COVAXIN, Indian COVID-19 Vaccine To Start Human Trials In July

COVAXIN, the first indigenous COVID-19 vaccine of India, developed by Bharat Biotech has received approval to carry out human clinical trials.

The Drug Controller General of India has allowed Bharat Biotech to conduct Phase I and II of human trials. As per the vaccine maker, its clinical trials of the vaccine will begin in July 2020.

The company said that the vaccine’s development was in collaboration with the National Institute of Virology and Indian Council of Medical Research.

Bharat Biotech developed the inactivated and indigenous vaccine at its Bio-Safety Level 3 (BSL-3) high containment facility in the Genome Valley, in Hyderabad.

The company got the approval to conduct human clinical trials after submitting results from its pre-clinical studies which demonstrate immune response and safety.

Dr. Krishna Ella, Bharat Biotech’s Chairman, and Managing Director said that it was CDSCO’s guidance and proactive support that has made this project a reality. The company’s manufacturing and R&D teams are putting their efforts in deploying Bharat Biotech’s technologies.

The company, while complying with the national regulatory protocols, accelerated its comprehensive pre-clinical studies. Results have been promising, showing effective immune responses and extensive safety.

Besides Bharat Biotech, there are at least five other companies in India that are working on developing a vaccine for the novel coronavirus. Other companies around the world are also racing to come up with a vaccine to tackle the disease.

Pune-based Serum India has stated that they will be in charge of manufacturing COVID-19 vaccines. The vaccine is currently on human trials at Oxford University, the UK. The company’s goal is to produce four to five million doses of vaccines each month in the first six months. After that, they might scale up the production to 10 million doses monthly. By September-October, Serum Institute is planning to produce 20 to 40 million doses. By doing this, the product will be available in other countries as well.

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