The recent circular from ICMR proposes an accelerated development pathway for the BBV152 COVID vaccine. It is clear from the letter that even the preclinical development of the vaccine is not complete as yet, and even patient enrolment for Phase-1 trial has not taken place. Phase-2 trial can begin only when the safety of the vaccine has been assured. Talk of launching the vaccine on a date presumes success of clinical trials as well. Considering these, ISRC views the acceleration with grave concern and urges ICMR to follow the standard norms for safe vaccine development.
We also refer to the press release by the Indian Academy of Sciences on this issue.