DCGI gives approval to Biological E for Corbevax

It has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India.

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DCGI CDSCO

Last Updated on December 31, 2021 by The Health Master

Biological E. has announced that its CORBEVAX, India’s first indigenously developed protein sub-unit vaccine against C-19, has received approval from the Drugs Controller General of India (DGCI).

CORBEVAX is a “recombinant protein sub-unit” vaccine, developed from the receptor binding domain (RBD) of the spike protein on the virus’s surface combined with Dynavax’s CpG 1018 adjuvant with alum, which helps the body build an immune response against the virus.

The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.

It has completed two Phase III clinical trials involving more than 3,000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well tolerated and immunogenic.

The government of India, Ministry of Health and Family Welfare said, “We are glad that India has produced yet another C-19 vaccine. We believe that this vaccine will address the needs of the world and help the global population fight against the spread of C-19. ”

Biological E. plans to complete production at a rate of 75 million doses per month, anticipating 100+ million doses per month by February 2022.

This capacity will enable the Hyderabad-based company to deliver 300 million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally.

Mahima Datla, Managing Director, Biological E. said, “While the C-19 Suraksha Program’s endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was setup with the support of the Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) allowed us to scale up to a capacity of about 1.2 billion doses per annum, making the dream of accessibility, affordability, and supply-a reality.”

We deeply appreciate CEPI, BCM, the Bill and Melinda Gates Foundation, DFC, Texas Children’s Hospital, Translational Health Science and Technology Institute (THSTI), and the Government of Telangana for their continuous support and cooperation during this journey.

We also thank our volunteers and our funding institutions IFC and EXIM for the trust placed in us. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge.”

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