Lead investigator of the study and Public Health Director Dr TS Selvavinayagam said the enrolment of volunteers would continue, as the trial is likely to continue after obtaining permission from DCGI. “We cannot rule out side effects at this point of time, as the study aims at finding if it is safe or not. This is not uncommon in a vaccine trial; the trial has only been paused, not stopped,” he said.
Though the illness of one participant could be a specific case, the move to enlist volunteers has raised questions.
Dr Jatin Ahuja, infectious diseases expert at All India Institute of Medical Science said it was not ethical to continue enrolment as investigation into the cause of illness in the participant is still on. “If SII has paused it, there is no point in continuing the enrolment of volunteers,” he said.
The human trial of the randomised study is conducted to determine the safety and immunogenicity of the vaccine in healthy Indian adults. Experts say that the data from the trial need to be analysed carefully.
Senior virologist Dr T Jacob John said that if necessary, the United Kingdom’s Data Safety Management Committee (DSMC) can find out whether the affected volunteer was given a placebo or the vaccine. Each country is undertaking its own trial based on the needs of its people, he said, adding that the reported complication could be a natural illness with no connection to the trial.