Hyderabad: Human trials begin for Covid-19 vaccine

HYDERABAD: Vaccine maker Bharat Biotech has kicked off human trials for its Covid-19 vaccine candidate Covaxin, an inactivated vaccine that it has developed in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).
The company commenced Phase I of the human clinical trials for Covaxin on July 15 with the first volunteer being administered the dose at AIIMS Patna, sources said. Apart from AIIMS Patna, volunteers at hospitals like PGI Rohtak have since been administered the vaccine dose on Friday. As many as a dozen hospitals across the country, including Nizam’s Institute of Medical Sciences (NIMS) Hyderabad, King George Hospital at Vizag, AIIMS Delhi, among others, are participating in the Covaxin trials.
Bharat Biotech said the clinical trial for Covaxin is a randomised, double-blind, placebo-controlled one being conducted on 375 volunteers across the country. A double-blind, placebo-controlled clinical trial is one where the human participants don’t know who is getting the actual dose of the vaccine or drug and a placebo (substance that has no therapeutic effect) is given to a control group.
Covaxin is India’s first indigenous Covid-19 vaccine to have received approval from the Indian drugs regulator Drug Controller General of India (DCGI) in June end. Bharat Biotech, which has a Bio Safety Level-3, high containment manufacturing facility at Hyderabad, hopes to complete the first and second phase of human trials by October this year. The SARS-CoV-2 virus strain for Covaxin was isolated from an asymptomatic Covid-19 patient at NIV, Pune, and transferred in early May to Bharat Biotech, which developed the vaccine candidate at its Hyderabad facility.