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Covaxin data brightens prospects for WHO, USFDA nod: Experts

Rutam Vora Ahmedabad | Updated on July 03, 2021

‘Showed 93.4% efficacy against severe symptomatic Covid’

Bharat Biotech's late-stage clinical trial data on Covaxin doesn't just lift the confidence in the ‘Made in India’ Covid-19 vaccine but also brightens its prospects for approvals by the United States Food and Drug Administration and the World Health Organization for global acceptance, experts noted.

On Saturday, Bharat Biotech had announced the long-awaited phase-III clinical trial data on its whole virion inactivated vaccine against SARS-CoV2, Covaxin. The vaccine had demonstrated efficacy of 77.8% against symptomatic and 93.4% against severe symptomatic Covid-19, it said. “This data is at a reasonable level. WHO had earlier stated that any vaccine which has an efficacy rate of higher than 50 per cent is good for use. In this context, this vaccine looks to be reasonably good,” DK Mangal, Advisor to S D Gupta School of Public Health, IIHMR University- Jaipur told Businessline.

Fit for global approval

Stakeholders say that Bharat Biotech is now a step closer to being listed for emergency use by the WHO. “WHO would require data in the absence of which, they could not approve Covaxin. But now that there is an encouraging data on symptomatic and severe symptomatic Covid-19; this makes it fit for a global approval," Dr Mangal said.

Also read:Covaxin 93.4% effective against severe Covid

Another feature to Covaxin’s advantage is its evidence-based data on efficacy against the Delta variant, first found in India. The data demonstrates 65.2 per cent protection against Delta variant.

Relevance of data

India has been using Covaxin for its mass vaccination programme under an Emergency Use Authorisation.

So, how relevant was the data, coming six months into the public vaccination?

Veeda Clinical Research Managing Director Ajay Tandon finds it relevant and important as it gives a full understanding of the vaccine response through large studies.

“We need to know the full amount of efficacy, and any other impact or side-effects that the vaccination may have in a wider population. It is still relevant even if it has come a little late,” Tandon said.

Covaxin had shown good immune response in its phase-I and II trial studies, based on which it was granted EUA in India. Outside India, it has received EUA in 15 other countries including, Brazil, Philippines, Iran, Mexico while it is in process of getting EUA in 50 other countries.

“There are so many other countries already relying on the quality of India made Covaxin. This data will certainly give regulators in those countries an enhanced confidence about the vaccine. They will be confident to step up vaccination programmes in their respective countries,” Tandon said adding that the data needs to be reviewed by peer-group. “The current data should meet the peer-review requirements as well. And once it is done, it should give good confidence even to WHO to make it recognised at the global level,” he said.

Published on July 03, 2021

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