Pharmaceutical company Zydus Cadila has formally registered an application to the office of Drugs Controller General of India (DCGI) to avail the emergency use authorization (EUA) for its Covid-19 vaccine candidate ZyCov-D.
Zydus aims to produce 120 million doses of ZyCov-D, which could potentially be the second indigenously developed Covid-19 vaccine to get the nod of the regulator after Bharat Biotech's Covaxin.
The drugmaker carried out clinical trials in across 50 centres in the country and even tested the same for the adolescent 12-18 year age-group individuals too. Around 100 subjects belonging to the latter category were brought on-board for the trials and the vaccine was reportedly found to be ‘very well tolerated’.
“Primary efficacy of 66.6% has been attained for symptomatic RT-PCR positive cases in the interim analysis. Whereas, no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100% efficacy for moderate disease,” Zydus Cadila’s statement was quoted in a report by the Mint.
Moreover, the company added that ZyCov-D has displayed a robust immunogenicity, tolerability and safety profile in the earlier adaptive Phase I/II clinical trials. An independent Data Safety Monitoring Board (DSMB) assessed all the three phases of the clinical trials.
The Ahmedabad-based pharmaceutical firm further assured, “No severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of the second dose of the vaccine.”
Notably, ZyCov-D is a three-dose vaccine -- to be administered at day 0, day 28, and day 56. The company is also said to be working on a two-dose regimen of this vaccine.
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