While 12 hospitals chosen to conduct clinical trials of Bharat Biotech’s Covaxin prepare to enrol participants this month, samples of the vaccine are still undergoing quality and safety tests at a government facility, The Indian Express has learnt.
The tests, which began last Friday, are expected to be completed by the end of next week and cannot be rushed as they are expected to ensure the vaccines are safe to use in humans, said senior officials.
Meanwhile, at least three of the hospitals – AIIMS in Delhi, SRM Hospital and Research Centre in Kancheepuram and King George Hospital in Vishakhapatnam — are learnt to still be awaiting ethics committee approvals to begin enrolling participants for the study. Other hospitals are awaiting site initiation visits and clearances to ensure their facilities are ready to conduct these trials.
Depending on the hospital, enrollment of participants is expected to begin between this week and the next, but the testing can only start once they receive stock of the vaccine. This will happen once Bharat Biotech receives a clearance from the Central Drugs Laboratory in Kasauli to use its vaccines in the trials.
“We have several volunteers. But paperwork on the government’s end is pending. The sponsor (Bharat Biotech) has not yet sent vaccines,” said Dr Savita Verma from PGIMS, Rohtak, one of the 12 sites.
PGIMS has started the process of short-listing volunteers for trial. Once the site initiation letter (to initiate trial) is received, they will begin collecting blood and urine samples of each prospective participant and send it to a central laboratory to assess whether the candidate is eligible for trial.
The delivery of the vaccine will depend on biosafety and bio sterility tests conducted at CDL Kasauli, said a senior government official. For this specific vaccine, the tests to check whether it is safe to inject in participants will take 14 days as per Indian and international protocols.
“Such tests cannot be sped up. They (the tests) are checking for the safety of the vaccine,” said the official. “This is necessary to make sure that no harm is caused to the patients during the trials.”
Following a clearance certificate, it may take a few days to ship the vaccines from Bharat Biotech’s facility to all trial sites. Investigators and officials expect the first phase of the study to begin in two week as a result.
One of the hospitals seeking ethics committee approvals told The Indian Express that the process for these approvals was taking time as the committee was being thorough to ensure no harm to the participants. “This is a stringent process, but it has to be this way. This is a trial on humans,” said the investigator.
The Clinical Trials Registry of India on Monday showed that the date of first enrollment for the vaccine is now set at July 13, while the phase I and II trials are estimated to take one year and three months. According to the protocol on the registry, the first phase alone will at least take a month, after which interim data will have to be submitted to the Drug Controller General of India before proceeding to the next stage.
Some investigators have said they are not under pressure to rush the trials for the sake of a faster launch date. Last week, the Indian Council of Medical Research (ICMR) had faced flak from the scientific community for seeking completion of “all” trials by August 15, adding that it was envisaged to launch the vaccine for public health use no later than that date. However, ICMR had later clarified that it was only seeking to fast-track clearances and cut red-tapism.
“I believe by the middle of the third week of this month, we will be able to start. Everything is going as per our expectations,” said Dr Sanjay Rai of AIIMS in Delhi. “You cannot do phase I and II together. Phase I is the safety trial. First, you have to establish the safety of the vaccine among the human population. We will move as per our protocol, based on the ethics committee’s approval.”
“On Tuesday our advertisement will come in regional newspapers to look for volunteers. But even if we speed up the process, it is not possible to produce results on safety by August 15,” said Dr Chandramani Singh, from AIIMS Patna.
Dr Amit Bhate from Jeevan Rekha hospital in Belgaum, that has been part of other trials for Bharat Biotech, said they would recruit around 50 participants in phase I. “Our job is to enroll, test and give data. But we cannot hurry into it. We cannot work under pressure. Humans are involved in this trial. The results can get delayed if patients don’t show up on assigned date or data collection is slow,” Bhate said.
In Redkar Hospital and Research centre, Goa, Dr Dhananjay Lad also said that enrolment can only begin after a few days. “Each participant has to be tested for Covid-19. We will be able to start enrollment by next week, not before.”
“Initially, we will be putting up 375 patients for phase I (across all sites)… The (results of the) initial 50 across the country will be subjected to a DSMB review–Data Safety and Monitoring Board. They will review and tell us whether it is okay to go ahead. If there are no issues, then we will continue the recruitment,” said Dr E Venkata Rao, who is the principal investigator from Bhubhaneshwar’s Institute of Medical Sciences & SUM Hospital.
In Prakhar hospital, an official said they have started reaching out to social workers to look for eligible candidates. “But unless vaccines come, we cannot proceed,” the official said.
Dr Satyajit Mohapatra from SRM Hospital and Research Centre in Kancheepuram said they are yet to get approval from the ethics committee to start the trial. “It’s a process and it will take time. Once approvals come, we will start the process of shortlisting and screening candidates.”
Dr Prabhakar Reddy from Nizam’s Institute of Medical Sciences said they are fast-tracking the whole process to help the government achieve early results. “Either today or tomorrow ethics committee approval should come. We are trying our best to speed up everything.”
“Whoever does whatever in the race, we should make sure that we always have things of quality in compliance with guidelines and regulations. That is going to be because patient safety is of paramount importance. There is a need for speed, no doubt. But our quality and scrutiny for science should be (upheld) in what we do,” said Dr Chirag Trivedi, president, Indian Society of Clinical Research.
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