Covaxin likely to get WHO's approval by mid-August as chief scientist says 'phase 3 data looks promising'
New Delhi | Jagran News Desk: Amid the wait for the World Health Organisation's (WHO) approval to India-made COVID-19 vaccine Covaxin, the chief scientist of the UN Organisation, Soumya Swaminathan, on Friday said that the phase 3 clinical data of Bharat Biotech's Covaxin looks promising and the vaccine may get the WHO's approval by mid-August.
In a recent interview, Swaminathan said that Covaxin's phase 3 data looks encouraging and the efficacy and safety of the vaccine also meet the parameters set by the WHO to approve any COVID-19 vaccine for emergency use authorisation.
"I think the Phase-3 trial data (of Covaxin) is good and encouraging. The good thing is that they have also looked at the variants and they are sequenced about 60 per cent of the breakthrough variants that were seen in the trial. The overall efficacy is high while efficacy against the Delta variant is comparatively low, but it's still very good," Soumya Swaminathan said.
"So all indications are that the efficacy and safety profile are meeting the WHO benchmarks. But the details are going to be looked at by the pre-qualification and regulatory team," she added.
On the question of WHO's awaited approval to the Covaxin, Swaminathan said, “Currently, the pre-submission meeting was held on June 23 and the data package is currently being submitted and assembled. Then it will be reviewed by a group that looks at safety, quality, good manufacturing practices, and a number of parameters that Bharat Biotech is very familiar with", she said.
"Hopefully, by mid to late August, we will have a decision on whether or not Covaxin will receive an emergency use approval," the chief scientist of WHO further added.
Hyderabad-based Bharat Biotech last week announced the phase 3 clinical data of Covaxin. As per the trial data, the India-made vaccine is found to be 77.8 per cent effective against symptomatic COVID-19 patients. Covaxin demonstrated 93.4 per cent efficacy against severe symptomatic Covid-19 and 63.6 per cent against asymptomatic Covid-19.
Covaxin showed 63.6 per cent efficacy against the Delta variant of Covid-19, which was responsible for the severe second coronavirus wave in India during April-May this year. Globally, Covaxin has already received emergency use authorisation in 16 countries including Brazil, India, the Philippines, Iran and Mexico.
Posted By: Talibuddin Khan