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New Delhi: Bharat Biotech, a Hyderabad-based company that developed the Covaxin indigenous Covid candidate vaccine, still has thousands of volunteers short of its target for its ongoing Phase 3 tests.
Test sites conducting the vaccine study say the company has given them an indicative deadline of December 31 to complete the recruitment of volunteers, but some say they are unlikely to be able to do so.
On December 22, Bharat Biotech announced it has recruited 13,000 volunteers – just over half of the total 25,800 volunteers needed – since the study was launched on 11 November. Speaking to ThePrint on Thursday, a company representative said another two thousand were recruited in the following days. They, however, denied that Bharat Biotech asked that the recruitment of volunteers be completed by a specific date.
Bharat Biotech is one of three companies seeking to obtain emergency use authorization in India, where no vaccine has been approved for use so far.
The vaccine phase 2 trial have found to be safe, without serious adverse events, according to an unrevised peer study released earlier this week, it needs to pass extensive Phase 3 tests before being released for public use.
The basic difference between Phase 2 and 3 trials – both involving humans – is that the latter requires a much larger group of participants to obtain a clearer and more accurate picture of the vaccine’s effectiveness and safety.
Read too: 8 Covid vaccines that seem most likely to get us out of the pandemic – and where they are
‘As soon as possible’
On Thursday, Covaxin, a joint initiative between Bharat Biotech and the Indian Medical Research Council, was being studied at 26 test sites across the country.
Speaking to ThePrint, chief investigators from several locations said the company verbally communicated to them at a virtual meeting that they should aim to complete recruiting volunteers by December 31, although not at the expense of proper procedures.
Bharat Biotech meets with leading test site investigators virtually at least once a week to be informed of the situation on the ground, as well as to provide support to the test sites.
“In a virtual meeting, we were invited to complete the recruitment of volunteers by the 31st – as soon as possible. Test sites that completed their initial target received more volunteers to recruit. Most places ended up with 1,000 volunteers, ”said Dr. Dhananjay Lad, administrative director of Goa-based CROM clinical research, who is helping two trial sites with recruitment.
The vaccine follows a schedule of two doses, administered 28 days apart. On the 31st, investigators said, Bharat Biotech expects all volunteers to receive at least the first injection. The investigators said it was not a difficult time, but described it as ambitious.
“We initially received a target of 1,000, which we completed in the first week of December. They asked us to do this for another 500 volunteers, but we refused because it was too much for us, ”added Dr. Mohammed Shameem, principal investigator at Aligarh Muslim University, a test site.
“We started with the second dose of the vaccine. Managing the documentation and monitoring 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 race as soon as possible, but safety comes first. We have already closed with 1,000 volunteers on our website and it was requested to recruit another 500, but it will take time, ”added the researcher, who declined to be identified.
“We may not be able to meet the deadline. People are arriving, but it is happening slowly. We cannot accelerate at the expense of security, so we will end the recruitment with all precautions ”, said the investigator.
Another researcher from an eastern state said that “everyone is trying our best to complete the recruitment process soon”.
“We were told that the sooner it is done, the better, and we have not been asked to commit anything. There is no hesitation in the vaccine, but we will have to spread the word faster and people will have to volunteer faster if we want to finish by the 31st, ”added the researcher.
Dr. NT Awad, one of the principal investigators at LOkmanya Tilak Municipal Medical College and General Hospital, Mumbai, said: “We entered the study late and it will be a challenge for us to complete (recruitment) by the 31st because the volunteers are not coming in large numbers. They made a request to complete the recruitment soon, but it will be difficult for us. “
Seeking emergency use authorization
On December 7, Bharat Biotech sought authorization for emergency use of Covaxin through a request to the Modi government’s Committee of Experts on Matters, which advises India’s General Medicines Controller regulator on approvals of new drugs and vaccines. However, it was advised to return with data from the ongoing Phase 3 study.
According to the study design, available from the Indian Clinical Trials Registry, the trial will be completed after a total of 130 participants have made Covid-19 positive, with safety to be monitored for another 12 months.
A first and a second formal intermediate analysis will occur when one third and two thirds of the participants become PCR-positive.
The purpose of this analysis is to compare the number of positive cases in the vaccine arm with the placebo arm, to verify the vaccine’s effectiveness.
An internal analysis of the vaccine’s immunogenicity will take place on the 56th day of the trial, or in early January 2021. This analysis will be carried out on a subset of 600 participants, 450 of which will be from the vaccine arm and 150 from the placebo arm.
“The immunogenicity study will evaluate the immune response of a 2-dose regimen of the BBV152B vaccine by means of geometric mean titers (GMTs) by neutralizing antibodies, protein S and RBD-specific anti-IgG binding titer in a subset of 600 (vaccine 450: 150 control participants), in three consecutive manufacturing batches ”, says a brief summary of the test project.
“The data generated up to the 56th (month 2) will be revealed only for the biostatistics to evaluate the immunological responses in the subset of immunogenicity”, adds the summary.
Read too: ‘How did we get there?’ – Bharat Biotech prepares for the difficult task of implementing the Covid vaccine
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