Nine days after getting his first jab, a 45 year old volunteer died in Bhopal on December 21. He participated in Phase-3 trial for Bharat Biotech, Indian Council of Medical Research (ICMR) and National Institute of Virology's vaccine candidate- Covaxin. Deceased Deepak Marawi was a father of three. The viscera report linked his death to "cardiac respiratory failure as a result of suspected poisoning." The report has been sent to regional forensic laboratory for tests.
Bharat Biotech, in a statement said, "serious adverse reaction" had been "thoroughly investigated" and was found "not related to vaccine or placebo." Being a double blind study, Bharat Biotech said, it couldn't confirm if Marawi received the vaccine or placebo.
Bharat Biotech said the volunteer had fulfilled all the inclusion and exclusion criteria at the time of enrolment. He was reported to be healthy post seven days of dosing. Last week, Covaxin got a green signal for emergency approval by the regulatory authorities and such adverse incidents have made its use controversial.
Marawi was one of the 1750 volunteers who was declared dead at Gandhi Medical College and Hospital (Hamidia). His son Suraj brought him to the hospital and said, "his father had bouts of incessant vomiting and frothing."
According to Mint, the family members of Marawi claimed that he felt uneasy when he returned home. He experienced some health problems, "he complained of shoulder pain on December 17 and died subsequently three days later" they added. While Mint published a statement by Rachana Dhingra, a Bhopal based social-activist who claimed Marawi's consent was not taken for participation in the clinical trials nor he was given any proof of participation. However, the authorities have denied the charges.
Marawi's death has been reported to the Institutional Ethics Committee, Central Drugs Controls Standards Organizations and Data Safety Monitoring Board, said Dean of people's hospital, A.K. Dixit while speaking to The Indian Express. He added that the trials continue in the hospital because no linkage was found between the death and vaccine candidate.
India has announced Covid-19 vaccination drive from January 16 while the above incident is making people conscious about the vaccine candidates approved for emergency and restricted use.