Covaxin trial volunteer dies after taking dose!
Galatta | Jan 10, 2021, 07:47 pm
Countries the world over have begun vaccinating their people, after emergency use approvals were given for vaccines manufactured by companies like Pfizer-BioNTech, Moderna and a couple of others. When the whole of India were waiting with bated breath to know when the vaccination drive against COVID-19 would begin in our country, the government recently announced that it would begin on January 16th! Reports stated that the Indian government had given emergency use authorisation for and would be using the two indigenously developed vaccines - Covishield, developed by Serum Institute of India & Covaxin, developed by Bharat Biotech International Ltd. However, a shocking development has happened now!
Reports state that a volunteer who participated in the clinical trials for Covaxin, has passed away. This incident has occurred in Bhopal, where a volunteer passed away on December 21st, 2020, about 9 days after receiving a dose of either the vaccine or the placebo. A government hospital which conducted the post-mortem on the volunteer's body has issued a report, stating that the person's death could not have been due to any medicinal dosage and that he died due to cardio respiratory failure. Poisoning is being suspected in this case. The report reads, "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 7 days of his dosing and no AE’s were observed or reported. 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."
It has still not even been determined if the volunteer had been administered the vaccine or a placebo shot during the Phase 3 trials, as the trial followed a double-blind method. However, Bharat Biotech has followed all rules mandated by the provisions of the New Drugs & Clinical Trials Rules (NDCTR) in this case. The company has also stated that the vaccine nor placebo has had no part to play in the volunteer's death. The respective authorities have also investigated these claims and confirmed the same. The Covaxin vaccine will go ahead as one of the vaccines to be used by the Indian government in the vaccination drive beginning on January 16th. Government sources state that about 3 Crore people including the frontline workers and healthcare workers would be vaccinated in the first phase of the Indian vaccinate drive.