Two Uttar Pradesh hospitals set to begin human trials of India’s Covid-19 vaccine, Covaxin
Two private hospitals in Uttar Pradesh will soon begin human trials of Covaxin, the Covid-19 vaccine developed by Bharat Biotech International Limited.
The two hospitals—Prakhar Hospital in Kanpur and Rana Hospital and Trauma Centre in Gorakhpur—are among the 12 institutes across the country where the human trial of the vaccine candidate will be conducted.
However, none of the two hospitals is affiliated to a medical college and is not a dedicated Covid-19 hospital.
Prakhar Hospital in Kanpur is looking at a sample size of 50 people in the first phase and another 150 in the second phase of the human trial. The Rana Hospital, meanwhile, is awaiting a safety certificate before the trials can begin.
“We are getting a number of calls from healthy people every day who want to volunteer for the clinical trial of Covaxin,” said Dr JS Kushwaha, owner of Prakhar Hospital.
“The hospital has a database of volunteers in place with a team of eight specialists, headed by a doctor, who has joined the hospital from All India Institute of Medical Sciences (AIIMS),” he said.
The hospital has received a letter from the Indian Council of Medical Research (ICMR) and is waiting for statutory permission from the Drug Controller General of India (DCGI).
“It is expected to come by next week. Then, we can move ahead in line with the ICMR protocols,” Dr JS Kushwaha said.
In the past, the hospital has conducted successful clinical trials for the rotavirus vaccine.
Bharat Biotech did not comment on the matter. A senior ICMR official, in the know of things, said the size of a hospital doesn’t matter when it comes to conducting clinical trials.
“There are a lot of other factors such as ethics committee approvals, infrastructure to support the type of trial, subject recruitment, qualified principal investigator etc. It’s better to have a mix of sites that is decided mutually by trial sponsors,” said the official, who did not wish to be named.
ICMR issues permits for conducting the trials to government facilities (67%) and the private sector (33%).
The primary task of the hospital would be to vaccinate and keenly observe the side-effects, if any, and send samples to an National Institute of Virology (NIV) or ICMR-sanctioned laboratory after 28 days—the period in which the antibodies are developed, said Dr Kushwaha.
After the recruitment of volunteers, the hospital would first send their samples for RT-PCR and antibody tests in Delhi. On the basis of the reports, the vaccine would be given to the subjects.
Their samples would be tested again to ascertain the increase in antibodies. The process would be repeated after another 14 days.
“The antibodies take 28 days to develop. All the data will be analysed at the level of ICMR and NIV. We have no capability here in Kanpur to evaluate that kind of data,” Dr Kushwaha said.
The hospital would monitor the subjects after they are given the vaccine.
“There is no problem in 99% of cases and if someone shows adverse symptoms, these would be treated and corrected by a team of specialists,” he said.
For the Rana Hospital, it will be the third vaccine trial in a span of one year.
“We completed two vaccine trials for typhoid and Japanese Encephalitis (JE) with a sample size of 100 volunteers in January. The third will be the Covid vaccine,” Venkatesh Chaturvedi, chief administrative officer of Rana Hospital, said.
Established in 2001, Rana Hospital is known for obstetrical and gynaecological services. The human trial at this hospital will be held under the supervision of physician Dr Ajit Pratap Singh and Dr Sona Ghosh.
Dr Ghosh, a senior consultant gynaecologist and one of the key members in the vaccine trial at the Rana hospital said the hospital was selected by Bharat Biotech when the trials for Covid-19 vaccine were announced.
“In eastern Uttar Pradesh, we are the only medical centre with the experience of conducting two vaccine trials,” Dr Ghosh added.
Chaturvedi said that delivery of the vaccine for the trials is awaited. “Also the sample size has to be decided by the company along with final guidelines for the trial method,” he said.
He said a list of volunteers was ready with the hospital and more volunteers were contacting the hospital.
“Random sampling will be done to check their health status and then a final list of volunteers will be made. Our prior experience will help us in the Covid vaccine trials,” he said.
Chaturvedi said the hospital would move ahead with the trials as soon as the guidelines and vaccines arrive.
ICMR director general Dr Balram Bhargava had said in a letter that the plan was to launch the vaccine for public health use latest by August 15, after completion of all clinical trials.
The hospitals had also been directed to enrol healthy people for the trial of the vaccine earlier this July.
Covaxin, India’s first potential indigenous Covid-19 vaccine, has been jointly developed by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL).
Hyderabad-based Bharat Biotech is among the seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials to test the vaccine for efficacy and safety.
Zydus Cadila has also got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for ZyCov-D, its indigenously developed vaccine candidates against Sars-Cov-2, which causes Covid-19.