Biological E seeks nod for phase 3 trial of Corbevax as booster dose

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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.

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Arushi Sana is the Co-Founder of Santerra Living, a bio-pellet factory that makes a renewable form of eco-coal and Co-Founder of NYK Daily, a global news platform. She was awarded the Times Power Women of the Year 2022, Times Digital Entrepreneur of the Year 2023, Silicon India's Top 10 Women Owned Startups of Hyderabad 2023 and IHW Council Climate Health Influencer 2024. Arushi is also a speaker for Sustainability and Entrepreneurship at various forms like the World Bank, UN International Solar Alliance and Universities, and was also invited to the UN COP28 UAE Climate Conference. She is a Sustainability Consultant for organisations looking to reduce their carbon footprint and also works with brands on social media to help them carve a presence in that niche. She holds a Degree in Computer Science Engineering from VIT University and a Diploma in Marketing Analytics from IIM Nagpur. She has previously worked in Ernst & Young and Deloitte as a Forensic Data Analyst. Arushi is a writer, political researcher, a social worker, a farmer and a singer with an interest in languages. Travel and nature are the biggest spiritual getaways for her, and she aims to develop a global community of knowledge and journalism par excellence through this News Platform.

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