Hyderabad: City-based Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, is upbeat while welcoming DGCI approval that its CORBEVAX, India’s first indigenously developed protein sub-unit vaccine against COVID-19, received the approval.
CORBEVAX is a “recombinant protein sub-unit” vaccine, developed from the receptor biding 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.
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, USA.
According to B.E., the vaccine will be effective both in scale and affordability, providing sustainable access to low-and middle-income countries.
Clinical Basis & Vaccine Characteristics:
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.
• 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. CORBEVAXTM vaccination also generated significant Th1 skewed cellular immune response.
• CORBEVAX nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.
• CORBEVAX nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent 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 percent fewer adverse events than COVISHIELD.
In the continuous monitoring of phase II studies, CORBEVAX showed high persistence of immune response as indicated by <30% drop in nAb GMT till six months second dose as compared to >80% drop observed with majority of the vaccines.
Vaccine Rollout Timeline:
Biological E. Limited plans to complete production at a rate of 75 million doses per month, anticipating 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.
Soon, the company plans to deliver more than one billion additional doses globally.
“Our scientists at the 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.
Mahima Datla, managing director, Biological E. 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.”
Mahima further added, “The journey of CORBEVAX has been eventful and any words will fall short to appreciate and acknowledge the contribution of all our collaborators and their continued support in this endeavour. We would like to take the opportunity to especially thank our Prime Minister Shri. Narendra Modi ji for making vaccination a national mission. His vision and the advance commitments we received towards CORBEVAX were instrumental in our ability to scale-up and manufacture at such huge capacities.”
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