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Prabhudas Lilladher Report
Cadila Healthcare Ltd.’s Covid-19 vaccine ZyCoV-D received emergency user approval from Drugs Controller General of India which is world’s first ever ‘plasmid DNA’ based three-dose vaccine with needle-free/painless delivery.
Cadila Healthcare conducted phase-III clinical trial of the vaccine on 28,000 volunteers, including 1400 subjects in the age group of 12-17 age group.
With favorable and acceptable safety profile, the approval was unique as it allows ZyCoV-D to be administered (first time in India) with adolescent age group (12-17 yrs) along with adult population (18 yrs and above).
The company also applied for two-dose vaccine which may take another one to two months for expert group of DCGI to evaluate its efficacy profile data.
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