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The month-long process leading to final interim guidance from the U.S Centers for Disease Control and Prevention (CDC), following an authorization of Pfizer (PFE)/BioNTech's (BNTX) COVID-19 vaccine booster shot has left some experts feeling queasy.
"If you were paying attention to the play-by-play, it's somewhat nauseating. It just feels weird and terrible," said Dr. Aaron Carroll, a professor of pediatrics at the University of Indiana.
Starting in August when President Joe Biden announced all eligible adults would soon be able to receive a COVID-19 booster, followed by the White House COVID-19 Response Team announcing a September 20 start date, a debate over the need for boosters, and who should be eligible, began in the scientific community.
At first, the projection was that boosters would be needed eight months after the initial course of two doses (which matched Moderna's (MRNA) data), then reduced to six and then five months (mirroring Pfizer's data). But it was unclear at the time where the projections were coming from and why they kept changing.
Then, an advisory panel to the U.S. Food and Drug Administration (FDA) voted last week to recommend a narrower set of adults to be eligible for the booster doses, which derailed Pfizer's supplemental filing for its fully-approved vaccine and Biden's plans.
Instead, the FDA issued an emergency use authorization (EUA) and followed the guidance of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). That included boosters for 65 and older and those of all ages at high risk, including those who face a risk of severe COVID-19 due to their occupation or institutional settings.
Here's why: The FDA's authorization, while it considered those highest at risk like teachers and health care workers, and individuals in prisons and homeless shelters, did not consider the impact of staffing shortages at health care settings — where COVID-19 cases have surged— causing many experts to lament the move was "tone-deaf."
The ACIP did not feel that overall infection was necessary, and would be a rare break from the FDA. The policy was defeated, with the idea that the language could be clarified and voted on again at an upcoming meeting.
In addition, another policy caused concern: Allowing adults 18-49 to get a booster based on their own risk and underlying conditions. The self-attestation created concerns that the CDC would be relying on a high level of health literacy among Americans in that category.
Panel member Dr. Pablo Sanchez expressed he was struggling and hesitated for a long moment before casting his "No" vote on the the policy.
"I'm really torn," he said, followed by an uncomfortable chuckle.
But in the wee hours of Friday morning, CDC director Dr. Rochelle Walensky went against her own panel and approved the policy for health care workers.
All of this has lead to confusing messages for the broader health and scientific community.
Only one thing became clearer in comparison to the FDA's authorization: there would be no way to verify what "underlying conditions" a person may have when going for a booster shot. That's because more than 70% of the vaccinations in the U.S. are occurring in pharmacies, according to the CDC.
And despite no guidance on Johnson & Johnson (J&J) and Moderna vaccine recipients, some have already chosen to get their boosters, while others are awaiting the data.
The ACIP discussions touched on mixing and matching of booster doses, already a practice in Europe, but the FDA and CDC have said there is not enough data available yet. Some members pointed out the irony that there were complaints of not enough data to make an evidence-based decision on boosters. A point the FDA's Dr. Dorian Fink conceded at the ACIP meeting Thursday.
Dr. Taison Bell, critical care and infectious disease physician at UVA Health, said nothing from the White House, FDA and now ACIP regarding boosters has been consistent.
"At every phase along the way, there's been a different recommendation," Bell told Yahoo Finance.
Dr. Eric Topol, founder and director of the Scripps Research Translational Institute, shared a timeline depicting the confusion.
He added, "You'd have to work really hard to mess this up this badly and engender this much confusion."
Carroll noted that the confusion also stems from few people previously paying attention to the pathways of vaccine approvals, and the system is not made for the quick responses needed in a pandemic.
"If you demand a certain level of data, you will always be crushed by a pandemic," he said.
But the oddity of the whole situation is also different, especially in the debate over mixing and matching doses.
"It's not as if each year we authorize a specific brand of the flu shot," Carroll said.
He noted that overall trying to prevent infections with boosters wasn't the right public health policy, but it made sense in the context of health care workers.
UVA's Bell applauded Walensky's move, saying that "its a difficult day to get through" when a handful of nurses or clinicians call out due to the severity of staffing shortages.
Boosters for all, he said, is the only way to protect health care workers in winter months when a potential surge could “paralyze hospital systems.”
Follow Anjalee on Twitter @AnjKhem