Hyderabad-based vaccine maker Bharat Biotech on Monday said that it has submitted all documents required for emergency use listing (EUL) of its Covid-19 vaccine Covaxin to the World Health Organization on July 9.
The company further said that WHO has begun reviewing its documents and that it expects to receive a green signal from the world health body at the earliest.
"All documents required for Emergency Use Listing (EUL) of Covaxin have been submitted to WHO as of 9th July. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," Bharat Biotech International Ltd Chairman and MD Krishna Ella said in a tweet posted by the company.
COVAXIN® EUL pic.twitter.com/dCilH7KbSk— BharatBiotech (@BharatBiotech) July 12, 2021
At present, the WHO has approved vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio, AstraZeneca EU, Janssen, Moderna and Sinopharm for emergency public use.
Last week, during a webinar organised by the Centre for Science and Environment (CSE), WHO chief scientist Soumya Swaminathan said, WHO is reviewing the consolidated data uploaded by Bharat Biotech on the health body’s portal and that it is likely to take a decision regarding Covaxin within four to six weeks.
According to WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
"We currently have six vaccines approved with EUL and have recommendations from our Strategic Advisory Group of Experts (SAGE). We continue to look at Covaxin. Bharat Biotech has now started uploading their data on our portal and that is the next vaccine that will be reviewed by our experts committee," Swaminathan had said.
At present, there are 105 candidate vaccines in clinical evaluation out of which 27 are in phase three or four, she said. There are another 184 candidate vaccines in preclinical evaluation. Most of the vaccines are designed for a two-dose schedule, she added.
(With PTI inputs)