Covaxin expected to receive WHO’s emergency use approval by August-end

Announcing that the Covaxin’s Phase-3 trial data ‘looks good’, WHO Chief Scientist Soumya Swaminathan indicated the vaccine may receive an emergency use approval by the WHO by mid to late August. Details here.

Gaon Connection
| Updated: July 9th, 2021

Saumya Swaminathan said the safety profile of the Covaxin ‘meets the WHO benchmarks’. Photo: @airnewsalerts/twitter

Saumya Swaminathan, Chief Scientist with the World Health Organization (WHO), has said that the final phase trial data for Bharat Biotech International Ltd’s COVID19 vaccine — Covaxin — ‘looks good’ and the safety profile of the vaccine ‘meets the WHO benchmarks’. Swaminathan was quoted as saying in an interview to a TV news channel yesterday on July 8.

Amid concerns raised over the absence of international recognition of Covaxin, this statement by WHO Chief Scientist could prove to be good news for Hyderabad-based vaccine manufacturer which awaits approval from the WHO for emergency use approval.

“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,” said Swaminathan.

Covaxin reportedly showed 63.6 per cent efficacy against the Delta variant of COVID19.

Covaxin has an overall efficacy rate of 77.8 per cent and there aren’t any safety concerns in its use.

Also Read: Explained: Delta Plus variant — how risky is it? Are COVID19 vaccines effective?

“All indications are that the efficacy and safety profile are meeting the WHO benchmarks… Hopefully, by mid to late August, we will have a decision on whether or not Covaxin will receive an emergency use approval,” she said.

Swaminathan said that the data packet is being assembled and the agency is awaiting more data for a final say on the matter.

Last week, on July 3, Bharat Biotech announced Covaxin’s Phase-3 clinical trial data. It stated that the indigenously developed COVID19 vaccine has an overall efficacy rate of 77.8 per cent and there aren’t any safety concerns in its use.

Also Read: Bharat Biotech shares phase 3 trial data of Covaxin with govt

It is to be noted that Covaxin has not found a place in the WHO’s emergency-use listing (EUL) of vaccines so far. However, Covaxin has already received emergency use authorisation in 16 countries including Brazil, Philippines, Iran and Mexico.

Also Read: Covaxin phase-3 trial data: 77.8% efficacy, no safety concerns, says Bharat Biotech