Bharat Biotech International Ltd’s (BBIL) Covaxin partner for the US and Canada Ocugen Inc has started a rolling submission to Health Canada for the dose jab, the US-based company informed. This comes after the BBIL’s Phase-III clinical trial results release that shown efficacy and safety in around 25,800 adults, reports news agency PTI.
Called a rolling review, it permits Health Canada to begin its review immediately as information starts coming in to expedite the overall process of review. Ocugen started the rolling submission via its affiliate Vaccigen Ltd. Health Canada will decide after reviewing the evidence submitted backing its safety, efficacy, and quality.
Ocugen’s Chairman of the Board, CEO and Co-founder Dr Shankar Musunuri has thanked Health Canada for the upcoming Covaxin’s review and expressed his keenness of working with the Canadian government’s health department to be able to provide a possibility of the use of an additional safe and effective alternative in their fight against the Covid-19 and its Delta variant.