Shares of Ocugen (OCGN) surged 2% when the company announced plans to go ahead and proceed with the rolling out of their COVID-19 vaccine in Canada with submission to Health Canada.
This follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults. 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.
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.
The ongoing battle against Covid-19 will take different forms and pathways. There are no easy solutions here. However, Ocugen appears to be on the right track — and that could mean great things for OCGN.