Need more information to give EUL to COVAXIN: WHO
The World Health Organization (WHO) has said that more information is required from Bharat Biotech, which is seeking emergency use listing (EUL) for its COVID-19 vaccine COVAXIN. 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.
EUL depends upon vaccine data meeting WHO's criteria
According to the WHO, submissions for pre-qualification or listing under the emergency use procedure are confidential. "If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the data quality submitted by the vaccine manufacturer and on those data meeting WHO criteria," according to the agency.
90% documents submitted to WHO: Bharat Biotech tells Centre
According to the guidance document, a pre-submission meeting is expected to be planned for May-June 2021. "Meanwhile, Hyderabad-based Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 percent of documents to WHO for obtaining emergency use listing (EUL) for the COVAXIN, and the remaining documents are expected to be submitted by June," sources said.
Eleven companies have shown interest in technology transfer, COVAXIN production
"Bharat Biotech is confident about obtaining WHO's emergency use listing," a source said. Noting that COVAXIN has already received regulatory approval from 11 countries, sources said that there was also interest from 11 other companies in seven nations for technology transfer and production of COVAXIN.
Company is planning to conduct Phase III trials in US
Meanwhile, the company 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 US. On Monday, Bharat Biotech held a meeting with the Indian Government. The meeting aimed to discuss obtaining the World Health Organization's authorization for emergency use listing for COVAXIN.
Beneficiaries vaccinated with COVAXIN might be barred from international travel
Last week, several reports pointed out that beneficiaries who are vaccinated with COVAXIN might be barred from international travel as the vaccine has not been included in the WHO's Emergency Use Listing so far. Notably, Oxford-AstraZeneca's Covishield, which is manufactured by the Pune-based Serum Institute of India, is the only Indian vaccine that has received emergency use approval from the WHO.