Seattle’s Infectious Disease Research Institute is working with Houston’s Baylor College of Medicine to multiply the doses of a potential COVID-19 vaccine by 30 to 100 times. Other partners in the effort include Seattle-based PATH and Texas Children’s Hospital Center for Vaccine Development.
If the project proceeds as planned, Baylor and its partners could repurpose a vaccine candidate originally created to counter a different coronavirus-based disease known as severe acute respiratory syndrome, or SARS, to fight off COVID-19.
The recombinant-protein vaccine was tested against the SARS virus in preclinical trials, but because the 2002-2003 SARS epidemic faded away, the vaccine never got a chance to advance to clinical trials.
Now researchers at Baylor suspect that their nearly 200,000 doses of stockpiled vaccine just might provide protection against COVID-19.
The vaccine candidate is designed to train the body’s immune system to recognize a key piece of the SARS coronavirus’ “spike protein,” which helps the virus gain entry into cells. The virus behind COVID-19, known as SARS-CoV-2, has a similar protein.
IDRI’s role is to determine whether ingredients known as adjuvants can be added to the vaccine to magnify its immunizing effect. If the adjuvants work, they could reduce the amount of vaccine needed per dose, said Corey Casper, IDRI’s CEO.
“We’ve pioneered probably the largest collection of these adjuvant formulations that can be safely added to vaccines to increase their efficacy, to increase their potency, to increase the ability to store them,” Casper told GeekWire. “They’ve really revolutionized vaccines.”
Most recently, adjuvants have provided a boost to GlaxoSmithKline’s Shingrix vaccine for shingles as well as a variety of vaccine candidates for tuberculosis, Casper said. Baylor and PATH are hoping they’ll do the same for their coronavirus vaccine.
“If you only have 200,000 doses, that’s not going to be enough to cover much of the population,” Casper said. “But if you added an adjuvant to that, and it increased the potency 30 to a hundredfold, all of a sudden you begin to have a really meaningful number of vaccines that could be used very quickly.”
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Even 20 million doses of safe, effective vaccine wouldn’t be enough to immunize everyone. Casper and others involved in the campaign to quell COVID-19, including Microsoft co-founder Bill Gates, say multiple manufacturers will have to make billions of doses. Among the other companies testing coronavirus vaccines are Moderna (which began its clinical trials in Seattle), Johnson & Johnson and AstraZeneca (in partnership with Oxford University).
If everything works out the way Casper hopes, Baylor’s vaccine could make a significant contribution to the cause. Vaccine manufacturing could conceivably ramp up to fill even more of the demand. But first, researchers have to verify that the vaccine is safe and effective.
Baylor and the Texas Children’s Hospital Center for Vaccine Development plan to start Phase 1 trials of the vaccine this fall. Researchers will be recruiting a relatively small number of healthy adults in Texas to check the vaccine’s safety. If the vaccine is safe, they’ll follow up with more ambitious trials.
“Our goal is to collaborate with IDRI and rapidly take our vaccine candidate, currently stored in the freezer, and manufacture clinical-grade vaccine formulations to accelerate their development and testing efforts in the clinic,” Maria Elena Bottazzi, co-director of the vaccine development center and associate dean of Baylor’s National School of Tropical Medicine, said today in a news release.
Baylor’s Peter Hotez, another co-director of the center, noted that IDRI has been a collaborator on previous vaccine formulations. “Similarly, we will accelerate our COVID-19 candidate and ensure we will have sufficient material to rapidly evaluate its safety and efficacy in the clinic,” Hotez said.
Casper said the project plays to his nonprofit institute’s strengths in vaccine formulation and manufacturing.
“What’s really unique about IDRI is that for small biotech [companies] and for academics, there’s very little access to manufacturing for vaccine products,” he said. “It’s a complicated process, and it’s one that typically exists only in large pharma. So, several years ago, IDRI established a manufacturing facility here that allows us to make vaccines that are fit for clinical use at a smaller scale.”
This isn’t the institute’s only project related to COVID-19. In April, IDRI and New Jersey-based Celularity won won clearance from the Food and Drug Administration to begin trials of an experimental cell-based therapy for the disease.
“We now have several clinical trial sites that have been identified,” Casper said.
One of the sites will be hosted by MultiCare Health System in Tacoma, Wash.
“There’s no data we can share just yet, but we continue to be very excited,” Casper said. “This represents a new opportunity for a therapeutic approach to COVID.”
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