Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, was given...
Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, was given the go-ahead for the third and final round of clinical trials on Thursday, NDTV reported. The study will cover 28,500 subjects aged 18 and above, the Hyderabad-based firm that makes the vaccines said.
Bharat Biotech had applied for permission for the third phase to the Drugs Controller General of India on October 2. The trials would be conducted in 19 sites, including Delhi, Mumbai, Patna and Lucknow, and across 10 states.
Savita Verma, principal investigator who leads the vaccine trial at PGI Rohtak, told The Economic Times that there were minor adverse reactions in some but overall the preliminary results showed that Covaxin is safe.
Drugs Controller General of India’s Subject Expert Committee recommended granting of permission to conduct phase three clinical trials for Covaxin after assessing data from phase one and two as well as animal challenge study. The nod is subject to a few minor amendments in how primary efficacy endpoint for symptomatic cases can be studied in the third phase, the drug regulator said.
“In continuation of the SEC meeting dated 05.10.2020, firm presented their data from Phase I...
