Ocugen begins Covaxin rolling submission in Canada

Hyderabad: Ocugen Inc, Bharat Biotech’s partner for US and Canada markets, on Thursday said it has initiated a rolling submission to Canadian health regulator Health Canada for Covid-19 vaccine Covaxin through its affiliate Vaccigen Ltd.

“The rolling submission process was recommended and accepted under the Minister of Health’s interim order respecting the importation, sale and advertising of drugs for use in relation to Covid-19 and transitioned to a new drug submission for Covid-19, which permits companies to submit safety and efficacy data and information as they become available,” Ocugen said in a regulatory filing to the US bourses. “Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process. Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality,” Ocugen added.

“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,” said Dr Shankar Musunuri, chairman of the board, CEO & co-founder, Ocugen Inc.