Biological E on Thursday said that it will submit final data of its Covid-19 vaccine Corbevax till November end. The announcement comes two days after the major pharma company 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.
Meanwhile, India logged 18,987 fresh coronavirus cases, taking the infection tally to 3,40,20,730 on Thursday, while the national Covid recovery rate increased to 98.07 per cent, according to the Union Health Ministry's data.
The death toll climbed to 4,51,435 with 246 fresh fatalities, the data updated at 8 am showed.
The daily rise in new coronavirus infections has been below 30,000 for 20 straight days and less than 50,000 daily new cases have been reported for 109 consecutive days now.
(With agency inputs)
