Biological E, a Hyderabad-based vaccine and pharmaceutical company, has announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India called Corbevax and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) – Subject Expert Committee (SEC). The trials are expected to be completed by July.

“We are delighted with the success of the Phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” said Ms. Mahima Datla, Managing Director, Biological E. Limited.

Why is government backing its production?

After failing to boost the production of Covishield and Covaxin at a rate that could help the Indian population gets vaccinated rapidly, to control the virus, we will need a range of safe and effective vaccines that can be manufactured to meet the demand for billions of doses. This vaccine candidate provides that scalability which could make it suitable for deployment in low-resource settings.

Considering the low production cost due to easy access to the raw materials at low prices, this vaccine is likely to be the cheapest vaccine we have till now and would probably be available at around ₹250 per dose. The government has also paid another 100 crores for pre-clinical and post-clinical trials.

“Bio E’s vaccine candidate has the potential to be produced at scale, and characteristics which could make it suitable for broad distribution in developing countries. I’m pleased to partner with Bio E to progress the development of this promising vaccine,” said Dr. Richard Hatchett, CEO of CEPI that partnered with Biological E in December, 2020 to enhance its development and production.

Besides CEPI, the manufacturers have also received initial investments from the Bill & Melinda Gates Foundation and Government of India’s Biotechnology Industry Research Assistance Council (BIRAC).

How is it different from other vaccines?

AstraZeneca/Covishield, Johnson & Johnson, and Sputnik are viral vector vaccines. The vaccines by Moderna and Pfizer are m-RNA based, and Covaxin, Sinopharm’s SARS-CoV-2 Vaccine, and Sinovac-CoronaVac are inactivated vaccines. On the other hand, Corbevax is a protein based vaccine.

After Australia’s Covax-19, this Indian candidate highlights the importance of advancing traditional protein-based vaccine platforms.

To read more on Covax-19:  NEW AUSTRALIAN VACCINE TO COMPLETELY PREVENT COVID-19 TRANSMISSION

The vaccine is based on the technology of a protein antigen, SARS-CoV-2 Spike RBD. The RBD of S1 subunit binds to the receptor on host cell membrane and facilitates virus entry.

The antigen was developed by Texas Children’s Hospital Centre for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) advanced adjuvant CpG 1018TM.