Biological E has received approval from the Drugs Controller General of India (DCGI) to start Phase III trials for its Covid-19 vaccine, Corbevax, for adults and phase II/III trials for children.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation has reviewed the company’s Phase I and II clinical trials data and approved safety and immunogenicity trial in adults. Bio E also received approval for Phase II/III study to evaluate safety, tolerability and immunogenicity of Corbevax in children five years and above as well as adolescents.
The Hyderabad-based company received support from the department of biotechnology (DBT) under the ministry of science & technology and Biotechnology Industry Research Assistance Council (BIRAC) from the pre-clinical stage to Phase III clinical studies and financial assistance of around Rs 100 crore.
The company has committed to supply 300 million doses by the end of the year to the government. The health ministry has made an advance payment of Rs 1,500 crore to Biological E for reserving these supplies.
“The approvals from the DCGI will encourage us to move forward and produce the Covid-19 vaccine to meet the country’s vaccination needs. These approvals will help support subsequent filings with the World Health Organisation as well,” Bio E MD Mahima Datla.
Renu Swarup, secretary, DBT and chairperson, BIRAC, said the department was committed to the development of safe and efficacious Covid-19 vaccines.
The two-dose Covid-19 vaccine, given 28 days apart, was found to be safe, well tolerated and immunogenic in Phase II trials.