Amid reports that Bharat Biotech failed to report an adverse incident during its coronavirus vaccine trial back in August, the Hyderabad-based vaccine maker has clarified that they had reported the event 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.”

Bharat Biotech and ICMR are working on Covaxin, one of the indigenous coronavirus vaccine candidates being developed in India. Bharat Biotech has already received approval of Central Drugs Standard Control Organisation (CDSCO) for initiating the phase III trials of the coronavirus vaccine candidate.

Following media reports on the adverse event during the phase I trials in August not being disclosed by Bharat Biotech, the company has issued the clarification and also confirmed the incident. It has said the adverse event was investigated thoroughly and determined as not being related to the vaccine.

As per the guidelines, all adverse events are to be reported to the site ethics committee, CDSCO-DCGI, data safety monitoring board and sponsors. Bharat Biotech and ICMR are conducting the clinical trials of Covaxin at 21 selected 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.

Further stressing its track record of being an efficient vaccine maker, Bharat Biotech has said, “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 said.

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