Bharat Biotech’s COVID-19 Vaccine ‘Gets Nod’ for Phase 3 Trials
The panel’s decision came after assessing data from phase 1 & 2, and an animal challenge study, a report said.
The Drugs Controller General of India's (DCGI) subject expert committee has recommended granting permission for phase 3 clinical trials for Covaxin, the COVID-19 vaccine candidate being developed by Bharat Biotech, reports said on Thursday, 22 October.
The panel’s decision came after assessing data from phase 1 and 2, along with the animal challenge study, CNBC-TV18 reported.
"In continuation of the SEC meeting dated 05.10.2020, firm presented their data from Phase I and II along with animal challenge data in two species including NHP on the Inactivated Coronavirus Vaccine (BBV152) along with the proposal to conduct event driven Phase III clinical trial to assess the efficacy of the vaccine," the expert committee was quoted as saying in a statement.
The phase 3 trials are expected to include as many as 28,500 subjects across 19 sites in 10 states, NDTV reported.
Bharat Biotech is developing its COVID-19 vaccine candidate in partnership with the Indian Council of Medical Research (ICMR). Apart from Covaxin, the other vaccine candidates undergoing clinical trials in India include the Oxford-AstraZeneca candidate as well as the one by Zydus Cadila Ltd.
(With inputs from CNBC-TV18, NDTV)
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