Pharma major Biological E has sought approval from drug regulator Drugs Controller General of India to conduct the phase-3 clinical trial of Covid vaccine Corbevax. The company has sought approval as a single booster dose for those fully vaccinated with Covishield or Covaxin vaccines.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) may discuss the matter in its next meeting.
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 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.