Vaccine maker Biological E (BE) on December 29 announced that it has secured $5 million funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for scaling up manufacturing of its protein subunit COVID-19 vaccine.
CEPI will also explore providing additional funds to BE with the goal of potentially enabling the production of 100 million doses in 2021, BE said.
The vaccine maker had initiated a Phase 1/2 clinical trial to evaluate the safety and immunogenicity of the vaccine candidate in India in November 2020, and expects interim data from the trial to be available in Q1 of 2021.
"CEPI and BE are committed to global equitable access of COVID-19 vaccines and have 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," BE and CEPI said in a joint statement.
The COVAX Facility aims at ensuring equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The BE COVID-19 vaccine candidate is being developed in collaboration with the Baylor College of Medicine, US.
The vaccine is based on SARS-CoV-2 Spike protein subunit, which is combined with two adjuvants -- Alhydrogel (Alum) and CpG 1018 -- to boost efficacy.
The Spike protein is expressed in yeast Pichia pastoris, and is similar to the technology BE is employing for large-scale commercial production of Hep B vaccines.
“We are very happy to have partnered with CEPI on this endeavour. This collaboration with CEPI validates the technology platform BE is working on for developing an effective COVID-19 vaccine candidate," Managing Director of BE Mahima Datla said."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," Datla added.
"Potential advantages of this vaccine candidate include scalability and thermostability, which could make it suitable for deployment at scale in low-resource settings," Dr Richard Hatchett, CEO of CEPI said.BE has also entered into a collaboration to manufacture Johnson & Johnson's potential COVID-19 vaccine which is in late-stage clinical trials in the US.