Bhubaneswar: India’s indigenous COVID-19 vaccine Covaxin reportedly faced an adverse incident during its Phase I trial back in August. The company claims that it reported the incident within 24 hours.
“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 said in a statement on Saturday.
The Hyderabad-based firm is working with ICMR to produce the vaccine which has now received approval for Phase III trials.
The vaccine is being tested at 21 medical institutes in the country, including IMS & SUM Hospital in Bhubaneswar.
“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.