Bharat Biotech had 'adverse event' during Covaxin phase 1 trial in August: Report

During the Phase I trial of India's Bharat Biotech Covid-19 vaccine in August, a volunteer was hospitalised after taking a dose of the vaccine candidate, according to multiple reports.

A 35-year-old participant with no comorbidities, who was part of Phase 1 trials in August was hospitalised with viral pneumonitis after taking the vaccine, The Times of India reported quoting investigators monitoring the study of the vaccine candidate.

"The company also tweaked its trial protocol for Phase II, with the dosing regimen modified from 14 days to 28 days, and the number of participants nearly halved to 380 from earlier 750," the report added.

According to a report by Mint, the company said in a statement that 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."

DH couldn't independently verify the reports.

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The private pharmaceutical company based in the southern city of Hyderabad is developing Covaxin that could be licensed by the second quarter of 2021.

The indigenous vaccine, which is being developed by Bharat Biotech and ICMR, has received the approval of the Central Drugs Standard Control Organisation (CDSCO) for initiating the third phase trial.

“All treatment costs for the subject was fully paid for by the sponsor, and the subject is safe… submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report,” the company said.

Bharat Biotech is currently recruiting 26,000 volunteers in India for the trials and the results are expected between March and April.

In October, two high-profile, late-stage clinical trials — Johnson & Johnson’s test of a coronavirus vaccine and Eli Lilly’s study of a Covid-19 drug — were put on pause because of possible safety concerns. And a month earlier, AstraZeneca’s vaccine trial was paused after two volunteers became seriously ill.

(With agency inputs)