The statement was issued following a report by Economic Times which revealed that a serious adverse event was seen in a case during the Phase I trial of its indigenous Covid vaccine.
“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,” the company said in a statement.
Unlike other companies like AstraZeneca and Johnson & Johnson which had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient, Bharat Biotech continued with the trial and the no public disclosure was made by the company.
According to sources 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 Nagpur. “The participant was hospitalised with viral pneumonitis after being administered the vaccine,” sources said.
“All treatment costs for the subject was fully paid for by the sponsor, and the subject is safe,” Bharat Biotech said.
The company is conducting Phase III clinical trials of Covaxin, in collaboration with Indian Council of Medical Research.
Bharat Biotech said that all adverse events were reported to the site ethics committee, CDSCO, data monitoring board and the sport. It said that it had submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report.
The company further said that got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.
ET had quoted a government official as saying the matter had been reported to the Drug Regulatory Authority.