New Delhi: The Drug Controller General of India (DCGI) has given nod to Bharat Biotech's COVID-19 vaccine candidate to start phase III clinical trial.
Officials in India's apex drug regulator (DCGI) told ETV Bharat that the Hyderabad based Pharma company presented phase III clinical trial protocol along with interim data of phase I and II clinical trials before the subject expert committee (SEC).
"The committee noted the interim data of Phase I and II clinical trials. After detailed deliberations the committee opined that the design of the Phase III study is in principle satisfactory except for clarification on the definition of the asymptomatic act," officials said.
Bharat Biotech is doing a clinical trial of COVID vaccine (BBV152).
The SEC said that the Phase III study should be initiated with an appropriate dose identified from the Phase II safety and immunogenicity data.
The committee has also asked the Pharma giant to submit safety and immunogenicity data from the Phase II trial.
Read: Coronavirus originated in various parts of world: China
The committee has also recommended for grant of permission to conduct Phase III clinical trial of Cadila pharmaceutical's Mycobactrium w (immunomodulator).
Reports suggest that an immunomodulator may be of potential benefit in managing critically ill Covid19 patients.
Significantly, Zydus Cadila which is doing a clinical trial of another indigenous Covid19 vaccine (ZyCov-D) is reportedly trying to complete trial for the vaccine by February or March so that it could produce up to 100 million doses a year initially if it's successful.
Meanwhile, as on Friday India has 893592 active Covid19 cases across different states with 70,496 new confirmed cases reported in the last 24 hours.
Health Ministry statistics said that 74 per cent of the new cases are coming from 10 states and UTs including Maharastra, Karnataka, Kerala, Andhra Pradesh among others.
India has also reported 106490 deaths till date with 964 fresh fatalities reported in the last 24 hours. Of the total fatalities, 82 per cent are concentrated in 10 states and UTs including Maharastra, Karnataka, Tamil Nadu, West Bengal among others.
As many as 5906069 people have also been cured of this infectious disease till date taking the total percentage to 85.52.
