Ocugen, Inc. Announces Initiation of Rolling Submission to Health Canada for COVAXIN™
MALVERN, Pa., July 15, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it had initiated a rolling submission to Health Canada for COVAXIN™, the company’s candidate vaccine against COVID-19, which it is co-developing with Bharat Biotech International Ltd. for the U.S. and Canadian markets. This follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults.
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. 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.
“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, Chief Executive Officer and Co-Founder of Ocugen.
In addition to generating strong immune response against multiple antigens, COVAXIN™ is designed to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Phase 3 clinical trial data demonstrates efficacy and safety against COVID-19 and its Delta variant. COVAXIN™ is packaged in multi-dose vials that can be stored at 2-8°C.?
Based on the more than 30 million doses supplied in India and other countries, COVAXIN™ has an excellent safety record. COVAXIN™ is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries. COVAXIN™ is considered an investigational drug in Canada and the United States and has not been approved or authorized for use in those countries.
Cautionary Note on Forward-Looking Statements
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