World Health Organisation's nod for Bharat Biotech's COVID-19 vaccine, Covaxin is expected this week. According to news agency ANI, sources said that the emergency nod to Covaxin is expected in this week.
With emergency approval from the WHO, it will allow Bharat Biotech to export Covaxin and also ease international travel of people who have received this vaccine. Covaxin is one of the three vaccines that is being administered in the country.
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.
The Hyderabad-based company earlier in August received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities.
Union Health Minister Mansukh Mandaviya in August had also met Dr Soumya Swaminathan and held a discussion over global health body's global authorisation of the vaccine.
Dr. Swaminathan– earlier 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 had said the agency’s assessment of Covaxin is at an advanced stage and a decision on emergency authorisation for Bharat Biotech’s vaccine would be likely taken in mid-September.
The India based vaccine maker had 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.
