In its letter, the Indian Council of Medical Research (ICMR) has told the 12 hospitals selected for carrying out clinical trials of Covaxin to “ensure that the subject enrolment is initiated no later than July 7”. While only six have got approval from their ethics committees so far, some of the hospitals cautioned against the timeline set by the ICMR.
Four of the six which have got approval — Gillurkar Multispecialty Hospital (Nagpur), Jeevan Rekha Hospital (Belgaum), Prakhar Hospital (Kanpur), and Rana Hospital and Trauma Centre (Gorakhpur) — are small private hospitals that are neither research centres nor attached with any medical college.
“We applied for approval from the ethics committee four days ago. The final meeting was scheduled today. Once we get approval, we will start seeking participants through e-mail and print media. But to start enrolment from July 7 is impossible,” said Dr Sanjay Rai, from AIIMS-Delhi.
“If a person is vaccinated, the body will take 28 days to produce antibodies. Theoretically, it is possible to see if antibodies generate in participants by August 15. But practically, it is impossible to provide confirmed data by then. The approval of the ethics committee takes time, selection and enrolment criteria takes time. Making the vaccine feasible for public use will take a year or more,” said Dr Venkat Rao, epidemiologist with the Institute of Medical Sciences and SUM Hospital, Jajapur (Odisha), who was earlier involved in the hexavalent vaccine, typhoid and Japanese encephalitis trials.
He said the hospital, which has been receiving calls from several doctors willing to participate, has a ready database of subjects.
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At the SRM Hospital and Research Centre, Kancheepuram, no preparations have been made so far. The approval of the ethics committee is awaited. “This letter from ICMR came yesterday. We didn’t have any idea about the timeline or protocol. How ICMR has issued instructions at such short notice is a matter of concern,” said a doctor from the hospital.
With just four days left, some of these hospitals are now reaching out to health workers, posting messages on WhatsApp groups and making phone calls in their search for “healthy volunteers”.
Dr Chandrashekhar Gillurkar, from the Gillurkar Multispecialty Hospital in Nagpur, said he has started posting messages on his local WhatsApp groups. “We plan to start enrolment by July 7. We already have the ethics committee’s approval. I have also asked health workers on the ground to look for healthy volunteers,” he said.
The hospital is looking at a sample size of 50 subjects for Phase-I. They must be between 18-55 years, with no heart, kidney, liver or lung illness, and no uncontrolled diabetes or hypertension. “Once we shortlist participants, we will do a preliminary screening,” said Dr Gillurkar.
In Visakhapatnam, Dr R Vasudev of the government-run King George Hospital, said he had received at least 20 phone calls, 10 of them from doctors, indicating willingness to join the trial. He said he was yet to approach the ethics committee for approval. “Enrolment and selection will take 3-4 days. But we cannot say whether a vaccine is effective or not within one month,” he said.
Dr Dhananjay Lad, Managing Director, CROM Clinical Research Private Ltd & Medical Tourism, that is monitoring the trial with Redkar Hospital and Research Centre, Goa, said hospital employees will be given first preference. The hospital is looking at a sample size of 150 participants for Phase I and II. “We will also use pamphlets and WhatsApp messages,” he said.
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Dr Prabhakar Reddy, from Nizam’s Institute of Medical Sciences, Hyderabad, also said he has been getting calls from people wanting to be a part of the trial. The hospital is yet to get approval from the ethics committee. “At a time of pandemic, the process can be fast-tracked. We are holding a meeting tomorrow to discuss the further course of action. We will rope in 30-40 participants,” he said.
Dr Chandrakant Singh, from AIIMS-Patna, said the ethics committee is scheduled to meet to take a final call. “This is an emergency situation and we can’t lose people. I am going to put advertisements in newspapers, and will also post on WhatsApp group to reach out to the general population,” he said.
Dr Amit Bhate, from Jeevan Rekha Hospital, Belgaum, said he was looking at a sample size of 200 subjects for Phase I and II. “Since ICMR has asked us to deliver results, we will try our best to comply. We are yet to start enrolment but publicity about the vaccine will help in getting consent,” he said. Jeevan Rekha is not a research centre, but has done trials on typhoid earlier, he said.
“Whether we can provide preliminary data by August 15 depends on the regulatory clearances. After the ethics committee approves, we will wait for the Clinical Trial Registry to issue a letter. We are yet to get the vaccine. The enrolment will start only after that,” said Dr Savita Verma, from PGIMS, Rohtak.
She said it was possible to generate some data on 100 or more subjects by August 15. “If immunoglobulins increase four-fold, the vaccine is considered a success and we move to the next phase,” Verma said.
Dr Jeetendra Kushwaha, consultant physician with Prakhar Hospital in Kanpur, was part of an Ayurveda trial to use herbal oil to prevent mosquito bites to control malaria in 2018. The hospital set up its ethics committee in 2018.
The Rana Hospital and Trauma Centre in Gorakhpur specialises in IVF services. It has not participated in any vaccine trial so far. Its ethics committee was set up in January this year.
Raising concern over some of the hospitals selected for the trials, public health expert Anant Bhan said, “Do these institutions have the wherewithal to carry out such trials? Infrastructure and expertise is required. How many hospitals have the experience to do it?”
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