AIIMS plans extensive campaign to get candidates for Covid-19 vaccine trial
There is a mammoth refusal rate for the enrollment of candidates to undergo the Phase III human clinical trials of Covaxin at AIIMS.
New Delhi: The All India Institute of Medical Sciences (AIIMS) has planned for an extensive publicity campaign to achieve the desired number of candidates it committed to the ethics committee for the Phase-III trial of Covid-19 vaccine by Bharat Biotech, currently underway in the institute, the officials informed IANS.
The trial underway for Covaxin, the Bharat Biotech vaccine, is struggling to find takers for its shots and this despite the phase-I trial showing "encouraging" results.
Sanjay Rai, the doctor who is Principal Investigator for the trial told IANS that the institute will use multiple media to raise awareness and encourage candidates for participation.
"We will advertise in newspapers seeking volunteers for the trial. Posters have already been put up. Our team will also take leads from calls and emails.
"People should come forward to participate in the trial as we will raise awareness about the importance of taking part in the clinical trial to achieve a safe and efficacious vaccine," he said.
There is a mammoth refusal rate for the enrollment of candidates to undergo the Phase-III human clinical trials of Covaxin at AIIMS.
Rai, who also heads the Department of Community Medicine at AIIMS told IANS that in the Phase-III trials, encountered around 80 per cent refusal rate on participation. Refusal rates were round 8 per cent for phase 1 and 2 trials.
"Earlier, when we had to recruit 20 volunteers, around 18 used to give consent for it. Now, for the same number of recruitment, we have to call and interview upto 150 candidates," he said.
In phase I and II, the clinical site had enrolled more than 800 candidates cumulatively while the target for phase III is around 1,500.
Rai stated that the institute is way behind the committed target.
"We had committed around 1,500 participants till December end. However, only 300 recruitments have been done so far. The recruitment of the volunteers is way behind the committed target," Rai said.
He shared that most of the candidates do not wish to turn into volunteers, and are under the impression that vaccines are coming very shortly and they think that they are going to be vaccinated anyway.
Besides, the 50 per cent probability of receiving the vaccine jabs discourages them further, Rai added.
"As it's a double-blind trial, volunteers when informed that they may also be given a placebo as it's a trial phase, refuse for participation.
"The enthusiasm which was seen in the earlier two phases is missing in the third phase.
"Many are under the assumption that a vaccine is anyway coming to India for everyone within a week or 15 days and so they don't want to become part of a trial," he said.
When asked if the adverse events reported in the media have also discouraged the candidates from undergoing the trials, he said that it could be a possibility as well.
However, he accepted that the institute needed to publicise more which it did not do for the third phase. "When the phase I trial was to begin, we needed 100 participants but received over 4,500 applications.
"Even during the phase-II trial, the hospital received around 4,000 applications. Since the response was unexpectedly high, we thought that the turnout for the candidates would be similar and did not advertise to avoid unnecessary crowding," he said.