Experts ‘shocked’ as India gives ‘rushed’ approval for indigenous Covid-19 vaccine

Health experts have slammed the government of India’s decision to give the green light to an indigenous Covid-19 vaccine, Covaxin, which hasn’t even released stage-three trial data.

On Sunday, Delhi gave its approval to the AstraZeneca jab which had already been approved in the UK, as well as to a lesser-known vaccine, produced by Indian company Bharat Biotech.

The decision to approve Bharat Biotech’s Covaxin jab has been widely condemned by India’s medical community as “rushed.”

Health watchdog All India Drug Action Network said it was "shocked,” adding that there were “intense concerns arising from the absence of the efficacy data.” 

The All India Drug Action Network stated that it was “baffled to understand what scientific logic has motivated” the relevant oversight committee to approve “an incompletely studied vaccine.”

The medical group asserted that the lack of transparency and hasty approval “raises more questions than answers and likely will not reinforce faith in our scientific decision-making bodies.”

Dr Gagandeep Kang, one of India's most distinguished medical experts, told the Times of India that she had "not seen anything like this before", and pointed out: “There is absolutely no efficacy data that has been presented or published.” 

Meanwhile, Indian MP Shashi Tharoor was among those who posted on Twitter to share their reservations.

“The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” he wrote. 

India's Drugs Controller General, VG Somani, said that Covaxin was “safe and provides a robust immune response.”  

Dr Debkishore Gupta, Consultant Clinical Microbiologist and Head of Infection Control at CK Birla Hospitals, also expressed concern at the approval of the AstraZeneca vaccine, suggesting its efficacy is “lower than any other vaccine that has been approved in many countries.”

“This is the average efficacy between the normal group which received two full doses (62 percent) and half-dose and full dose (90 percent). India approved a full-dose regimen. Based on the full-dose regimen for both shots that got approved, AZ had shown 62-percent efficacy based on their own paper submitted to The Lancet magazine,” he explained.

Other experts have warned against comparing trial data. Prof Eleanor Riley, Professor of Immunology and Infectious Disease at the University of Edinburgh, previously noted that AstraZeneca, in contrast to other trials, had administered weekly swab tests from trial participants to look for asymptomatic infections.

India produces around 60 percent of the world’s total vaccine output and is likely to play a major role in the manufacturing of many Covid-19 vaccines.

According to reports, the Serum Institute of India - the world’s largest producer of vaccines - already has 50 million doses of the AstraZeneca jab in vials. 

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