Hyderabad, Dec The Coalition for Epidemic Preparedness Innovations (CEPI) will contribute up to $5 million toward the cost of scaling up the process for manufacturing of Biological E. Limited's Covid-19 subunit vaccine.
CEPI will also explore providing additional funding to Biological E (Bio E) with the goal of potentially enabling the production of 100 million doses in 2021.
Last month, Bio E initiated a Phase 1/2 clinical trial to evaluate the safety and immunogenicity of the vaccine candidate in India. The Hyderabad-based vaccines and pharmaceutical company expects interim data from the trial to be available in Q1 of 2021.
CEPI and Bio E said in a joint statement that they are committed to global equitable access of Covid-19 vaccines. They agreed that vaccine output funded by CEPI's investment will be made available for procurement and allocation, if proven to be safe and effective, 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 levels of development, that wish to participate.
Bio E's Covid-19 vaccine candidate is based on classical vaccine technology of a protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Alhydrogel (Alum), in combination 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.
Potential advantages of this vaccine candidate include scalability and thermostability, which could make it suitable for deployment at scale in low-resource settings, says Bio E.
"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," said Dr Richard Hatchett, CEO of CEPI.
"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," he added.
"This collaboration with CEPI validates the technology platform BioE 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 the Government of India's Biotechnology Industry Research Assistance Council (BIRAC), and provides the impetus for accelerated efforts towards a successful and scalable outcome for global access," said Mahima Datla, Managing Director, Biological E.
CEPI is supporting the research and development of a diverse portfolio of vaccine candidates based on a range of vaccine approaches. Including Bio E, CEPI has invested in 11 vaccine candidates, nine of which are still in development, and seven of which are in clinical trials.
CEPI has raised $1.3 billion in support of Covid-19 vaccine research and development, but urgently needs $800m in additional funds to achieve its aim of developing three safe and effective vaccines which can be made globally available through COVAX.
( With inputs from IANS )
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