Biological E plans to produce its Covid19 vaccine Corbevax at the 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. Soon, the company plans to deliver more than one billion additional doses globally.

The Hyderabad-based BE's Corbevax, India’s first indigenously developed protein sub-unit vaccine against Covid-19, received approval from the Drugs Controller General of India (DGCI).

The double dose vaccine 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.

“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 Datla, Managing Director, Biological E, said in a release on Tuesday.

On the journey of Corbevax, Dalta said: “We would like to take the opportunity to specially thank Prime Minister Narendra Modi 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.''

While Covid Suraksha Program’s endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was set-up with the support of Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) allowed BE to scale up to a capacity of about 1.2 billion doses per annum, she added.

“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 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.

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 will be effective both in scale and affordability, providing sustainable access to low-and middle-income countries.

Clinical trials

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.

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 per cent 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 over 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 percent fewer adverse events than Covishield,'” the company said.