New Delhi: The World Health Organisation’s (WHO) approval for Bharat Biotech’s COVID-19 vaccine, Covaxin, is expected this week, sources said on Monday.
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).
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.
Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.
The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
The WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.