‘WHO decision on Covaxin a serious setback for India’

A national network of scientists and people’s science movements has expressed concern over the World Health Organisation not granting emergency use listing for ICMR-Bharat Biotech’s Covaxin. It warned that India looked set to repeat the blunders it committed in the Covaxin approval process in the way it was approving Zydus Cadilla’s ZyCov-D three-dose vaccine for those 12 years and older.

As the WHO delayed clearance for Covaxin seeking more technical details, the All India Peoples Science Network (AIPSN) said it was a serious setback to India’s plans to distribute the vaccine to other countries and to those travelling abroad, especially students, who took Covaxin.

In a statement on Wednesday, AIPSN referred to its earlier call for disclosure of Covaxin’s trial data and said serious damage was done to India’s reputation by this flawed application to the WHO regulators “which has also besmirched the standing of Indian science and regulatory systems, which will now come under heightened international scrutiny and suspicion”. “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,” stated AIPSN. It said despite criticism from scientists and others, Bharat Biotech was yet to publish these results in a peer-reviewed journal. after posting just a pre-publication paper.

Zydus had applied for EUA on July 1, 2021 based on interim data and obtained it on August 20. “However, this interim data has not been made public or published anywhere, even in pre-print form, raising the same concerns and criticisms as with Covaxin,” stated the AIPSN.

It urged Centre, ministries and concerned departments to adhere to scientific standards for conduct and analysis of clinical trial results, publication of results as peer-reviewed articles and complete transparency.