Bharat Biotech's much-awaited COVID-19 vaccine Covaxin reported a serious adverse event during the Phase 1 clinical trials in August. Bharat Biotech Chairman and Managing Director Dr Krishna Ella reportedly confirmed that the adverse event took place and was duly reported to the drug regulator Central Drugs Standard Control Organisation (CDSCO).
"The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. The adverse event was investigated thoroughly and determined as not vaccine related," LiveMint quoted the company as saying in a statement.
According to the Times of India report, a 35-year-old participant with no co-morbidities was affected by the adverse event during the Phase 1 trials at a site in western India.
The participant was admitted to a hospital with viral pneumonitis, few days after being given the vaccine.
He was discharged after a week from the hospital.
During such large scale trials, side-effects or adverse effects are very common.
However, when such incidents occurred earlier with trials undertaken by AstraZeneca and Johnson & Johnson, they were halted. Only after thorough investigations, the Covid vaccine trials were restarted.
Hyderabad-based Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR), has developed Covaxin, a wholly inactivated novel coronavirus vaccine, which is undergoing three-stage clinical trials.
The vaccine entered the third phase of clinical trials on November 16.
Bharat Biotech said it submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report, and got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed, LiveMint reported.