Cosplayers acquire wicked colds from comic conventions so frequently that they’ve dubbed the inevitable malady “con-crud,” or “con-plague.” But this year’s Emerald City Comic Con, slated for mid-March, posed an unprecedented health threat to the geeks prepared to gather in its midst.
The new coronavirus had already begun to ravage Life Care Center of Kirkland and spread elsewhere around the Puget Sound region, the disease’s original stateside epicenter. Missy Peña, a local comic book illustrator at the time, worried that inviting gamers and anime aficionados to visit sickly Seattle seemed like a prescription for something far worse than a standard con-bug. “This one would be deadly.”
Dismay accompanied her relief, though, when organizers postponed the annual event at the Washington State Convention Center less than a week before its start. Peña made her living selling art on the convention circuit. The Capitol Hill resident had just returned from a fruitful weekend at the Chicago Comic and Entertainment Expo, and the Seattle conference would feature her debut on a panel—two days before her birthday, no less. Now coronavirus had imperiled the future of comic cons, of her career.
As Peña pondered her predicament, she happened upon the news that Kaiser Permanente Washington Health Research Institute needed volunteers for the very first human trial of any coronavirus vaccine. A federal health department had tapped the Seattle center to perform the initial jabs of a shot developed by the National Institutes of Health and Moderna, a Massachusetts-based biotech firm, to protect against the virus that causes Covid-19. Phase one would test the potential vaccine’s ability to generate antibodies and something far more fundamental—its safety—in a small group of people.
Peña had wondered how she could help hasten the return of conventions. Here was that opportunity; the sooner a vaccine could arrive, the sooner such gatherings could come back. She already visited Kaiser Permanente’s Capitol Hill branch for doctor’s appointments anyway, and she met the study’s criteria for participation: healthy, 18–55, no underlying conditions. The clincher? The institute was just a short walk from home. “I felt like it was my duty, in a weird way,” she says.
So Peña ushered in her 33rd year not with a boost in art sales but with a shot in the arm of messenger RNA. As outbreaks mushroomed around the globe, she and 27 other volunteers visited a Seattle clinic to receive two doses of an mRNA vaccine, produced in record time, with unknown side effects. Nobody knew how their bodies would react.
The world waited.
In one sense, Seattle is an improbable place to mount a global vaccine testing campaign. Smallpox and measles outbreaks in Washington flanked our last two pandemics, and the proportion of the state’s students without vaccines for non-medical reasons remains well above the national average, at nearly 5 percent. “Parents don’t see these diseases anymore, so it’s sort of out of sight, out of mind,” Seattle Children’s pediatrician Dr. Douglas Opel says of those refraining from immunizing their children. In 2018, a year before the most recent measles outbreak in Washington, the journal PLOS Medicine deemed Seattle an anti-vaccine hot spot.
Conversely, one of the city’s medical institutions was well-positioned to play a pivotal role in advancing the study of coronavirus vaccines. Since 2007, Kaiser Permanente Washington Health Research Institute in the Denny Regrade has served as a Vaccine and Treatment Evaluation Unit. Ten VTEUs across the country conduct clinical trials at the request of the National Institute of Allergy and Infectious Diseases. Kaiser Permanente has tested immunizations for swine and avian flu, the latter during a pandemic preparedness exercise a few years ago.
In January, as Snohomish County reported the nation’s first confirmed case of the virus that had devastated Wuhan, China, Dr. Lisa Jackson and her team at the clinic began crafting a proposal to enroll trial participants for a coronavirus vaccine. With FDA approval, the NIH trial would begin in Seattle just 66 days after Chinese scientists released the virus’s initial genome, the genetic characteristics that would guide vaccine-making. A process that can take years, streamlined to two months and change. Dr. Colin Fields, one of Jackson’s colleagues, calls that pace “remarkable.”
