Bharat Biotech had adverse event during Covaxin phase one trial in August

 Bharat Biotech International Ltd had an adverse event during the phase 1 trial in August, when a patient was hospitalised after receiving a dose of the covid-19 vaccine Covaxin. But the matter was not made public by either the company or the regulator, Central Drugs Standard Control Organisation and its head Drug Controller General of India V.G. Somani.

“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," the company said in a statement.

Unlike Bharat Biotech, AstraZeneca and Johnson & Johnson had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient each after they received their respective vaccines.

Bharat Biotech’s issue came to light on Saturday when The Times of India and The Economic Times reported the story.

As per The Times of India report, 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.

“All treatment costs for the subject was fully paid for by the sponsor, and the subject is safe," Bharat Biotech said.

Bharat Biotech is conducting three-stage clinical trials of Covaxin, a wholly-inactivated novel coronavirus vaccine, in collaboration with apex bio-research agency the Indian Council of Medical Research.

Bharat Biotech said it submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report.

The company says it got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.

Bharat Biotech earlier this week started its third and final stage of the clinical trial at Nizam’s Institute of Medical Sciences in Hyderabad. The company plans to enrol up to 26,000 participants in the massive phase 3 trial, the largest efficacy trial ever in India, expected to cost the company about ₹150 crore.

Mint is awaiting reply to queries sent to the company and Somani, especially about making its detailed phase 3 protocol public and reporting adverse events in the final stage study.(Leroy Leo)


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