India's First COVID-19 Vaccine Gets DGCI Nod for Human Clinical Trials

Elias Hubbard
June 30, 2020

Dr Krishna further said the permission was granted after the company submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response. "CoroFlu could be in human clinical trials by the fall of 2020".

None have yet been approved for commercial use against the coronavirus. Half a dozen Indian firms are developing vaccines. "The proactive support and guidance from the Central Drugs Standard Control Organisation have enabled approvals to this project". The most significant of their developments is arguably the rotavirus vaccine Rotavac, a next-gen vaccine against a viral gastroenteritis that got pre-approval from the World Health Organization after an Oxford laboratory found it safe and efficacious. After securing regulatory approvals, the company conducted extensive preclinical studies within two months. He said they had been rushing to create a vaccine and are at the point where it has been tested on animals and is now in its second human trial in the United Kingdom where 6000 people have been given the COVID-19 vaccine and 6000 a dead vaccine. Since January, J&J has been working directly with governments and health authorities to help end this fast-moving COVID-19 pandemic.

The trials are among many across the world - there are around 120 vaccine programmes under way.

Since the outbreak of the pandemic, a global race has been under way for a vaccination against Covid-19.

A vaccine would see potential profits for the medical and science industry, makers of medicine and researchers. But for the U.S. or China, it would also be a massive geopolitical victory.

Of the 10 vaccines that are at the stage of human trials, six are Chinese.

This is not the first landmark for Bharat Biotech as the company had also produced the H1N1 vaccine during the outbreak of swine flu in the country.

Another front-runner from CanSino Biological and the Beijing Institute of Biotechnology is in phase 2 development and received clearance to be used in the country's military late last week.

"Stoffels, who is also vice chairperson of the executive committee of J&J, said the lead vaccine candidate is a non-replicating viral-vector vaccine that contains a piece of DNA that codes for the coronavirus 'spike" protein.

Other reports by Click Lancashire

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