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New Delhi: Bharat Biotech, the Hyderabad-based company that has developed the Covaxin vaccine candidate for the indigenous Covid vaccine, still has thousands of volunteers short of its target for its ongoing phase 3 trials.
The test sites conducting the vaccine study say the company has given them an indicative December 31 deadline to complete volunteer recruitment, but some say they are unlikely to be able to do so.
On December 22, Bharat Biotech Announced had recruited 13,000 volunteers, just over half of the total 25,800 volunteers needed, since the study began on November 11. Speaking to ThePrint on Thursday, a company representative said another two thousand have been recruited in the days since. However, they denied that Bharat Biotech requested that the recruitment of volunteers be completed by a certain date.
Bharat Biotech is one of three companies seeking to obtain an emergency use authorization in India, where no vaccine has been approved for use so far.
The phase 2 vaccine trial has he found to be safe with no serious adverse effects, according to a non-peer-reviewed study published earlier this week, but it must undergo comprehensive phase 3 trials before it can be approved for use in the public.
The basic difference between Phase 2 and Phase 3 trials, both with human subjects, is that the latter requires a much larger group of participants to get a clearer and more accurate picture of the efficacy and safety of the vaccine.
Read also: 8 Covid vaccines that seem more likely to get us out of the pandemic, and what is their situation
‘As soon as possible’
As of Thursday, Covaxin, a joint initiative between Bharat Biotech and the Indian Council for Medical Research, was being studied at 26 test sites across the country.
Speaking to ThePrint, lead investigators at various sites said the company had verbally conveyed to them in a virtual meeting that they should aim to complete volunteer recruitment by December 31, though not at the cost of proper procedure.
Bharat Biotech meets with the principal investigators of the test sites practically at least once a week to keep abreast of the situation on the ground and to provide support to the test sites.
“In a virtual meeting, we were asked to complete the volunteer recruitment before the 31st, as soon as possible. Test sites that had completed their initial goal received more volunteers to recruit. Most of the sites have finished with 1,000 volunteers, ”said Dr. Dhananjay Lad, Goa-based managing director of CROM clinical research, who is assisting two test sites with recruitment.
The vaccine follows a two-dose schedule, administered 28 days apart. By the 31st, the researchers said, Bharat Biotech hopes that all volunteers will receive at least the first chance. The researchers said it is not a strict deadline, but described it as ambitious.
“They initially gave us a goal of 1,000, which we completed in the first week of December. They asked us to do it for 500 more volunteers, but we refused because it was too much for us, ”added Dr. Mohammed Shameem, principal investigator at the Muslim University of Aligarh. a test site.
“We have started with the second dose of the vaccine. Managing documentation and follow-up would have become a challenge if we hired more volunteers, ”he said.
A principal investigator at a site in southern India said recruiting more volunteers will take time.
“The sponsor is a sponsor, so they want to finish the test as soon as possible, but safety comes first. We have already finished with 1,000 volunteers on our site and have been asked to recruit 500 more, but it will take time, ”added the researcher, who did not want to be identified.
“We may not be able to meet the deadline. People are coming, but it is happening slowly. We cannot accelerate at the cost of safety, so we will end the recruitment with all precautions, “said the researcher.
Another researcher from an eastern state said “we are all doing everything we can to get the hiring process done soon.”
“They told us the sooner it is done the better, and we were not asked to compromise anything. There is no hesitation in vaccines, but we will have to spread the word faster and people will have to volunteer faster if we want to finish on the 31st, “added the researcher.
Dr. NT Awad, Principal Investigator of LOkmanya Tilak Municipal Medical College and General Hospital, Mumbai, said: “We joined the trial late and it will be a challenge for us to complete (the recruitment) before the 31st because the volunteers are not showing up in large numbers. They made a request to complete the recruitment soon, but it will be difficult for us. “
Seeking authorization for emergency use
On December 7, Bharat Biotech applied for the emergency use authorization of Covaxin through a request to the Modi government’s Matter Expert Committee, which advises India’s general drug regulator on approvals of new drugs and vaccines. . However, it was recommended to return with data from the ongoing phase 3 trial.
According to the trial design, available from the Indian Clinical Trials Registry, the trial will conclude after a total of 130 participants become positive for Covid-19, and safety will be monitored for a further 12 months.
A formal first and second intermediate analysis will be carried out when one third and two thirds of the participants are PCR positive.
The purpose of this analysis is to compare the number of positive cases in the vaccine arm with the placebo arm, to determine the efficacy of the vaccine.
An internal analysis of the immunogenicity of the vaccine will be carried out on day 56 of the trial or early January 2021. This analysis will be carried out on a subset of 600 participants, 450 of whom will be from the vaccine group and 150 from the placebo group. . arm.
“The immunogenicity study will evaluate the immune response of a 2-dose regimen of the BBV152B vaccine through geometric mean titers (GMT) by neutralizing the specific anti-IgG binding titer of RBD, protein S and RBD in a subset of 600 (450 vaccines: 150 controls) participants, in three consecutive manufacturing batches, ”says a brief summary of the test design.
“Data generated up to day 56 (month 2) will not only be blinded to biostatistics for the assessment of immune responses in the immunogenicity subset,” adds the abstract.
Read also: ‘How do we get there?’ – Bharat Biotech prepares for the arduous task of launching the Covid vaccine
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