PERNEM: Pernem-based Redkar Hospital has stopped screening volunteers for the Phase II of COVID 19 vaccine trial following Drugs Controller General of India’s (DCGI) deciding to review the data of Phase I from all the 12 sites in the country.
Dr Dhananjay Lad from Redkar Hospital said, “DCGI wants to review the data of the Phase I that is data of all 375 volunteers from all over India. Initially, the design was to continue Phase I and II, but now based on the available data of Phase I; DCGI wants to review the 14 days data of the antibodies.”
Dr Lad said, “After 14 days that is on August 13, we will submit the data to the PM and DCGI. The PM will declare the result in August 15, but still we will take permission from DCGI to start the Phase II”.
“In the first phase, the safety of the vaccine has been proved. All 375 volunteers have not shown any major reaction”, Dr Lad informed.
“By August 13, we will have the antibodies available with us and based on that, we will declare the result. The second phase is expected to begin in the third or fourth week of August”, Dr Lad added.
