Hyderabad-based vaccine maker Bharat Biotech has rejected reports that it did not report an adverse incident during its coronavirus vaccine trial in August, adding that the adverse incident was reported by the company within 24 hours.
In a statement on Saturday, Bharat Biotech 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.”
It is to be noted that Bharat Biotech and ICMR are working on Covaxin, one of the indigenous coronavirus vaccine candidates. The Central Drugs Standard Control Organisation (CDSCO) has also given its approval to Bharat Biotech to launch the phase III trials of COVID-19 vaccine candidate.
Reacting to media reports that the adverse event during the phase I trials which was underway in August was not reported by Bharat Biotech, the pharmaceutical giant on Saturday (November 21) confirmed the incident and issued the clarification. According to Bharat Biotech, the adverse incident was probed thoroughly and it was found that the adverse event was not related to the vaccine.
It is to be noted that as per the guidelines laid down by the Centre, all adverse events are to be reported to the site ethics committee, CDSCO-DCGI, data safety monitoring board and sponsors. The clinical trials of Covxain is currently being conducted by Bharat Biotech and ICMR at 21 medical institutes across the country.
“The adverse event was investigated thoroughly, and presented to the CDSCO-DCGI, prior to obtaining permission for Phase II and Phase III clinical trials,” said Bharat Biotech.
“Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom while it’s is also conducting other clinical trials USA and UK. Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety during vaccine development,” it added.