Canadian health authorities have placed Covaxin, Indian company Bharat Biotech’s Covid-19 vaccine, under review for possible emergency-use authorization (EUA).
The confirmation came in the form of an updated list of vaccines, antivirals and other Covid-19-related treatment listed by Health Canada.
Among the latest entries 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.
The date listed by Health Canada for the application was June 30.
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.
However, a decision to approve Covaxin is likely to depend less on domestic demand and more on an effort to standardise Covid-19 vaccines globally.
In a media briefing on Thursday, Canada’s deputy chief public health officer, Howard Njoo, said they were “looking more now at international collaboration, and international consistency”, according to a report in the outlet iPolitics.
Ocugen had commenced discussions with Health Canada with regard to the authorisation of Covaxin in June.
On Thursday, it released a statement saying “it had initiated a rolling submission to Health Canada”. That process was recommended and accepted by Canada’s interim order relating to Covid-19 drugs, 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”.
Shankar Musunuri, chairman of the board, CEO and co-founder of 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.”
The Canadian review comes as Bharat Biotech has also submitted Phase 3 trial data to the World Health Organization (WHO) for its authorisation.
