Now, COVAXIN gains EUA Rolling Review approval in Canada

    Bharat Biotech’s Covid-19 vaccine, COVAXIN US co-development partner OCUGEN has applied for EUA rolling review in Canada according to the latest updated reports coming in Canadian Health Authorities today. Canada has accepted the candidate for review and it is currently reviewing the Indian made vaccine for possible emergency-use authorization (EUA).

    The confirmation emanate in the form of an updated list of vaccines, antivirals and other Covid-19-related treatment listed by Health Canada and from the official tweet of OCUGEN under rolling review process.

    Joining the latest entries for EUA in Canada is the candidate proposed by Vaccigen, the Canadian affiliate of Ocugen, the US biopharma company that has entered into an agreement with Bharat Biotech for manufacturing and distributing Covaxin in North America.

    Ocugen senior executive in a tweet wrote: 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.

    The date listed by Health Canada for the application was June 30.

    The rolling submission process for COVAXIN 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.

    Latest list of coronavirus vaccines, antivirals and other Covid-19-related treatment listed by Health Canada confirm the same

    While Covaxin was not specifically named, its medical ingredients were described as a “whole virion inactivated coronavirus” meant for human use.

    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.


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