With the coronavirus vaccine hurtling toward its public debut as early as late fall, the United States is about to enter a new and precarious phase of the pandemic response. Regardless of when a vaccine becomes available, the rollout is almost destined to be messy for logistical reasons, as public-health officials must ready a massive campaign to convince 330 million citizens to take it. But after months of misinformation and disingenuous optimism from the White House — underlined by revelations that President Trump knew all along that the coronavirus is deadly — will anyone trust the administration’s assurances about the new vaccine’s safety?
There are already clear signs that the public is suspicious about the rigor with which a vaccine will have been assessed before its release, and experts are increasingly concerned that conflicting information about who should be immunized, and when, will further erode public confidence. A recent CBS News poll indicated that only 21 percent of Americans would be inclined to take a COVID-19 vaccine as soon as possible, while 62 percent expressed concern that the Trump administration is pressuring the Food and Drug Administration to relax safety and efficacy standards to rush out a vaccine, according to a survey conducted by the Kaiser Family Foundation.
This public distrust has likely been fueled by continued hints from the president that a vaccine might be available before Election Day — a timeline most experts believe is unfeasible without a short circuit of the normal vetting process. That could include authorizing a vaccine before Phase 3 clinical trials are complete or marginalizing the input of the FDA’s independent vaccine advisory committee. While the Centers for Disease Control and Prevention recently notified state and local health officials to be prepared to distribute potential vaccines as soon as late October, as the New York Times reported, many public-health experts are skeptical about what even the CDC has labeled a “hypothetical” scenario. “It would be surprising if we had statistically robust evidence for this vaccine working by the end of October,” says Paul Offit, a vaccine expert at the University of Pennsylvania School of Medicine and a member of the FDA advisory panel.
In a 1976 episode illustrating the dangers of a rushed vaccine, a Gallup poll reported that only 52 percent of Americans intended to get a hastily prepared swine-flu vaccine, and the government’s immunization program was suspended within months of its launch because of rare side effects perceived to be associated with the shot.
Today’s resistance isn’t even limited to anti-vaxxers or laypeople worrying about side effects. The concern is so great that some clinicians are already talking about not administering a vaccine when it becomes available if they believe the approval process was rushed. That friction is what led nine pharmaceutical companies involved in the vaccine race to make a rare public pledge last week not to cut corners.
Of course, beyond the question of when a vaccine will be released is the question of who will get it first. In July, the National Academies of Sciences, Engineering, and Medicine announced the formation of a new expert panel to make recommendations on a scheme for rolling out a COVID-19 vaccine with an initially limited supply. In the midst of a viral invasion that has claimed nearly 192,000 American lives, cost trillions of dollars, and wagered billions more in taxpayers’ money on a corporate horse race to produce a vaccine, the announcement of this panel should have been welcome news. The problem, however, was that a separate group, the Advisory Committee on Immunization Practices (ACIP), already exists and has advised the CDC on vaccine usage in the U.S. since 1964.
Overlapping recommendations from two obscure panels may seem like a bureaucratic footnote to a historic national calamity. But the redundancy is emblematic of how, six months into the pandemic, the federal government manages, almost effortlessly, to sow confusion and undermine faith in public-health institutions at every turn.
Normally, the FDA is tasked with ensuring vaccines are safe and effective prior to licensure, and it also has the option to allow one to be distributed under an Emergency Use Authorization. The CDC then publishes guidelines for who should get that vaccine, usually following the recommendations of ACIP, whose membership is appointed by the Department of Health and Human Services. But the National Academies assembled its panel in response to a request from Francis Collins, director of the National Institutes of Health, and Robert Redfield, director of the CDC — both members of the White House Coronavirus Task Force. Redfield’s participation in particular has mystified the infectious-disease community, given that the new panel effectively complicates the processes put in place at his own agency and seemingly diminishes the CDC’s independence. Another potential worry is that the Washington-based panel might become one more target in a larger campaign of politicization. “This administration has been willing to throw science-based federal agencies under the bus, whether it’s EPA, the National Weather Service, now the FDA,” says Offit, “or to at least exert pressure on them to do things the administration wants, even if it goes against the science.”
The National Academies’ draft allocation plan was released early this month and, despite the fears, has won praise in initial reviews. It envisions four phases. A “jump-start” (Phase 1a) would give priority to high-risk workers in health-care facilities and first responders. Phase 1b would include people with co-morbid conditions that put them at significantly higher risk and older adults living in congregate settings such as nursing homes. Phase 2 would add workers in industries that are “essential to the functioning of society,” along with teachers, school staff, people at “moderately higher risk,” incarcerated people, and those living in homeless shelters. Phase 3 would include children, young adults, and other workers in essential industries. Phase 4 would cover “everyone residing in the United States’’ who had not previously received the vaccine.
Yet six days before the National Academies’ plan came out, the CDC had already sent a planning document to public-health officials identifying its own prioritized populations, and both plans are beset by uncertainty. The National Academies outlined a scenario based on doses for 10 million to 15 million people; the CDC’s “hypothetical” scenarios envisioned 1 million to 3 million doses by the end of October, 10 to 30 million doses by the end of November, and 15 million to 45 million doses by the end of the year.
And the sheer logistics of vaccine distribution will be daunting. The Pfizer vaccine in advanced trials, for example, would need to be stored at minus-70 degrees Celsius prior to use. Only large, primarily academic medical centers and health departments have freezers with that capacity, effectively ruling out traditional vaccination sites like pharmacies and doctors’ offices. “This is a very complicated vaccine program,” says Luciana Borio, former acting chief scientist at the FDA. “You have multiple vaccines, different technologies, staggered availability, uncertainties. That on top of vaccine hesitancy. It’s going to be very messy.”
That mess would be complicated by the perception of corner-cutting. The FDA has already come under criticism for issuing Emergency Use Authorizations for controversial treatments like hydroxychloroquine and convalescent plasma; an EUA for a COVID-19 vaccine would be met with considerable skepticism. “If a decision were made to use the vaccine that short-circuited the FDA’s advisory committee,” says William Schaffner, an infectious-disease expert at Vanderbilt University School of Medicine, “you would lose much of the support of the clinical community and the public-health community. There would be prominent people who would stand up and say, ‘Wait a minute. We’re going to wait because you haven’t gone through the right process.’ ”
Offit also raises an unexpected worst-case scenario in addition to those that the public and health officials have been mulling: “To me, the irony — the ultimate irony — would be if a vaccine works and then Donald Trump stands up and oversells it, as he oversells everything, and people don’t want to get it because they don’t trust him, because he’s not trustworthy.”
*This article appears in the September 14, 2020, issue of New York Magazine. Subscribe Now!