A participant in the early stages of Bharat Biotech’s trial for Covaxin had developed an adverse reaction reportedly leading to hospitalisation. However, the issue was “investigated thoroughly” and was found not to be related to the Covid-19 vaccine, the company said on Saturday.
The adverse event, reportedly a case of the participant developing viral pneumonitis, was found in the first phase of the trials and the company claims it followed the proper protocols of reporting the issue. “The adverse event during phase 1 clinical trials during August 2020, was reported to the CDSCO-DCGI (Central Drugs Standard Control Organisation-Drug Controller General of India), within 24 hours of its occurrence and confirmation…As per the guidelines, all adverse events were reported to the site ethics committee, CDSCO-DCGI, Data Safety Monitoring Board (DSMB) and Sponsor,” Bharat Biotech’s spokesperson told The Sunday Express in emailed responses about the issue.
“The adverse event was investigated thoroughly and determined as not vaccine related,” the spokesperson added.
Bharat Biotech did not respond to queries about whether it had halted the trials while it investigated the issue. Queries sent to DCGI Dr VG Somani and Indian Council of Medical Research Director General Dr Balram Bhargava about this issue also remained unanswered by press time on Saturday.
In the last three months, companies like AstraZeneca and Johnson & Johnson have announced that they were temporarily halting recruitment and vaccination in late-stage trials of their vaccine candidates while they examined unanticipated serious adverse events. The companies resumed trials after it was confirmed the issue was not caused by their vaccine. Other investigators who conducted first phase of the Covaxin trial at different sites were not apprised of the issue, The Sunday Express has learnt.
“All such issues are required to be reported to the DSMB and, accordingly, the DSMB has to take a decision. It is not necessary that everything should be reported to every site,” said one of the principal investigators in the phase 1 trial of Covaxin. Another principal investigator told The Sunday Express the adverse event seems to have occurred after most participants for the phase 1 trial had been recruited, considering it was reported in August. Recruitment and vaccinations in first phase of this trial began in mid-July and the second shot for these was administered by the end of the month, after DSMB approved safety data collected from first 50 participants.x
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