Ocugen has commenced the rolling submission to Health Canada for its Covid-19 vaccine candidate, COVAXIN, which is being jointly developed with Bharat Biotech International for use in the US and Canada.
COVAXIN is a purified and inactivated vaccine. Bharat Biotech developed the vaccine in partnership with the Indian Council of Medical Research’s National Institute of Virology.
The latest submission comes after Bharat Biotech reported positive data from Phase III clinical trial, which showed vaccine efficacy and safety in approximately 25,800 adult subjects.
The vaccine demonstrated an efficacy of 77.8% against mild, moderate and severe Covid-19 and offered increased protection against emerging B.1.617.2 (Delta) and B.1.351 (Beta) variants of SARS-CoV-2.
Under the Minister of Health’s interim order, the rolling submission process was suggested and accepted by Health Canada.
This submission was changed to a new drug submission for Covid-19, which allows companies to provide safety and efficacy data and information when they are available.
The rolling review aids Health Canada to initiate the assessment of the vaccine immediately, upon the data availability, to expedite the review process.
Through its subsidiary, Vaccigen, Ocugen started the rolling submission.
Ocugen CEO, co-founder and board chairman Dr Shankar Musunuri 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 vaccine can induce a robust immune response against several antigens, Ocugen noted. It can also stimulate memory T cell responses, for its various epitopes, signifying durable and quick antibody response to infections in the future.
Available as a package of multi-dose vials, which can be stored at temperatures of 2⁰C to 8⁰C, the vaccine is being used under emergency use authorisations (EUA) in 13 countries globally.
EUA applications for COVAXIN are pending in nearly 60 more countries.