The Lokmanya Tilak Municipal General (Sion) and Sir Jamshedji Jeejeebhoy (JJ) Hospitals are now planning to extend the deadline for the selection of volunteers in Bharat Biotech's Covaxin trial. According to ICMR guidelines, both these hospitals have to select 1,000 volunteers each by December 31, but so far, only 120 and 399 respectively have come forward at both hospitals. Doctors have attributed this to lack of awareness, confusion over the efficacy of the vaccine and transport issues.
Dr Dinesh Dhondi, coordinator, JJ hospital, said the Covaxin trial has slowed down for want of sufficient volunteers, unlike in the initial stage. “Daily we would administer the vaccine to around 30-40 screened volunteers but now, we hardly have 10 volunteers. It seems people are scared to come forward. Moreover, there is also a lack of awareness regarding the vaccine,” he said. So far, 368 of 399 volunteers have been found eligible for the vaccine trial at JJ hospital.
Dr Mohan Joshi, dean of Sion Hospital, said over 100 volunteers had taken the vaccine in the trial so far, which is expected to have 1,000 volunteers. “We have over two more months to complete the trial. However, for lack of awareness, the number of volunteers have declined,” said Dr Joshi.
However, a public hospital doctor said interest in the trials had reduced as it is a matter of time before private companies get emergency use approval for their vaccines. "People are questioning why they should participate in clinical trials when the product is likely to be available soon,'' he said.
Doctors believe that there are other reasons behind the lukewarm response to the trial. Firstly, due to restrictions on transport, many of those eager to volunteer, are failing to reach hospitals. Secondly, some reports about the adverse effects of the vaccine on volunteers is causing many to desist from participating in the trial.
In August, during the first phase of the trial, an adverse effect of the vaccine was reported. A patient was hospitalised after receiving a dose of the Covid-19 vaccine Covaxin. The issue was reported to the Central Drugs Standard Control Organisation-Drug Controller General of India (CDSCO-DCGI), within 24 hours of its occurrence. “The adverse event was investigated thoroughly and determined as not vaccine-related,” the spokesperson of Bharat Biotech said in a statement.
In the trial, of the 1,000 volunteers, almost 500 will be given a placebo. This too is proving a deterrent because many volunteers want the actual vaccine, according to doctors.
According to the ‘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 December 21, 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,” reads the report.
