The news reports on Bharat Biotech submitting Phase-3 data to WHO is incorrect and lacks any evidence.— BharatBiotech (@BharatBiotech) June 17, 2021
Bharat Biotech on Wednesday refuted the reports which claimed that the company has submitted its Phase-3 trial data to the World Health Organisation (WHO).
“The news reports on Bharat Biotech submitting Phase-3 data to WHO is incorrect and lacks any evidence,” said Bharat Biotech in a tweet.
Earlier, some reports suggested that Bharat Biotech has submitted Phase-3 trial data to WHO for clearance.
Last month, the firm had said that it expects Emergency Use Authorisation (EUA) approval from the WHO in July-September.“Application for Emergency Use Listing submitted to WHO-Geneva, regulatory approvals are expected Jul-Sept 2021,” Bharat Biotech said in a statement.
Bharat Biotech had conveyed to the Centre that it has already submitted 90 percent of documents to WHO for obtaining EUL for Covaxin. It had further said that the remaining documents would be submitted this month.
EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, according to WHO guidelines.