Biological E. Limited, whose Corbevax on Tuesday received the approval from the Drugs Controller General of India (DGCI), plans to produce 75 million doses per month and anticipates over 100 million doses per month from February 2022.
The Hyderabad-based company said these capacities will enable it 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.
Corbevax, India's first indigenously developed protein sub-unit vaccine against Covid-19, has been developed by Biological E in collaboration with Texas Children's Hospital Center for Vaccine Development (Texas Children's CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.
The vaccine will be effective both in scale and affordability, providing sustainable access to low-and middle-income countries, the vaccine maker 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," said Dr. 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.
"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," said Mahima Datla, Managing Director, Biological E. Limited.
Corbevax 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.
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 the immune response against the virus.
"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 Neutralising Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. Corbevax vaccination also generated a significant Th1 skewed cellular immune response," Biological E said.
According to the vaccine-maker, Corbevax nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of more than 90 per cent for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.
Against the Delta strain, it indicates a vaccine effectiveness of more than 80 per cent for the prevention of symptomatic infections based on published studies.
While none of the subjects who took Corbevax or Covishield had serious adverse events, Corbevax had 50 per cent fewer adverse events than Covishield.