Bharat Biotech stated that its US partner, Ocugen has received a recommendation from US FDA to pursue Biologics License Applications (BLA) path for Covaxin, which is full approval instead of EUA.
The company stated that all applications have to follow the BLA process, which is the standard process for vaccines.
Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin. This process will extend our timelines.
“With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the US FDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines,” Bharat Biotech said.
Covaxin has received EUA’s from 14 countries with more than 50 countries in the process.
The company added that no vaccine manufactured or developed from India has ever received EUA or full licensure from US FDA.
