It happened again.
The scramble for a novel coronavirus vaccine hit a new roadblock on Monday when pharmaceutical giant Johnson & Johnson paused large-scale, Phase 3 trials of its vaccine candidate after a test subject got sick. The testing halt increases to two the number of major COVID-19 vaccine contenders that are on hold owing to possible safety risks, further clouding the picture of when inoculation might bring the coronavirus nightmare to an end.
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Johnson & Johnson joins U.K. pharma AstraZeneca—which has resumed its own vaccine trials abroad, but not in the United States, after one of that company’s own trial participants got sick—in a sort of pandemic inoculation purgatory.
But experts canvassed by The Daily Beast were careful not to panic about the situation. On one hand, the fact that both companies halted trials after a test subject fell ill is a reminder that pharmaceutical safety protocols are working, and should prevent an unsafe vaccine from reaching the public. On the other, with two of the six leading vaccine candidates on hold, there’s growing risk that none of the vaccines will end up being safe and effective any time soon.
“Maybe this will be a wake-up call,” Lawrence Gostin, a Georgetown University global health expert, told The Daily Beast.
Johnson & Johnson began Phase 3 trials for its vaccine candidate, Ad.26.COV2.S, in late September, aiming to enroll as many as 60,000 volunteers at 215 sites in the United States and internationally.
Johnson & Johnson’s vaccine is one of six receiving major funding from Operation Warp Speed, the federal government’s $13-billion vaccine-accelerator.
In a field of vaccines that includes several highly experimental types, Ad.26.COV2.S is a fairly conventional vaccine candidate. It uses a common adenovirus called Ad.26 to transport coronavirus proteins into cells, potentially triggering an immune response.
But it didn’t take long for something to go wrong. “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials … due to an unexplained illness in a study participant,” the company announced Monday.
Johnson & Johnson declined to specify what illness the volunteer came down with. The company also declined to broach whether the volunteer had received Ad.26.COV2.S or a placebo. “We must respect this participant’s privacy,” the company stated. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
AstraZeneca paused its own vaccine trials in the United States and internationally in early September after a female volunteer fell ill with spinal inflammation. The volunteer recovered, however, and trials quickly resumed in the U.K., Brazil, India and South Africa. But testing remains on hold in the U.S. as investigators try to determine for sure whether the illness was related to the vaccine.
“This pause while the adverse event is fully investigated means the science based, data-driven process is working as it should,” a spokesperson for the U.S. Department of Health and Human Services told The Daily Beast of the AstraZeneca pause.
“With our portfolio of vaccine candidates and platforms, Operation Warp Speed has maximized every opportunity for success and the operation is still on track to achieve its goal of delivering a safe and effective vaccine by year’s end,” the spokesperson added.
All the same, the twin trial freezes underscore the difficulty the pharmaceutical industry and its government boosters face in their crash efforts to quickly develop and deploy a coronavirus vaccine. It is also a reminder of the risk a faulty vaccine could pose to the health of potentially millions of people.
For all the recent advancements in vaccine technology, inducing immunity in people still involves injecting them with portions of some genetically-engineered or natural pathogen and hoping that the body responds with antibodies and T-cells—all without also making patients too sick.
And inducing population-wide immunity means injecting tens of millions of people in the United States alone with a vaccine. The risk and uncertainty scale up as the number of vaccinated people increases. “Even very rare safety problems can be magnified when a vaccine is given to a large population,” Gostin pointed out.
“This is why it’s so difficult to fast-track a vaccine,” added Irwin Redlener, the founding director of Columbia University’s National Center for Disaster Preparedness.
Still, the White House has, for months, leaned on the U.S. Food and Drug Administration to approve a vaccine—for emergency use, at least—before the Nov. 3 presidential election. That pressure, and a few suspicious administrative moves by the FDA and the U.S. Centers for Disease Control, undermined the FDA’s reputation in the eyes of health experts and countless everyday Americans.
Seemingly recognizing the hits it was taking to its credibility, the FDA in early October strengthened the rules for approving a vaccine for emergency use. The rules-change all but ensures that the agency won’t clear a vaccine before the election—unless, of course, Trump simply orders the FDA to release a vaccine.
The two recent safety pauses underscore the wisdom of the FDA’s caution. “If we carried on with a vaccine that was unsafe, it could have catastrophic consequences,” Gostin said.
But the pauses in testing also have the effect of reducing the number and variety of vaccines that are likely to complete phase-three trials in coming months. Of the four Operation Warp Speed candidates that are still undergoing testing, the two leading candidates—from Moderna and Pfizer—both rely on unproven “messenger RNA” technology.
There’s never been an mRNA vaccine before. And if the basic tech of this vaccine type proves unworkable and the Johnson & Johnson and AstraZeneca testing freezes continue, Operation Warp Speed will be left supporting just two viable vaccine candidates.
The situation could be worse, of course. “We are lucky to have so many vaccines in the pipeline,” Jeffrey Klausner, a professor of medicine and public health at UCLA who previously worked at the U.S. Centers for Disease Control and Preventions, told The Daily Beast.
But the rapid winnowing of the vaccine field is also a warning to health authorities and millions of Americans who are counting on a safe and effective vaccine to end the pandemic, and soon, Gostin said.
“The world is just simply expecting that we’re going to have a magic bullet and it’s going to pull us out of it—and it’s going to be a vaccine,” he said. “That’s by no means a foregone conclusion.”
