A new agreement will see work begin on the creation of a ground-breaking vaccine system that has been designed to combat future COVID-19 variants.

This week the World Health Organisation has said there have been more people infected with COVID in the first five months of 2021 then the whole of last year and warned the world is “still in the acute phase of the pandemic”.

As such CEPI, the Coalition for Epidemic Preparedness Innovations, has announced that it entered into a funding agreement with Gritstone bio, to advance development of a self-amplifying mRNA vaccine candidate against COVID-19 variants. CEPI will provide up to US$20.6 million to support a phase 1 clinical trial, including manufacturing of clinical trial materials as well as supporting preclinical studies and optimisation of manufacturing processes.

This funding forms part of CEPI’s programme to develop “next-generation” COVID-19 vaccines that are differentiated from those already in advanced development and can be used against COVID-19 variants. CEPI’s portfolio of “next-generation” vaccines currently includes SK bioscience’s nanoparticle vaccine candidate (GBP510), the University of Hong Kong’s intranasal vaccine candidate, VBI Vaccines’ virus-like particle candidate, and ZerunBio’s recombinant vaccine candidate.

CEPI was launched at Davos in 2017 as a partnership between public, private, philanthropic, and civil organisations, to develop vaccines against future epidemics.

Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus. Currently it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

During the current pandemic, CEPI has initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access.

CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens.

As with the mRNA-based COVID-19 vaccines that are now in global use, self-amplifying mRNA vaccines use the body’s own machinery to make antigenic protein itself rather than injecting the antigen directly into the body.

However, in self-amplifying mRNA vaccines, viral RNA is adapted in a way that allows only the genetic sequence for a specific antigen to be expressed, while keeping the part of the RNA that allows it to produce multiple copies of itself – the self-amplification machinery.

“The benefit of this approach is that the dose of RNA can be reduced while maintaining the potency of the vaccine,” explained CEPI. “Gritstone’s vaccine candidate may also elicit T-cell immune responses against non-Spike gene fragments, which are slower to mutate than the genes associated with the SARS-CoV-2 Spike protein and could potentially provide broad protection against other SARS-CoV-2 strains.”

“COVID-19 variants are already rendering some of our vaccines less effective, so it is critical that we don’t let our guard down: we must continue to invest in critical vaccine R&D if we are to stay one step ahead of this deadly virus,” added Dr Richard Hatchett, Chief Executive Officer, CEPI. “CEPI is planning for the longer-term management of COVID-19 by investing in vaccines to address the threat of variants, and I’m pleased to work with Gritstone to advance the development of this innovative vaccine candidate, which can be made globally accessible through COVAX if it is proven to be safe and effective.”

He added CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone have agreed that this vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective.

“Our unique approach combines our self-amplifying mRNA platform with a broad set of viral antigens beyond spike intended to drive robust and durable immune responses comprising both neutralizing antibodies and CD8+ T cells,” explained Dr Andrew Allen Co-founder, President and CEO of Gritstone. “With this unique antigenic breadth, our CORAL vaccine may offer protection against emerging spike variants of SARS-CoV-2 that appear challenging for first generation vaccines. We are honoured to be supporting CEPI in their mission to help find new vaccines solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks.”

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