma index, all the other sectoral indices on the NSE ended in the green. Banks, metals and realty stocks rallied.
As per provisional closing data, the barometer index, the S&P BSE Sensex, rose 380.21 points or 0.81% to 47,353.75. The Nifty 50 index added 134 points or 0.97% to 13,883.25.
Investor sentiment was upbeat after the U.S. President Trump signed a $2.3 trillion pandemic aid while the U.K. and the E.U. struck a a Brexit trade deal last week.
The broader market ended firm. The S&P BSE Mid-Cap index rose 0.83% while the S&P BSE Small-Cap index rallied 1.49%.
Zydus Cadila on Thursday submitted data from phase one and two clinical trials for its coronavirus vaccine ZyCov-D and sought approval for the next phase of tests. The vaccine was found to be safe and well tolerated in tests on more than a thousand healthy adult volunteers, said the company, adding phase three clinical trial in around 30,000 volunteers upon receiving necessary approvals. The multi-centre and randomized trials were reviewed by an independent Data Safety Monitoring Board (DSMB). Reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome. Zydus Group chairperson Pankaj Patel said that company is optimistic of the phase III clinical trial outcomes as well. We would be able to start production of the novel vaccine on its successful completion, he said.
ZyCoV-D vaccine trial: Zydus Cadila seeks govt nod to start Phase-III clinical trials of COVID-19 vaccine financialexpress.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from financialexpress.com Daily Mail and Mail on Sunday newspapers.