Bharat Bio to start human trials for indigenous Covid vaccine in July

Chinese coronavirus vaccine approved for military use

A worker at a lab at the Yisheng Biopharma company where researchers are trying to develop a vaccine for Covid-19

The vaccine was developed by researchers at University of Oxford in United Kingdom and the British firm has already begun large-scale human trials for it. Bharat Biotech has a biosafety level-3 plant in Hyderabad.

Safety trials are meant to ensure that candidate vaccines are safe for use in humans while efficacy trials are created to determine whether it can protect recipients from the infection.

No vaccine has yet been approved for commercial use against the illness caused by the new coronavirus, but over a dozen vaccines from more than 100 candidates globally are being tested in humans.

There have been 16,475 people who have succumbed to the virus.

In a statement, the consortia said, the Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare has granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

Of these 16 vaccine candidates, five are being researched in China, three in the U.S., two in the United Kingdom, and one each in Australia, Germany, and Russian Federation.

"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.

The vaccine has been named Covaxin and is an inactivated vaccine developed indigenously. The company - which produces vaccines for H1N1 influenza, rotavirus, Japanese encephalitis and rabies - has delivered more than four billion doses of vaccines across the world. The vaccine is under development by Hyderbad-based biotechnology firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Another four or five home-grown vaccines are in early stages of development.

If the results from Phase-1, 2 trials are promising and the volunteers show sufficient neutralizing antibodies, the candidate will be tested on a much larger group as part of Phase-3. On vaccines, he said several candidates are being studied and "hopefully there will be doses available by the beginning of next year".

A vaccine candidate against COVID-19 (the SARS-CoV-2 virus), provided by Imperial College London.

"J&J has a long-standing commitment to address global health crisis and will continue to work closely with partners worldwide to combat the current COVID-19 pandemic through a multi-pronged approach.We will continue to bring our full resources and best scientific minds to combat this pandemic", Mr Stoffels said.

Democrats said the administration had to make a commitment to be transparent and guided by science, not politics, in approving any covid-19 vaccine.

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