Call for transparency in Covaxin clinical trials

The World Health Organization’s (WHO) refusal to grant Emergency Use Listing (EUL) for ICMR-Bharat Biotech’s Covaxin vaccine is a setback for the country’s vaccination programme.

Indians travelling abroad with Covaxin shots are also finding it difficult to obtain visas or entry into other countries which generally recognise only WHO-approved vaccines.

While the WHO has asked the company for more details, it is felt that the lack of transparency and public accountability has led to such a situation.

All India People’s Science Network (AIPSN) representatives say the government’s failure to be transparent about the vaccine’s scientific rigour is also hardening vaccine hesitancy in India. AIPSN member in Madurai S. Krishnaswamy said failure of disclosing the clinical trials data during the earlier approval stage and now with its flawed application to WHO regulators, the government had damaged the country’s reputation.

“It besmirches the standing of Indian science and regulatory systems. They will now come under heightened international scrutiny,” he said, adding “this was entirely foreseeable and yet no remedial steps were taken.” Prof. Krishnaswamy said Covaxin, among the first few COVID-19 vaccines developed, would have boosted India’s prestige if it had obtained approvals in India and abroad following the proper channel.

In January, Bharat Biotech had applied to the Indian regulator with grossly inadequate data from clinical trials inviting rejection.

Despite criticism from scientists and others in India, Bharat Biotech has failed to publish the results in peer-reviewed journals. Instead, it got away with the backing of the Centre and recently even announced that the WHO approval was expected soon.

Those who criticised and called for greater transparency were attacked by the government as anti-nationals, he pointed out.

The AIPSN was now apprehensive of India repeating the same blunder in the approval process of Zydus Cadilla’s ZyCov-D 3-dose, the vaccine for those aged 12 and above.

It was one of the 11 DNA-based vaccine candidates worldwide.

“The regulatory agencies should assert their independence from both government and corporate interests, and make judgments based on scientific analysis,” read a statement from the AIPSN.

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