Gujarat Exclusive > National-World > Bharat Biotech submits Covaxin’s Phase 3 clinical trial data to DCGI

Bharat Biotech submits Covaxin’s Phase 3 clinical trial data to DCGI


Vaccine maker Bharat Biotech has submitted the third phase clinical trial data of its vaccine against COVID-19 ‘Covaxin’ to the Drugs Controller General of India (DCGI). The subject expert committee of the regulator is going to meet today to deliberate on the data submitted by the company.

On Wednesday, the company is supposed to hold a pre-submission meeting with the World Health Organisation for securing emergency use listing of Covaxin. During the pre-submission meeting, the company will get guidance from WHO experts before final submission. Notably, WHO had earlier sought additional data for providing emergency use listing to Covaxin.

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.

USFDA declined emergency authorisation

Earlier this month, the US Food and Drug Administration (FDA) asked Bharat Biotech’s US partner, Ocugen, to go for the lengthier biologics license application (BLA) route and submit additional data.

The development put an end to the company’s hope of getting an emergency use authorisation—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.

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.

Apart from Covaxin, the drug regulator has approved Covishield and Sputnik-V for emergency use. Two foreign vaccine makers—Pfizer and Moderna—were seeking indemnity from any claims arising out of their vaccines in India from the Indian government for providing vaccines to India. However, the Indian government is not likely to provide the same to the companies.


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