The World Health Organisation's (WHO) is expected to give its approval for Bharat Biotech's COVID-19 vaccine, Covaxin, this week, according to sources. Bharat Biotech has submitted its Phase 3 clinical trials data that present Covaxin to have 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) was held in June. The meeting provided advise before final dossier submission.

Union Health Minister Mansukh Mandaviya had also met WHO Chief Scientist Dr Soumya Swaminathan and discussed approval of Covaxin, Bharat Biotech's Covid-19 vaccine.

Marianne Simao, a WHO assistant director general for vaccines, also said that WHO’s assessment of Covaxin was very advanced and decision was hoped by mid-September. 

Hyderabad-based Bharat Biotech has developed Covaxin in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Covaxin 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 makes distribution very feasible and logistically practical using existing vaccine supply chain channels. T

COVID-19 vaccines already approved by the WHO are those by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.