JJ hospital has begun administering the second dose of Bharat Biotech’s Covaxin from this week as part of Phase III trials.
Until Tuesday, 27 people had received the second dose of the inactivated Covid-19 vaccine. Hospital authorities said they have to counsel people to return for the second dose with many excusing themselves, citing lack of time to travel to the hospital.
Bharat Biotech has developed the inactivated vaccine in collaboration with the Indian Council of Medical Research (ICMR).
Mumbai’s Sion and JJ hospitals are part of the 25 sites across India selected to immunise over 26,000 participants in the Phase III trials. Both hospitals have administered the first dose to 555 people so far.
Principal investigators in both hospitals said “very few” adverse effects — in around 2 to 3 per cent of those immunised — have been witnessed. Most adverse effects were witnessed within 24 hours and are limited to fever and pain at the place where the vaccine was administered.
But even so, “vaccine hesitancy” has kept many at bay from participating in the trial. Each hospital requires 1,000 participants to conduct a trial.
JJ hospital has vaccinated 404 people and Sion hospital 151 so far. Each day, both hospitals vaccinate about 15 to 20 people.
On Tuesday, of the 16 people vaccinated in JJ hospital, nine had come for a second dose after 28 days.
“We are using help of healthcare workers to raise awareness. About 30 to 40 per cent of the participants are women and 5 per cent aged above 50 years,” said Dr Dinesh Dhodi, coinvestigator in the trial at JJ hospital.
While most clinical trials are excluding senior citizens or those with comorbidity, this trial has no age limit and is admitting people with hypertension and diabetes that are under control.
“When a participant signs a consent form, we test them for hypertension, diabetes and blood pressure. Those with controlled comorbidity are immunised,” Dhodi said.
He added that senior citizens coming for the trial demand that they be administered the vaccine and not placebo (fake treatment). “At least eight people aged above 50 have requested this. We have to counsel them that it is a random double blind trial and we have no control over who will get placebo and who will get the vaccine,” Dhodi said.
An 84-year-old man had approached JJ hospital with request to be administered the vaccine. Eventually, he dropped out after he was counselled there was a 50 per cent chance that he would receive placebo.
Dr N T Awad, principle investigator in Sion hospital, said that due to poor response, they have started roping in healthcare workers for vaccination. “Our doctors are also participating in the trial. People still hesitate to participate in a trial because of stories in the media on adverse effects noted abroad,” he added.
Additional Municipal Commissioner Suresh Kakani admitted that the trial is proceeding at a slow pace in Mumbai. “We are getting few inquiries every day. The problem is that many people have already been exposed to the virus and may not fit the criteria,” he said.
JJ and Sion hospitals allow people to walk in to inquire about the trial from 9.30 am to 4 pm. Each participant will be monitored for a year. After two doses 28 days apart, some sites will test for antibody and others will conduct RT-PCR test every month to look for antibody titers and active infection, respectively.
In JJ hospital, those part of the trial said their main challenge remains convincing participants to return for the second dose.
“Dropping out after first dose is common,” a doctor said.
Bharat Biotech got Drugs Controller General of India (DCGI) approval for Phase I and II human trials, which commenced in July. Based on Phase I and II results, the pharma company applied for emergency use authorisation with DCGI earlier this month.