'Submit Covaxin's Phase II data before proceeding for phase III': CDSCO to Bharat Biotech

Bharat Biotech, the developer of India's first potential COVID-19 vaccine Covaxin, will be required to submit safety and immunogenicity data from ongoing phase II trial in order to conduct phase III clinical trial of its vaccine candidate.

The expert panel at the Central Drugs Standard Control Organisation (CDSCO) asked the manufacturer to submit the data of the phase II trials before proceeding for phase III.

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This comes after the vaccine developer sought Drug Controller General of India (DCGI) approval to conduct phase III clinical trials of its vaccine candidate. Bharat Biotech presented the phase III clinical trial protocol along with interim data of phase I and II clinical trials on October 2, according to the Subject Expert Committee (SEC) meeting.

"The committee noted the interim data of phase I and II clinical trials. After detailed deliberation, the committee opined that the design of the phase III study is in principle satisfactory except for clarification on the definition of asymptomatic, etc," SEC noted on 114th meeting on October 5.

"However, the study should be initiated with an appropriate dose identified from phase II safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from the phase II trial for consideration," it said.

India's vaccine candidates

Bharat Biotech got DCGA's approval in July to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19. Covaxin is the first of the indigenously developed vaccines against COVID-19 by India. Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) to develop the vaccine. Besides the Covaxin, India has two more vaccine candidates in the run. Ahmedabad based Zydus Cadila's ZyCoV-D and another one is being developed by Serum Institute of India in collaboration with the Oxford University vaccine and UK's Pharmaceutical giant AstraZeneca. 

(With ANI inputs)

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