The eradication of any disease requires a proper medical development, trial, and a full-fledged vaccine drive. Clinical trials have always played a major role in medical science. The Covid 19 pandemic is the only headline these days, but we seldom get to know about those unsung heroes who volunteer for the risky jobs, offering themselves for vaccine trials.
In December 2020, when Rishav Mukherjee a member of Microbiology society of India and also a student of M.Sc. at St. Xaviers got to know about the Sputnik V trials that would take place at Peerless hospitals, the only place in the eastern region of India, under the guidance of Dr Shubrajyoti Bhowmick, he decided to become a volunteer.
Speaking to News Sense the 21-year-old says, “I feel such initiatives are very important and people should come forward and volunteer instead of worrying.” The active participation of many such daring souls is required to make the vaccine available for the public at large. The trial for Sputnik V happened in the ratio of 3:1 wherein three people got the vaccine and 1 got placebo. Around 1500 people over 20 sites participated.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, intervention. Often a clinical trial is used to learn if a new treatment is more effective or has less harmful side effects than the standard treatment.
Once the drive was finalized and the vaccine arrived, everyone interested were rigorously screened. A lot of tests were done including RT-PCR to be sure that they did not have covid at that point of time and are physiologically healthy. An Interim analysis was done after 42 days since the trial happened and the follow up will continue for 6 months-till July end. The Interim Analysis Data which was submitted to the Government helped them prove that sputnik V is working and hence this vaccine has now been approved.
An approximate of 20 people participated for the trail in Peerless Hospital, Kolkata and were asked to maintain an electronic diary after being administered the vaccine thus enabling the clinical trial specialists’ team to monitor and track the volunteers’ symptoms and conditions. After 21 days of being administered the first shot each volunteer got a second shot.
Dr Shubrajyoti Bhowmick, Clinical trial specialist and clinical Pharmacologist and Director, Clinical Research Peerless Hospital, Kolkata says “All volunteers are doing well after getting the vaccine, overall, it has been a safe vaccination drive and no adverse effects have been reported.” He further adds “Clinical trials have made it possible for various medical treatments become reality. With the rise in new projects, the response for participation in such projects is also overwhelming.”
Dr Reddy’s lab is already in the process of starting the vaccination drive and Sputnik V is expected to arrive by 2nd or 3rd week of June in Kolkata.
