Vaccine trial participants in Kolkata set to get CoWin certificates or real jabs – Times of India

Kolkata News

KOLKATA: Volunteers who were part of two clinical trials of Covid vaccines in the city — starting December 2020 — will finally start receiving either CoWin-generated vaccine certificates or vaccine shots, depending on whether they had received real shots or placebos during trials.
The trials on around 1,100 participants were “double-blinded”, which means they were — in accordance with global standard testing practice — kept in the dark about whether they had received actual vaccines or placebos. Later, those who received actual vaccines received certificates from the respective institutes, in the “unblinding” process. The problem was, while CoWin-generated vaccination certificates have become mandatory for several outdoor activities, the trial certificates are not.
Two weeks ago, the Union health ministry had asked the Indian Council of Medical Research (ICMR) to compile the data of unblinded participants. But even though the process — to either give out real vaccines or certificates to trial participants — has been started, several participants feel let down. In the absence of a certificate, something as simple as entering a park is impossible, let alone air travel.
“People like me rushed in to participate in the trial so that scientists could assess the efficacy and safety of vaccines,” said Saptarshi Bhose, a credit risk management professional. “I am happy I did it. But why couldn’t a system be developed for faster certification, since it has become mandatory for entering public places?”
Bhose, along with his wife Rai, had participated in the phase-III clinical trial of Covaxin at Kolkata’s NICED that began in December 2020. In the unblinding process, Saptarshi was informed that he got both doses of the real vaccine, but Rai had been given a placebo.
Soumya Sarathi Ganguly, a student of chemical and molecular biology at IIT Kharagpur, said it was frustrating because vaccination certificates are mandatory for entering public places. “I just have a certificate from the hospital, saying I participated in the clinical trial, which people would not recognise,” he told TOI. Ganguly participated in the Sputnik V trial at Peerlesss Hospital.
Senior clinical trial specialist Santanu Tripathi said he hoped a way would soon be found to expedite the process.
“We are getting a lot of anxious calls from our trial volunteers, some of whom need to travel abroad. We should recognize their gesture and ensure that they get their rightful vaccination certificate within a stipulated time,” said Peerlesss Hospital clinical research and academics director Subhrojyoti Bhowmick, who was the principal investigator for the Sputnik V trial.
The Union health ministry had earlier said that physical certificates provided by trial-conducting hospitals would suffice. The ministry will now provide a template to ICMR for compiling vaccination data for unblinded participants. This data is expected to be captured in CoWin for generating vaccination certificates.
“I am hopeful of ICMR coming out with something definite soon. By the time the clinical trial in which I am participating gets over, a system should be in place,” said Suman Das, a participant of a vaccine trial currently underway in the city.