Hyderabad-based pharmaceutical company Biological E. Limited has been approved by the Drugs Controller General of India (DCGI) to conduct further trials of its vaccine Corbevax on children and adolescents.
Following Zycov-D by Zydus Cadilla and Covaxin by Bharat Biotech, Corbevax becomes the third India-made vaccine that may be available for use in children. Zycov-D has already received authorisation for emergency use in children who are over 12 years. Covaxin is being tested in children who are younger and officials have said that the vaccine is likely to be ready by September.
There are an estimated 44 crore children in India, 12 crore of whom are in the 12-17 years age group. Typically, the safety and immunogenicity of vaccines are first established in adults, following which trials begin in children.
Corbevax is based on a vaccine technology of a protein antigen, in this case the spike protein, which binds to the Angiotensin Converting Enzyme-2 (ACE2) receptor on the host cell membrane and facilitates virus entry. The body’s own cells then make more copies of this protein that then stimulates the immune system of the body to produce antibodies to protect against a potential, future infection.
Biological E. expects to launch its vaccine for adults by October, Dr. V.K. Paul, Member (Health), NITI Aayog said on Thursday. Health Ministry officials said in June that the Centre had reserved 30 crore doses of the vaccine for inclusion into India’s vaccination drive.
“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 Mahima Datla, managing director, Biological E., in a statement.
The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC), have supported Biological E.’s COVID-19 vaccine candidate from preclinical stage to Phase-3 clinical studies, Renu Swarup, Secretary, DBT, said in a statement.