Doctors not trusting the Covid-19 vaccine trial

Doctors not trusting the Covid-19 vaccine trial slam ICMR’s earliest August 15 deadline

Covid 19 vaccination for human trials suppose to Begin

Four days after India’s first indigenous vaccine candidate for Covid-19 was Doctors not trusting the Covid-19 vaccine trial  by the drug regulator, the Indian Council of Medical Research on Thursday said that it wanted to “launch the vaccine for public health use latest by August 15”.

On July 2, the council’s director-general Balram Bhargava wrote to the 12 institutions participating in the trial to “fast-track all approvals”, adding that participants on whom the vaccine would be tested should be enrolled “no later than July 7”.ADVERTISEMENT

“Non-compliance will be viewed very seriously,” the letter warned, adding that the vaccine was “the top-most priority” of the government.

The vaccine candidate, named Covaxin, has been jointly developed by the Hyderabad-based private company Bharat Biotech and the ICMR. It was approved for human trial on June 29. In effect, the ICMR is saying it would release a vaccine for human use in less than two months of it being approved for trial – a timeline unheard of anywhere in the world.

Independent experts have criticised the letter. “I don’t think anywhere in the world has anyone ever given a date in advance for the release of a new vaccine before a clinical trial has even begun,” said Amar Jesani, editor of the Indian Journal of Medical Ethics and a public health activist. “That is not how science works.”

Vasantha Muthuswamy, chairperson of the ethics advisory committee of the ICMR’s bioethics cell, said she had not seen Bhargava’s letter, but conceded the timelines were too short. “By general experience, a month to decide whether to release a vaccine is a very short time,” she said. “Even if you fast-track it, it will take a minimum of one year.”ADVERTISEMENT

Strikingly, the expected duration of the trial, according to the government’s official clinical trial registry, is one year and three months.

Even many doctors entrusted with conducting the trial told the timelines laid down in the ICMR letter were unrealistic.

‘This is a trial on humans not animals’

For starters, seven of the 12 participating institutes are yet to receive a green-signal from independent ethics committees, a prerequisite for conducting clinical trials.

“As a principal investigator, I would not move unless I get a clearance, let it be anyone who is telling,” said Venkata Rao, in charge of the trial at the Institute of Medical Sciences and SUM Hospital in Odisha, one of the 12 chosen sites.

Rao added: “It is not that I am being adamant, but I am humbly saying that we should follow the principles. And the first and the most important principle is: do no harm.”