Uproar after India's Covid-19 vaccine is approved before clinical trials end

BANGALORE – India’s indigenously produced Covid-19 vaccine is at the centre of a controversy after it was licensed with clinical trials for effectiveness still incomplete.

Covaxin was granted emergency approval on Sunday (Jan 3) by the Indian drug regulator. Also getting the nod was AstraZeneca-Oxford University’s Covishield, to be made in India by Serum Institute, the world’s largest vaccine producer by volume.

The decision to approve Covaxin, developed and manufactured by Hyderabad-based Bharat Biotech, triggered a row. The Indian health minister said it was granted permission for “restricted use in emergency situations” in the “larger public interest”.

The Indian drug regulator said Covaxin’s inactivated virus formulation would be effective protection against mutant strains.

Health experts, however, said there was no data in the public domain to support any such claims.

Covaxin has completed only two of three required phases of clinical trials. The first two ensured that the drug is safe. The third one that tests for efficacy began only in late November.

Dr Gagandeep Kang, vice-chair of the board of Coalition for Epidemic Preparedness Innovations, a global partnership seeking to develop vaccines, said she had seen nothing like this approval before.

“This is hypothetical at best,” she told CNBC-TV18.

On Sunday, Serum Institute chief executive Adar Poonawalla told Indian channel NDTV: “There are only three vaccines with proven efficacy – Pfizer, Moderna and Oxford/AstraZeneca. Everything else has been proven to be safe, just like water.”

Serum Institute’s Covishield has completed all three trial phases.

The Indian government approved it based on AstraZeneca’s interim data from the British trial, which showed 70.42 per cent efficacy, although there were doubts about dosages given.

In a virtual press meeting on Monday, Bharat Biotech chairman Krishna Ella slammed critics. “We are a global company operating in 12 countries, including the US and UK, and have a proven track record of 16 vaccines,” including for the Zika virus, typhoid, chikungunya and rotavirus, he added.

“Why are Indian companies and scientists bashed? If other companies can get approvals based on just 100 people’s data, why not me?” He was referring to Covishield’s data submitted to the Indian regulator.

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Asked if Covaxin’s approval was premature, he quoted the health ministry’s clinical trial rules that allow accelerated authorisation for vaccines based on “remarkable efficacy” shown in phase two trials.

He said Covaxin was licensed based on its efficacy in trials involving animals, proven “platform technology” (the manufacturing mechanism) and robust immune responses to multiple viral proteins in the 375 and 380 people who got two doses in the first two phases.

In the past month, many sites conducting the Covaxin trials admitted to delays due to shortages of volunteers. Bangalore’s Vydehi Institute of Medical Sciences and Research Centre aimed to administer the first dose to 1,000 people but only about 500 turned up.

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In Bhopal, activist Rachna Dhingra alleged about 700 people were administered the first dose of Covaxin without informed consent.

They are from poor neighbourhoods adjacent to People’s Hospital, which is running the trial, and many said they were told they were getting the vaccine, not the trial vaccine.

The investigator at the Bhopal hospital refused to answer questions, and Bharat Biotech’s media adviser said the company was not aware of the developments.

Experts fear hasty approvals, incomplete trials and a lack of transparency could discourage people from getting vaccinated. A scientist in Bangalore admitted: “I for one will skip vaccination.”

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