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

A body of national scientists and science movements have warned that India is repeating the same mistakes in approving Zydus Cadilla’s ZyCov-D three-dose vaccine for children 12 years and older, which it did with ICMR-Bharat Biotech’s Covaxin.

They also expressed concern over the World Health Organisation not granting emergency use clearance for Covaxin, and delaying it by seeking more details. All India Peoples Science Network (AIPSN) believes this to be a “serious setback to India’s plans to distribute the vaccine to other countries and to those travelling abroad who took Covaxin”.

"All India Peoples Science Network (AIPSN) notes with sorrow and grave concern that the World Health Organization (WHO) has not granted Emergency Use Listing (EUL) for ICMR-Bharat Biotech’s (BB) Covaxin vaccine, but has asked BB for more technical details. This is a serious setback for Covaxin and for India’s vaccination programme in the country, and a blow to India’s plans to distribute vaccines to other countries," the scientists' organisation said in a statement released on Wednesday.

AIPSN further said that there was a need to disclose the data from Covaxin’s trial in a peer-reviewed journal after posting the results in a pre-publication paper, as India’s reputation is at stake in front of 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”. AIPSN has urged the government to be transparent and adhere to the standards of the trials. The AIPSN sought “public accountability, transparency and scientific rigour” in the process of granting approvals for emergency use authorisation

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.