The World Health Organisation’s (WHO) nod for Bharat Biotech’s coronavirus vaccine, Covaxin, is expected this week, sources informed on September 13, 2021.
Bharat Biotech has submitted its Phase 3 clinical trials data that showed 77.8% efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Earlier in the month of June, a pre-submission meet was also held for WHO’s Emergency Use Listing Procedure (EUL), which provides advice before the submission of the final dossier.
The Indian Health Minister Mansukh Mandaviya had also met WHO Chief Scientist Dr. Soumya Swaminathan earlier and held discussions over the approval of Bharat Biotech’s Covaxin.
A WHO assistant director-general for vaccines, Marianne Simao also said that the UN health agency’s assessment of this vaccine was quite advanced and authorities expected a decision by mid-September.
Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology developed Covaxin.