(p. A10) Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14.
Together, the sisters make up about 5 percent of the first ever clinical trial of a DNA vaccine for the novel coronavirus. How they respond to it will help determine the future of the vaccine. If it proves safe in this trial and effective in future trials, it could become not only one of the first coronavirus vaccines, but also the first DNA vaccine ever approved for commercial use against a human disease.
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In many of these studies, the vaccine recipe isn’t the only thing on trial. Gene-based vaccines — and at least 20 coronavirus vaccines in development fall into this category — have yet to make it to market. Should one end up in doctors’ offices amid the rush to shield billions from Covid-19, it would represent a new chapter for vaccine development.
And though vaccine research has never moved this quickly — potentially meaning enhanced risks for volunteers — it has never been easier to recruit subjects, according to Dr. John E. Ervin, who is overseeing the DNA vaccine trial at the Center for Pharmaceutical Research in Kansas City, Mo., in which the sisters are involved. For the Phase 1 trial of the vaccine, which was developed by Inovio Pharmaceuticals, 90 people applied for the 20 slots in Kansas City.
“We probably could charge people to let them in and still fill it up,” he said. (In fact, the participants were paid per visit.)
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Inovio researchers engineered the vaccine in just three hours, according to Kate Broderick, the company’s senior vice president for research and development. Or, rather, their computer algorithm did: On Jan. 10 [2020], when Chinese researchers released the genetic code of the novel coronavirus, the team ran the sequence through its software, which popped out a formula.
This timeline struck some in the financial sector as too good to be true. Citron Research, which advises investors on companies to bet on, called Inovio “the Covid-19 version of Theranos,” referring to the blood-testing device company that imploded as its supposedly revolutionary product was revealed to be a hoax.
“Much like Theranos, Inovio claims to have a ‘secret sauce’ that, miraculously, no pharma giant has been able to figure out,” Citron Research wrote. “This is the same ‘secret sauce’ that supposedly developed a vaccine for Covid-19 in just three hours.”
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(Note: the online version of the story was updated June 22 [sic], 2020, and has the title “Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers.”)