Several health experts have raised concerns over the delay in the grant of Emergency Use Listing (EUL) for Bharat Biotech’s Covaxin by the World Health Organization and sought to know why it is getting stuck.
The Indian Council of Medical Research (ICMR), which collaborated in developing the Covid-19 vaccine, said the issue is between the WHO and Bharat Biotech.
Samiran Panda, head of epidemiology and infectious diseases at the ICMR, said though the council helped in developing the vaccine, this issue is between the WHO and the company. “It’s a healthy process of looking into the scientific and quality-related issues. We should not jump into conclusions that there has to be something wrong,” he told ET.
Giridhara Babu, a senior epidemiologist, said the remit of the technical advisory committee would be to ensure that they work with the stakeholders constructively to ensure that the procedures and documentation are of reasonable standards
“As the hopes of millions vaccinated with Covaxin are at stake here, there is great attention on the process of these meetings. I do hope that the company complies with the requirements of the TAG for faster approval,” he said.
The Technical Advisory Committee of the WHO on Tuesday sought additional data from Bharat Biotech to conduct a final EUL risk benefit assessment for global use of Covaxin.
Malini Aisola, co-convenor the All India Drugs Action Network, said the thorough review is not surprising given what she termed as “inconsistencies” in the trial data and red flags during the conduct of the clinical trials of Covaxin.
Some experts had earlier raised questions over the hasty approval granted to Covaxin in January.
Aisola said a number of issues had surfaced when the approval was given to the vaccine by the Indian regulator and those cannot be ignored.
“To name just a few issues – the number of participants claimed to have been recruited into the Phase-1 trial does not match the information provided to the SEC or mentioned in trial protocols,” she said.
Aisola said major changes were also made to the Phase-2 trial protocol for which the official rationale given was simply to “expedite the Phase-2 trial”, which included the dropping of the control arm. “In fact Phase-2 appears to have been completely redundant, even at the time of approval of the Phase-3 protocol, the Phase-2 results were not ready,” she said.
The fact that the Phase-3 data remain unpublished is also a cause of concern for some experts. Siddhartha Das, a civil society member, alleged that a “deep conflict of interest of the government co-developing this vaccine through the ICMR has played out in easing regulatory approval in India and shielding Covaxin from scientific and ethical scrutiny, as well as defending the corrupt business practices of Bharat Biotech in its global deals and partnerships for foreign sale & approval of the vaccine”.Internet Explorer Channel Network