A national network of scientists and people's science movements has raised concern about the World Health Organization's refusal to identify ICMR-Bharat Biotech's Covaxin as an emergency drug. It noted that India appeared to be repeating the mistakes it made during the Covaxin clearance process by certifying Zydus Cadilla's ZyCov-D three-dose vaccination for people aged 12 and above.
The All India Peoples Science Network ( AIPSN) said in a statement, “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.”
Zydus applied for EUA on the basis of interim data on July 1, 2021 and received it on August 20. The AIPSN noted that however, this interim data has not been made public or published anywhere, even in pre-print form, posing the same issues and complaints as Covaxin.
Concerning these facts, it asked the Centre, ministries and departments concerned to follow scientific norms for conducting and analysing clinical trials, publishing results in peer-reviewed journals and maintaining complete transparency.