India’s drug regulator the Drug Controller General of India (DCGI) on Friday approved Zydus Cadila’s three-dose Covid-19 DNA vaccine for emergency use in adults and children above 12 years of age.
Developed in partnership with the Department of Biotechnology, Government of India under the ‘Mission COVID Suraksha’ and implemented by BIRAC, the plasmid DNA-based ZyCoV-D is the world’s first DNA-based vaccine developed by an Indian company.
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The Ministry of Science & Technology said in a press release that interim results from Phase 3 clinical trials in over 28,000 volunteers showed an efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. “This has been the largest vaccine trial so far in India for COVID-19.
This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” the press release said.
The Ahmedabad-based pharma major had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine. The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
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