A national network of scientists and people’s science movements are concerned over the World Health Organization not giving emergency use listing for Covaxin. It cautioned that India appeared set to repeat the mistake it committed in the Covaxin approval process in the way it was approving ZyCov-D vaccine for individuals 12 years of age and older.

The WHO has delayed the approval for Covaxin and has sought more technical details. The All India Peoples Science Network (AIPSN) called it a serious setback to the country’s plans to distribute the vaccine to other nations and to those travelling abroad, particularly students, who were administered Covaxin.

Referring to its earlier call for disclosure of Covaxin trial data, AIPSN said in a statement that India’s reputation has been seriously damaged by the inaccurate application to the WHO regulators which has tarnished the position of Indian science and regulatory systems, which will be subjected to increased international scrutiny now. It stated that Bharat Biotech applied to DCGI for EUA with inadequate data from clinical trials. More detailed results of Phase-3 trials were submitted by the company in instalments, interim results after two months and complete trial data in June 2021. It further stated that Bharat Biotech was yet to publish the results in a peer-reviewed journal. 

Zydus had applied for EUA on July 1 this year on the basis of interim data and was granted authorization on August 20. AIPSN said that this interim data has not been released in public domain or published anywhere, thus raising the same concerns as with Covaxin.

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

Source: ET Healthworld