Ocugen Inc., Bharat Biotech's partner for USA and Canada for Covid-19 vaccine Covaxin, has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing.
As per the Canadian Government norms, a rolling submission facilitates faster review of the vaccine for approval on the safety, efficacy and quality data.
“We thank Health Canada for their upcoming review of Covaxin and look forward to working with them so that we can offer the possibility of another safe and effective option to be used in their fight against Covid-19 and its Delta variant,” Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.
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Early this month, Hyderabad-based Bharat Biotech announced that as per the safety and efficacy analysis of data from the phase 3 clinical trials, Covaxin is 77.8 percent effective against symptomatic Covid-19, according to Bharat Biotech.
It was found to be 93.4 percent effective against severe symptomatic Covid and had a 63.6 percent efficacy against asymptomatic pandemic, the company said.
Efforts are also on to obtain approval for Covaxin in the US. Last month, the US Food and Drug Administration has advised Ocugen to apply for approval for a full biological licence instead of an emergency use authorisation.