|Phase III trial of Covaxin in Guwahati soon|
GUWAHATI, Sept 22 - As part of the Phase III clinical trial of India’s first COVID-19 vaccine candidate, around 2,000 people are likely to be administered doses of Covaxin in Guwahati. Official sources said though the date for commencement of human trials in Guwahati are yet to be finalized, it is likely to begin by the end of this month or early next month. “The pool in Guwahati will be around 2,000. The total pool in Phase III across India would be around 26,000,” the sources said.
The volunteers would be a “diverse group” and their details are being worked out. “The trial would take about a month’s time, or may be even more,” the sources added. Guwahati initially was picked as a centre for the Phase II trials, but later it was decided that it will be one of the centres in the Phase III trials. The coronavirus tally in Assam, where the first case was reported on March 31, stood at 1,61,393 on Tuesday, and the death toll climbed to 586. Covaxin – BBV152 coronavirus vaccine – is one of the frontrunners in the race for a COVID-19 vaccine in India. It is being developed by Bharat Biotech in collaboration with researchers from the ICMR’s National Institute of Virology.
Latest reports indicated that the vaccine candidate produced a “robust immune response” in monkeys. An ICMR study said that two doses of the vaccine were able to effectively prevent the virus from replicating in the nasal cavity, throat and lung tissues of monkeys. As part of the animal trials, the vaccine was administered in 20 rhesus macaques.
Each stage of a vaccine’s clinical trial tests its safety and ability to develop an effective immune response. While the first phase focuses on safety in healthy participants, the second phase looks at the effectiveness. The third phase looks into these aspects in a much larger population that would represent a wider demography.
In the first phase of the Covaxin trial, around 375 participants were studied across 12 sites and the results were said to be “encouraging”, but nothing is public yet on the second phase trials that had commenced in the second week of September.
Covaxin falls under the category of inactivated vaccines. In such vaccines, the pathogen is ‘deactivated’ so that it can no longer cause infection. However, parts of the virus can still be identified by the body’s immune system, which triggers an immune reaction. Hepatitis A, influenza, and polio vaccines used in India are some examples of inactivated vaccines.
Around 170 groups across the world are working on developing an effective vaccine. Only a handful among these, frontrunner candidates have reached critical phases of development and planning to roll out vaccines in the coming months.