TIRUCHY: Was informed consent obtained from all security personnel and sanitary workers who were inoculated against COVID-19 at the Tiruchy Mahatma Gandhi Memorial Government Hospital (MGMGH) on Sunday? This reporter found that pre-vaccine counselling may have been skipped and consent forms not immediately filled for at least some workers who were administered Bharat Biotech’s Covaxin vaccine at the hospital on day 2 of the vaccine drive in the State.
As Covaxin is still in Phase 3 trials, protocol mandates that recipients of the vaccine are made aware of this and consent forms are filled and signed before the vaccine is administered. On Saturday, Trichy district saw no takers for the indigenously developed shot, and so on Sunday, health secretary Dr J Radhakrishnan and office bearers of the Indian Medical Association opted for Covaxin to assuage concerns.
However, the protocol was altered on Days 1 and 2 as the CoWIN app, through which participants are to register and receive the vaccine, was malfunctioning. As a result of the glitches, it appears the counselling and consent for Covaxin recipients may have been skipped.
In the vaccination room, this reporter saw at least 10 security personnel and sanitary workers from MGMGH receive vaccines from a vial taken out of a Covaxin box. After a group of 20 people received the shots from one vial, the details of the recipients, including the 10, were entered into a register. This reporter met five of those workers in the observation room after they received the shot. All of them said they were not aware of which vaccine they had received. They said they had not been given any explanation or counselling about the shots, nor had they signed any consent form.
However, when questioned about this, the hospital’s dean claimed that every recipient was briefed in advance and consent was obtained. "We have informed everyone about the process and the vaccines. Everyone’s consent was taken and all the forms have been submitted. Due process has been followed. We will ensure that the process is smoother," said MGMGH Dean Dr K Vanitha.
Those handling the consent forms at the vaccination centre also claimed that all forms had been signed. But, sources claimed that the forms were "signed later". Asked about this, Radhakrishnan said that he would look into the matter and ensure such lapses were avoided in future.
A total of 70 people were vaccinated at MGMGH on Sunday. Forty of them received Covaxin and 30 received Serum Institute’s Covishield.