Covid vaccine clinical trial participants must approach trial sites for certificates

Clinical trial participants of Covishield and Covaxin vaccine who volunteered to take the jab before anyone else did, and before the Co-WIN portal came into existence, need final vaccination certificates that are QR-coded to prove their vaccination status.

While 2,250 Covaxin clinical trial participants at Jeevan Rekha Hospital, Belagavi, and hundreds at Vydehi Hospital have been given hospital certificates that they were participants of the phase 3 Covaxin trials, now they have to approach government vaccination centres to register on Co-WIN and get final QR-coded vaccination certificates.

This will enable them to prove their vaccination status at workplaces.

Placebo recipients have also been contacted by the trial sites to get vaccinated. Child participants who were a part of Zydus Cadilla's ZyCoV-D vaccine trial however will have to wait till the trial is unblinded to get vaccination certificates.

There are over 2,000 people in Karnataka who participated in various Covid vaccine clinical trials including paediatric vaccine trials where 20 children were enrolled. ZyCoV-D got emergency use authorisation in India for use in individuals above the age of 12 on Friday.

Dr Amit Bhate, director, Jeevan Rekha Hospital, told DH, "While we did not provide hospital-level vaccination certificates for all, whoever reached out to us and demanded it were given one. They can go to a government CVC, who will register them on Co-WIN and get final QR-coded certificates.

"While 1,125 trial participants were given the placebo during the trial, another 1,125 participants were given the Covaxin vaccine. Contacting all placebo recipients and vaccinating them has been completed too."

"As far as the paediatric trials of ZyCoV-D goes, it depends on when the company decides to unblind the trial as the trial is still ongoing and the observation period will end in February 2022," he added.

A clinical research expert at Clintrac International Pvt Ltd, the clinical research institute that did the Covaxin vaccine trial at Vydehi Hospital said, the trial is considered ongoing as the participants' safety will be monitored for one year.

"We still need long term safety data from the participants. They have trial participant IDs plus their data has been sent to the Indian Council of Medical Research to be uploaded on Co-WIN so that they can download the QR coded vaccination certificate. Our trial participants were even able to go to the US and UK with just these IDs.

"Even I have travelled abroad with this ID (the expert was Vydehi's advisor and was jabbed as a part of the trial). Only some universities needed students to quarantine themselves upon arrival for a certain period or take a WHO-approved vaccine upon arrival if they were previously jabbed with Covaxin in India," he said.

B Suresh, Pro Chancellor, JSS Academy of Higher Education and Research, Mysuru, where 250 participated in Covishield's clinical trial, said, "The details of participants of Covishield were sent to the government to upload on the Cowin portal and they will shortly get their certificates. The placebo group have also been vaccinated with Covishield in March itself if they wanted to get vaccinated."