Scientists’ body says WHO’s delay in approving Covaxin is a serious setback to India

Criticising Bharat Biotech for approaching the Drug Controller General of India (DCGI) “with inadequate data of clinical trials”, in December last year, the scientists’ body said, “BB applied to DCGI for EUA with grossly inadequate data from clinical trials inviting rejection, followed by behind-the-scenes arm twisting by government which resulted in the grant of EUA. More detailed results of Phase-3 clinical trials were then released by BB in instalments, interim results two months later and complete trial data in June 2021.” AIPSN also warned the government to not repeat the mistakes while granting approval to ZyCov-D, a vaccine for children in the 12-18 age group, since its trial results have not been made public yet. The All Indian People Science Network urged the concerned ministries and authorities to strictly follow the scientific standards of clinical trials results and publish them and exercise complete transparency. It also appealed to the regulatory bodies to not be pressurised by either the government or corporate interests and form their assessment on scientific analysis.



Source link