Biological E developed Corbevax in partnership with Baylor College of Medicine and biopharmaceutical company Dynavax Technologies
Biological E has received the Drugs Controller General of India (DCGI) approval to initiate the Phase 2/3 study of its Covid-19 vaccine Corbevax in children and adolescents.
The Phase 2/3 study is designed to evaluate the safety, reactogenicity, tolerability and immunogenicity of the Corbevax vaccine in children and adolescents.
Corbevax was developed by Biological E, in partnership with Baylor College of Medicine in Houston, US, and biopharmaceutical firm Dynavax Technologies.
In April this year, Biological E has secured funding support from the US International Development Finance Corporation (DFC), to expand its manufacturing capabilities.
In the same month, DCGI has approved the Phase 3 comparator study of Corbevax in adults, based on subject expert committee (SEC) review of Phase 1 and 2 trial data.
Biological E Limited managing director Mahima Datla said: “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.
“We are grateful to BIRAC for their support and we are enthused that these approvals would help support our subsequent filings with WHO as well. We appreciate and acknowledge the contribution of all our collaborators for their continued support in this endeavour.”
Biological E’s vaccine development is backed by Mission COVID Suraksha Programme, initiated by The Government of India (GoI)’s Department of Biotechnology (DBT).
DBT, together with its unit Biotechnology Industry Research Assistance Council (BIRAC), has been supporting the Corbevax vaccine from the preclinical stage.
In addition, the vaccine candidate has also obtained financial support under Covid-19 Research Consortia through National Biopharma Mission, BIRAC.
In August last year, Biological E has signed an agreement with Johnson & Johnson (J&J) to manufacture the latter’s vaccine candidate at its Hyderabad facility.
The company is committed to manufacturing more than 600 million doses of Janssen’s single-dose vaccine annually.
BIRAC chairperson and DBT secretary Renu Swarup said: “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.”