WHO Chief Scientist Soumya Swaminathan said Covaxin's Phase-3 trial data looks good and the vaccine can hopefully be approved by the WHO by mid to late August. Her statement comes as Bharat Biotech awaits WHO's approval for the emergency use listing for Covaxin.
As Hyderabad-based pharma firm Bharat Biotech awaits the World Health Organisation's approval for the emergency use listing for Covaxin, WHO Chief Scientist Soumya Swaminathan has said Covaxin's Phase-3 data looks promising and the vaccine can hopefully be approved by the WHO by mid to late August.
In a recent interview, Swaminathan said the Phase-3 trial data of Covaxin looks encouraging and all indications are that the efficacy and safety profile meet the WHO benchmarks.
"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," she 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.
Talking about the status of Covaxin's approval at the WHO, 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. Hopefully, by mid to late August, we will have a decision on whether or not Covaxin will receive an emergency use approval," she said.
Bharat Biotech announced Covaxin's Phase-3 clinical trial data on Saturday last week. As per the trial report, Covaxin has been found to be 77.8 per cent effective against symptomatic Covid-19.
The indigenously developed vaccine 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, Philippines, Iran and Mexico.
Source: India Today