New Delhi: Pharma company Biological E has reportedly sought approval from Indian drug regulators to conduct the third-phase clinical trial of its Covid-19 vaccine Corbevax that would serve as a booster dose for those who are fully vaccinated with Covishield and Covaxin.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) may discuss the matter in its next meeting.
In a statement, the Hyderabad-based company has said a lot of studies has suggested that antibodies decline even among inoculated individuals and many countries have already begun or are planning to start booster doses for their citizens. Hence, it wants to evaluate the safety of Corbevax, in vaccinated people.
The Phase 2/3 clinical trials of Corbevax are underway and the results are likely to be declared this month.
Corbevax is based on a protein antigen technology that binds to the Angiotensin-Converting Enzyme-2 (ACE2) receptor on the host cell membrane and facilitates virus entry. The body's own cells stimulate the immune system of the body to produce antibodies to protect against the infection.
Biological E. received DCGI approval for conducting Phase III Comparator Safety & Immunogenicity trial in adults after the Subject Expert Committee's review of Phase I and II clinical trials data last month. Additionally, Biological E. A also received approval to initiate the Phase II/III study to evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX in children and adolescents last month.
The pharma company has submitted the application seeking the nod from DCGA to conduct the phase-3 clinical study of Corbevax.