In what potentially comes as a piece of good news for Hyderabad-based vaccine manufacturer Bharat Biotech, the World Health Organization (WHO) has indicated that it might just provide its much-awaited approval to Covaxin, the company’s indigenous jab against the coronavirus disease (Covid-19).
Soumya Swaminathan, the chief scientist at WHO, told a Mumbai-based news organisation that the final phase trial data for Covaxin “looks good” and meets the safety profile of the international public health agency so far.
The Phase-3 trial data looks good, they’ve looked at the variants too, she said in an interview to CNBC-TV18. “The overall efficacy is quite high. The vaccine efficacy against the Delta variant is low but it is still quite good,” she said. The safety profile so far meets the WHO benchmarks, the scientist said.
“We keep a close eye on all vaccines which have received emergency use listing. We continue to seek more data,” she said.
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.
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.
Bharat Biotech held a pre-submission meeting with the WHO on June 23 for the international emergency use listing (EUL) of its COVID-19 vaccine Covaxin. Though the meeting was not a detailed review on the product, the vaccine maker had an opportunity to submit a summary on overall quality of the jab.
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.
