500 more from Nagpur to get Covaxin trial shots

NAGPUR: Looking at the overwhelming response to the phase III trial of Covaxin, a Made-in-India vaccine for Covid-19, its manufacturer Bharat Biotech Ltd has increased volunteer enrolment by 500 for the city. Instead of earlier 1,000 volunteers, now a total of 1,500 from city will get Covaxin shots.
The trial site is Dr Rahate’s hospital where more than 550 slots for volunteers are still vacant, as per trial coordinator Dr Ashish Tajane.
“We are administering Covaxin to nearly 50 volunteers per day. Our target was to complete 1,000 volunteers by December 31. But due to overwhelming response in Nagpur, we are going to complete the same by December 21. Now, the company has allotted 500 more volunteer slots to us,” said Dr Tajane.
The competition to get emergency use authorization has intensified in the last two weeks. Bharat Biotech is targeting Phase III trials on 25,800 participants across the country.
According to doctors, medical tests for Phase III trials are not as tough for those of first two phases. “In phase I trial, it was mandatory for participants to be completely healthy. So, they underwent many tests. In Phase II, age limit was extended and senior citizens as well as adolescents were added into the trials, but health parameters were same.
“In phase III, people with comorbid conditions, and elderly people are also allowed. So, health related tests are less,” said Dr Tajane.
Only RT-PCR and antibody tests are conducted on people interested to becoming volunteers. As soon as both results come negative, they are called for administering vaccine.
Those who got placebo to get vaccine for free
Phase III trial of Covaxin is randomized, double-blind, placebo-controlled multicentre study. Placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine In these trials, participants are randomized to receive either the vaccine under investigation or a placebo (i.e. an inert substance, such as a saline injection).
In Nagpur, nearly 50% participants who have volunteered for Phase III trial will receive placebo which means they will not get real vaccine. So, the company, Bharat Biotech, has decided to administer them the original vaccine for free once it gets emergency use approval.
For this, a record is maintained for participants who have received placebo during the trial. “Such participants will be called later and vaccinated for free because they had volunteered for our trials,” said Dr Tajane.