Zydus Cadila has received the Drugs Controller General of India (DCGI) nod to begin phase-3 clinical trials of coronavirus vaccine -- ZyCoV-D -- in around 30,000 volunteers. The vaccine was found safe, immunogenic and well-tolerated in phase-1 and phase-2 clinical trials.
The phase-2 trials of Zydus Cadila's coronavirus vaccine had been conducted in around 1,000 healthy adults. These trials comprised dose-escalation, multi-centric, randomised, double-blind placebo-controlled study, according to the Gujarat-based pharma major.
The trial results have been reviewed by an independent data safety monitoring board (DSMB). These reports were later submitted to the Central Drugs Standard Control Organisation (CDSCO) for safety outcome updates.
On Zy-CovD being approved for the third-stage trials, Zydus Group chief Pankaj R Patel 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."
Patel stated that the launch of phase-3 trials will determine the efficacy of the vaccine in preventing coronavirus. Union Health Minister Harsh Vardhan also tweeted about the vaccine, saying 'it is safe'.
.@Cadila_Pharma ने DNA platform प्रौद्योगिकी का उपयोग करते हुए #NCOV vaccine विकसित किया है।— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Interim data से पता चलता है कि यह vaccine सुरक्षित है और तीन doses के साथ immunogenic है।@PMOIndia#DCGIpic.twitter.com/QgebcXIXEo
Meanwhile, the DCGI has given emergency use authorisation to SII-AstraZeneca's Covishield and Bharat Biotech-ICMR's Covaxin. Serum Institute CEO Adar Poonawalla has said his company will providde the Indian government with an initial supply of 100 million doses. He said the government wants to ensure "the most vulnerable people of the country get it first - I fully endorse and support their decision."