Bharat Biotech’s Covaxin is still not cleared by WHO


A national network of scientists and people’s science movements has expressed concern over the World Health Organization 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 said it was a serious setback to India’s plans to distribute the vaccine to other countries and to those travelling abroad who took Covaxin.

According to the WHO, submissions to WHO for prequalification or listing under the emergency use procedure are confidential.

If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.

Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

Only 1 in 11 gets Covaxin as Bharat Biotech falls short of production targets.

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 the government which resulted in the grant of EUA. More detailed results of Phase-3 clinical trials were then released by BB in installments, 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 results in a peer-reviewed journal after posting just a pre-publication paper.

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