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A COVID-19 vaccine, developed at the University of Washington School of Medicine, has been proven safe and effective in late-stage clinical testing.

SK bioscience developed the vaccine, named GPB510, alongside the UW School of Medicine at the school’s facilities. The two are seeking South Korea’s authorization for use within a month. The company is seeking review and approval of the vaccine from the Korean Ministry of Food and Drug, and then will seek pre-authorization from the World Health Organization.

South Korea has agreed to buy 10 million doses.

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SK Bioscience has developed vaccines since 2008, with the cell-cultured trivalent flu vaccine in 2015, followed by the cell-cultured quadrivalent flu vaccine, the zoster vaccine, and the varicella vaccine. In 2020, the company pivoted into the global market with the development of the COVID-19 vaccine.

Unlike the earliest approved vaccines for COVID-19 that make use of mRNA, viral vectors, or an inactivated virus, GPB510 is made of proteins that form tiny particles studded with fragments of the pandemic coronavirus. These nanoparticles were designed by scientists at UW Medicine and advanced into clinical trials by SK bioscience and GlaxoSmithKline with financial support from the Coalition for Epidemic Preparedness Innovations.

“The advantage of the nanoparticle vaccine over a traditional protein subunit vaccine is that, by presenting the antigen in this repetitive array, you will elicit a stronger immune response, which should translate to better protection,” said Neil King, assistant professor of biochemistry for the UW School of Medicine, in a news release.

King also stressed that a protein nanoparticle vaccine will be easier to produce and store. It’s effective at low doses and simple to make on a large scale while not requiring deep freezing in order to become stable.

GPB510 will be available through COVID-19 Vaccines Global Access, (COVAX), a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization.

“We know we have more than 2 billion people worldwide that have not received a single dose of vaccine,” said David Veesler, associate professor of biochemistry at UW School of Medicine, in a news release. “If our vaccine is distributed through COVAX, it will allow it to reach these people that need to have access to doses.”

“It was 26 months from initiation of the project to meeting the primary endpoint in the Phase 3 clinical trial,” said Leila Gray, the public communications manager for University of Washington. But building this vaccine relied on years of previous research in the Veesler lab on coronaviruses and on existing technology platforms at the UW Medicine Institute for Protein.

This type of vaccine has been researched since 2016, as scientists in the King lab at the UW School of Medicine began developing a strategy to design proteins that self-assemble into precise spherical particles. This research showed that these nanoparticles could be decorated with proteins from a virus.

Researchers from the two labs worked together in the earliest months of the COVID-19 pandemic to design a protein nanoparticle decorated with 60 copies of the Spike protein receptor-binding domain. The designed nanostructure mimics the repetitive nature of proteins on the surface of viruses, a property that the immune system responds strongly to.

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In initial animal studies reported in late 2020, the nanoparticle vaccine was found to produce high levels of virus-neutralizing antibodies at low doses. These antibodies target several different sites on the coronavirus Spike protein, a desirable quality that may enhance protection against future coronavirus variants.

“The hope with those vaccines is that we will prevent the next pandemic instead of responding to it,” said King. “And so, the current vaccine and meeting its primary endpoint suggests that this technology may be a viable route forward.”