Indian COVAXIN to seek full license in USA |
Indian vaccine manufacturer Bharat Biotech now has a US partner, Ocugen. The American company said on 10th June said that it will pursue submission of a biologics license application for Covaxin, instead of emergency-use authorization as originally planned. The US FDA has recommended that Ocugen submit an application for a BLA to pursue full approval for the vaccine, rather than initial approval under an emergency use authorization. Ocugen anticipates that data from an additional clinical trial will be required to support the submission. Ocugen said it will take the longer route despite the fact that it was close to finalizing our Emergency Use Application. It may extend the timeline, but Ocugen and Bharat Biotech are committed to bringing Covaxin to the US. Ocugen is in discussions with the FDA to understand the extra information required to support a BLA submission. Ocugen has also secured exclusive rights to market the vaccine in Canada and had initiated discussions with Health Canada for approval.
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