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

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

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

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

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

"However, study should be initiated with an appropriate dose identified from phase II safety and immugenicity data. Accordingly, firm should submit safety and immugenicity data from 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 indigeus vaccine for COVID-19. Covaxin is first of indigeusly developed vaccines against COVID-19 by India. Bharat Biotech has collaborated with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) to develop  vaccine. Besides Covaxin, India has two more vaccine candidates in run. Ahmedab based Zydus Cila's ZyCoV-D and ar one is being developed by Serum Institute of India in collaboration with Oxford University vaccine and UK's Pharmaceutical giant AstraZeneca. 

(With ANI inputs)

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