Bharat Biotech's Covaxin reported 'adverse reaction' during Phase 1 trials
New Delhi, Nov 21: Covaxin, a potential COVID-19 vaccine being developed by Bharat Biotech, currently under phase-3 trials. reported a serious adverse event during the Phase I clinical trials in August. But the trials were not halted.
Clarifying on the deveopment, Bharat Biotech said, "The adverse event during phase I clinical trials in August 2020 was reported to the CDSCO-DCGI, within 24 hours of its occurrence and confirmation."
As per 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.
However, in a similar incident, AstraZeneca and Johnson & Johnson had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient each after being administered vaccines.
Bharat Biotech International Ltd plans to enrol about 2,000 participants each in metros - Delhi, Mumbai, Hyderabad and Kolkata for phase 3 trials of its coronavirus vaccine Covaxin that began earlier this week.
Covaxin is being developed byBharatBiotech, in collaboration with the ICMR - National Institute of Virology (NIV).
The city-based vaccine-maker had, on October 2, sought the Drug Controller General of India's (DCGI) permission to conduct phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine.
The India-made COVID-19 vaccine could be launched as early as February - months earlier than expected - as last-stage trials begin this month.If launched on time, COVAXIN would be the first India-made vaccine to be rolled out.