The transfer follows the discharge by Bharat Biotech of Part 3 scientific trial outcomes, which demonstrated efficacy and security in almost 25,800 adults, it stated on Thursday.
Sometimes called a rolling evaluate, this permits Well being Canada to start out its evaluate instantly, as data continues to return in, to speed up the general evaluate course of.
Ocugen initiated the rolling submission by its affiliate, Vaccigen, Ltd.
Well being Canada will decide upon evaluate of the proof submitted that helps its security, efficacy and high quality.
The rolling submission course of was beneficial and accepted below the Minister of Well being’s Interim Order Respecting the Importation, Sale and Promoting of Medication for Use in Relation to COVID-19 and transitioned to a brand new drug, Ocugen stated.
“We thank Well being Canada for his or her upcoming evaluate of Covaxin and look ahead to working with them in order that we are able to supply the potential for one other secure and efficient possibility for use of their battle towards COVID-19 and its
variant,” Dr. Shankar Musunuri, Chairman of the Board, Chief Govt Officer and Co-Founding father of Ocugen stated.
Covaxin was developed in collaboration with the Indian Council of Medical Analysis (ICMR) Nationwide Institute of Virology (NIV).