NEW DELHI: An Indian pharmaceutical company whose coronavirus vaccine has been approved for restricted use has brushed off accusations of irregularities in its clinical trials by participants alleging lack of informed consent.
The vaccine, Covaxin, developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), was approved last week by the Drug Controller General of India for emergency use, despite concerns among health experts that its late-stage trials have not been completed.
The treatment is currently at the center of a controversy in Bhopal, in the central Indian state of Madhya Pradesh, with volunteers who took part in its trials saying they did not know they were participating in clinical research — an accusation the producer denies.
“Each and every volunteer who is part of the trial is informed about the details very clearly in a regional language, the language the person understands, and on top of that an informed person’s form is filled out and taken care of,” Dr. Rajni Kant, spokesman for the ICMR, which is India’s apex body for biomedical research, told Arab News.
However, those who received Covaxin shots at a People’s College of Medical Sciences and Research hospital in Bhopal, complain that they were unaware it was a trial.
“I was told that it’s a vaccine for coronavirus,” said Jitendra Narwariya, 37, a laborer from Bhopal’s Shankar Nagar who was vaccinated on Dec. 10.
He heard an announcement from a vehicle in his neighborhood offering participants 750 rupees ($11), substantially more than his wage, which does not exceed 600 rupees a day.
“I boarded the vehicle and went to the hospital where I came to know about Covaxin,” he told Arab News. “I was told that the vaccine is for protecting us from the deadly virus — that’s why I decided to come to the hospital.”
Narwariya is not alone. More than 600 people from the city’s poorer areas were enrolled for the trial.
“I was promised a vaccine for coronavirus. I was not aware that they were using a vaccine on me as a trial,” said Man Singh, 60, a daily wage worker, who was inoculated on Dec. 21.
Both men fell ill a few days after vaccination. In Narwariya’s case, the hospital carrying out Covaxin trials initially refused free treatment, but later accepted him after local activists intervened.
“Around 600 to 700 people from the poor neighborhoods went for testing. Not all of them are having trouble,” Bhopal-based social activist Rachana Dhingra said.
“The issue is that none of those we met received their informed consent form,” she said. “You are supposed to take audio-video consent of people who are illiterate. Lots of these people are vulnerable.”
According to the country’s 2018 New Drugs and Clinical Trials Rules, a freely given, informed, written consent must be obtained from each study subject. Hospitals are required to maintain an audio-video recording of consent being given if the person cannot write.
Rajesh Kapoor, vice-chancellor of the People’s College of Medical Sciences and Research, rejects all the accusations.
“There is no question of violations of any rule. We followed all the procedures for all the 1,702 people who took part in the trial. Everybody’s consent was taken,” he told Arab News.
Kant, the ICMR spokesman, said that it should be obvious that the vaccination was a trial.
“We all know that there is no vaccine available right now so only trials are happening. If people don’t know it, then it is their ignorance,” he said, while adding that “informed consent is a must.”
Bharat Biotech, the company producing Covaxin in collaboration with ICMR, declined to comment.
According to Dr. Anand Rai from Indore in Madhya Pradesh, the coronavirus vaccine race is encouraging companies to compromise the rules.
“Vaccine manufacturers who are in a rush to launch their product and earn money are violating all the norms of trial,” he said.
Mumbai-based health expert Dr. Amar Jesani flagged several problems related to the Covaxin trial, including the financial incentive for participants, which he said violate ICMR’s own guidelines.
“Not taking consent properly, being insensitive in terms of money, not providing a copy of the informed consent along with the participant information sheet to the participants — these are all violations of the Indian Council of Medical Research guidelines,” he told Arab News.