Covaxin rejected by US FDA for emergency usage
11-06-2021 Fri 18:28
Bharat Biotech has released a statement that the US FDA has decided not to give emergency approval to any new covid vaccine due to healthy immunity, carrying out the vaccination process on a large scale and declining corona cases. The US FDA has advised its partner, Ocugen, to seek full approval for covaxin. It has recommended following the Biological License Application-BLA route, which is the entire licensing process for vaccination approval. Bharat Biotech has announced that this will require additional clinical trial data and will take some more time. Covaxin has received emergency clearances in 14 countries, while Bharat Biotech said the process is ongoing in another 50 countries.
The drug manufacturing company has clarified that the vaccine manufactured in India has not yet received an emergency use permit or full license from the US FDA. Therefore, it is clear that the USFDA approval would be a significant step forward for the development and manufacture of the vaccine in India.
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