CORBEVAX’ gets DCGI approval for Clinical trials

The Drug Controller General of India (DCGI) gave approval to another indigenous COVID-19 vaccine candidate called CORBEVAX for two clinical trials.

Highlights

  • Vaccine maker Biological E received approval to conduct phase two and three clinical trials on children between five to eighteen years of age.
  • Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E’s COVID-19 vaccine candidate of Biological E, right from Preclinical Stage to Phase-III clinical studies.
  • vaccine has also received financial assistance under Mission COVID Suraksha and a financial support under COVID-19 Research Consortia through National Biopharma Mission, BIRAC.

Corbevax Vaccine

This vaccine is also called as BioE COVID-19 vaccine. This COVID-19 vaccine candidate has been developed by Indian biopharmaceutical firm Biological E. Limited (BioE) in collaboration with the Baylor College of Medicine, Houston in United States and American company Dynavax Technologies (DVAX). Vaccine is a protein subunit vaccine. Ministry of Health and Family Welfare has already ordered 300 million doses of Corbevax in June 2021.

Who is funding the vaccine?

U.S. International Development Finance Corporation (DFC) announced in April 2021 to fund the expansion of BioE’s manufacturing capabilities in order to produce at least 1 billion doses by end of 2022.

Background

Phase I clinical trial was carried in 360 participants in order to evaluate the safety and immunogenicity of the vaccine candidate. Its phase II trial was concluded in April 2021. Permission to conduct phase III clinical trials was given in April 2021.

Month: 

Category: 

Topics: 

Latest E-Books

Comments