Is Covaxin Approval By WHO On The Anvil?

New Delhi: Hope is running high that the World Health Organisation (WHO) will approve the emergency use of Hyderabad-based pharma firm Bharat Biotech’s COVID-19 vaccine, Covaxin.

WHO Chief Scientist Soumya Swaminathan was quoted as saying that Covaxin’s Phase-3 data looks promising and the vaccine can hopefully be approved by the WHO by mid to late August.

The Phase-3 trial data of Covaxin looks encouraging and all indications are that the efficacy and safety profile meet the WHO benchmarks, India Today quoted Swaminathan as saying in an interview.

“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 was reported as saying.