India / 'Why is everyone suspicious in this country?': Bharat Biotech MD on Covaxin

Hyderabad: "Which other vaccine has as much data as us?" asks Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech who has been under fire over the rollout of his Covid-19 vaccine, Covaxin. The vaccine, based on the inactivated virus platform is one of two that have been approved for use by Indian authorities and 55 lakh doses have been procured for use in the first phase of India's vaccination drive.

Phase three trials are underway with 25,800 volunteers but results are not out yet. Many have questioned why the vaccine's rollout has been allowed without this data. Dr Krishna Ella cites successful trials in monkeys and hamsters as well as robust Phase 1 and Phase 2 trials with humans as proof of safety. "Monkeys have given predictive vaccine data. After vaccinating monkeys we give the live virus after 30 days," explains Dr Ella.

The other controversy dogging Bharat Biotech is the death of a volunteer participating in clinical trials in Bhopal. "Nothing points out that the death was a vaccine-related incident," says Suchitra Ella who claims that the FIR states cause of death as a heart attack. She explains that since this is a randomized double-blinded study, they have no information about whether the volunteer was given the vaccine or the placebo.

To questions over volunteers in Bhopal not knowing that they were participating in clinical trials, the Ellas say all protocols have been followed by the third-party company hired to carry out the trials. "Why is everyone suspicious in this country?" he asks.