Corbevax 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.
Biological E. Limited plans to complete production at a rate of 75 million doses of its COVID-19 vaccine Corbevax per month, anticipating over 100 million doses per month from February 2022 which will enable the city-based company to deliver 300 Million doses as promised to the Centre, BE said on Tuesday.
Corbevax , India's first indigenously developed protein sub-unit vaccine against the virus, received the approval from the Drugs Controller General of India (DGCI) today, it said. According to a press release issued by the vaccine maker soon, the company plans to deliver more than one billion additional doses globally.
"Biological E. Limited plans to complete production at a rate of 75 Million doses per month, anticipating over 100 million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Government of India," it said. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children's Hospital Centre for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.
Mahima Datla, Managing Director, BE limited said, "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. Corbevax 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. The vaccine was found to be safe, well tolerated and immunogenic, the company said.
In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, Corbevax demonstrated superior immune response in comparison with Covishield vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant, the release said.
"Our scientists at Texas Children’s Hospital and Baylor College of Medicine are thrilled to help in the development of this vaccine, possibly the first covid vaccine specifically designed for global health," Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Centre for Vaccine Development said.
-With PTI Inputs