COVID-19 Vaccine | Bharat Biotech's Covaxin reported adverse event during Phase 1 trials, trials not halted

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Covaxin, a potential COVID-19 vaccine being developed by Bharat Biotech, reported a serious adverse event during the Phase I clinical trials in August.

However, neither the company nor the regulator, Central Drugs Standard Control Organisation (CDSCO) and its head Drug Controller General of India V.G. Somani, disclosed the matter to the public.

The incident came to light on November 21, when it was reported by The Times of India and The Economic Times.

Later, Bharat Biotech Chairman and Managing Director Dr Krishna Ella also confirmed that the adverse event took place and was duly reported to the 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, the adverse event occurred in a 35-year-old participant with no co-morbidities, who was part of Phase 1 trials at a site in western India. The participant was hospitalised with viral pneumonitis, a couple of days after being administered the vaccine. He was discharged after a week’s stay in the hospital.

Side-effects or adverse effects are largely common in such large studies. However, previously when such incidents occurred, trials were halted. This was the case with the trials undertaken by AstraZeneca and Johnson & Johnson, which only resumed trials after a thorough investigations.

The Hyderabad-based company, 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 trails.

It entered the third phase of clinical trials on November 16.

The company 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.