Covaxin volunteer dies after 10 days; Bharat Biotech says death “not related” to vaccine trials

After the approval of Covaxin criticized, a 42-year-old man died after 10 days of participating in the clinical trial for the vaccine. Bharat Biotech says the death of the volunteer not related to vaccine trial.

After the approval of Covaxin criticized, a 42-year-old man died after 10 days of the participated in the clinical trial for Covaxin. Bharat Biotech says the death of the volunteer not related to vaccine trial.

Coronavirus vaccines came as a sigh of relief for many, but it turns out that there is more that people need to know. A 42-year-old man died 10 days after getting Bharat Biotech's Covaxin.

After the alleged death of the volunteer, the Hyderabad-based company clarified on Saturday that the death was unrelated to the vaccine. They further elaborated that the probable cause of death was a cardiorespiratory failure as a result of suspected poisoning.

"As per the post-mortem report issued by the Gandhi Medical College, Bhopal, that the site received from the Bhopal Police, the probable cause of death was due to cardiorespiratory failure as a result of suspected poisoning and the case is under police investigation as well," Bharat Biotech said in a statement.

According to media reports, the volunteer died on December 21, 10 days after he participated in the clinical trial for Covaxin held at a private hospital in Bhopal.

According to Bharat Biotech, the volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow up calls post seven days of his dosing and no adverse events were observed or reported.

"There are several factors that can cause an adverse event during a clinical trial, including the patient's underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal," Bharat Biotech added.

Approval Of Covaxin Criticised

On January 3, The Drugs Controller General of India (DCGI) had approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

The efficacy of Bharat Biotech's Covaxin is yet to be determined, which is why the decision of giving it a go-ahead by The Drugs Controller General of India (DCGI) was criticised globally.

Criticism of India's approval of a local COVID-19 vaccine without proof of its efficacy grew on Wednesday after news that a regulatory panel approved the shot just one day after asking the vaccine maker for more evidence it would work.

Covaxin, India's indigenous COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV). The vaccine is prepared in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility.

(with inputs from IANS)