Bharat Biotech clarifies on the US-FDA’s EUA denial for COVAXIN

As per Bharat Biotech, its US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval instead of EUA

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New Delhi: In response to the Drug Master File on the COVID-19 vaccine, COVAXIN submitted by Ocugen Inc, the US partner of Bharat Biotech, the United States-Food and Drug Administration (USFDA) has recommended it to pursue a Biologics Licence Application (BLA) submission instead of an Emergency Use Authorisation (EUA) application.
USFDA has also sought additional information and data on the vaccine candidate.
Meanwhile, Bharat Biotech in its latest statement has played down the denial by the USFDA. It pointed towards the fact that the USFDA had earlier communicated that no new EUA would be approved for new Covid-19 vaccines in the backdrop if factors such as herd immunity and accelerated vaccination program, and reduction in cases in the United States.
“Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval instead of EUA. 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,” mentioned the statement.
COVAXIN has received EUA’s from 14 countries with more than 50 countries in the process.
“No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved,” statement concluded.