Pharmaceutical company Bharat Biotech on Saturday said that the death of a 45-year-old volunteer in Bhopal during the clinical trials of its coronavirus vaccine was not related to the jab, reported The Hindu.
“The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing,” the company said in a statement. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”
It said that according to the autopsy reported by Bhopal’s Gandhi Medical College, the volunteer died due to cardio-respiratory failure, resulting from a suspected case of poisoning. The case is under police investigation, the statement said.
“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,” Bharat BioTech said.
The company said that the volunteer had fulfilled all the criteria to be accepted as a participant in the trial and was reported to be healthy with no adverse event noted seven days after his dosing. An adverse event is any untoward medical occurrence in patients when they are administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
In in accordance with the provisions of the New Drugs & Clinical Trials Rules, Bharat Biotech said, the serious adverse event was reported by the site team to the Institutional Ethics Committee, the Central Drugs Control Standards Organization and the Data Safety Monitoring Board.
On January 3, India had approved vaccines developed by the Serum Institute and Bharat Biotech for emergency use. Bharat Biotech has manufactured India’s first indigenous vaccine candidate Covaxin in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The Serum Institute is the local maker of Covishield, the vaccine developed by Oxford University and pharmaceuticals company AstraZeneca.
The Union Health Ministry on Saturday announced that India’s massive vaccination programme against the coronavirus will begin on January 16. Priority will be given to frontline healthcare workers, which is estimated to be around three crore people. This will be followed by those above 50 years of age, and the under-50 population groups with co-morbidities. An estimated 27 crore people fall under the second category.
Meanwhile, India on Sunday registered 18,645 new coronavirus cases, taking the overall count to 1,04,50,284. The new infections are just 0.2% higher than Saturday’s cases. India’s toll rose by 201 to 1,50,999. Its active cases stood at 2,23,335, while the number of recoveries reached 1,00,75,950.