Ninedays after getting his first jab, a 45 year old volunteer died in Bhopal onDecember 21. He participated in Phase-3 trial for Bharat Biotech, IndianCouncil of Medical Research (ICMR) and National Institute of Virology's vaccinecandidate- Covaxin. Deceased Deepak Marawi was a father of three. The viscerareport linked his death to "cardiac respiratory failure as a result ofsuspected poisoning." The report has been sent to regional forensiclaboratory for tests.
BharatBiotech, in a statement said, "serious adverse reaction" had been"thoroughly investigated" and was found "not related to vaccineor placebo." Being a double blind study, Bharat Biotech said, it couldn'tconfirm if Marawi received the vaccine or placebo.
BharatBiotech said the volunteer had fulfilled all the inclusion and exclusion criteriaat the time of enrolment. He was reported to be healthy post seven days ofdosing. Last week, Covaxin got a green signal for emergency approval by theregulatory authorities and such adverse incidents have made its usecontroversial.
Marawiwas one of the 1750 volunteers who was declared dead at Gandhi Medical Collegeand Hospital (Hamidia). His son Suraj brought him to the hospital and said,"his father had bouts of incessant vomiting and frothing."
Accordingto Mint, the family members of Marawi claimed that he felt uneasy when hereturned home. He experienced some health problems, "he complained ofshoulder pain on December 17 and died subsequently three days later" theyadded. While Mint published a statement by Rachana Dhingra, a Bhopal based social-activistwho claimed Marawi's consent was not taken for participation in the clinicaltrials nor he was given any proof of participation. However, the authoritieshave denied the charges.
Marawi'sdeath has been reported to the Institutional Ethics Committee, Central DrugsControls Standards Organizations and Data Safety Monitoring Board, said Dean ofpeople's hospital, A.K. Dixit while speaking to The Indian Express. He addedthat the trials continue in the hospital because no linkage was found betweenthe death and vaccine candidate.
Indiahas announced Covid-19 vaccination drive from January 16 while the aboveincident is making people conscious about the vaccine candidates approved foremergency and restricted use.