Bharat Biotech partner Ocugen seeks approval of Covaxin in Canada
The move follows Bharat Biotech’s publication of the results of phase 3 clinical trials, which have demonstrated efficacy and safety in nearly 25,800 adults, he said Thursday.
Often referred to as a continuous review, this allows Health Canada to begin its review immediately, as information continues to arrive, in order to expedite the overall review process.
Ocugen initiated continuous submission through its subsidiary, Vaccigen, Ltd.
Health Canada will make a decision after reviewing the submitted evidence that supports its safety, efficacy and quality.
The continuous submission process has been recommended and accepted under the Minister of Health’s Interim Order Regarding the Importation, Sale and Advertising of Drugs for Use in Connection with COVID-19 and has moved 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 provide the possibility of another safe and effective option to use in their fight against COVID-19 and its
variant, ”said Dr Shankar Musunuri, Chairman of the Board, CEO and Co-Founder of Ocugen.
Covaxin was developed in collaboration with the National Institute of Virology (NIV) of the Indian Council of Medical Research (ICMR).