Adverse reaction in Covaxin participant ‘investigated’, unrelated to vaccine, says company


Through: ENS Economic Office | New Delhi |

Nov. 22, 2020, 12:49 a.m.

COVAXIN has been evaluated in approximately 1000 subjects in phase I and phase II clinical trials, with promising data on safety and immunogenicity.

A participant in the early stages of Bharat Biotech’s trial to Covaxin had developed an adverse reaction leading to hospitalization. However, the issue has been “thoroughly investigated” and was not found to be vaccine-related, the company said on Saturday.

The adverse event, believed to be a case of the participant developing viral lung disease, was detected in the first phase of the trials and the company says it followed the appropriate protocols to report the problem. “The adverse event during phase 1 clinical trials in August 2020 was reported to CDSCO-DCGI (Central Drugs Standard Control Organization-Drug Controller General of India), within 24 hours of onset and confirmation… In accordance with guidelines, all events have been reported to the site’s ethics committee, CDSCO-DCGI, Data Security Oversight Board (DSMB) and sponsor, ”Bharat Biotech spokesperson told Sunday Express in email replies to this.

“The adverse event has been fully investigated and determined to be unrelated to the vaccine,” the spokesperson added.

Bharat Biotech did not respond to questions about whether it had halted the trials while it investigated the matter. Questions to DCGI Dr VG Somani and the Director General of the Indian Council of Medical Research Dr Balram Bhargava about the matter also went unanswered on Saturday at press time.

Over the past three months, companies like AstraZeneca and Johnson & Johnson have announced that they are temporarily halting recruitment and vaccination in late-stage trials of their candidate vaccines as they review serious unforeseen adverse events. The companies resumed trials after confirming that the problem was not caused by their vaccine. Other investigators who conducted the first phase of the Covaxin trial at various sites were not made aware of the problem, The Sunday Express has learned.

“All of these issues need to be reported to the DSMB and therefore the DSMB needs to make a decision. It doesn’t have to be all reported at every site, ”said one of the lead investigators in the Phase 1 trial of Covaxin. Another lead researcher told The Sunday Express that the adverse event appears to have occurred after most participants were recruited into the Phase 1 trial, given that it was reported in August. Recruitment and vaccinations in the first phase of this trial began in mid-July and the second vaccine for the latter was given at the end of the month, after the DSMB approved safety data collected from the first 50 participants.

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