The World Health Organisation is likely to approve India’s only indigenously developed vaccine in use so far, Bharat Biotech’s Covaxin, for an emergency use listing in the next four to six weeks, said chief scientist Dr Soumya Swaminathan.
“There is a process to be followed for approval. Companies have to submit their safety data, complete trial data, and even manufacturing quality data for approval. Bharat Biotech has already started submitting the data and the dossier is being assessed. It is the next vaccine to be reviewed by our committee. There will be a decision on inclusion in the next four to six weeks,” said Dr Swaminathan during a webinar on vaccine access across the world.
In a recent interview, Swaminathan said the Phase 3 trial data of Covaxin “looks good” and meets the safety profile of the international public health agency so far.
Bharat Biotech announced Covaxin’s Phase-3 clinical trial data recently. As per the trial report, Covaxin has been found to be 77.8% effective against symptomatic Covid-19.
Globally, Covaxin has already received emergency use authorization in 16 countries, including Brazil, Mexico, Philippines and Iran.
{{/usCountry}}Globally, Covaxin has already received emergency use authorization in 16 countries, including Brazil, Mexico, Philippines and Iran.
{{/usCountry}}The WHO approval, if granted, will come as a relief to Indians and citizens of at least 12 countries where the vaccine is being administered.
Addressing the event, Swaminathan also discussed the recent meta-analysis data on anti-parasitic drug Ivermectin as a possible Covid-19 treatment.
“The quality of studies were poor so when we put it in meta-analysis they did not suggest any evidence to use Ivermectin. The drug should be used only in clinical trials. There are a lot of medicines being used without evidence,” she said.