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Biological E Covid Vaccine's Phase-3 Result May be Out Next Month, Stockpile Being Produced: Govt

The trials of Biological E’s Covid-19 vaccine for children will be conducted across 10 sites in the country. (Image: Reuters)

The trials of Biological E’s Covid-19 vaccine for children will be conducted across 10 sites in the country. (Image: Reuters)

The DCGI had earlier granted permission to Biological E Limited to conduct phase 2/3 clinical trials on children aged between 5 and 18 years.

The Phase-3 trial work of Biological E Covid vaccine is ongoing, and results should be out in at least the next two months, NITI Aayog Member (Health) Dr VK Paul said Thursday after a press briefing on the country’s vaccine drive and Covid-19 situation.

“The Phase-3 trial work of Biological E going on. Stockpile is being produced. We should wait for results, we hope it’ll be in the next month or two. They have made broad commitment that they will supply a significant amount by the year-end," he said, ANI reported.

The Drugs Controller General of India (DCGI) on Wednesday had granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trials of its ‘Made in India’ COVID-19 vaccine on children aged between 5 and 18 years with certain conditions.

ALSO READ | Biological E’s Covid-19 Vaccine Gets DGCI Nod for Phase 2/3 Trials on Those Aged Between 5 and 18

The phase 2 and 3 clinical trials have be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo controlled, Phase-2/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents’, a source had said.

The trial will be conducted across 10 sites in the country. The DCGI’s permission was given based on the recommendations by the Subject Expert Committee (SEC) on COVID-19.

So far, indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country. Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech’s Covaxin in the age group 2 to 18 years is underway.

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first published:September 02, 2021, 17:56 IST