Covaxin's emergency use listing: All papers sent to WHO, says Bharat Biotech

Bharat Biotech also attended a pre-submission meeting scheduled with representatives of WHO on June 23.

Indian vaccine manufacturer Bharat Biotech on Monday said that it submitted all documents required for emergency use listing (EUL) of its Covid-19 vaccine, Covaxin, to the World Health Organisation (WHO) on July 9.

A health worker prepares a dose of the Bharat Biotech Ltd. Covaxin vaccine at a Covid-19 vaccination center set up at the Delhi Municipal Corp. (Sumit Dayal / Bloomberg)

“All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of 9th July. The review process has commenced with the expectation that we will receive EUL from WHO at the earliest,” said Krishna Ella, chairman and managing director, Bharat Biotech.

Bharat Biotech also attended a pre-submission meeting scheduled with representatives of WHO on June 23.

On June 22, the subject expert committee (SEC) of the central drugs standards control organisation (CDSCO) assessed Bharat Biotech’s Phase 3 clinical trials data of Covaxin, and found it to be 77.8% efficacious.

WHO chief scientist, Dr Soumya Swaminathan, on July 9 had said the UN agency is likely to approve India’s only indigenously developed vaccine in use for emergency use listing in the next four to six weeks.