Updated: July 18, 2020 7:58:01 am
Bharat Biotech and Zydus Cadila kicked off human trials for their Covid-19 vaccines this week, with some of their centres vaccinating the first set of persons in what is expected to be a closely watched race for immunisation against the contagious virus. Both firms inoculated their first set of persons on July 15.
Since then, the All India Institute of Medical Sciences in Patna, testing Bharat Biotech’s Covaxin, has injected nine participants with the inactivated vaccine. PGIMS Rohtak on Friday became the second of the 12 sites testing the safety and effectiveness of the vaccine to begin phase I of the clinical trials by vaccinating three participants.
Both sites aim to vaccinate 18-20 participants in the first round, 7-14 days after which a Data Safety Monitoring Board review is expected to take place.
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“Accordingly, we will decide how many more people to recruit and how many to vaccinate… only if the safety (of the vaccine) is established,” said Dr C M Singh, the principal investigator from AIIMS Patna. However, given the current situation of the lockdown in Bihar, it is unclear when the site will be able to meet its target for the first round, he said.
“There is a delay because of the lockdown. Those who stay far away are facing a problem in coming (to the site),” he told The Indian Express. Around 200 people have expressed interest in enrolling for the trials at this site, according to him.
PGIMS Rohtak expects to complete vaccination of its target group in the next three days, by when it is expected to receive test results of 14 additional participants that will ensure they are fit to be vaccinated as part of the trial. “As soon as their results come, they can be vaccinated,” Dr Savita Verma, the principal investigator for the site, told The Indian Express.
“We have already had 70 registrations who have volunteered for the study and I hope, after today, we will receive more people,” she said. So far, the site has received 10 doses of the vaccine from Bharat Biotech, and will get 10 more by Saturday.
A statement from Bharat Biotech on Friday said that this is a randomised, double blind placebo controlled clinical trial in 375 volunteers in the country. “Eventually we plan to enrol 1125 for both phase I and II. The human clinical trials commenced at AIIMS Patna,” the statement added.
It is unclear how many participants Zydus has vaccinated as part of the adaptive phase I/II trial of its plasmid DNA vaccine, ZyCov-D. A query about this to the company on Friday night was unanswered. The firm is targeting a sample size of 1,048 participants in the trials, according to the Clinical Trials Registry of India. The trials will be conducted at one site and are expected to take a year to complete, according to CTRI.
Of the remaining 10 sites involved in the Covaxin trial, some like AIIMS Delhi are still awaiting ethics committee approval, without which the site cannot advertise for recruiting participants. Others, like Nizam’s Institute of Medical Sciences, have received approvals and will begin vaccination next week. Tamil Nadu’s SRM Hospital & Research Centre has started choosing volunteers while Odisha’s Institute of Medical Sciences and SUM Hospital have chosen participants.
According to CTRI, the Covaxin phase I and II trials are expected to take one year and three months.
— With inputs from ENS Pune, New Delhi and Chandigarh
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