NEW DELHI: The research ethics committee of AIIMS, Delhi has objected to several points in the study protocol proposed for the clinical trial of Covid-19 vaccine candidate Covaxin, without giving in to pressure by the Indian Council of Medical Research to fast-track the tests.
AIIMS, Delhi is one of the 12 hospitals across 10 states that have been selected for human trials of the vaccine candidate developed by Bharat Biotech and the ICMR.
The suggestion for change in the study design comes even as most other hospitals chosen for the trial have approved the study protocol, this newspaper has learnt.
Sources said the ethics committee has demanded modification in the study design that proposed a sample size of 1,125 healthy volunteers for Phase I and II trials, and will discuss it again. “The committee objected to 11 points in the proposed protocol and has suggested that they be amended,” said a senior official in the institution.
“This is the difference between AIIMS and other institutions in the country. We take pride in the highest ethical standards and rigour that we follow for every research project.”
ICMR’s July 2 letter to the 12 hospitals had demanded that the trials be fast-tracked. It wanted subject enrolment by July 7 so as to launch the vaccine by August 15, a target dubbed as rushed and unrealistic by experts. As for AIIMS, Delhi, subject enrolment may begin only on July 7; it will take several days to wrap it up.
As per the original protocol, the vaccine is to be studied on 375 individuals in Phase 1, followed by Phase II trial to evaluate its safety, reactogenicity, tolerability and immunogenicity. Volunteers will be administered two intramuscular shots.
Age group for trial
The proposed age groups for the trials are 18-55 years for Phase I and 12-65 years for Phase II. The study design, however, could see some changes following objections by the AIIMS, Delhi panel