NEW DELHI: Hyderabad-based biotech firm Bharat Biotech has rejected reports that it did not report an adverse incident during the human trial of its COVID-19 vaccine candidate Covaxin, adding that the details related to the incident were promptly shared with the relevant authorities within a day.
In a statement on Saturday, the company 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." Bharat Biotech and Indian Council of Medical Research (ICMR) have been working on Covaxin, one of the indigenous coronavirus vaccine candidates whose human trials had started in July.
The Central Drugs Standard Control Organisation (CDSCO) had recently given its approval to Bharat Biotech to launch the phase 3 trials of COVID-19 vaccine candidate, developed from inactivated SARS CoV-2, at over 20 centres, after reviewing data from phase 1 and 2.
The late stage trial, which will involve over 23,000 participants, of the potential vaccine has kicked off at several sites beginning November 16. There have been some reports which said that there had been an adverse event during the early stage trial, in which a 35-year-old volunteer with no pre-existing conditions had developed viral pneumonitis and had to be hospitalised for a week.
Reports also said that the event was not duly reported. The company while confirming the adverse event however clarified that it was probed thoroughly, and it was found that the adverse event was not related to the vaccine.
This, said sources, was later categorised as "severe and not related to vaccine". Phase 1 and 2 trials of the vaccine had involved about 700 participants.