After a deflating announcement of more Covid-19 restrictions over the weekend, Seattle has since received a couple doses of good news. Today pharma giant Pfizer released data that suggests its vaccine candidate is 95 percent effective. And earlier this week Moderna, a Cambridge, Massachusetts–based biotech firm, reported that its coronavirus vaccine candidate reached just about the same efficacy, which would clear the FDA’s 50 percent standard for approval.
Moderna's shot, called mRNA-1273, was developed in conjunction with the National Institutes of Health (NIH) and first administered to a group of volunteers at Kaiser Permanente Washington Health Research Institute in the Denny Regrade. But the vaccine’s revelatory phase three trial, and Pfizer's, are both tied to a different Emerald City medical institution.
Since July, the Fred Hutchinson Cancer Research Center in South Lake Union has served as the operations hub for the NIH’s Covid-19 Prevention Network. This scientific command center coordinates the study of vaccines and monoclonal antibodies for SARS-CoV-2, the virus that causes Covid-19, at trial sites across the globe. As companies race to produce the first effective coronavirus shot, the network preserves the integrity of these sprints, safeguarding the enrollment and assessment of phase three clinical trials with tens of thousands of subjects, like Moderna’s. “Our job is to deliver a vaccine with as much veracity and as quickly as we can,” Dr. Larry Corey, a co-leader of the network and a former president and director of Fred Hutch, said earlier this fall.
Fred Hutch labs examine the effects of coronavirus vaccines and the virus itself. But its work within the Covid-19 Prevention Network is often logistical, less photo-friendly than white lab coats bending over beakers ("lots of Zoom calls," Corey said). That doesn't make it any less vital. The network, for instance, must pinpoint trial sites and conduct community outreach to guarantee that studies represent the population. Its enrollment approach not only ensures the studies' legitimacy but also can inform the vaccines' eventual distribution: Certain shots may be more effective than others for various demographics. Consistent lab and enrollment processes across trials allow researchers to measure any differences. “We actually know we have designed these trials incredibly well,” Corey said.
Skeptics of "Operation Warp Speed” might question this scientific mad dash. The network falls under the Trump administration’s frightening umbrella term for the mission to deliver a vaccine as soon as possible. Its strategic engagement plan, however, cites a couple of the most common explanations for the potentially expedited results: the U.S.'s unusual upfront investment in producing vaccines after early-stage success, and a reduction of the oft-maligned "bureaucracy." And Corey's confidence about the final stages of the process stems from something more fundamental, something decades in the making: infrastructure. "We can enroll the right demography," he said, "if we use the right sites and use the networks that we have built up over the last 20 years."
For the past two decades, the HIV Vaccine Trials Network at Fred Hutch has run more than 50 vaccine clinical trials across five continents for the virus that causes AIDS. Corey co-founded the network in 1998 with the backing of his good friend Dr. Anthony Fauci, the National Institute of Allergy and Infectious Diseases (NIAID) director known today as the nation’s unofficial coronavirus czar. The two grew close in the 1980s, when they began studying treatments to address the HIV/AIDS crisis, and speak nearly every day. "He's an extraordinary person of great intellect, and he's a great communicator," said Corey, adding, "He's incredibly principled."
Before Operation Warp Speed entered the lexicon and Fauci became a fixture on every imaginable medium, the doctors discussed launching another network, this time to coordinate and study vaccine trials for the new coronavirus. Though the HIV Vaccine Trials Network hadn't yet yielded shots that prevented the AIDS-causing virus's transmission, the design of those studies was sound; it was just the elusive miracle vaccine that was missing. A similar setup at Fred Hutch would work just fine for Covid research, making it the natural choice for the Covid network's coordinating center. It would just require even greater urgency. "I'm not going to minimize HIV," says Corey, "but this coronavirus has affected all of us every day."
Corey had just returned from a meeting about HIV overseas when the coronavirus outbreak emerged in the U.S. "It took me about two and a half to three weeks to get my head around the fact that we needed to pivot," he says. "I was already starting to talk to the companies about working with the NIH in the clinical trials business by sort of the third week of March."
It wasn't hard to get buy-in from the infectious disease specialists at Fred Hutch, according to Corey. While the institution's name suggests a site solely devoted to cancer research, its mission has long encompassed the study of other diseases that cause "human suffering and death." Findings in one area of research have advanced discoveries in others, and its role in global health research continues to expand. Fred Hutch recently announced that its main campus would not just facilitate but host a phase three trial of the AstraZeneca vaccine candidate. It can also now tout a new Covid-19 clinical research center and a 106,000-square-foot research space in the renovated Lake Union Steam Plant.
The shiny digs shouldn't overshadow the work of those toiling within them. Nor should the politics of licensure, Corey said. He stressed that scientists working 12 or 14 hours on experiments every single day are responsible for the "unbelievable feat" of developing a vaccine this quickly: "That's what's gotten us here."