Udayavni Special

Bharat Biotech confirms volunteer was hospitalised during Covaxin vaccine trial, says illness unrelated


Team Udayavani, Nov 21, 2020, 6:43 PM IST

New Delhi: Bharat Biotech on Saturday confirmed that an adverse event took place Covaxin trials in August 2020 and that the matter was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation.

The clarification from the Hyderabad-based vaccine maker comes in backdrop of media reports that the company failed to report an adverse incident during its coronavirus vaccine trial back in August.

“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.

The statement further claimed that the adverse event was investigated thoroughly and determined as not vaccine-related.

According to media reports, the health volunteer who had received the vaccine shot was hospitalised for a week. However, the matter, it is reported, was not made public nor trails were halted.

Covaxin is being developed by Bharat Biotech, in collaboration with the ICMR – National Institute of Virology (NIV). On October 2, the city-based vaccine-maker had sought the Drug Controller General of India’s (DCGI) permission to conduct phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vacine.

 

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