Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), ANI reported.
Earlier in June, a pre-submission meeting for WHO Emergency Use Listing Procedure (EUL), which provides advice before the submission of the final dossier, was also held.
Union Health Minister Mansukh Mandaviya had also earlier met WHO Chief Scientist Dr Soumya Swaminathan and held discussions over the approval of Bharat Biotech’s Covid-19 vaccine Covaxin.
Marianne Simao, a WHO assistant director general for vaccines, also said that the UN health agency’s assessment of this vaccine was quite advanced and officials hoped for decision by mid-September.
Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.