Vaccine manufacturer Bharat Biotech has submitted 90% of the required documents to the World Health Organisation for emergency use listing of its Covaxin shot, The Indian Express reported on Tuesday. The company is expected to file the remaining documents in June and is confident about obtaining the WHO approval.
However, the latest guidance document issued by the WHO on the status of approval of vaccines under evaluation for emergency use listing showed that Bharat Biotech had submitted an Expression of Interest, or EOI, on April 19. The health body’s document, released on May 18, said that “more information [was] required” for the EOI and a pre-submission meeting was scheduled for May-June.
According to the WHO, submissions made to it 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 publishes the results widely. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to PTI.
Meanwhile, in a meeting between officials of the foreign ministry, health ministry, department of biotech and Bharat Biotech executives, it was noted that Covaxin had already received regulatory approval from 11 countries. Eleven other companies in seven countries have also shown interest for technology transfer and production of Covaxin, PTI reported quoting unidentified officials.
Bharat Biotech is also in the final stages of negotiations with the Food and Drug Administration of the United States for conducting small-scale third phase clinical trials of Covaxin in the country, the sources added.
The emergency use approval for Covaxin is crucial as more than 2.09 crore doses of the vaccine have already been administered in India, according to government data. Several top dignitaries, including Prime Minister Narendra Modi and other central ministers, have received the vaccine.