Adverse Event in Phase I Trials Not Vaccine-Related: Covaxin Maker
“The adverse event was investigated thoroughly, and presented to the CDSCO-DCGI,” Bharat Biotech said.
Hyderabad-based biotechnology company Bharat Biotech, which is holding human trials of India's first indigenous coronavirus vaccine, Covaxin, issued a statement confirming that an ‘adverse event’ had taken place during Phase I of the clinical trials and that it was reported to the Drugs Comptroller General of India (DCGI) within 24 hours.
The Economic Times had reported that a volunteer, who had been administered the shot in July, had fallen ill and had to be hospitalised in August 2020. However, the trials were not halted at the time. Responding to the media report, Bharat Biotech stated that the event was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation.
“The adverse event was investigated thoroughly, and presented to the CDSCO-DCGI, prior to obtaining permission for Phase II and Phase III clinical trials. The adverse event was investigated thoroughly and determined as not vaccine-related,” Bharat Biotech said in the statement.
The statement by the Hyderabad company added that as per the guidelines, all adverse events were reported to the site ethics committee, CDSCO-DCGI, Data safety monitoring board and sponsor and that the Sponsor submitted all documentation within the timeline, and as mandated by the ethics committees and CDSCO-DCGI, including a complete causality report.
“All treatment costs for the subject was fully paid for by the sponsor, and that the subject is safe,” the company said in the statement, adding that it follows all safety guidelines as mandated.
On 16 November, Bharat Biotech commenced Phase III trials of Covaxin. The Phase III trials will involve 26,000 volunteers across India, the company said, adding that it is the largest clinical trial conducted for a COVID-19 vaccine in India.
Bharat Biotech had announced on 29 June that it had successfully developed Covaxin in collaboration with ICMR and NIV. The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The vaccine candidate has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad. The Phase I trials began in July while Phase II trials started in September.
(This article was originally published on The News Minute and has been re-published in an arrangement with The Quint)
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