The Booster-Shot Debate Was a Debacle

Posted by on October 22, 2021 8:00 am
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At long last, the booster-shot debate has come to an end. On Wednesday, the FDA authorized boosters of the Moderna and Johnson & Johnson COVID-19 vaccines as well as the “mix and match” approach to booster shots. Yesterday, a CDC advisory panel sanctioned that authorization and CDC Director Rochelle Walensky endorsed it. With a green light for all vaccines from both agencies, the booster plan first announced by the Biden administration in August can finally roll out in full.

In its wake, it will leave behind a trail of chaos. Since that announcement, the three agencies spearheading the United States’s response to the coronavirus pandemic—the FDA, the CDC, and the Department of Health and Human Services—have, at best, operated independently of one another. At worst, they have been embroiled in ugly open warfare. These fractures in the American public-health system not only deepened public confusion and mistrust in health authorities but also displayed the country’s mismanagement of its extra doses on the global stage in the midst of a mounting international vaccine-inequity crisis. In short, the past two months have been a health-messaging nightmare with abysmal optics.

“The entire booster discussion played out in the public eye,” Monica Gandhi, a professor of medicine at UC San Francisco and an associate division chief at San Francisco General Hospital, told me. “It played out that we weren’t a ‘together’ country in terms of our health recommendations.” Without clear guidance, some Americans started “taking matters into their own hands” by getting boosters before they were authorized or mixing and matching vaccines on their own, Leana Wen, an emergency physician and public-health professor at George Washington University, told me.

[Read: A better name for booster shots]

Managing public-health messaging in real time isn’t easy, especially when the science is changing quickly. But it’s become painfully evident that a system in which three separate agencies do so at once is not working, and Americans are suffering for it.

Experts have publicly debated since at least February whether boosters are necessary or ethical, given the limited data on waning immunity and the large number of people worldwide who have yet to receive a first dose. The debate was far from resolved on August 18, when the Biden administration announced that it would offer boosters to the general public beginning September 20, bolstering its decision with CDC data released the same day.

The short timeline put immense pressure on the FDA to authorize boosters and on the CDC to recommend them. The heads of both agencies warned the White House that they would likely be unable to gather and review the evidence quickly enough for a mid-September rollout. Many scientists balked at the White House’s sudden decision, noting that the Pfizer booster hadn’t been approved by the FDA and that Moderna hadn’t even applied for approval of its booster. (Johnson & Johnson’s booster data wouldn’t be released for another week.) The World Health Organization condemned the plan as a narrow and nationalistic goal.

Things degenerated quickly. At the end of August, two top FDA officials announced that they would be leaving the agency. Days later, they published a review in The Lancet concluding that there was no evidence for recommending boosters for the general population—an unusually public display of dissent. “This is exactly how to look like they’re not on the same page [as an agency],” said Gandhi (who occasionally contributes to The Atlantic).

The FDA and CDC advisory-panel meetings that ensued—bewilderingly dense discussions that were several hours long and live-streamed—were sometimes tumultuous. On September 22, after an FDA advisory-panel meeting marked by frustration, the agency authorized Pfizer boosters, but only for elderly people, adults at high risk for severe disease, and people whose jobs put them at risk. The CDC advisory panel that followed voted to recommend boosters for the same groups except high-risk workers—a decision that Walensky unexpectedly overruled late that night.

The impacts of this public discord have rippled through the U.S. and beyond its borders. Chief among them is widespread confusion. In the aftermath of the Pfizer authorization, doctors and patients alike struggled to interpret Walensky’s order, because it was unclear which jobs qualified as high-risk. Bear in mind that this ruling applied only to people who had received the Pfizer vaccine, leaving in the dark those who had gotten Moderna or Johnson & Johnson.

[Read: Should you mix and match your booster shot?]

Until today, anyone trying to figure out whether they could or should get a booster shot has had a hard time. Who can blame them? Each of the three vaccines has different regulations determined by three separate government agencies that release their guidance independently of one another, with subtle variations that the public does not always understand. How many Americans actually know that, in order to authorize the booster doses that President Joe Biden called for, the FDA must first bring together an independent advisory panel, which votes on a recommendation that’s later taken into account in a final FDA ruling, and that the policy can’t be implemented until the CDC independently carries out a similar process and releases a final recommendation? Yes, these agencies bear the burden of decisions that carry life-and-death consequences, but even accounting for that, the bureaucracy is head-spinning—including to those of us who write about public health for a living.

Transparency from government agencies is noble and warranted. At the same time, for health communication to be effective, it must be straightforward and understandable. Too much information—and not enough guidance on how to make sense of it—causes confusion that “leads to mistrust in health authorities and undermines the public health response,” according to the WHO.

[Read: You might want to wait to get a booster shot]

The U.S. can’t afford more mistrust. But that’s exactly what developed when mismanaged messaging about boosters “served to terrify the vaccinated and make unvaccinated eligible adults doubt the effectiveness of the vaccines,” as Gandhi put it on Twitter. The latter group is of particular concern because vaccinating its members is crucial for ending the pandemic. According to a Kaiser Family Foundation poll from mid-September, 71 percent of unvaccinated people said the booster conversation was a sign that the vaccines weren’t working. Just 24 percent of unvaccinated people found the information they had seen about boosters helpful, while 45 percent found it confusing. The anti-vaccine crowd “went wild,” Gandhi told me.

To be clear, the FDA and CDC scientists should be commended for gathering and reviewing the booster data under intense pressure. Not only were they rushing to stay on schedule, but they also needed to get the science exactly right: After research-based ideas touted in the early days of the pandemic later backfired—such as treating COVID with hydroxychloroquine or the antibiotic azithromycin—it’s understandable that officials were hesitant to make sweeping proclamations about vaccines. Offering COVID booster shots and mixing and matching vaccine brands were mostly biological hypotheses—good ideas backed by sound scientific reasoning—until they were validated with real-life data and clinical experience. “What the pandemic has shown is that a lot of good hypotheses end up not working out the way we expect them to when we put them through vigorous research trials,” Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins University, told me. Ultimately, the FDA’s review led it to reject the Biden administration’s hypothesis that everyone should get a Pfizer booster.

All of this infighting happened while the rest of the world grappled with a mounting vaccine-inequity crisis. The president of Namibia called it a “pity” that some countries could roll out boosters while others hadn’t received their first doses. One South Africa–based biologist said it was “criminal.” The WHO still doesn’t support boosters.

During this pandemic and in the face of health crises to come, these arms of the U.S. government must come up with a way to present a more unified message to the public. In an ideal world, they would collaborate on and publish guidance jointly. At the bare minimum, they would find a way to agree on what the message actually is before the president uses it as the foundation for a new national policy.

It’s been a baffling and exhausting few months, but the worst is over. “At least it’s done,” Gandhi said, “and that makes me happy.”

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