Fields credits the rapid response to advancements in scientific technologies, including the use of a messenger RNA, or mRNA, vaccine that’s easy to scale. The federally backed “mRNA-1273” produces the spike protein found in SARS-CoV-2 without using a weakened or dead sample of the virus, which is the traditional way to generate antibodies. Scientists have previously created messenger RNA vaccines for MERS and Ebola—“it’s not unique,” says Fields. But the new vaccine technology has never before reached the licensing stage for humans.
Skepticism about this coronavirus shot’s development, and others, abounds. In September, a Pew Research survey found that only 51 percent of U.S. adults would “definitely or probably” accept a vaccine were it offered to them that day, well below what experts believe the country will need to achieve herd immunity. “It emphasizes that the studies need to be thorough,” says Fields, “and we need to investigate the safety and efficacy as best that we can.”
The NIH study initially gauged what the body could tolerate by delivering low, medium, and high doses to 45 participants, including a smaller group in Atlanta. Unlike later samples, these human guinea pigs weren’t representative of society—beyond age and health restrictions, 40 were white—but their experiences in the weeks after their injections were plenty varied.
On the morning of St. Patrick’s Day, Missy Peña downed a bottle of orange juice. She wanted to be gentle with herself; she’d soon receive her first injection of a vaccine with uncertain effects on humans, one that came with a tome of a consent form. She anticipated stronger reactions than ones from, say, a flu shot.
Her friends and family members had supported her participation in the study. Her parents are retired firefighters, as was her grandfather; growing up around their selflessness had inspired her decision to volunteer for the trial as much as her interest in returning to artist alleys at conventions.
She’d need that motivation. The study demanded a 14-month commitment. Peña and her fellow subjects would regularly submit to blood-draws and checkups in addition to two shots—one primer, one booster—administered four weeks apart. They’d agree to some predictable (no international travel) and less predictable (no unprotected sex) behavioral restrictions. And for their troubles, they’d collect $100 per appointment as they tested a product potentially worth billions.
Peña didn’t ask which amount of the vaccine she’d be getting before a doctor stuck a needle in her arm on March 17. It stung a little—“kind of like a tetanus shot”—but she’d leave with nothing more than a sore arm that day. No chills. No nausea. No fanfare.
The interview requests started the minute Jennifer Haller stepped out of the clinic that’s tucked inside a Denny Regrade office building. First, via a call from her mother. “She’s like, ‘I’ve got Deborah Horne from KIRO!’” Haller remembers. Later, from CNN, MSNBC, NPR, and many, many other outlets.
On March 16, Haller became the first person in the world to receive a coronavirus vaccine. Like Peña, Haller had felt little effect from her initial dose of mRNA-1273. Some arm soreness, sure, and perhaps a slightly elevated temperature, but it was hard to tell if the rise stemmed from the shot or merely the feverish media attention in its aftermath. While Peña could spend the mandatory hour-long observation post-vaccination devouring fanfic on her phone, Haller had to field questions from the Associated Press, which had filmed her injection.
Haller knew what was coming—to some extent. The night before the shot, the then 43-year-old Ballard resident saw a report that the first human trial would begin the next morning. Her appointment was scheduled for 8am. That might be me, she thought.
Haller had never joined such a study, but she had volunteered her newborn son to participate as a healthy control in research conducted by the University of Washington many years earlier. “For somebody to go first like this,” she says now, “it probably takes somebody like me, who’s a bit optimistic and trusting and trusts science.”
When Haller saw a Facebook post promoting the NIH study at Kaiser Permanente, she quickly filled out a form that asked basic questions about her health history. A follow-up call to confirm her interest interrupted dinner with a friend at El Chupacabra on Phinney Ridge. “There’s doubt, of course. There’s risk and concern,” says Haller of her participation. “But thinking about it big-picture, thinking about the good that this can do for the world…it was a simple choice for me.”
As Haller made headlines, she noticed other volunteers appearing in news stories. She contacted one who’d impressed her with his scientific knowledge and coherence in front of the camera, especially given what he’d just endured.
