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

New Delhi: Bharat Biotech has started the first phase of human clinical trials for India’s first coronavirus vaccine candidate Covaxin. Covaxin is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research’s Pune-based National Institute of Virology.
Volunteers at 14 locations across India are undergoing what is termed as “safety and screening” study to check 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,” a senior ICMR official told ET.



At present, ICMR-NIV have 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,” the ICMR official said.

The vaccine trials would have a considerable sample size of 1,500 persons. The locations include New Delhi, Patna, Chennai, Kanpur, Goa, Gorakhpur, Bhubaneswar, Rohtak, Visakhapatnam and Hyderabad.

“There have been trainings of phlebotomists on how to collect samples, and kits have been despatched to all 14 locations,” a source involved in the process said. “This safety and screening hurdle will be cleared and we will move on to the dosing stage soon.”

Bharat Biotech had on June 29 said that it has received permission from the Drugs Controller General of India (DCGI) to begin trials.

Covaxin has been in news since ICMR director-general Balram Bhargava shot off 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. This had raised eyebrows 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.