Canada reviews Covaxin for emergency use authorisation
Ocugen Inc., Bharat Biotech’s partner for 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.
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.
Whether Canada requires an additional vaccine is a separate debate, since it has placed orders for up to 404 million doses from various manufacturers, including 180 million doses from the four vaccines that currently have EUA in the country the ones developed by Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson.
COVAXIN, a COVID-19 vaccine by Bharat Biotech, was developed in collaboration with the Indian Council of Medical Research National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record, having been used to develop more than 300 million doses of its inactivated vaccines. It is a two-dose vaccine given four weeks apart.