According to WHO Chief Scientist Soumya Swaminathan, Covaxin’s Phase-3 trial data looks promising, and the vaccine should be approved by the WHO by mid to late August. Her statement comes as Bharat Biotech awaits WHO approval for Covaxin’s emergency use listing.
While Hyderabad-based pharma firm Bharat Biotech awaits World Health Organization approval for Covaxin’s emergency use listing, WHO Chief Scientist Soumya Swaminathan has stated that Covaxin’s Phase-3 data looks promising and that the vaccine could be approved by the WHO by mid to late August.
Swaminathan stated in a recent interview that the Phase-3 trial data for Covaxin looks promising, and that all indications are that the efficacy and safety profile meet the WHO benchmarks.
“I believe the Phase-3 trial data (for Covaxin) are positive and encouraging. The good news is that they have looked at the variants and have sequenced approximately 60% of the breakthrough variants found in the trial. Overall efficacy is high, while efficacy against the Delta variant is lower, but still very good,” she explained.
“All indications are that the efficacy and safety profile meet WHO standards. However, the details will be reviewed by the pre-qualification and regulatory teams,” she added.
Swaminathan explained the current status of Covaxin approval at the WHO, saying, “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 will look at safety, quality, good manufacturing practices, and a number of parameters that Bharat Biotech is well-versed in. “We hope to have a decision on whether or not Covaxin will be approved for emergency use by mid to late August,” she said.
On Saturday of last week, Bharat Biotech announced the Phase-3 clinical trial data for Covaxin. According to the trial report, Covaxin is 77.8 percent effective against symptomatic Covid-19.
The indigenously developed vaccine was 93.4 percent effective against severe symptomatic Covid-19 and 63.6 percent effective against asymptomatic Covid-19.
Covaxin was found to be 63.6 percent effective against the Delta variant of Covid-19, which was responsible for India’s severe second coronavirus wave in April-May of this year.
Covaxin has already been approved for emergency use in 16 countries around the world, including Brazil, India, the Philippines, Iran, and Mexico.