The US Food and Drug administration has denied the emergency use authorisation to Covaxin and have asked for additional data, biopharmaceutical.
Covaxin, the first indigenous vaccine, is a whole-virus inactivated vaccine manufactured by Bharat Biotech, Hyderabad. It received accelerated approval in India on January 3, 2021, and is one of the two main vaccines given in India. Over 29 million doses of Covaxin have been administered in India so far.
Bharat Biotech had also applied for approvals with the US FDA and the WHO. But in its latest announcement, it has been denied emergency use approval. FDA has asked Ocugen, Bharat Biotech’s trial partner in the US, to conduct a new local trial.
The vaccine will then be re-evaluated on the basis of trial’s findings. If the vaccine is approved based on the local trial, it will become eligible for a full approval.