According to the latest update on the COVID-19 vaccine, Bharat Biotech has successfully started human trials on its vaccine candidate 'COVAXIN'.
The human trial of Bharat Biotech's anti-COVID-19 vaccine has been initiated in Rohtak's Post-Graduate Institute of Medical Sciences today, Haryana Health Minister Anil Vij tweeted.
"Human trial with Corona vaccine (COVAXIN) of Bharat Biotech started at PGI Rohtak today," said Vij.
"Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse effects," he said.
COVAXIN, being developed by the Hyderabad-based biotech company in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), is India's first indigenous COVID-19 vaccine. The human trial of COVAXIN has started in All India Institute of Medical Sciences in Patna and Post-Graduate Institute of Medical Sciences in Rohtak.
Bharat Biotech got the country's drug regulator's permission to start clinical trials of its anti-Corona vaccine Covaxin last month. The Drug Controller General of India (DCGI) granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
The Indian Council of Medical Research (ICMR) has selected 12 institutes to conduct these trials, including cities such as Mumbai, New Delhi, Hyderabad, Rohtak, Chennai, Patna, Vishakhapatnam among others.
COVAXIN, the country's first possible vaccine against COVID-19, will be tested on over 1,100 people in two phases. The company plans to enroll 375 participants to test COVID-19 vaccine candidate in the first phase of clinical trials. Based on the first trial's results, it has a plan to enroll 750 people in the second phase of trial.
COVAXIN is derived from a strain of SARS-CoV-2 virus which had been isolated at National Institute of Virology, Pune, which was later transferred to Bharat Biotech to produce into a vaccine candidate. The indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
There are over seven anti-corona vaccines at various stages of development in the country with two of them having received the drug regulator's go-ahead to start the human clinical trials of their vaccines.
Earlier this month, Zydus had said it has received approval from the DCGI to conduct human trials for the coronavirus vaccine it has named ZyCoV-D. The trials will begin this month with 1,000 volunteers across multiple cities.
The Gurugram-based Biotech company that has developed a triple antigen virus-like particle (VLP) vaccine candidate has said that it has moved to the animal trial phase.
By Chitranjan Kumar