Submit previous trial data for Covaxin before rolling out phase III: Drug regulator to Bharat Biotech
Oct 10, 2020
By Priyanka Sharma
New Delhi [India], October 10 : The expert panel at Central Drugs Standard Control Organisation (CDSCO) has asked drug maker Bharat Biotech to submit safety and immunogenicity data from ongoing phase II trial in order to conduct phase III clinical trial of indigenous COVID-19 vaccine, Covaxin.
According to the Subject Expert Committee (SEC) meeting, the firm presented the phase III clinical trial protocol along with interim data of phase I and II clinical trials on October 2.
"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.
In July, the Drug Controller General of India had granted permission to pharma company Bharat Biotech to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.
In this regard, Bharat Biotech has partnered with Indian Council of Medical Research (ICMR) to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR's National Institute of Virology, Pune.
