As Bharat Biotech awaits approval from WHO, the Chief scientist from the world health body– Dr. Soumya Swaminathan– said that the overall efficacy of Covaxin is quite high and the phase-3 trials of the Coronavirus vaccine look good.
Hyderabad-based vaccine maker had a pre-submission meeting on June 23 and now it is awaiting a nod for an emergency-use listing (EUL) from the health body. “The overall efficacy is quite high. The vaccine efficacy against the Delta variant is low but it is still quite good,” the scientist told. The safety profile so far meets the WHO benchmarks, the scientist added.
A few days ago, Bharat Biotech had released the phase 3 clinical trial results of Covaxin after evaluating 130 symptomatic COVID-19 cases. It said the vaccine demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. The efficacy analysis demonstrated Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19 cases while safety analysis showed adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent feeling serious adverse events.
Bharat Biotech had earlier said that it expected to get approval for emergency use listing of Covaxin from the WHO by July-September.
As per WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
The whole virion inactivated vaccine against SARS-CoV2 was developed in partnership with the Indian Council of Medical Research and the National Institute of Virology in Pune.