Adverse event kept a secret, vaccine volunteers feel betrayed

NEW DELHI: Several participants in Serum Institute’s Covid

vaccine

trial who were given the second shot of the vaccine well after the

serious adverse event

reported by a

trial participant

in Chennai feel betrayed that they were not told about the Chennai incident.


Trial participants that TOI spoke to confirmed that none of them had been informed about the adverse event that occurred in Chennai. All of them had participated in the trial out of a sense of doing something useful and good for the larger society.

Meanwhile, in a press briefing on Tuesday, the Union health secretary said he could not go comment on the specific adverse event because the participant had filed a case in court and he did not want to comment on a court matter. However, the trial participant’s lawyer said only a legal notice has been sent and two weeks have been given for all parties to respond. “No case has been filed yet. And the company has not even sent a legal notice, only talked about filing a suit in the media,” said his advocate R Rajaram.

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“I got my first shot on October 8 and the second shot on November 6. The participant in Chennai reported sick on October 11. Why didn’t they tell us about it? This case came out only because the participant threatened to file a suit. Who knows how many such cases have actually happened that we don’t even know about,” asked Anil Hebbar, adding that he would have taken the second dose anyway but feels it was the duty of those involved to inform all the participants. Hebbar said he felt compelled to speak out on behalf of other trial participants and the millions who would be getting the vaccine.



Another participant said she was told by her doctor on Tuesday who called up because she is due for a physical check-up after taking the second shot on November 6.

“She claimed that she did not know anything about it till now and said I did not have to worry because the adverse event reported from Chennai was not because of the vaccine. They should have told us. At this moment, I am not completely trusting them,” said the participant, adding that she was trying not to think too much about it.

Yet another participant said the principal investigator at the trial site claimed that all PIs in the vaccine trial were informed of the adverse event. “But the person decided not to tell the participants, which I don’t think is right,” said the trial volunteer. “They are saying they didn’t tell me because they thought I might get scared. Now my doctor is saying the serious adverse event was not caused by the vaccine. But what if it was causally linked? Should she not have waited to find that out before giving all of us the second dose?” asked Hebbar. He added that he has lost friends to Covid-19 and has seen his 85-year-old mother, a cancer survivor, live in fear of being infected, which impelled him to volunteer.

“I participated hoping that could help bring out a vaccine faster. But I am shocked by the company threatening to sue a participant like me,” said Hebbar.