Not enough volunteers for Covaxin trial: Mumbai hospitals

According to ICMR, 2,000 volunteers have to be a part of the trial. However, only 128 volunteers have come forward at Sion hospital, while JJ Hospital has had 368 volunteers for the trial so far
Many opt out after filling consent forms, say doctors at JJ.(HT FILE)
Many opt out after filling consent forms, say doctors at JJ.(HT FILE)
Updated on Dec 26, 2020 12:54 AM IST
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ByRupsa Chakraborty

City’s civic hospitals are not getting enough volunteers to conduct the clinical trial of the first indigenous vaccine, Covaxin, owing to lack of awareness and scepticism about Covid-19 vaccines. Doctors fear this may further delay the compulsory completion of the clinical trial process.

In the last week of October, the Indian Council of Medical Research (ICMR) selected two hospitals – the Lokmanya Tilak General Hospital (Sion hospital) and Sir JJ Hospital in Parel for the pan-Indian clinical trial of Covaxin, manufactured by Hyderabad-based Bharat Biotech. According to ICMR, 2,000 volunteers in the age group of 18-60 have to be a part of the trial. By December 31, the hospitals were supposed to complete the selection process. However, only 128 volunteers have come forward at Sion hospital, while JJ Hospital has had 368 volunteers for the trial so far.

“We aren’t getting enough volunteers to take part in the trial. Earlier, we were getting 30-35 volunteers for the trial. But now, it has gone down to 10-12 volunteers. Many of them opt out of the trial after filling up the consent forms,” said Dr Dinesh Dhodi, department of pharmacology and in-charge of the trial at JJ Hospital.

Doctors believe that the lukewarm response from volunteers could be attributed to several reasons. Many who wish to volunteer are unable to reach the hospitals owing to restrictions on travel. Secondly, following a few reports about the adverse effects of the vaccine on volunteers, many are hesitating to participate in the trial.

During the first phase of the trial in August, a volunteer was hospitalised after receiving a dose of Covaxin. The issue was reported to the Central Drugs Standard Control Organisation-Drug Controller General of India (CDSCO-DCGI) within 24 hours. “The adverse event was probed thoroughly and determined as ‘not vaccine related’,” said the spokesperson, Bharat Biotech.

On September 6, AstraZeneca, which is developing the vaccine Covishield along with the University of Oxford, temporarily had to halt the phase-3 trials around the globe after a participant reportedly developed severe adverse reactions in the United Kingdom. Later, the company resumed clinical trials of its vaccine candidate after confirmation from the regulatory authorities that it was safe to do so.

“We started the trial on December 5 when the response was higher. But gradually, the response has declined. There is not much awareness among people about vaccine. So, not many are coming forward,” said Dr Mohan Joshi, dean of Sion hospital. “We cannot force volunteers to take part in it if they don’t want to,” he said.

In the trial, out of the 1,000 volunteers, around 500 will be given a placebo (a replica of the actual vaccine which does not contain an active drug). However, this has discouraged many volunteers from taking part in the trial as they do not wish to get themselves administered with the placebo, doctors said.

“We haven’t received any deadline about the completion process of the trial yet. But if we don’t get proper response from citizens, we might have to write to the ICMR seeking additional time for the trial,” said a senior official from the civic body.

Doctors have urged citizens to trust the efficiency of the vaccine. “Experts with several years of experience in medicine have developed this vaccine. People should come forward to help in developing it,” said Dr Joshi.

According to a study report — Safety and immunogenicity clinical trial of an inactivated SARS-CoV-2 vaccine, BBV152 (a phase 2, double-blind, randomised controlled trial) and the persistence of immune responses from a phase 1 follow-up report — published by Biotech on Monday, the vaccine was well-tolerated with no serious adverse events in its Phase-2 trials.

“In the Phase-2 trial, BBV152 led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses,” read the report.

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Tuesday, November 30, 2021