Exactly 12 hours after receiving his second dose of the vaccine, Ian Haydon started to shiver. His girlfriend, Taylor Lidsky, assured him that their Roosevelt apartment was perfectly temperate on this early-May eve. But Haydon still felt chilly. Around 10pm, he wrapped himself in a sweatshirt and sweatpants and went to bed.
That night, the 29-year-old’s body treated his vaccine consent form like a script. He awoke at 1am with a headache, nausea, fatigue, and, most troublingly, a raging 103-degree fever. “All this stuff on the watch list sort of hit me all at once,” he recalls.
Haydon wanted to sleep it off. But at 3am, with his fever still topping 103, Lidsky convinced him that the couple should call the study’s 24-hour hotline. They immediately reached the principal investigator, Dr. Lisa Jackson, and she encouraged them to drive to Kaiser Permanente’s urgent care clinic.
A team in “spacesuits” greeted him—a precaution in case he’d somehow contracted coronavirus (a swab came back negative). They gave him IV fluids and Tylenol, and his temperature dropped a couple of degrees. He started to feel better. Back home, Haydon slept for hours before getting up to pee and, unexpectedly, vomiting. In the kitchen shortly thereafter, he fainted (Lidsky caught him). His condition didn’t require another urgent care visit, but more traditional remedies—the couch, hydration. Within 24 hours, he’d recover. Researchers told him his immune system had overreacted even as he’d kept calm. “I never felt the sort of, ‘Oh, my God, I’m going to die’ panic,” he says.
Haydon speaks about his side effects with a scientist’s remove for a reason. He works at UW’s Institute for Protein Design, where development of a different Covid-19 vaccine is underway, and has a background in molecular biology and biochemistry. He learned about the trial at Kaiser Permanente through a Slack message from a coworker.
Unlike Peña and Haller, Haydon belonged to the trial group that received the highest dose of the vaccine. He wasn’t concerned when he found out; a lack of potency was one reason mRNA vaccines had never been licensed, Haydon thought. That would explain the second shot of mRNA-1273.
But a preliminary report published this July documented three “severe adverse events” in the high-dose cohort. The paper in The New England Journal of Medicine says “no trial-limiting safety concerns were identified.” Still, the larger amount wouldn’t resurface in future research.
Haydon, who inspired his mother to join a phase three study in California, remains pragmatic about his vaccine experience. “I wish it didn’t happen to me,” he says, “but the fact that the high dose of this vaccine can sometimes produce this kind of side effect is really important information to know.”
Whether it was Haydon’s steady intonation or measured take on the vaccine, internet anti-vaxxers didn’t buy his story when he first shared it publicly this spring. In short order, they called him a robot, an actor, a pharmaceutical company worker, and an operative for Bill Gates. They also fabricated stories about his health.
Yet the trolling couldn’t suppress the most important takeaway from phase one of the NIH trial: that it had worked. The vaccine had spawned antibodies in every participant, and an expanded study involving older adults later found the same.
There’s at least anecdotal evidence that skeptics might ultimately accept a vaccine like the NIH-Moderna one. Dr. Douglas Opel, the Seattle Children’s pediatrician, says that parents who once focused on the risks of immunization can no longer overlook the toll of infectious diseases because they’re currently witnessing it. “I’m on board now,” multiple converts have told him.
Since his immune system’s 24-hour revolt, Haydon has felt normal. So have Haller and Peña. But their early-stage vaccination hasn’t let them walk around more freely in a contagious world. Only phase three trials can prove broad levels of vaccine protection. Trial participants still practice social distancing, still wear masks. Haydon worries about seeding more vaccine doubts if he catches Covid-19.
Even as vaccines progress into their final stages of testing and, potentially, move toward approval, phase one participants of the initial NIH trial must continue to honor their commitment, visiting Kaiser Permanente for checkups. You don’t have to remind Peña. In early September, she shed her financial dependence on comic cons, landing a senior illustrator position at a mobile games company. Her employer wants her to work out of its Barcelona office.
Eventually, she says. She has a trial to see through first.