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Covaxin manufacturer initiates regulatory process for obtaining EUL from WHO

G Naga Sridhar Hyderabad | Updated on July 08, 2021

The company participated in a pre-submission meeting with WHO on Wednesday

 

Bharat Biotech has initiated the regulatory process for obtaining Emergency Use Listing (EUL) from World Health Organisation (WHO) for its Covid19 vaccine, Covaxin.

The representatives of the Hyderabad-based company participated in a virtual pre-submission meeting with WHO officials on Wednesday night.

According to sources, the company had used the occasion to submit its version on quality of its manufacturing as well its efficacy backed by relevant data. The company, however, is tight-lipped on the outcome of the meeting.

Bharat Biotech had earlier said it had submitted about 90 percent of relevant data to global health organsiation .

Bharat Biotech has claimed that the vaccine had showed an efficacy of 77.8 per cent against Covid-19 in the Phase 3 trials.

The subject expert committee (SEC) on Tuesday reviewed phase 3 data pertaining to Covaxin. An official announcement in this regard from the Drug Controller General of India is awaited.

As of now, WHO has included only eight Covid vaccines in EUL including AstraZeneca-Oxford University vaccine produced and sold in India as Covishield by Serum Institute.

Published on June 24, 2021

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