COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is an inactivated vaccine is currently being administered under emergency use authorizations in 13 countries. Pennsylvania-headquarted Ocugen and Bharat Biotech have partnered to bring the vaccine to North America.
The companies say the vaccine has the potential to address variants, and also plan to undertake paediatric and booster trials.
“Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada,” said JP Gabriel, Ocugen’s Senior Vice President, Manufacturing and Supply Chain.
“Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN to our new partner.”
This month, Ocugen announced it would pursue submission of a biologics license application (BLA) in the US for the vaccine, rather than an EUA application, following feedback from the US Food and Drug Administration (FDA). In Canada, it has initiated discussions with Health Canada for regulatory approval: planning for expedited authorization.
Phase 3 interim results for the vaccine show 78% efficacy, as well as is being 100% effective against severe disease, notes the company. Furthermore, “COVAXIN has demonstrated its potential effectiveness against all the major variants including the delta variant which now starting to spread in the US.”