The Booster-Shot debate was a public health debacle


Ait doesn’t last long, the recall debate is over. Wednesday, the FDA authorized Moderna and Johnson & Johnson COVID-19 vaccine boosters as well as the “mix and match” approach for booster injections. Yesterday an advisory committee of the CDC sanctioned this authorization and CDC director Rochelle Walensky endorsed it. With a green light for all vaccines from both agencies, the recall plan first announced by the Biden administration in August can finally be rolled out in full.

In its wake, it will leave behind a trail of chaos. Since that announcement, the three agencies leading the United States’ response to the coronavirus pandemic – the FDA, the CDC, and the Department of Health and Human Services – have, at best, operated independently of each other. . At worst, they have been drawn into a horrific open war. These fractures in the U.S. public health system have not only deepened public confusion and mistrust of health officials, but have also shown the country’s mismanagement of its extra doses on the global stage amid an international crisis. growing inequality of vaccines. In short, the past two months have been a health messaging nightmare with an abysmal lens.

“The whole recall discussion was in the public eye,” Monica Gandhi, professor of medicine at UC San Francisco and associate division chief at San Francisco General Hospital, told me. “It turned out that we were not a ‘whole’ country in terms of our health recommendations.” Without clear guidelines, some Americans have started to “take matters into their own hands” by getting reminders before being cleared or by mixing and matching vaccines themselves, Leana Wen, emergency physician and professor told me. of Public Health at George Washington University.

Managing public health messages in real time is not easy, especially when science is changing rapidly. But it has become painfully obvious that a system in which three separate agencies do it at once doesn’t work, and Americans suffer.

Ethe experts have publicly debated since at least February whether the boosters are necessary or ethical, given the limited data on the decline in immunity and the large number of people around the world who have not yet received a first dose. The debate was far from resolved on August 18, when the Biden administration announcement that it would offer boosters to the general public from September 20, confirming its decision with data from the CDC released the same day.

The short delay put enormous pressure on the FDA to authorize the boosters and on the CDC to recommend them. The heads of the two agencies warned the White House that they would likely be unable to gather and review the evidence quickly enough for a mid-September deployment. Many scientists reluctant to the sudden White House decision, noting that the Pfizer booster had not been approved by the FDA and Moderna had not even sought approval for its booster. (Johnson & Johnson recall data would not be released for another week.) The World Health Organization condemned the plan as a narrow and nationalistic goal.

Things quickly escalated. At the end of August, two senior FDA officials announced that they would be leaving the agency. A few days later, they posted a review in The Lancet concluding that there was no evidence to recommend recalls for the general population – an unusually public display of dissent. “This is exactly how they look like they’re not on the same page [as an agency]said Gandhi (who occasionally contributes to Atlantic).

The FDA and CDC advisory group meetings that followed – incredibly dense discussions that lasted several hours and broadcast live – were at times tumultuous. September 22, after an FDA advisory group meeting marked by frustration, the Pfizer boosters approved by the agency, but only for the elderly, adults at high risk of serious illness and people whose work puts them at risk. The ensuing CDC advisory committee voted to recommend recalls for the same groups except high-risk workers – a move Walensky unexpectedly made canceled late at night.

The impacts of this public discord have reverberated in the United States and beyond its borders. The main one is widespread confusion. In the aftermath of Pfizer’s clearance, doctors and patients struggled to interpret Walensky’s orderbecause it was not clear which jobs were considered high risk. Keep in mind that this ruling only applied to people who received the Pfizer vaccine, leaving those who received Moderna or Johnson & Johnson in the dark.

Until today, anyone trying to find out if they could or should receive a booster has struggled. Who can blame them? Each of the three vaccines has different regulations determined by three separate government agencies that issue their guidelines independently of each other, with subtle variations that the public does not always understand. How many Americans actually know that in order to allow the booster doses requested by President Joe Biden, the FDA must first convene an independent advisory committee, which votes on a recommendation that will then be taken into account in a final decision of the FDA, and that the policy cannot be implemented until the CDC independently conducts a similar process and issues a final recommendation? Yes, these agencies carry the burden of decisions that have life and death consequences, but even with that in mind, bureaucracy turns heads, including for those of us who write about public health to win. their life.

The transparency of government agencies is noble and justified. At the same time, for health communication to be effective, it must be simple and understandable. Too much information – and not enough advice on how to understand it – causes confusion that “leads to mistrust of health authorities and undermines the public health response,” according to the WHO.

The United States cannot afford more mistrust. But that’s exactly what happened when mismanaged messages on reminders “served to terrify those vaccinated and make eligible unvaccinated adults doubt the effectiveness of vaccines,” as Gandhi put it. Twitter. The latter group is of particular concern because the vaccination of its members is crucial to end the pandemic. According to a Kaiser Family Foundation Survey As of mid-September, 71% of unvaccinated people said the reminder conversation was a sign the vaccines were not working. Only 24% of unvaccinated people found the information they saw on boosters useful, while 45% found it confusing. The anti-vaccine mob “went wild,” Gandhi told me.

To be clear, scientists at the FDA and CDC are to be commended for collecting and reviewing the recall data under intense pressure. Not only were they rushing to meet the schedule, but they also had to get the exact science: after the research-based ideas touted at the start of the pandemic later backfired, like treating COVID with COVID. hydroxychloroquine or the antibiotic azithromycin– understandably officials were reluctant to make sweeping vaccine proclamations. Offering COVID booster shots and mixing and matching vaccine brands were mostly biological assumptions – good ideas backed by solid scientific reasoning – until validated with real data and clinical experience. “What the pandemic has shown is that a lot of good hypotheses end up not working the way we expect when we put them through vigorous research trials,” Panagis Galiatsatos, assistant professor of medicine at Johns Hopkins University. Ultimately, the FDA review led him to to reject the Biden administration’s assumption that everyone should receive a Pfizer booster.

All of these infighting happened as the rest of the world grappled with a growing crisis of vaccine inequalities. The President of Namibia called him “pity”That some countries could deploy booster shots while others had not received their first doses. A South African-based biologist said it was “criminal. “WHO still does not support boosters.

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

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

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