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SKYCovione, developed by the University of Washington. (UW Photo)

Two COVID-19 vaccines with roots in Seattle cleared major regulatory milestones Wednesday. South Korea approved a shot developed by University of Washington researchers and Indian regulatory authorities issued an emergency use approval for another shot linked to Seattle startup HDT Bio.

Both vaccines are stable at refrigerator temperature and were developed with an eye towards worldwide distribution, including in areas of the word under-served by COVID-19 vaccinations.

The UW’s all-protein vaccine has its origins in the labs of biochemistry researchers David Veesler and Neil King, based at the UW Institute for Protein Design.

The vaccine is a spherical particle studded with portions of the viral spike protein; it self-assembles from the separate components, easing manufacture.

The UW shot was licensed to South Korean biopharma company SK bioscience, which combined it with an adjuvant from GlaxoSmithKline. GSK’s adjuvant serves an immune-boosting function in the vaccine, called SKYCovione.

The Korean Ministry of Food and Drug Safety approved SKYCovione for adults over aged 18 and the South Korean government agreed to purchase 10 million doses for domestic use. In addition, SK bioscience is seeking approval for authorizations at other regulatory agencies, including for emergency use listing to the World Health Organization.

The vaccine with origins at HDT Bio is based on RNA, like the approved vaccines from Moderna and Pfizer. But the new shot is additionally powered to make multiple copies of itself, which yields a potent vaccine at lower doses, and at lower costs. It’s also easier to manufacture, according to HDT.

HDT Bio licensed the vaccine to Emcure subsidiary Gennova Biopharmaceuticals, based in Pune India, and is embroiled in a lawsuit alleging that Emcure stole its trade secrets and failed to share clinical data. The company has not released its phase 3 study on the shot. Gennova reportedly has 7 million doses on hand.

UW researcher Neil King at the GeekWire Summit. (GeekWire Photo/Kevin Lisota)

The UW shot is the first vaccine or therapy approved based on computational design, King told GeekWire. And SK bioscience studies suggest it prompts a robust immune response.

SK bioscience tested SKYCovione in a two-dose phase 3 clinical trial in 4,037 adults over age 18. The study found it resulted in a more robust immune response to the original COVID-19 strain than AstraZeneca’s shot Vaxzevria. SKYCovione yielded three times more “neutralizing” antibodies directed against the virus.

In King’s view the data suggest SKYCovione could have the potential to go head-to-head with known RNA vaccines, he told GeekWire. Though the shot was not tested directly against the Moderna and Pfizer vaccines, based on the SK bioscience data SKYCovione may be “at least as potent” he speculated in an interview earlier this month.

Many earlier shots were approved based on clinical efficacy against the disease, but the use of such measures of immunity may become more common as researchers understand more about how they correlate with protection.

“I anticipate this will become more and more common as the pandemic evolves,” said Veesler in an email. A recent preprint study led by researchers at Fred Hutchinson Cancer Canter, for instance, showed that neutralizing antibodies tracked with protection against Novavax’s vaccine.

Data from earlier clinical trials of SKYCovione are available as a preprint study and the phase 3 data will be published soon, said Veesler.

SK bioscience is currently working on a study evaluating the shot against Omicron and other COVID-19 variants. The platform also has potential to be used as a shot to protect against a range of variants said King, which SK bioscience is also studying.

The idea is to stud the nanoparticle with protein fragments from different variants.

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Carl Walker

Carl Walker

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