Ocugen said it has initiated the rolling submission in Canada through its affiliate Vaccigen Ltd and that Health Canada would make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.
“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. Ocugen initiated the rolling submission through its affiliate, Vaccigen Ltd
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.
The US-based company said the submission follows the release of Phase-3 clinical trials data of Covaxin that demonstrated efficacy and safety in nearly 25,800 adults. The data showed Covaxin is 77.8% effective against symptomatic Covid-19, 93.4% effective against severe symptomatic Covid-19 and 65.2% efficacy against the Delta variant.