Digital Desk, New Delhi. The US has decided not to grant Emergency Use Authorization (EUA) to Bharat Biotech’s Covaxin. The main reason for this is insufficient information. For approval, the US FDA needs more information about human clinical trials to ensure that the vaccine is completely safe and works well.
In the US, Bharat Biotech’s partner company is Ocugen Inc. OcuGen applied for approval for emergency use of Covaxin, but was recommended full approval due to insufficient data. As such, OcuGen Inc. will now submit an application for a Biologics
BLA is the FDA’s ‘Full Approval’ process under which drugs and vaccines are approved. So Covaxin may take some more time to get US approval. Dr. Shankar Musunuri, CEO of OcuGen, said, we were close to getting approval for emergency use, but the FDA has suggested us to go through the biologics license application. . This will push the launch forward, but we remain committed to launching Covaxin in the US.
Dr. Musunuri said, Covaxin protects against different variants of the corona virus and will prove to be an important weapon in the fight against the epidemic. In the past, a study by the National Institute of Virology, Indian Council of Medical Research and Bharat Biotech was also revealed in Pune. It was said that Covaxin protects against beta and delta variants of the virus.
On the other hand, efforts are also being made to get Covaxin approved from the World Health Organization (WHO). After getting WHO approval, it becomes easy for any company to send its vaccine abroad. Apart from this, people who have taken a dose of vaccine approved by WHO are comfortable in international travel.