Biological E's Covid-19 vaccine Corbevax gets approval for Phase II, III clinical trials on children
Corbevax has also received the nod for Phase III clinical trials on adults
The Drugs Controller General of India (DCGI) has granted approval to Biological E for two clinical trials of its Covid-19 vaccine candidate Corbevax.
This includes permission to begin phase II and III studies of its Covid-19 vaccine in children and adolescents.
Corbevax is a RBD protein sub-unit vaccine.
The approvals have been granted for:
* Active controlled Phase III Clinical trial in Adult population
* Phase II/III Paediatric trial in Children and Adolescents (5yrs and above)
According to an official press release issued on Friday, Biological E. has received DCGI approval for conducting Phase III Comparator Safety & Immunogenicity trial in adults after Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data.
Biological E. also received approval on September 1 to initiate the Phase II/III Study to evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax vaccine in Children and Adolescents, the release added.
The Department of Biotechnology (DBT), under the Ministry of Science & Technology, Government of India, and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E.’s Covid-19 Vaccine candidate from Preclinical Stage to Phase III clinical studies.
In addition to receiving financial assistance under Mission COVID Suraksha, this vaccine candidate has also obtained a financial support under Covid-19 Research Consortia through National Biopharma Mission, BIRAC.
Secretary, DBT and Chairperson, BIRAC Renu Swarup was quoted by the press release as saying, "Department through Mission COVID Suraksha launched under Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is committed to development of safe and efficacious COVID-19 vaccines. We look forward to the clinical development of candidate CORBEVAX for paediatric and adults .”
"We are delighted to receive these significant approvals from the DCGI. These approvals encourage our organisation to move forward and successfully produce our COVID-19 vaccine to meet the vaccination needs," said Managing Director Biological E. Limited Mahima Datla.
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India.
BE develops, manufactures and supplies vaccines and therapeutics. It supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.