Indian Economy News

Bharat Bio begins first phase of human trials of indigenously developed Covaxin

  • IBEF
  • July 14, 2020

Bharat Biotech has started the first phase of human clinical trials for India’s first COVID-19 vaccine candidate Covaxin. The drug is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research’s Pune-based National Institute of Virology.

The trial is being conducted at 14 locations across India where volunteers are undergoing “safety and screening” study to examine all parameters, including infections, liver functions, possible exposure to COVID-19 or similar infectious diseases.

“After an all-clear, the subjects would be given what we call a ‘naïve’ status. This would mean that they can be administered small doses of the vaccine,” said a senior ICMR official.

Currently, ICMR-NIV added an additional protocol of conducting antibody test on the volunteers. “This would help further in knowing whether the person has been infected by the virus. If yes, the subject would not participate in further stages of trial,” said the ICMR official.

The sample size of 1,500 people is there for the vaccine trials. The locations include New Delhi, Patna, Chennai, Kanpur, Gorakhpur, Goa, Bhubaneswar, Rohtak, Hyderabad and Visakhapatnam.

On June 29, 2020, Bharat Biotech had received permission from the Drugs Controller General of India (DCGI) to begin trials.

ICMR director-general Mr Balram Bhargava has written a letter on July 2 to 12 hospitals and research centres, asking them to enrol subjects for human trials of Covaxin, so that the vaccine is ready for public use by August 15. Although, this had raised questions in the scientific community as vaccine trials can go on for years and production can begin only after clearing three phases of human clinical trials.

 

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.

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