In the latest development, India is all set to get its second “Made in India” vaccination after Biological E. Limited (BE) on Saturday announced that it has successfully completed Phase I/II clinical trials of its Covid-19 subunit vaccine candidate and has received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).
Biological E managing director Mahima Datla said, “We are delighted with the success of the Phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials.”
Dr VK Paul Niti Aayog member (health) said that this is a very significant development as “they have a capacity of seven crore vaccines per month".
The Phase III clinical study to be conducted in 15 sites across the country will evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 vaccine for protection against COVID-19 in about 1,268 healthy subjects aged 18-80 years.
As per reports, Hyderabad-based Biological E is testing a two-dose vaccine. Similar to Covaxin, the jab will be administered at a 28-day interval. The firm has tied up with Baylor College of Medicine in Houston and Dynavax Technologies Corp to develop the jab. Biological E has also partnered with Johnson & Johnson to manufacture its single-dose vaccine to fulfil global supply orders.