Bharat Biotech says EUL for COVAXIN submitted to WHO, approval expected by July-Sept
New Delhi: COVID-19 vaccine COVAXIN's manufacturer Bharat Biotech on Tuesday said application for Emergency Use Listing (EUL) of its vaccine has been submitted to World Health Organisation (WHO), Geneva, and regulatory approvals are expected between July and September.
The latest status of COVID-19 vaccines within WHO EUL/PQ evaluation process' guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that more information is required.
"Regulatory approvals for COVAXIN are in process in more than 60 countries, including USA, Brazil, Hungary etc. Emergency use authorisations have been obtained in 13 countries and there are more to follow. Application for EUL has been submitted to WHO, Geneva. Regulatory approvals are expected Jul-Sept 2021," Bharat Biotech said in a statement.
The WHO has given approvals to the Pfizer/BioNTech vaccine for emergency use on December 31. The AstraZeneca/Oxford COVID-19 vaccine got its approvals on February 15, and the COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) was approved on March 12. Moderna's COVID-19 vaccine and China's Sinopharm COVID-19 vaccine have also both been approved in the EUL.
