A COVID-19 vaccine developed by UW Medicine researchers has been approved in Korea, becoming the first COVID therapeutic technology from the Seattle health care system to be greenlighted for patient use.

UW Medicine scientists who worked on the technology behind the vaccine say their version is a “second-generation” COVID immunization that’s protein-based — different from the mRNA vaccines developed by Pfizer and Moderna. As a result, the vaccine, trademarked as SKYCovione, is effective in low doses, simple to manufacture and stable without deep freezing, said Neil King and David Veesler, both UW Medicine biochemistry professors and vaccine co-developers.

“We had already been working together before the pandemic, but when the pandemic hit, it was just this immediate, ‘Let’s do this’ joining of the forces between our two groups, which was really fun and highly productive,” King said.

The vaccine, which was approved for patient use by the Korean Ministry of Food and Drug Safety last week, is now pursuing authorization in the U.K. and other countries, according to a UW Medicine statement. If the vaccine is approved for emergency use by the World Health Organization, it will become available through COVAX, an international effort to distribute vaccines equitably around the world.

UW Medicine is licensing the vaccine technology royalty-free for as long as the pandemic lasts, the statement said. Several donors, including the Bill & Melinda Gates Foundation, National Institutes of Health and Pew Charitable Trust, among others, also helped fund the vaccine development.

It’s unclear whether the team will pursue U.S. Food and Drug Administration licensure in the future, instead focusing on getting shots to more undervaccinated countries.

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“We’ve heard stories about wealthy counties giving doses to lower and middle income countries, and then … pointing fingers at receiving countries for not being able to use them [before they expire],” Veesler said. “That doesn’t really make sense.

“These are anecdotes, but they’re still stories that happen,” he added. “These superior storage properties might make a huge difference to reach people who still have not received vaccines.”

King’s lab designed the vaccine’s self-assembling protein nanoparticle technology — a vaccine-building strategy the lab developed in 2016. Veesler’s team integrated a key fragment of the coronavirus’ spike protein onto the nanoparticles.

SKYCovione, unlike Pfizer and Moderna vaccines, is made of proteins that form tiny particles studded with fragments of SARS-COV-2. That property makes the vaccine more stable and could enable broader vaccination efforts in parts of the world where medical and storage resources are harder to find, King said.

Protein-based vaccines are considered more traditional, King added, and have been used for decades to protect against hepatitis and other viral infections.

The researchers knew early on in the pandemic that while they were chipping away at building the technology behind the vaccine, manufacturing and distribution would be key.

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So, through connections at the Gates Foundation, King and Veesler were introduced to South Korean biotech company SK bioscience, which has in-house vaccine manufacturing resources and has long developed immunizations abroad.

“In March and April 2020, we were already talking with SK and transferring our technology to them to really build that groundwork,” King said. “They did all the manufacturing and did all the clinical trials.”

The vaccine is South Korea’s first domestically manufactured COVID therapeutic, according to a statement from SK bioscience. The South Korean government has agreed to buy 10 million doses for domestic use.

In clinical trials, the vaccine was tested among more than 4,000 adults over the age of 18 and found to elicit about three times more antibodies than Covishield, the vaccine developed by AstraZeneca that does not have FDA approval, according to UW Medicine. The antibody conversion rate — the proportion of participants whose antibody levels increased fourfold or more — was also much higher with the UW-developed vaccine compared to Covishield.

No serious adverse reactions were recorded in any of the clinical trials.

While SKYCovione is arriving to the global public almost a year and a half after mRNA vaccines, its development has been “unbelievably fast” for protein-based vaccines, King said.

“Manufacturing speed is the key advantage of mRNA,” he said. “It just takes longer to manufacture proteins … But once you have it booted up, it scales beautifully.”

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