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.
Notably, the 'needle-free' triple shot Zydus Cadila vaccine will come with an applicator, which the company has developed with PharmaJet, reports India Today.
The drugmaker carried out clinical trials in across 50 centres in the country and even tested the same for the adolescents in 12-18 year age-group. Around 1000 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.”
Sharvil Patel, managing director, Zydus Cadila, said that the pharmaceutical company is committed to manufacturing 10 to 12 crore doses annually. The company will also come up with a new facilty in July. The company plans to roll out 5 crore doses by the end of this year.
"We believe the vaccine can be launched in 45 to 60 days after drug regulator approval," added Patel.
Notably, ZyCov-D is a three-dose, intradermal vaccine, which is applied using The PharmaJet® needle-free system, Tropis. It is 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.