Bharat Biotech's partner seeks approval for India-made Covaxin in Canada
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Rolling reviews allow Health Canada to start its review as soon as information becomes available, thus accelerating the overall review process
Ocugen Inc., Bharat Biotech's partner for the 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.
The move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults, it said on Thursday.
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 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, Ocugen said.
"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," Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said.
Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV)