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Covaxin’s US approval gets delayed as FDA seeks more data

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In a major blow to Bharat Biotech that manufactures the COVID-19 vaccine ‘Covaxin’, the US Food and Drug Administration (FDA) has asked the vaccine maker’s US partner, Ocugen, to go for the lengthier biologics license application (BLA) route and submit additional data.

The development has put an end to the company’s hope of getting an emergency use authorization—a clearance that has been already granted to vaccines manufactured by Pfizer and BioNTech, Moderna and Janssen. Notably, the BLA route takes time, but once issued, it means a full US approval for the vaccine shot.

What Ocugen said

Ocugen in a statement said it is expecting data from an additional clinical trial will be required to support the submission. It has also clarified that it will no longer pursue an emergency use authorisation for Covaxin from the US FDA.

“Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Ocugen chairman Shankar Musunuri said.

No WHO clearance

India’s first indigenously developed COVID-19 vaccine—Covaxin— has been developed by Hyderabad-based Bharat Biotech, in association with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The vaccine is yet to be cleared by the World Health Organisation (WHO) for emergency use listing.

The WHO has asked Bharat Biotech to submit additional data for securing the emergency use listing. The importance of emergency use listing is that once a vaccine secures it, it will be eligible for the global vaccine programme. Also, low-income countries that do not have a robust infrastructure or processes in place depend on WHO clearance for adopting a vaccine.

Covaxin use approved in India

Although Covaxin is yet to get a US FDA or WHO clearance, the Indian drug regulator has approved the vaccine for emergency use after careful assessment even before the third phase trial could be completed. It is being used across the country, with millions of doses already administered to the Indian population.

 

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