Bharat Biotech asked to submit complete ph 2 data of its COVID-19 vaccine before ph 3 trial

Bharat Biotech, which h sought DCGI's d for conducting phase-3 clinical trials of its COVID-19 vaccine candidate, has been asked to submit complete safety and immugenicity data of ongoing phase-2 trial, besides providing some clarifications, before proceeding for next st.

vaccine candidate -- 'Covaxin' -- is being indigeusly developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR).

According to officials, Hyderab-based vaccine maker applied to Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate.

firm in its application said that study would cover 28,500 subjects d 18 years and above and would be conducted in 19 sites -- including Delhi, Mumbai, Patna and Luckw -- across 10 states.

According to sources, phase-2 trial of Covaxin is going on and second dose is yet to be given to volunteers at some sites.

" company presented phase-3 clinical trial protocol along with interim data of phase 1 and 2 clinical trials," an official said.

subject expert committee (SEC) at Central Drugs Standard Control Organisation(CDSCO) deliberated on application on October 5.

"After a detailed deliberation, committee opined that design of phase-3 study is in principle satisfactory except for clarification on definition of asymptomatic, etc.

"However, study should be initiated with appropriate dose identified from phase-2 safety and immugenicity data. Accordingly, firm should submit safety and immugenicity data from phase-2 trial for consideration," panel said in its recommendations.

SEC during its discussion also observed that vaccine was well-tolerated in all dose groups and serious verse events have been reported so far, a source said.

most common verse event was pain at injection site, which resolved transiently, source said.

phase-3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources said.

Besides, Bharat Biotech, indigeusly developed vaccine candidate by Zydus Cila Ltd is in phase 2 of human clinical trials.

Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of candidate in India.