'More Info Required': WHO To Bharat Biotech As It Submits ‘90% Documents’ For Emergency Use Listing Of Covaxin

Bharat Biotech Ltd told the Central government that the remaining documents are expected to be submitted by June. 

Hyderabad: Bharat Biotech International Limited (BBIL) has reportedly  submitted 90 per cent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine.

During a discussion on obtaining the World Health Organisation's authorisation for emergency use listing for Covaxin, Bharat Biotech Ltd told the Central government that the remaining documents are expected to be submitted by June. 

However, the WHO has said that “more information” is “required” for emergency use listing (EUL) for its Covaxin vaccine for Covid-19. 

As reported by news agency PTI, the latest ‘Status of Covid-19 Vaccines within WHO EUL/PQ evaluation process’ guidance document dated May 18 available on website of WHO claims that Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that “More information required”. According to the report, a pre-submission meeting is expected “to be planned May-June 2021". 

Accoding to the health agency, submissions for prequalification or listing under the emergency use procedure are confidential, WHO published the results only after the a product submitted for assessment is found to meet the criteria for listing. 

Bharat Biotech is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States. 

Meanwhile, the Union Health Ministry reported that the cumulative number of COVID-19 vaccine doses administered in the country exceeded 19.84 crores (19,84,43,550) as per the 8 pm provisional report on Monday, May 24. 

(With PTI Inputs)