Union Health Minister Mansukh Mandaviya on Thursday met World Health Organisation (WHO) chief scientist Dr Soumya Swaminathan and held a discussion over global health body's global authorisation of Bharat Biotech's Covaxin. Hyderabad-based Bharat Biotech had in May this year submitted an application to the WHO for Emergency Use Listing (EUL).
Emergency Use Listing is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, according to WHO guidelines.
Notably, over a month ago, Dr. Swaminathan– had said that the overall efficacy of Covaxin is quite high and the phase-3 trials of the Coronavirus vaccine look good. “The overall efficacy is quite high. The vaccine efficacy against the Delta variant is low but it is still quite good,” the scientist said. The safety profile so far meets the WHO benchmarks, the scientist added.
According to a report, a WHO official has said the agency’s assessment of Covaxin is at an advanced stage and a decision on emergency authorisation for Bharat Biotech’s vaccine is likely by mid-September.
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The official said the agency expects to make a decision next month on an emergency authorization for the Indian-made Covid-19 vaccine made by Bharat Biotech, a shot that has yet to be authorized by any Western regulatory authorities.
The India based vaccine maker recently said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
The jab demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the B.1.617.2 Delta variant, it said.
At present, the WHO has approved vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm for emergency use.
Meanwhile, yesterday, the Drugs Controller General of India (DCGI) has given the approval to conduct a study on mixing of Covishield and Covaxin vaccines. The step has been taken to boost the mass vaccination drive against the coronavirus across the nation.
