CEPI, the Coalition for Epidemic Preparedness Innovations, is collaborating with an India-based pharmaceutical company to develop a COVID-19 subunit vaccine candidate.
The partnership is with Biological E Limited, or Bio E, a Hyderabad-based vaccine and pharmaceutical company. CEPI will contribute up to $5 million to scale up the process for manufacturing the vaccine and will consider additional funding after that. The goal is to enable the production of 100 million doses in 2021.
Bio E conducted Phase 1 and 2 clinical trials to evaluate the vaccine candidate’s safety and immunogenicity in November. It expects interim data from the trial to be available in the first quarter of 2021. CEPI and Bio E have agreed that vaccine output funded by CEPI’s investment will be made available through the COVID-19 Vaccine Global Access (COVAX) Facility. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries at all development levels.
Bio E’s COVID-19 vaccine candidate is based on the protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Alhydrogel, combined with another approved adjuvant, CpG 1018. The RBD of S1 subunit binds to the Angiotensin Converting Enzyme-2 (ACE2) receptor on host cell membrane and facilitates virus entry.
“The world has made huge strides in developing vaccines against COVID-19, but there is still much work ahead of us, and it is absolutely critical that vaccine R&D continues at pace. To end the acute phase of the pandemic and control the virus in the longer term, we will need a range of safe and effective vaccines that can be manufactured at scale to meet global demand for billions of doses and deployed to a wide range of populations and settings so that nobody is left behind,” CEPI CEO Richard Hatchett said. “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.”
This vaccine candidate’s potential advantages are its scalability and thermostability, which could make it suitable for deployment at scale in low-resource settings.
“This collaboration with CEPI validates the technology platform Bio E is working on for developing an effective COVID-19 vaccine candidate. The initial investment from CEPI comes on the heels of investments from the Bill & Melinda Gates Foundation and Biotechnology Industry Research Assistance Council (BIRAC) under the National Biopharma Mission of Dept of Biotechnology, Govt of India, and provides the impetus for accelerated efforts towards a successful and scalable outcome for global access,” Mahima Datla, managing director, Biological E, said. “Over the past 10 months, the world has witnessed an unprecedented health emergency and is eagerly awaiting a COVID-19 vaccine. We are working tirelessly to produce a safe and effective vaccine against COVID-19 at an unprecedented pace.”
Including Bio E, CEPI has invested in 11 COVID-19 vaccine candidates. Of the 11, nine of them are still in development, and seven are in clinical trials. Overall, CEPI has raised $1.3 billion in support of COVID-19 vaccine research and development.